CQC agreement for HES, MHSDS, MSDS, CSDS and ECDS and associated datasets

Care Quality Commission (CQC) is requesting data that is critical to its regulatory oversight of health and care providers. CQC’s remit is to make sure health and adult social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve.

Access to these data help to ensure CQC can make use of its wide set of powers to protect people who use regulated services from harm and the risk of harm, and to ensure they receive health and social care services of an appropriate standard. These powers also hold registered providers and managers to account for failures in how the service is provided. CQC's enforcement policy sets out CQC's approach to taking action where CQC identify poor care, or where registered providers and managers do not meet the standards required in the regulations.

In CQC's monitoring role, it prioritises the care and welfare of patients. People who use services should experience effective, safe and appropriate care, treatment and support that meets their needs and protects their rights.

CQC uses these data to help determine five core questions about services:

- Are they safe?

- Are they effective?

- Are they caring?

- Are they well-led?

- Are they responsive to people’s needs?

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC)

> HES Outpatients (OP)

> HES Critical Care (CC)

> HES Accident and Emergency (A&E) and Emergency Care Data Set (ECDS)

> Mental Health Services Data Set (MHSDS) and Mental Health and Learning Disabilities Dataset (MHLDDS)

> Community Services Data Set (CSDS)

> Maternity Services Data Set (MSDS)

> Civil Registration of Deaths

CQC use these data to;

(i) populate indicators within their Data & Insight Unit products and associated dashboards, to support prioritisation of regulatory activity (including inspections)

(ii) to inform judgements about the level of quality in services within CQCs Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation

(iii) support CQC's statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act

(iv) Use in thematic reviews and national reporting; for example, the Annual State of Care report and

(v) to support the development and implementation of CQC’s new remit to assess ICSs and Local Authorities (with respect to health and care responsibilities).

The level of data will be:

> Identifiable

Local patient identifier is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. Local patient identifier is used as the Token Person ID is not known to the trust. With this exception, no record level data is released to third parties.

The patient's postcode is used for assigning data to new Local Authority /Integrated Care Systems boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

The Health and Social Care Act 2008 imposes notifications requirements for NHS bodies, which are managed and processed by CQC, which has a duty under the Mental Health Act 1983 (MHA) to monitor how services exercise their powers and discharge their duties when patients are detained in hospital, subject to community treatment orders or guardianship.

Among these are

• Reg 16: Death of a person who uses the service

• Reg 17: Deaths of people detained or liable to be detained under the Mental Health Act

The availability of Date of Death allows CQC to verify whether the team have received all death notifications from a provider for a period. Indicators will be related to absence of notification, or its completeness.

• Reg 18: Other incidents: Admission of a child or young person to an adult psychiatric ward or unit

Date of Birth allows CQC to know whether a child or young person was admitted to an adult ward and produce an indicator. It will also inform analysis of interventions related to age.

CQC's use of identifying data is subject to CQC's statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’) clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions

The Data will be minimised as follows:

> Data required to cover activity within the whole of England.

> The data subjects will cover all individuals who have undergone treatment in these pathways.

> Limited to data between 2014/15 to latest available. Monthly latest available extracts are required to ensure CQC have access to the most up-to-date data for ongoing analyses and oversight. This is particularly important in understanding an organisation's most recent performance. Historic data from 2014/15 is required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

For record-level data, CQC will process these data lawfully under UK GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 under which CQC was formed and has a duty of confidentiality under enactment set out in sections 76 and 77.

As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) – processing is necessary for reasons of public interest in the area of public health in that CQC’s remit is to make sure that health and adult social care services provide people with safe, effective, compassionate, high-quality care. As per the Information Commissioner’s Officer (ICO) guidance; if an organisation is relying on Article 9(2)(i), they also need to meet the associated condition in UK law, set out in Part 1 of Schedule 1 of the DPA 2018.

For Public health, this condition is met if the processing is necessary for reasons of public interest in the area of public health (as illustrated above). This condition is also met if the processing is carried out by another person who in the circumstances owes a duty of confidentiality under an enactment or rule of law, and CQC has a duty of confidentiality under the enactment set out in sections 76 and 77.

CQC's statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS England (previously NHS Digital/Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, a Data Protection Impact Assessment has been reviewed and completed by CQC.

Microsoft Limited is a processor acting under the instructions of CQC. Microsoft Limited role is limited to cloud storage (Microsoft Azure).

Data will be accessed by:

• Substantive employees of CQC

• Non-substantive employees (Contractors)

CQC must maintain records in a single location that cover the following details of each individual given access under a contract:

o Their substantive employer;

o Their role in respect of the purpose for the processing specified in the DSA;

o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the contract holder.

The expected outputs of the processing will be:

> Insight products (which includes a range of dashboards and outputs that support monitoring and judgement), including outputs that are shared with providers. These products use aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes. As the new CQC Data & Insight Unit takes shape, additional dashboards and early alerts are expected to become available for inspectors.

> Outliers Programme: analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on 'Perinatal mortality and neonatal readmissions' used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Telstra - investigated death rates for endoscopic procedures. On the latter, CQC review their own available NHS England data to make a decision on the highlighted risk with reference to local intelligence known about the trust. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. The impact of COVID led to CQC suspending its mortality outlier processes, but its approach to monitoring mortality will be reviewed over the next 12 months.

> Thematic reviews: used internally to inform CQC’s regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS England's HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

> In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England.

The creation of CQC’s new Data & Insight Unit has started to embed and improve on its previous insight programme and associated dashboards. Core data from this data sharing agreement were used in the production of indicators that align to CQC’s key lines of enquiry for a particular sector (e.g., hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used to inform planning regulatory activity (including to inform inspection planning decisions). The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in Insight products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted, and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

CQC has made extensive use of NHS England data within its insight pre-inspection activity within the hospital/ Mental Health sectors. The core NHS Englnad data acts to highlight any particular concerns (or good practice) that would then be followed up between an inspector and a given organisation or used to determine where an inspection might be focused. The reports provide trust-level indicators and national comparisons from the most readily available data and so allow the inspection team to hone in on particular areas of interest. Where this has been necessary, an inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality-of-care provision and examples of good practice that other organisations could adopt. The NHS England data are therefore critical in this process for driving up the quality-of-care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS England featured in the 2020/21 State of Care report. This year, it highlighted the impact of the pandemic as part of its design to provide a high-level commentary on year-on-year changes to care provision within England.

Over 2021/22 CQC issued 100 letters of intent to Hospital services across England where CQC identified poor care or where the standards of registration were not being met. However, these levels were likely to be lower than for other years, as this period covers the pandemic during which CQC reduced the number of inspections to a minimum level across Hospital services.

CQC continues to monitor a suite of indicators covering secondary health acute services.

In addition, CQC has a suite of indicators relating to safety and quality in mental health services for which it uses the Mental health services dataset.

CQC is also developing analytical methodologies to present data at core service level for Mental health services.

Core services are the unit of rating for CQC's assessments of mental health services, and our objective is to present more granular analysis from MHSDS (and other sources) mapped to these services.

Thematic reviews provide in-depth analyses of chosen topics to inform CQC staff, clinicians and the public about that service/area of care while also highlighting areas for improvement/best practice; working with inspector colleagues, themed inspections allow CQC to develop recommendations for making improvements in the delivery of care. These recommendations are then incorporated into future inspections to encourage continual improvement. ‘Restraint, segregation, and seclusion’, ‘Do not attempt CPR decisions’, and ‘Provider collaboration’ are examples of recent thematic data reviews/themed inspections that helped/ are helping to raise specific questions on the monitoring and provision of care in these areas with a focus on future improvement.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS England's HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2020/21 publication appeared in February 2022.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of health and care providers. CQC’s remit is to make sure health and adult social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. Its role will be expanded to encompass an assessment of quality for Integrated Care Systems (ICSs) and assurance of Local Authorities – in relation to their respected roles for health and adult social care. Its regulatory model is underpinned by a Data & Insight programme that draws together indicators of quality and risk about services. The data directly influence the risk and benchmarking models used to prioritise regulatory activity and inform its judgements of quality in services. The datasets also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act and to deliver national reports to parliament. Processing these data allow CQC to meet this public benefit.

Access to these data help to ensure CQC can make use of its wide set of powers to protect people who use regulated services from harm and the risk of harm, and to ensure they receive health and social care services of an appropriate standard. These powers also hold registered providers and managers to account for failures in how the service is provided. CQC's enforcement policy sets out CQC's approach to taking action where CQC identify poor care, or where registered providers and managers do not meet the standards required in the regulations. The level of enforcement is dependent on many factors but start at a requirement notice (stipulating a timeframe within which a given improvement must take place) for a less serious breach up to the possible cancellation of services in extreme cases.

For record-level data, CQC will process these data lawfully under UK GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 under which CQC was formed and has a duty of confidentiality under enactment set out in sections 76 and 77. As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) – processing is necessary for reasons of public interest in the area of public health in that CQC’s remit is to make sure that health and adult social care services provide people with safe, effective, compassionate, high-quality care. As per the Information Commissioner’s Officer (ICO) guidance; if an organisation is relying on Article 9(2)(i), they also need to meet the associated condition in UK law, set out in Part 1 of Schedule 1 of the DPA 2018. For Public health, this condition is met if the processing is necessary for reasons of public interest in the area of public health (as illustrated above). This condition is also met if the processing is carried out by another person who in the circumstances owes a duty of confidentiality under an enactment or rule of law, and CQC has a duty of confidentiality under the enactment set out in sections 76 and 77.

CQC's statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS England (previously NHS Digital/Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, a Data Protection Impact Assessment has been reviewed and completed by CQC.

CQC currently has receipt/use of Hospital Episode Statistics (HES) inpatient, outpatient, critical care, and A&E, Mental Health Services Data Set (MHSDS) and the legacy Mental Health and Learning Disabilities Dataset, Community Services Data Set (CSDS), Maternity Services Data Set (MSDS), Emergency Care Data Set (ECDS), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Monthly extracts ensure CQC have access to the most up-to-date data for ongoing analyses and oversight - particularly important in understanding an organisation's most recent performance. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

CQC use these data (i) to populate indicators within their Data & Insight Unit products and associated dashboards, to support prioritisation of regulatory activity (including inspections) and to inform judgements about the level of quality in services (ii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iii) towards CQC's statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; (iv) in thematic reviews and national reporting; for example, the Annual State of Care report and (v) to support the development and implementation of CQC’s new remit to assess ICSs and Local Authorities (with respect to health and care responsibilities).

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: 'postcode' and 'local patient identifier'. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. 'Local patient identifier' is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient's postcode is used for assigning data to new LA/ICS boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continues to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The latest review again focused on requests submitted to the CQC central analytical team. CQC has confirmed that, in the review period, analyses were still conducted on the postcode and local patient identifier fields. In a previous iteration of this agreement (v10) additional MHSDS fields were included in the application. Future analyses using birth date, death date, and unique restrictive intervention incident ID from the MHSDS data set will support work related to mortality and for monitoring Use Of Force Act 2018. Unique restrictive intervention incident ID has been requested to facilitate monitoring of restrictive interventions. The Mental Health Units (Use of Force) Act 2018 CHAPTER 27 makes provision about the oversight and management of the appropriate use of force in relation to people in mental health units; to make provision about the use of body cameras by police officers in the course of duties in relation to people in mental health units; and for connected purposes. CQC's statutory powers under s9(a) allow it to require information about restrictive interventions for the purposes of investigation of deaths and serious injury.

The Health and Social Care Act 2008 imposes notifications requirements for NHS bodies, which are managed and processed by CQC, which has a duty under the Mental Health Act 1983 (MHA) to monitor how services exercise their powers and discharge their duties when patients are detained in hospital, subject to community treatment orders or guardianship.

Among these are

• Reg 16: Death of a person who uses the service

• Reg 17: Deaths of people detained or liable to be detained under the Mental Health Act

The availability of Date of Death allows us to verify whether the team have received all death notifications from a provider for a period. Indicators will be related to absence of notification, or its completeness.

• Reg 18: Other incidents: Admission of a child or young person to an adult psychiatric ward or unit

Date of Birth allows us to know whether a child or young person was admitted to an adult ward and produce an indicator. It will also inform analysis of interventions related to age.

CQC's use of identifying data is subject to CQC's statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’) clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this Agreement meets this requirement.

CQC is the sole data controller and also processes the data. Now held on Microsoft Azure’s cloud environment, the NHS England data will only be accessed by CQC substantive employees and non-substantive employees (contractors). Where CQC used non-substantive employees (contractors), CQC would insist on confidentiality clauses within contracts and oblige individuals to complete in-house training on data protection and confidentiality. The local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section.

On-going produced outputs include:

-incorporates data indicators that align to CQC's assessment framework for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Over the course of the Covid pandemic lockdown, CQC took the decision that it would desist from on-site inspection unless the matter was a threat to life. The emphasis shifted to monitoring the NHS England data and other sources, including concerns from the public. With excessive mortality rates through Covid, some of the key indicators below were suspended; for example, mortality outliers. The outputs listed below therefore contain what CQC anticipate (and have experienced) outside of lockdown.

Insight products (which includes a range of dashboards and outputs that support monitoring and judgement), including outputs that are shared with providers. These products use aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes. As the new CQC Data & Insight Unit takes shape over the next twelve months, additional dashboards and early alerts are expected to become available for inspectors.

Outliers Programme: analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on 'Perinatal mortality and neonatal readmissions' used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Telstra - investigated death rates for endoscopic procedures. On the latter, CQC review their own available NHS England data to make a decision on the highlighted risk with reference to local intelligence known about the trust. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. The impact of COVID led to CQC suspending its mortality outlier processes, but its approach to monitoring mortality will be reviewed over the next 12 months.

Thematic reviews: used internally to inform CQC’s regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS England's HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

The creation of CQC’s new Data & Insight Unit has started to embed and improve on its previous insight programme and associated dashboards. Core data from this data sharing agreement were used in the production of indicators that align to CQC’s key lines of enquiry for a particular sector (e.g., hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used to inform planning regulatory activity (including to inform inspection planning decisions). The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in Insight products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted, and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

CQC has made extensive use of NHS England data within its insight pre-inspection activity within the hospital/ Mental Health sectors. The core NHS Englnad data acts to highlight any particular concerns (or good practice) that would then be followed up between an inspector and a given organisation or used to determine where an inspection might be focused. The reports provide trust-level indicators and national comparisons from the most readily available data and so allow the inspection team to hone in on particular areas of interest. Where this has been necessary, an inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality-of-care provision and examples of good practice that other organisations could adopt. The NHS England data are therefore critical in this process for driving up the quality-of-care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS England featured in the 2020/21 State of Care report. This year, it highlighted the impact of the pandemic as part of its design to provide a high-level commentary on year-on-year changes to care provision within England.

Over 2021/22 CQC issued 100 letters of intent to Hospital services across England where CQC identified poor care or where the standards of registration were not being met. However, these levels were likely to be lower than for other years, as this period covers the pandemic during which CQC reduced the number of inspections to a minimum level across Hospital services.

CQC continues to monitor a suite of indicators covering secondary health acute services.

In addition, CQC has a suite of indicators relating to safety and quality in mental health services for which it uses the Mental health services dataset.

CQC is also developing analytical methodologies to present data at core service level for Mental health services.

Core services are the unit of rating for CQC's assessments of mental health services, and our objective is to present more granular analysis from MHSDS (and other sources) mapped to these services.

Thematic reviews provide in-depth analyses of chosen topics to inform CQC staff, clinicians and the public about that service/area of care while also highlighting areas for improvement/best practice; working with inspector colleagues, themed inspections allow CQC to develop recommendations for making improvements in the delivery of care. These recommendations are then incorporated into future inspections to encourage continual improvement. ‘Restraint, segregation, and seclusion’, ‘Do not attempt CPR decisions’, and ‘Provider collaboration’ are examples of recent thematic data reviews/themed inspections that helped/ are helping to raise specific questions on the monitoring and provision of care in these areas with a focus on future improvement.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS England's HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2020/21 publication appeared in February 2022.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of health and care providers. CQC’s remit is to make sure health and adult social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. Its role will be expanded to encompass an assessment of quality for Integrated Care Systems (ICSs) and assurance of Local Authorities – in relation to their respected roles for health and adult social care. Its regulatory model is underpinned by a Data & Insight programme that draws together indicators of quality and risk about services. The data directly influence the risk and benchmarking models used to prioritise regulatory activity and inform its judgements of quality in services. The datasets also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act and to deliver national reports to parliament. Processing these data allow CQC to meet this public benefit.

Access to these data help to ensure CQC can make use of its wide set of powers to protect people who use regulated services from harm and the risk of harm, and to ensure they receive health and social care services of an appropriate standard. These powers also hold registered providers and managers to account for failures in how the service is provided. CQC's enforcement policy sets out CQC's approach to taking action where CQC identify poor care, or where registered providers and managers do not meet the standards required in the regulations. The level of enforcement is dependent on many factors but start at a requirement notice (stipulating a timeframe within which a given improvement must take place) for a less serious breach up to the possible cancellation of services in extreme cases.

For record-level data, CQC will process these data lawfully under UK GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 under which CQC was formed and has a duty of confidentiality under enactment set out in sections 76 and 77. As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) – processing is necessary for reasons of public interest in the area of public health in that CQC’s remit is to make sure that health and adult social care services provide people with safe, effective, compassionate, high-quality care. As per the Information Commissioner’s Officer (ICO) guidance; if an organisation is relying on Article 9(2)(i), they also need to meet the associated condition in UK law, set out in Part 1 of Schedule 1 of the DPA 2018. For Public health, this condition is met if the processing is necessary for reasons of public interest in the area of public health (as illustrated above). This condition is also met if the processing is carried out by another person who in the circumstances owes a duty of confidentiality under an enactment or rule of law, and CQC has a duty of confidentiality under the enactment set out in sections 76 and 77.

CQC's statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS England (previously NHS Digital/Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, a Data Protection Impact Assessment has been reviewed and completed by CQC.

CQC currently has receipt/use of Hospital Episode Statistics (HES) inpatient, outpatient, critical care, and A&E, Mental Health Services Data Set (MHSDS) and the legacy Mental Health and Learning Disabilities Dataset, Community Services Data Set (CSDS), Maternity Services Data Set (MSDS), Emergency Care Data Set (ECDS), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Monthly extracts ensure CQC have access to the most up-to-date data for ongoing analyses and oversight - particularly important in understanding an organisation's most recent performance. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

CQC use these data (i) to populate indicators within their Data & Insight Unit products and associated dashboards, to support prioritisation of regulatory activity (including inspections) and to inform judgements about the level of quality in services (ii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iii) towards CQC's statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; (iv) in thematic reviews and national reporting; for example, the Annual State of Care report and (v) to support the development and implementation of CQC’s new remit to assess ICSs and Local Authorities (with respect to health and care responsibilities).

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: 'postcode' and 'local patient identifier'. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. 'Local patient identifier' is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient's postcode is used for assigning data to new LA/ICS boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continues to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The latest review again focused on requests submitted to the CQC central analytical team. CQC has confirmed that, in the review period, analyses were still conducted on the postcode and local patient identifier fields. In a previous iteration of this agreement (v10) additional MHSDS fields were included in the application. Future analyses using birth date, death date, and unique restrictive intervention incident ID from the MHSDS data set will support work related to mortality and for monitoring Use Of Force Act 2018. Unique restrictive intervention incident ID has been requested to facilitate monitoring of restrictive interventions. The Mental Health Units (Use of Force) Act 2018 CHAPTER 27 makes provision about the oversight and management of the appropriate use of force in relation to people in mental health units; to make provision about the use of body cameras by police officers in the course of duties in relation to people in mental health units; and for connected purposes. CQC's statutory powers under s9(a) allow it to require information about restrictive interventions for the purposes of investigation of deaths and serious injury.

The Health and Social Care Act 2008 imposes notifications requirements for NHS bodies, which are managed and processed by CQC, which has a duty under the Mental Health Act 1983 (MHA) to monitor how services exercise their powers and discharge their duties when patients are detained in hospital, subject to community treatment orders or guardianship.

Among these are

• Reg 16: Death of a person who uses the service

• Reg 17: Deaths of people detained or liable to be detained under the Mental Health Act

The availability of Date of Death allows us to verify whether the team have received all death notifications from a provider for a period. Indicators will be related to absence of notification, or its completeness.

• Reg 18: Other incidents: Admission of a child or young person to an adult psychiatric ward or unit

Date of Birth allows us to know whether a child or young person was admitted to an adult ward and produce an indicator. It will also inform analysis of interventions related to age.

CQC's use of identifying data is subject to CQC's statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’) clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this Agreement meets this requirement.

CQC is the sole data controller and also processes the data. Now held on Microsoft Azure’s cloud environment, the NHS England data will only be accessed by CQC substantive employees and non-substantive employees (contractors). Where CQC used non-substantive employees (contractors), CQC would insist on confidentiality clauses within contracts and oblige individuals to complete in-house training on data protection and confidentiality. The local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section.

On-going produced outputs include:

-incorporates data indicators that align to CQC's assessment framework for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Over the course of the Covid pandemic lockdown, CQC took the decision that it would desist from on-site inspection unless the matter was a threat to life. The emphasis shifted to monitoring the NHS England data and other sources, including concerns from the public. With excessive mortality rates through Covid, some of the key indicators below were suspended; for example, mortality outliers. The outputs listed below therefore contain what CQC anticipate (and have experienced) outside of lockdown.

Insight products (which includes a range of dashboards and outputs that support monitoring and judgement), including outputs that are shared with providers. These products use aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes. As the new CQC Data & Insight Unit takes shape over the next twelve months, additional dashboards and early alerts are expected to become available for inspectors.

Outliers Programme: analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on 'Perinatal mortality and neonatal readmissions' used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Telstra - investigated death rates for endoscopic procedures. On the latter, CQC review their own available NHS England data to make a decision on the highlighted risk with reference to local intelligence known about the trust. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. The impact of COVID led to CQC suspending its mortality outlier processes, but its approach to monitoring mortality will be reviewed over the next 12 months.

Thematic reviews: used internally to inform CQC’s regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS England's HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

The creation of CQC’s new Data & Insight Unit has started to embed and improve on its previous insight programme and associated dashboards. Core data from this data sharing agreement were used in the production of indicators that align to CQC’s key lines of enquiry for a particular sector (e.g., hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used to inform planning regulatory activity (including to inform inspection planning decisions). The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in Insight products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted, and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

CQC has made extensive use of NHS England data within its insight pre-inspection activity within the hospital/ Mental Health sectors. The core NHS Englnad data acts to highlight any particular concerns (or good practice) that would then be followed up between an inspector and a given organisation or used to determine where an inspection might be focused. The reports provide trust-level indicators and national comparisons from the most readily available data and so allow the inspection team to hone in on particular areas of interest. Where this has been necessary, an inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality-of-care provision and examples of good practice that other organisations could adopt. The NHS England data are therefore critical in this process for driving up the quality-of-care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS England featured in the 2020/21 State of Care report. This year, it highlighted the impact of the pandemic as part of its design to provide a high-level commentary on year-on-year changes to care provision within England.

Over 2021/22 CQC issued 100 letters of intent to Hospital services across England where CQC identified poor care or where the standards of registration were not being met. However, these levels were likely to be lower than for other years, as this period covers the pandemic during which CQC reduced the number of inspections to a minimum level across Hospital services.

CQC continues to monitor a suite of indicators covering secondary health acute services.

In addition, CQC has a suite of indicators relating to safety and quality in mental health services for which it uses the Mental health services dataset.

CQC is also developing analytical methodologies to present data at core service level for Mental health services.

Core services are the unit of rating for CQC's assessments of mental health services, and our objective is to present more granular analysis from MHSDS (and other sources) mapped to these services.

Thematic reviews provide in-depth analyses of chosen topics to inform CQC staff, clinicians and the public about that service/area of care while also highlighting areas for improvement/best practice; working with inspector colleagues, themed inspections allow CQC to develop recommendations for making improvements in the delivery of care. These recommendations are then incorporated into future inspections to encourage continual improvement. ‘Restraint, segregation, and seclusion’, ‘Do not attempt CPR decisions’, and ‘Provider collaboration’ are examples of recent thematic data reviews/themed inspections that helped/ are helping to raise specific questions on the monitoring and provision of care in these areas with a focus on future improvement.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS England's HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2020/21 publication appeared in February 2022.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of health and care providers. CQC’s remit is to make sure health and adult social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. Its role will be expanded to encompass an assessment of quality for Integrated Care Systems (ICSs) and assurance of Local Authorities – in relation to their respected roles for health and adult social care. Its regulatory model is underpinned by a Data & Insight programme that draws together indicators of quality and risk about services. The data directly influence the risk and benchmarking models used to prioritise regulatory activity and inform its judgements of quality in services. The datasets also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act and to deliver national reports to parliament. Processing these data allow CQC to meet this public benefit.

Access to these data help to ensure CQC can make use of its wide set of powers to protect people who use regulated services from harm and the risk of harm, and to ensure they receive health and social care services of an appropriate standard. These powers also hold registered providers and managers to account for failures in how the service is provided. CQC's enforcement policy sets out CQC's approach to taking action where CQC identify poor care, or where registered providers and managers do not meet the standards required in the regulations. The level of enforcement is dependent on many factors but start at a requirement notice (stipulating a timeframe within which a given improvement must take place) for a less serious breach up to the possible cancellation of services in extreme cases.

For record-level data, CQC will process these data lawfully under UK GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 under which CQC was formed and has a duty of confidentiality under enactment set out in sections 76 and 77. As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) – processing is necessary for reasons of public interest in the area of public health in that CQC’s remit is to make sure that health and adult social care services provide people with safe, effective, compassionate, high-quality care. As per the Information Commissioner’s Officer (ICO) guidance; if an organisation is relying on Article 9(2)(i), they also need to meet the associated condition in UK law, set out in Part 1 of Schedule 1 of the DPA 2018. For Public health, this condition is met if the processing is necessary for reasons of public interest in the area of public health (as illustrated above). This condition is also met if the processing is carried out by another person who in the circumstances owes a duty of confidentiality under an enactment or rule of law, and CQC has a duty of confidentiality under the enactment set out in sections 76 and 77.

CQC's statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS England (previously NHS Digital/Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, a Data Protection Impact Assessment has been reviewed and completed by CQC.

CQC currently has receipt/use of Hospital Episode Statistics (HES) inpatient, outpatient, critical care, and A&E, Mental Health Services Data Set (MHSDS) and the legacy Mental Health and Learning Disabilities Dataset, Community Services Data Set (CSDS), Maternity Services Data Set (MSDS), Emergency Care Data Set (ECDS), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Monthly extracts ensure CQC have access to the most up-to-date data for ongoing analyses and oversight - particularly important in understanding an organisation's most recent performance. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

CQC use these data (i) to populate indicators within their Data & Insight Unit products and associated dashboards, to support prioritisation of regulatory activity (including inspections) and to inform judgements about the level of quality in services (ii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iii) towards CQC's statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; (iv) in thematic reviews and national reporting; for example, the Annual State of Care report and (v) to support the development and implementation of CQC’s new remit to assess ICSs and Local Authorities (with respect to health and care responsibilities).

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: 'postcode' and 'local patient identifier'. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. 'Local patient identifier' is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient's postcode is used for assigning data to new LA/ICS boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continues to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The latest review again focused on requests submitted to the CQC central analytical team. CQC has confirmed that, in the review period, analyses were still conducted on the postcode and local patient identifier fields. In a previous iteration of this agreement (v10) additional MHSDS fields were included in the application. Future analyses using birth date, death date, and unique restrictive intervention incident ID from the MHSDS data set will support work related to mortality and for monitoring Use Of Force Act 2018. Unique restrictive intervention incident ID has been requested to facilitate monitoring of restrictive interventions. The Mental Health Units (Use of Force) Act 2018 CHAPTER 27 makes provision about the oversight and management of the appropriate use of force in relation to people in mental health units; to make provision about the use of body cameras by police officers in the course of duties in relation to people in mental health units; and for connected purposes. CQC's statutory powers under s9(a) allow it to require information about restrictive interventions for the purposes of investigation of deaths and serious injury.

The Health and Social Care Act 2008 imposes notifications requirements for NHS bodies, which are managed and processed by CQC, which has a duty under the Mental Health Act 1983 (MHA) to monitor how services exercise their powers and discharge their duties when patients are detained in hospital, subject to community treatment orders or guardianship.

Among these are

• Reg 16: Death of a person who uses the service

• Reg 17: Deaths of people detained or liable to be detained under the Mental Health Act

The availability of Date of Death allows us to verify whether the team have received all death notifications from a provider for a period. Indicators will be related to absence of notification, or its completeness.

• Reg 18: Other incidents: Admission of a child or young person to an adult psychiatric ward or unit

Date of Birth allows us to know whether a child or young person was admitted to an adult ward and produce an indicator. It will also inform analysis of interventions related to age.

CQC's use of identifying data is subject to CQC's statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’) clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this Agreement meets this requirement.

CQC is the sole data controller and also processes the data. Now held on Microsoft Azure’s cloud environment, the NHS England data will only be accessed by CQC substantive employees and non-substantive employees (contractors). Where CQC used non-substantive employees (contractors), CQC would insist on confidentiality clauses within contracts and oblige individuals to complete in-house training on data protection and confidentiality. The local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section.

On-going produced outputs include:

-incorporates data indicators that align to CQC's assessment framework for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Over the course of the Covid pandemic lockdown, CQC took the decision that it would desist from on-site inspection unless the matter was a threat to life. The emphasis shifted to monitoring the NHS England data and other sources, including concerns from the public. With excessive mortality rates through Covid, some of the key indicators below were suspended; for example, mortality outliers. The outputs listed below therefore contain what CQC anticipate (and have experienced) outside of lockdown.

Insight products (which includes a range of dashboards and outputs that support monitoring and judgement), including outputs that are shared with providers. These products use aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes. As the new CQC Data & Insight Unit takes shape over the next twelve months, additional dashboards and early alerts are expected to become available for inspectors.

Outliers Programme: analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on 'Perinatal mortality and neonatal readmissions' used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Telstra - investigated death rates for endoscopic procedures. On the latter, CQC review their own available NHS England data to make a decision on the highlighted risk with reference to local intelligence known about the trust. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. The impact of COVID led to CQC suspending its mortality outlier processes, but its approach to monitoring mortality will be reviewed over the next 12 months.

Thematic reviews: used internally to inform CQC’s regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS England's HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

The creation of CQC’s new Data & Insight Unit has started to embed and improve on its previous insight programme and associated dashboards. Core data from this data sharing agreement were used in the production of indicators that align to CQC’s key lines of enquiry for a particular sector (e.g., hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used to inform planning regulatory activity (including to inform inspection planning decisions). The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in Insight products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted, and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

CQC has made extensive use of NHS England data within its insight pre-inspection activity within the hospital/ Mental Health sectors. The core NHS Englnad data acts to highlight any particular concerns (or good practice) that would then be followed up between an inspector and a given organisation or used to determine where an inspection might be focused. The reports provide trust-level indicators and national comparisons from the most readily available data and so allow the inspection team to hone in on particular areas of interest. Where this has been necessary, an inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality-of-care provision and examples of good practice that other organisations could adopt. The NHS England data are therefore critical in this process for driving up the quality-of-care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS England featured in the 2020/21 State of Care report. This year, it highlighted the impact of the pandemic as part of its design to provide a high-level commentary on year-on-year changes to care provision within England.

Over 2021/22 CQC issued 100 letters of intent to Hospital services across England where CQC identified poor care or where the standards of registration were not being met. However, these levels were likely to be lower than for other years, as this period covers the pandemic during which CQC reduced the number of inspections to a minimum level across Hospital services.

CQC continues to monitor a suite of indicators covering secondary health acute services.

In addition, CQC has a suite of indicators relating to safety and quality in mental health services for which it uses the Mental health services dataset.

CQC is also developing analytical methodologies to present data at core service level for Mental health services.

Core services are the unit of rating for CQC's assessments of mental health services, and our objective is to present more granular analysis from MHSDS (and other sources) mapped to these services.

Thematic reviews provide in-depth analyses of chosen topics to inform CQC staff, clinicians and the public about that service/area of care while also highlighting areas for improvement/best practice; working with inspector colleagues, themed inspections allow CQC to develop recommendations for making improvements in the delivery of care. These recommendations are then incorporated into future inspections to encourage continual improvement. ‘Restraint, segregation, and seclusion’, ‘Do not attempt CPR decisions’, and ‘Provider collaboration’ are examples of recent thematic data reviews/themed inspections that helped/ are helping to raise specific questions on the monitoring and provision of care in these areas with a focus on future improvement.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS England's HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2020/21 publication appeared in February 2022.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of health and care providers. CQC’s remit is to make sure health and adult social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. Its role will be expanded to encompass an assessment of quality for Integrated Care Systems (ICSs) and assurance of Local Authorities – in relation to their respected roles for health and adult social care. Its regulatory model is underpinned by a Data & Insight programme that draws together indicators of quality and risk about services. The data directly influence the risk and benchmarking models used to prioritise regulatory activity and inform its judgements of quality in services. The datasets also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act and to deliver national reports to parliament. Processing these data allow CQC to meet this public benefit.

Access to these data help to ensure CQC can make use of its wide set of powers to protect people who use regulated services from harm and the risk of harm, and to ensure they receive health and social care services of an appropriate standard. These powers also hold registered providers and managers to account for failures in how the service is provided. CQC's enforcement policy sets out CQC's approach to taking action where CQC identify poor care, or where registered providers and managers do not meet the standards required in the regulations. The level of enforcement is dependent on many factors but start at a requirement notice (stipulating a timeframe within which a given improvement must take place) for a less serious breach up to the possible cancellation of services in extreme cases.

For record-level data, CQC will process these data lawfully under GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 under which CQC was formed and has a duty of confidentiality under enactment set out in sections 76 and 77. As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) – processing is necessary for reasons of public interest in the area of public health in that CQC’s remit is to make sure that health and adult social care services provide people with safe, effective, compassionate, high-quality care. As per the Information Commissioner’s Officer (ICO) guidance; if an organisation is relying on Article 9(2)(i), they also need to meet the associated condition in UK law, set out in Part 1 of Schedule 1 of the DPA 2018. For Public health, this condition is met if the processing is necessary for reasons of public interest in the area of public health (as illustrated above). This condition is also met if the processing is carried out by another person who in the circumstances owes a duty of confidentiality under an enactment or rule of law, and CQC has a duty of confidentiality under enactment set out in sections 76 and 77.

CQC's statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS Digital (Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, a Data Protection Impact Assessment was finalised on 31 May 2019 and subsequently reviewed 04 December 2020. It is currently undergoing review (September 2022).

CQC currently has receipt/use of Hospital Episode Statistics (HES) inpatient, outpatient, critical care, and A&E, Mental Health Services Data Set (MHSDS) and the legacy Mental Health and Learning Disabilities Dataset, Community Services Data Set (CSDS), Maternity Services Data Set (MSDS), Emergency Care Data Set (ECDS), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Monthly extracts ensure CQC have access to the most up-to-date data for ongoing analyses and oversight - particularly important in understanding an organisation's most recent performance. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

CQC use these data (i) to populate indicators within their Data & Insight Unit products and associated dashboards, to support prioritisation of regulatory activity (including inspections) and to inform judgements about the level of quality in services (ii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iii) towards CQC's statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; (iv) in thematic reviews and national reporting; for example, the Annual State of Care report and (v) to support the development and implementation of CQC’s new remit to assess ICSs and Local Authorities (with respect to health and care responsibilities).

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: 'postcode' and 'local patient identifier'. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. 'Local patient identifier' is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient's postcode is used for assigning data to new LA/CCG boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continues to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The latest review again focused on requests submitted to the CQC central analytical team. CQC has confirmed that, in the review period, analyses were still conducted on the postcode and local patient identifier fields. This application requests three additional patient identifying fields from MHSDS. Future analyses using birth date, death date, and unique restrictive intervention incident ID from the MHSDS data set will support work related to mortality and for monitoring Use Of Force Act 2018. Unique restrictive intervention incident ID has been requested to facilitate monitoring of restrictive interventions. The Mental Health Units (Use of Force) Act 2018 CHAPTER 27 makes provision about the oversight and management of the appropriate use of force in relation to people in mental health units; to make provision about the use of body cameras by police officers in the course of duties in relation to people in mental health units; and for connected purposes. CQC's statutory powers under s9(a) allow it to require information about restrictive interventions for the purposes of investigation of deaths and serious injury.

The Health and Social Care Act 2008 imposes notifications requirements for NHS bodies, which are managed and processed by CQC, which has a duty under the Mental Health Act 1983 (MHA) to monitor how services exercise their powers and discharge their duties when patients are detained in hospital, subject to community treatment orders or guardianship.

Among these are

• Reg 16: Death of a person who uses the service

• Reg 17: Deaths of people detained or liable to be detained under the Mental Health Act

The availability of Date of Death allows us to verify whether we have received all death notifications from a provider for a period. Indicators will be related to absence of notification, or its completeness.

• Reg 18: Other incidents: Admission of a child or young person to an adult psychiatric ward or unit

Date of Birth allows us to know whether a child or young person was admitted to an adult ward and produce an indicator. It will also inform analysis of interventions related to age.

CQC's use of identifying data is subject to CQC's statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’) clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this Agreement meets this requirement.

CQC is the sole data controller and also processes the data. Now held on Microsoft Azure’s cloud environment, the NHS Digital data will only be accessed by CQC substantive employees and non-substantive employees (contractors). Where CQC used non-substantive employees (contractors), CQC would insist on confidentiality clauses within contracts and oblige individuals to complete in-house training on data protection and confidentiality. The local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section.

On-going produced outputs include:

-incorporates data indicators that align to CQC's assessment framework for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Over the course of the Covid pandemic lockdown, CQC took the decision that it would desist from on-site inspection unless the matter was a threat to life. The emphasis shifted to monitoring the NHS Digital data and other sources, including concerns from the public. With excessive mortality rates through Covid, some of the key indicators below were suspended; for example, mortality outliers. The outputs listed below therefore contain what CQC anticipate (and have experienced) outside of lockdown.

Insight products (which includes a range of dashboards and outputs that support monitoring and judgement), including outputs that are shared with providers. These products use aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes. As the new CQC Data & Insight Unit takes shape over the next twelve months, additional dashboards and early alerts are expected to become available for inspectors.

Outliers Programme: analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on 'Perinatal mortality and neonatal readmissions' used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Dr Foster Intelligence Ltd (now known as Telstra) - investigated death rates for endoscopic procedures. On the latter, CQC review their own available NHS Digital data to make a decision on the highlighted risk with reference to local intelligence known about the trust. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. The impact of COVID led to CQC suspending its mortality outlier processes, but its approach to monitoring mortality will be reviewed over the next 12 months.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS Digital’s HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2020/21 publication appeared in February 2022.

Thematic reviews: used internally to inform CQC’s regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS Digital's HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

The creation of CQC’s new Data & Insight Unit has started to embed and improve on its previous insight programme and associated dashboards. Core data from this data sharing agreement were used in the production of indicators that align to CQC’s key lines of enquiry for a particular sector (e.g., hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used to inform planning regulatory activity (including to inform inspection planning decisions). The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in Insight products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted, and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

CQC has made extensive use of NHS Digital data within its insight pre-inspection activity within the hospital/ Mental Health sectors. The core NHS Digital data acts to highlight any particular concerns (or good practice) that would then be followed up between an inspector and a given organisation or used to determine where an inspection might be focused. The reports provide trust-level indicators and national comparisons from the most readily available data and so allow the inspection team to hone in on particular areas of interest. Where this has been necessary, an inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality-of-care provision and examples of good practice that other organisations could adopt. The NHS Digital data are therefore critical in this process for driving up the quality-of-care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS Digital featured in the 2020/21 State of Care report. This year, it highlighted the impact of the pandemic as part of its design to provide a high-level commentary on year-on-year changes to care provision within England.

Over 2021/22 CQC issued 100 letters of intent to Hospital services across England where CQC identified poor care or where the standards of registration were not being met. However, these levels were likely to be lower than for other years, as this period covers the pandemic during which CQC reduced the number of inspections to a minimum level across Hospital services.

CQC continues to monitor a suite of indicators covering secondary health acute services.

In addition, CQC has a suite of indicators relating to safety and quality in mental health services for which it uses the Mental health services dataset.

CQC is also developing analytical methodologies to present data at core service level for Mental health services.

Core services are the unit of rating for CQC's assessments of mental health services, and our objective is to present more granular analysis from MHSDS (and other sources) mapped to these services.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of health and care providers. CQC’s remit is to make sure health and adult social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. Its role will be expanded to encompass an assessment of quality for Integrated Care Systems (ICSs) and assurance of Local Authorities – in relation to their respected roles for health and adult social care. Its regulatory model is underpinned by a Data & Insight programme that draws together indicators of quality and risk about services. The data directly influence the risk and benchmarking models used to prioritise regulatory activity and inform its judgements of quality in services. The datasets also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act and to deliver national reports to parliament. Processing these data allow CQC to meet this public benefit.

Access to these data help to ensure CQC can make use of its wide set of powers to protect people who use regulated services from harm and the risk of harm, and to ensure they receive health and social care services of an appropriate standard. These powers also hold registered providers and managers to account for failures in how the service is provided. CQC's enforcement policy sets out CQC's approach to taking action where CQC identify poor care, or where registered providers and managers do not meet the standards required in the regulations. The level of enforcement is dependent on many factors but start at a requirement notice (stipulating a timeframe within which a given improvement must take place) for a less serious breach up to the possible cancellation of services in extreme cases.

For record-level data, CQC will process these data lawfully under GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 under which CQC was formed and has a duty of confidentiality under enactment set out in sections 76 and 77. As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) – processing is necessary for reasons of public interest in the area of public health in that CQC’s remit is to make sure that health and adult social care services provide people with safe, effective, compassionate, high-quality care. As per the Information Commissioner’s Officer (ICO) guidance; if an organisation is relying on Article 9(2)(i), they also need to meet the associated condition in UK law, set out in Part 1 of Schedule 1 of the DPA 2018. For Public health, this condition is met if the processing is necessary for reasons of public interest in the area of public health (as illustrated above). This condition is also met if the processing is carried out by another person who in the circumstances owes a duty of confidentiality under an enactment or rule of law, and CQC has a duty of confidentiality under enactment set out in sections 76 and 77.

CQC's statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS Digital (Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, a Data Protection Impact Assessment was finalised on 31 May 2019 and subsequently reviewed 04 December 2020. It is currently undergoing review (September 2022).

CQC currently has receipt/use of Hospital Episode Statistics (HES) inpatient, outpatient, critical care, and A&E, Mental Health Services Data Set (MHSDS) and the legacy Mental Health and Learning Disabilities Dataset, Community Services Data Set (CSDS), Maternity Services Data Set (MSDS), Emergency Care Data Set (ECDS), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Monthly extracts ensure CQC have access to the most up-to-date data for ongoing analyses and oversight - particularly important in understanding an organisation's most recent performance. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

CQC use these data (i) to populate indicators within their Data & Insight Unit products and associated dashboards, to support prioritisation of regulatory activity (including inspections) and to inform judgements about the level of quality in services (ii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iii) towards CQC's statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; (iv) in thematic reviews and national reporting; for example, the Annual State of Care report and (v) to support the development and implementation of CQC’s new remit to assess ICSs and Local Authorities (with respect to health and care responsibilities).

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: 'postcode' and 'local patient identifier'. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. 'Local patient identifier' is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient's postcode is used for assigning data to new LA/CCG boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continues to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The latest review again focused on requests submitted to the CQC central analytical team. CQC has confirmed that, in the review period, analyses were still conducted on the postcode and local patient identifier fields. This application requests three additional patient identifying fields from MHSDS. Future analyses using birth date, death date, and unique restrictive intervention incident ID from the MHSDS data set will support work related to mortality and for monitoring Use Of Force Act 2018. Unique restrictive intervention incident ID has been requested to facilitate monitoring of restrictive interventions. The Mental Health Units (Use of Force) Act 2018 CHAPTER 27 makes provision about the oversight and management of the appropriate use of force in relation to people in mental health units; to make provision about the use of body cameras by police officers in the course of duties in relation to people in mental health units; and for connected purposes. CQC's statutory powers under s9(a) allow it to require information about restrictive interventions for the purposes of investigation of deaths and serious injury.

The Health and Social Care Act 2008 imposes notifications requirements for NHS bodies, which are managed and processed by CQC, which has a duty under the Mental Health Act 1983 (MHA) to monitor how services exercise their powers and discharge their duties when patients are detained in hospital, subject to community treatment orders or guardianship.

Among these are

• Reg 16: Death of a person who uses the service

• Reg 17: Deaths of people detained or liable to be detained under the Mental Health Act

The availability of Date of Death allows us to verify whether we have received all death notifications from a provider for a period. Indicators will be related to absence of notification, or its completeness.

• Reg 18: Other incidents: Admission of a child or young person to an adult psychiatric ward or unit

Date of Birth allows us to know whether a child or young person was admitted to an adult ward and produce an indicator. It will also inform analysis of interventions related to age.

CQC's use of identifying data is subject to CQC's statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’) clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this Agreement meets this requirement.

CQC is the sole data controller and also processes the data. Now held on Microsoft Azure’s cloud environment, the NHS Digital data will only be accessed by CQC substantive employees and non-substantive employees (contractors). Where CQC used non-substantive employees (contractors), CQC would insist on confidentiality clauses within contracts and oblige individuals to complete in-house training on data protection and confidentiality. The local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section.

On-going produced outputs include:

-incorporates data indicators that align to CQC's assessment framework for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Over the course of the Covid pandemic lockdown, CQC took the decision that it would desist from on-site inspection unless the matter was a threat to life. The emphasis shifted to monitoring the NHS Digital data and other sources, including concerns from the public. With excessive mortality rates through Covid, some of the key indicators below were suspended; for example, mortality outliers. The outputs listed below therefore contain what CQC anticipate (and have experienced) outside of lockdown.

Insight products (which includes a range of dashboards and outputs that support monitoring and judgement), including outputs that are shared with providers. These products use aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes. As the new CQC Data & Insight Unit takes shape over the next twelve months, additional dashboards and early alerts are expected to become available for inspectors.

Outliers Programme: analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on 'Perinatal mortality and neonatal readmissions' used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Dr Foster Intelligence Ltd (now known as Telstra) - investigated death rates for endoscopic procedures. On the latter, CQC review their own available NHS Digital data to make a decision on the highlighted risk with reference to local intelligence known about the trust. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. The impact of COVID led to CQC suspending its mortality outlier processes, but its approach to monitoring mortality will be reviewed over the next 12 months.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS Digital’s HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2020/21 publication appeared in February 2022.

Thematic reviews: used internally to inform CQC’s regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS Digital's HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

The creation of CQC’s new Data & Insight Unit has started to embed and improve on its previous insight programme and associated dashboards. Core data from this data sharing agreement were used in the production of indicators that align to CQC’s key lines of enquiry for a particular sector (e.g., hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used to inform planning regulatory activity (including to inform inspection planning decisions). The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in Insight products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted, and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

CQC has made extensive use of NHS Digital data within its insight pre-inspection activity within the hospital/ Mental Health sectors. The core NHS Digital data acts to highlight any particular concerns (or good practice) that would then be followed up between an inspector and a given organisation or used to determine where an inspection might be focused. The reports provide trust-level indicators and national comparisons from the most readily available data and so allow the inspection team to hone in on particular areas of interest. Where this has been necessary, an inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality-of-care provision and examples of good practice that other organisations could adopt. The NHS Digital data are therefore critical in this process for driving up the quality-of-care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS Digital featured in the 2020/21 State of Care report. This year, it highlighted the impact of the pandemic as part of its design to provide a high-level commentary on year-on-year changes to care provision within England.

Over 2021/22 CQC issued 100 letters of intent to Hospital services across England where CQC identified poor care or where the standards of registration were not being met. However, these levels were likely to be lower than for other years, as this period covers the pandemic during which CQC reduced the number of inspections to a minimum level across Hospital services.

CQC continues to monitor a suite of indicators covering secondary health acute services.

In addition, CQC has a suite of indicators relating to safety and quality in mental health services for which it uses the Mental health services dataset.

CQC is also developing analytical methodologies to present data at core service level for Mental health services.

Core services are the unit of rating for CQC's assessments of mental health services, and our objective is to present more granular analysis from MHSDS (and other sources) mapped to these services.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of care providers. CQC’s remit is to make sure health and social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. It does that through effective monitoring and inspection activity underpinned by an Intelligence insight programme that draws together risk and bench marking metrics at core service level. The data directly influence the risk and benchmarking models and help determine both when inspections take place and where they should focus. They also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act.

For record-level data, CQC will process these data lawfully under GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 (under which CQC was formed). As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) in, ‘processing is necessary for reasons of public interest in the area of public health, such as…ensuring high standards of quality and safety of health care…on the basis of Union or Member State law…’.

CQC’s statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS Digital (Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test. CQC’s core purpose is to seek to protect the public from poor provision of care, highlight good practice, and publish information (for example, inspection reports and ratings) that allow the public an improved understanding of the quality of provision of care by individual providers. Processing these data allow CQC to meet that public benefit.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, a Data Protection Impact Assessment was finalised on 31 May 2019 and subsequently reviewed 04 December 2020.

CQC currently has receipt/use of Hospital Episode Statistics (HES) inpatient, outpatient, critical care, and A&E, Mental Health Services Data Set (MHSDS) and the legacy Mental Health and Learning Disabilities Dataset, Community Services Data Set (CSDS), Maternity Services Data Set (MSDS), Emergency Care Data Set (ECDS), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. With the phasing out of the HES mortality file, CQC is now requesting access to the civil registration mortality file as a replacement with the addition of the Token_Person_ID field that will allow linkage between NHS datasets, once this field is embedded in their outputs. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

CQC use these data (i) to populate indicators within their Intelligent insight products and associated dashboards, which help CQC focus inspections of providers by deciding when, where and what to inspect; (ii) to construct evidence tables / data packs, which bring together information and analysis for each provider and are used for inspection planning; (iii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iv) towards CQC’s statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; and (v) in thematic reviews and national reporting; for example, the Annual State of Care report.

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: ‘postcode’ and ‘local patient identifier’. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. ‘Local patient identifier’ is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient’s postcode is used for assigning data to new LA/CCG boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continues to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The latest review again focused on requests submitted to the CQC central analytical team. CQC has confirmed that, in the review period, analyses were still conducted on the held identifiers. With respect to the period of data, it concluded that CQC only needed to retain data from 2014/15. Subsequently, all data older than 2014/15 have been deleted from CQC systems. This covers HES, HES-associated data, and all of MHMDS. The detail is set out in the data destruction form.

CQC’s use of identifying data is subject to CQC’s statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’), clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this Agreement meets this requirement.

CQC is the sole data controller and also processes the data. Atos was CQC’s ICT service provider and was engaged through the IMS3 framework contract, let by the Department of Health and Social Care. This contract came to an end at the end in March 2020 but was temporarily extended while this Agreement was finalised to permit these data to be stored within the cloud environment of Microsoft Azure. The data were subsequently transferred from Atos to Microsoft Azure. An NHS Digital data destruction form has now been submitted and this version of the agreement removes Atos.

Now transferred to Microsoft Azure’s cloud environment, the NHS Digital data will only be accessed by substantive employees of CQC but note that the local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section.

On-going produced outputs include risk-based monitoring through CQC insight:

-incorporates data indicators that align to CQC’s key lines of enquiry for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England/ NHS Improvement. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Pre-inspection data evidence grids and monitoring dashboards: used by the inspections teams and shared with providers. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes.

Outliers Programme: analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on ‘Perinatal mortality and neonatal readmissions’ used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Dr Foster Intelligence Ltd - investigated death rates for endoscopic procedures. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS Digital’s HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2019/20 publication appeared in February 2021.

Thematic reviews: used internally to inform CQC's regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS Digital’s HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In the monitoring of organisations for ongoing compliance against essential quality and safety standards, CQC uses screening techniques in its CQC insight tools, which analyse a wide variety of data sources to highlight possible outlying concerns that trigger actions where concerns are raised. Such screening methods are aided by a more local approach to information gathering and analysis, which is being developed in consultation with appropriate stakeholders. These techniques, currently along with national surveys of patients, help to create a more holistic understanding in informing its work with ongoing compliance, investigations, and thematic reviews.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

CQC has embedded its insight programme and associate dashboards over the last four years. Core data from this data sharing agreement were used in the production of indictors that align to CQC’s key lines of enquiry for a particular sector (e.g., hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used in the regulatory planning meetings (RPMs) as well as in the production of pre-inspection data evidence grids and dashboards. These have allowed lead inspectors to decide which core services to inspect. The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in these products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted, and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

Side-by-side with this process, CQC’s outliers programme has continued to monitor and review potential outliers of high mortality and readmission rates. CQC received data from Dr Foster Intelligence Ltd that provided an additional route for identification in addition to CQC’s own. Where concerns were identified, these were taken up by the relevant relationship owner in conjunction with appropriate analytical support to understand whether an issue existed and, where this might have been the case, whether the trust were aware of the concern and what remedial action had been put in place. The mortality data are therefore used to provide a fundamental resource in the understanding of the quality of the provision of care and provide a tool to highlight where possible concerns may exist and where further investigation is required.

CQC has made extensive use of NHS Digital data within its insight pre-inspection activity within the hospital/ Mental Health sectors. Over the previous 12 months, the CQC response to Covid has been to focus more heavily on the information it receives in helping determine levels of risk and the development of dashboards. These provide a breakdown of analysis by highlighted service (for example, surgery) and allow the inspection team to determine where to focus the inspection. The reports provide trust-level indicators and national comparisons from the most-readily available data and so allow the inspection team to hone in on particular areas of interest. Where this has been necessary, an inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality-of-care provision and examples of good practice that other organisations could adopt. The NHS Digital data are therefore critical in this process for driving up the quality-of-care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS Digital featured in the 2019/20 State of Care report. This year, it highlighted the impact of the pandemic as part of its design to provide a high-level commentary on year-on-year changes to care provision within England.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of care providers. CQC’s remit is to make sure health and social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. It does that through effective monitoring and inspection activity underpinned by an Intelligence insight programme that draws together risk and bench marking metrics at core service level. The data directly influence the risk and benchmarking models and help determine both when inspections take place and where they should focus. They also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act.

For record-level data, CQC will process these data lawfully under GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 (under which CQC was formed). As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) in, ‘processing is necessary for reasons of public interest in the area of public health, such as…ensuring high standards of quality and safety of health care…on the basis of Union or Member State law…’.

CQC’s statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS Digital (Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test. CQC’s core purpose is to seek to protect the public from poor provision of care, highlight good practice, and publish information (for example, inspection reports and ratings) that allow the public an improved understanding of the quality of provision of care by individual providers. Processing these data allow CQC to meet that public benefit.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, a Data Protection Impact Assessment was undertaken and finalised on 31 May 2019.

CQC currently has receipt/use of Hospital Episode Statistics (HES) inpatient, outpatient, critical care, and A&E, Mental Health Services Data Set (MHSDS) and legacy datasets, Community Services Data Set (CSDS), Maternity Services Data Set (MSDS), Emergency Care Data Set (ECDS), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

To expand on the Mental Health legacy datasets, these include Mental Health & Learning Disabilities Dataset, Mental Health Minimum Dataset, and KP90 Dataset.

CQC use these data (i) to populate indicators within their Intelligent insight products, which help CQC focus inspections of providers by deciding when, where and what to inspect; (ii) to construct evidence tables / data packs, which bring together information and analysis for each provider and are used for inspection planning; (iii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iv) towards CQC’s statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; and (v) in thematic reviews and national reporting; for example, the Annual State of Care report.

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: ‘postcode’ and ‘local patient identifier’. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. ‘Local patient identifier’ is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient’s postcode is used for assigning data to new LA/CCG boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continues to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The latest review again focused on requests submitted to the CQC central analytical team. CQC has confirmed that, in the review period, analyses were still conducted on the held identifiers. With respect to the period of data, it concluded that CQC only needed to retain a rolling period of 5 full FY years (annual refresh or equivalent) plus the current in-year data. Subsequently, all data older than 2014/15 have been deleted from CQC systems. This covers HES, HES-associated data, and all of MHMDS.

CQC’s use of identifying data is subject to CQC’s statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’), clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this Agreement meets this requirement.

CQC is the sole data controller and also processes the data. Atos is CQC’s ICT service provider and was engaged through the IMS3 framework contract, let by the Department of Health. This contract was due to come to an end at the end in March 2020 but was temporarily extended while CQC requested this Agreement permitting these data to be stored within the cloud environment of Microsoft Azure. Full details have been submitted to, and approved by, NHS Digital’s security consultant. Under this Agreement, the data will be transferred from Atos to Microsoft Azure. Atos will then confirm destruction of all copies of the data previously held on its servers and CQC will request a further amendment to this Data Sharing Agreement to remove Atos as an approved Data Processor.

Once stored in Microsoft Azure’s cloud environment, the data from NHS Digital will only be accessed by substantive employees of CQC but note that the local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section.

Capgemini has been commissioned to transfer the data from the current storage to the Microsoft Azure platform (discussed in separate technical response). Capgemini will have no access to the underlying data and will therefore not be processing the data. There are no other organisations involved in the wider project nor any commissioners involved. NHS Digital has considered the nature of Capgemini's role in moving the data from the old system to the Microsoft Azure platform and is content that Capgemini is not a data processor given that because the data are encrypted Capgemini is unable to access, view, modify the data whilst Capgemini will be transferring the data in this respect without the keys it is not possible for Capgemini to have access to the data to act as a data processor.

On-going produced outputs include risk-based monitoring through CQC insight:

-incorporates data indicators that align to CQC’s key lines of enquiry for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England/ NHS Improvement. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Pre-inspection data evidence grids: used by the inspections teams and shared with providers. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes.

Outliers Programme: analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on ‘Perinatal mortality and neonatal readmissions’ used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Dr Foster Intelligence Ltd - investigated death rates for endoscopic procedures. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS Digital’s HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2018/19 publication appeared in February 2020.

Thematic reviews: used internally to inform CQC's regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS Digital’s HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In the monitoring of organisations for ongoing compliance against essential quality and safety standards, CQC uses screening techniques in its CQC insight tools, which analyse a wide variety of data sources to highlight possible outlying concerns that trigger actions where concerns are raised. Such screening methods are aided by a more local approach to information gathering and analysis, which is being developed in consultation with appropriate stakeholders. These techniques, currently along with national surveys of patients, help to create a more holistic understanding in informing its work with ongoing compliance, investigations, and thematic reviews.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

CQC has embedded its new insight programme over the last three years. Core data from this data sharing agreement were used in the production of indictors that align to CQC’s key lines of enquiry for a particular sector (e.g. hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used in the regulatory planning meetings (RPMs) as well as in the production of pre-inspection data evidence grids. These have allowed lead inspectors to decide which core services to inspect. The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in these products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

Side-by-side with this process, CQC’s outliers programme has continued to monitor and review potential outliers of high mortality and readmission rates. CQC received data from Dr Foster Intelligence Ltd that provided an additional route for identification in addition to CQC’s own. Where concerns were identified, these were taken up by the relevant relationship owner in conjunction with appropriate analytical support to understand whether an issue existed and, where this might have been the case, whether the trust were aware of the concern and what remedial action had been put in place. The mortality data are therefore used to provide a fundamental resource in the understanding of the quality of the provision of care and provide a tool to highlight where possible concerns may exist and where further investigation is required.

CQC has made extensive use of NHS Digital data within its insight pre-inspection reports within the hospital/ MH sectors. Over the previous 12 months, CQC have produced approximately 150 of these reports, which provide a breakdown of analysis by highlighted service (for example, surgery) and allow the inspection team to determine where to focus the inspection. The reports provide trust-level indicators and national comparisons from the most-readily available data and so allow the inspection team to hone in on particular areas of interest. An inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality of care provision and examples of good practice that other organisations could adopt. The NHS Digital data are therefore critical in this process for driving up the quality of care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS Digital featured in the 2017/18 State of Care report that is designed to provide a high-level commentary on year-on-year changes to care provision within England. This year, it highlighted the ‘safety’ domain as a particular concern with the aim of creating debate and policy changes to make long-term improvements in this area.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of care providers. CQC’s remit is to make sure health and social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. It does that through effective monitoring and inspection activity underpinned by an Intelligence insight programme that draws together risk and bench marking metrics at core service level. The data directly influence the risk and benchmarking models and help determine both when inspections take place and where they should focus. They also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act.

For record-level data, CQC will process these data lawfully under GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 (under which CQC was formed). As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) in, ‘processing is necessary for reasons of public interest in the area of public health, such as…ensuring high standards of quality and safety of health care…on the basis of Union or Member State law…’.

CQC’s statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS Digital (Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test. CQC’s core purpose is to seek to protect the public from poor provision of care, highlight good practice, and publish information (for example, inspection reports and ratings) that allow the public an improved understanding of the quality of provision of care by individual providers. Processing these data allow CQC to meet that public benefit.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, CQC's Caldicott Guardian conducted an internal review and signed it off for the previous iteration of this Data Sharing Agreement to determine the necessity of the data released by NHS Digital under previous iterations of this Agreement and the data (and new datasets) under this Agreement. With the augmentation of additional datasets (as discussed below), a Data Protection Impact Assessment was undertaken and finalised on 31 May 2019.

CQC currently has receipt/use of HES (inpatient, outpatient, critical care, and A&E), MHSDS (and legacy datasets), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

To expand on the Mental Health legacy datasets, these include Mental Health & Learning Disabilities Dataset, Mental Health Minimum Dataset, and KP90 Dataset. CQC has not held nor processed Learning Disabilities Census data under any of the past iterations of this Agreement.

CQC use these data (i) to populate indicators within their Intelligent insight products, which help CQC focus inspections of providers by deciding when, where and what to inspect; (ii) to construct evidence tables / data packs, which bring together information and analysis for each provider and are used for inspection planning; (iii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iv) towards CQC’s statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; and (v) in thematic reviews and national reporting; for example, the Annual State of Care report.

Under this Agreement, CQC are also requesting access to:

• the Maternity Services Data Set (MSDS) to improve its ability to report on this sector;

• the Community Services Dataset (CSDS) to develop a community-specific Intelligence insight product) and emergency care;

• the Emergency Care Data Set (ECDS) to provide a parallel feed to HES A&E and create new metrics as this product is rolled out/replaces the HES Accident & Emergency dataset.

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: ‘postcode’ and ‘local patient identifier’. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. ‘Local patient identifier’ is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient’s postcode is used for assigning data to new LA/CCG boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continue to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The review focuses on requests submitted to the CQC central analytical team. It confirmed that, in the review period, analyses were still conducted on the held identifiers and over the full period of retained HES. For MHMDS, no use had been made of 2008/09 and 2009/10 data and a decision was taken to delete these years from the system. These years of MHMDS data will be removed from this Data Sharing Agreement in the next iteration, by which time deletion will have taken place.

CQC’s use of identifying data is subject to CQC’s statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’), clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this agreement meets this requirement.

CQC is the sole data controller and also processes the data. Atos is a data processor for CQC. Atos is CQC’s ICT service provider and was engaged through the IMS3 framework contract, let by the Department of Health. The data from NHS Digital will only be processed by substantive employees of CQC and ATOS (note that the local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section). CQC wish to flag that the IMS3 contract will be expiring at the end of the 2019/20 financial year. A new supplier(s) for these services will be agreed over the course of the next 12 months. Any such change will result in an amendment of this Data Sharing Agreement before the new changes can take effect.

There are no other organisations involved in the wider project nor any commissioners involved.

On-going produced outputs include risk-based monitoring through CQC insight:

-incorporates data indicators that align to CQC’s key lines of enquiry for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England/ NHS Improvement. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Pre-inspection data evidence grids: used by the inspections teams and shared with providers. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes.

Outliers Programme : analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on ‘Perinatal mortality and neonatal readmissions’ used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Dr Foster Intelligence Ltd - investigated death rates for endoscopic procedures. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS Digital’s HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2017/18 publication appeared in February 2019.

Thematic reviews: used internally to inform CQC's regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS Digital’s HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In the monitoring of organisations for ongoing compliance against essential quality and safety standards, CQC uses screening techniques in its CQC insight tools, which analyse a wide variety of data sources to highlight possible outlying concerns that trigger actions where concerns are raised. Such screening methods are aided by a more local approach to information gathering and analysis, which is being developed in consultation with appropriate stakeholders. These techniques, currently along with national surveys of patients, help to create a more holistic understanding in informing its work with ongoing compliance, investigations, and thematic reviews.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

CQC has been embedding its new insight programme over the last two years. Core data from this data sharing agreement were used in the production of indictors that align to CQC’s key lines of enquiry for a particular sector (e.g. hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used in the regulatory planning meetings (RPMs) as well as in the production of pre-inspection data evidence grids. These have allowed lead inspectors to decide which core services to inspect. The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in these products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

Side-by-side with this process, CQC’s outliers programme has continued to monitor and review potential outliers of high mortality and readmission rates. CQC received data from Dr Foster Intelligence Ltd that provided an additional route for identification in addition to CQC’s own. Where concerns were identified, these were taken up by the relevant relationship owner in conjunction with appropriate analytical support to understand whether an issue existed and, where this might have been the case, whether the trust were aware of the concern and what remedial action had been put in place. The mortality data are therefore used to provide a fundamental resource in the understanding of the quality of the provision of care and provide a tool to highlight where possible concerns may exist and where further investigation is required.

CQC has made extensive use of NHS Digital data within its insight pre-inspection reports within the hospital/ MH sectors. Over the previous 12 months, CQC have produced approximately 150 of these reports, which provide a breakdown of analysis by highlighted service (for example, surgery) and allow the inspection team to determine where to focus the inspection. The reports provide trust-level indicators and national comparisons from the most-readily available data and so allow the inspection team to hone in on particular areas of interest. An inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality of care provision and examples of good practice that other organisations could adopt. The NHS Digital data are therefore critical in this process for driving up the quality of care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS Digital featured in the 2017/18 State of Care report that is designed to provide a high-level commentary on year-on-year changes to care provision within England. This year, it highlighted the ‘safety’ domain as a particular concern with the aim of creating debate and policy changes to make long-term improvements in this area.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of care providers. CQC’s remit is to make sure health and social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. It does that through effective monitoring and inspection activity underpinned by an Intelligence insight programme that draws together risk and bench marking metrics at core service level. The data directly influence the risk and benchmarking models and help determine both when inspections take place and where they should focus. They also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act.

For record-level data, CQC will process these data lawfully under GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 (under which CQC was formed). As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) in, ‘processing is necessary for reasons of public interest in the area of public health, such as…ensuring high standards of quality and safety of health care…on the basis of Union or Member State law…’.

CQC’s statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS Digital (Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test. CQC’s core purpose is to seek to protect the public from poor provision of care, highlight good practice, and publish information (for example, inspection reports and ratings) that allow the public an improved understanding of the quality of provision of care by individual providers. Processing these data allow CQC to meet that public benefit.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, CQC's Caldicott Guardian conducted an internal review and signed it off for the previous iteration of this Data Sharing Agreement to determine the necessity of the data released by NHS Digital under previous iterations of this Agreement and the data (and new datasets) under this Agreement. With the augmentation of additional datasets (as discussed below), a Data Protection Impact Assessment was undertaken and finalised on 31 May 2019.

CQC currently has receipt/use of HES (inpatient, outpatient, critical care, and A&E), MHSDS (and legacy datasets), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

To expand on the Mental Health legacy datasets, these include Mental Health & Learning Disabilities Dataset, Mental Health Minimum Dataset, and KP90 Dataset. CQC has not held nor processed Learning Disabilities Census data under any of the past iterations of this Agreement.

CQC use these data (i) to populate indicators within their Intelligent insight products, which help CQC focus inspections of providers by deciding when, where and what to inspect; (ii) to construct evidence tables / data packs, which bring together information and analysis for each provider and are used for inspection planning; (iii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iv) towards CQC’s statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; and (v) in thematic reviews and national reporting; for example, the Annual State of Care report.

Under this Agreement, CQC are also requesting access to:

• the Maternity Services Data Set (MSDS) to improve its ability to report on this sector;

• the Community Services Dataset (CSDS) to develop a community-specific Intelligence insight product) and emergency care;

• the Emergency Care Data Set (ECDS) to provide a parallel feed to HES A&E and create new metrics as this product is rolled out/replaces the HES Accident & Emergency dataset.

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: ‘postcode’ and ‘local patient identifier’. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. ‘Local patient identifier’ is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient’s postcode is used for assigning data to new LA/CCG boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continue to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The review focuses on requests submitted to the CQC central analytical team. It confirmed that, in the review period, analyses were still conducted on the held identifiers and over the full period of retained HES. For MHMDS, no use had been made of 2008/09 and 2009/10 data and a decision was taken to delete these years from the system. These years of MHMDS data will be removed from this Data Sharing Agreement in the next iteration, by which time deletion will have taken place.

CQC’s use of identifying data is subject to CQC’s statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’), clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this agreement meets this requirement.

CQC is the sole data controller and also processes the data. Atos is a data processor for CQC. Atos is CQC’s ICT service provider and was engaged through the IMS3 framework contract, let by the Department of Health. The data from NHS Digital will only be processed by substantive employees of CQC and ATOS (note that the local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section). CQC wish to flag that the IMS3 contract will be expiring at the end of the 2019/20 financial year. A new supplier(s) for these services will be agreed over the course of the next 12 months. Any such change will result in an amendment of this Data Sharing Agreement before the new changes can take effect.

There are no other organisations involved in the wider project nor any commissioners involved.

On-going produced outputs include risk-based monitoring through CQC insight:

-incorporates data indicators that align to CQC’s key lines of enquiry for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England/ NHS Improvement. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Pre-inspection data evidence grids: used by the inspections teams and shared with providers. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes.

Outliers Programme : analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on ‘Perinatal mortality and neonatal readmissions’ used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Dr Foster Intelligence Ltd - investigated death rates for endoscopic procedures. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS Digital’s HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2017/18 publication appeared in February 2019.

Thematic reviews: used internally to inform CQC's regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS Digital’s HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In the monitoring of organisations for ongoing compliance against essential quality and safety standards, CQC uses screening techniques in its CQC insight tools, which analyse a wide variety of data sources to highlight possible outlying concerns that trigger actions where concerns are raised. Such screening methods are aided by a more local approach to information gathering and analysis, which is being developed in consultation with appropriate stakeholders. These techniques, currently along with national surveys of patients, help to create a more holistic understanding in informing its work with ongoing compliance, investigations, and thematic reviews.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

CQC has been embedding its new insight programme over the last two years. Core data from this data sharing agreement were used in the production of indictors that align to CQC’s key lines of enquiry for a particular sector (e.g. hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used in the regulatory planning meetings (RPMs) as well as in the production of pre-inspection data evidence grids. These have allowed lead inspectors to decide which core services to inspect. The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in these products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

Side-by-side with this process, CQC’s outliers programme has continued to monitor and review potential outliers of high mortality and readmission rates. CQC received data from Dr Foster Intelligence Ltd that provided an additional route for identification in addition to CQC’s own. Where concerns were identified, these were taken up by the relevant relationship owner in conjunction with appropriate analytical support to understand whether an issue existed and, where this might have been the case, whether the trust were aware of the concern and what remedial action had been put in place. The mortality data are therefore used to provide a fundamental resource in the understanding of the quality of the provision of care and provide a tool to highlight where possible concerns may exist and where further investigation is required.

CQC has made extensive use of NHS Digital data within its insight pre-inspection reports within the hospital/ MH sectors. Over the previous 12 months, CQC have produced approximately 150 of these reports, which provide a breakdown of analysis by highlighted service (for example, surgery) and allow the inspection team to determine where to focus the inspection. The reports provide trust-level indicators and national comparisons from the most-readily available data and so allow the inspection team to hone in on particular areas of interest. An inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality of care provision and examples of good practice that other organisations could adopt. The NHS Digital data are therefore critical in this process for driving up the quality of care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS Digital featured in the 2017/18 State of Care report that is designed to provide a high-level commentary on year-on-year changes to care provision within England. This year, it highlighted the ‘safety’ domain as a particular concern with the aim of creating debate and policy changes to make long-term improvements in this area.

Under this Data Sharing Agreement, the Care Quality Commission (CQC) is requesting record-level data that is critical to its regulatory oversight of care providers. CQC’s remit is to make sure health and social care services provide people with safe, effective, compassionate, high-quality care and CQC encourages them to improve. It does that through effective monitoring and inspection activity underpinned by an Intelligence insight programme that draws together risk and bench marking metrics at core service level. The data directly influence the risk and benchmarking models and help determine both when inspections take place and where they should focus. They also help with CQC’s statutory responsibility to monitor the use of the Mental Health Act.

For record-level data, CQC will process these data lawfully under GDPR Article 6(1)(e) with CQC’s statutory powers arising from the Health and Social Care Act 2008 (under which CQC was formed). As the regulator of health and adult social care in England, CQC will process special category data under Article 9(2)(i) in, ‘processing is necessary for reasons of public interest in the area of public health, such as…ensuring high standards of quality and safety of health care…on the basis of Union or Member State law…’.

CQC’s statutory powers under s64 of the 2008 Act allow it to require information from all registered providers as well as key organisations in the oversight of health and social care; for example, local authorities and NHS Digital (Health and Social Care Information Centre). These powers are constrained by the application of CQC’s Code of Practice for Confidential Personal Information that requires all consideration of the use of (potentially) identifying data to meet the necessity test. CQC’s core purpose is to seek to protect the public from poor provision of care, highlight good practice, and publish information (for example, inspection reports and ratings) that allow the public an improved understanding of the quality of provision of care by individual providers. Processing these data allow CQC to meet that public benefit.

As part of the process for weighing up the risk of potential harm to the public by the dissemination of data against the public benefit of its use for the organisation, CQC's Caldicott Guardian conducted an internal review and signed it off for the previous iteration of this Data Sharing Agreement to determine the necessity of the data released by NHS Digital under previous iterations of this Agreement and the data (and new datasets) under this Agreement. With the augmentation of additional datasets (as discussed below), a Data Protection Impact Assessment was undertaken and finalised on 31 May 2019.

CQC currently has receipt/use of HES (inpatient, outpatient, critical care, and A&E), MHSDS (and legacy datasets), civil registration mortality, as well as HES-mortality and HES-MHSDS bridging files. These data are received at record-level and cover activity within the whole of England. The data subjects will cover all individuals who have undergone treatment in these pathways. Multi-year extracts are required to produce time-series analyses. These review change over time and allow CQC to identify trends/ themes in organisations’ provision of care.

To expand on the Mental Health legacy datasets, these include Mental Health & Learning Disabilities Dataset, Mental Health Minimum Dataset, and KP90 Dataset. CQC has not held nor processed Learning Disabilities Census data under any of the past iterations of this Agreement.

CQC use these data (i) to populate indicators within their Intelligent insight products, which help CQC focus inspections of providers by deciding when, where and what to inspect; (ii) to construct evidence tables / data packs, which bring together information and analysis for each provider and are used for inspection planning; (iii) within the applicants Outliers programme to identify when key metrics relating to mortality rates and maternity outcomes reach a level that may warrant further investigation; (iv) towards CQC’s statutory role of monitoring the Mental Health Act and protecting the interests of people whose rights are restricted under the Act; and (v) in thematic reviews and national reporting; for example, the Annual State of Care report.

Under this Agreement, CQC are also requesting access to:

• the Maternity Services Data Set (MSDS) to improve its ability to report on this sector;

• the Community Services Dataset (CSDS) to develop a community-specific Intelligence insight product) and emergency care;

• the Emergency Care Data Set (ECDS) to provide a parallel feed to HES A&E and create new metrics as this product is rolled out/replaces the HES Accident & Emergency dataset.

The data contain patient identifying details although CQC have worked to reduce the number of identifying fields CQC hold to two: ‘postcode’ and ‘local patient identifier’. For the latter, it is occasionally necessary to identify to a trust examples of their own patients whose care appears problematical. ‘Local patient identifier’ is used as the HESID is not known to the trust. With this exception, no record level data is released to third parties. For the former, the patient’s postcode is used for assigning data to new LA/CCG boundaries, and for identifying other geography-related data (such as linking with deprivation tables, calculating distances from the address to the Trust, to help monitor for adverse events for people living in care homes).

CQC continue to review its use of identifiers and whether the amount of retained identifiable data continues to be necessary. The review focuses on requests submitted to the CQC central analytical team. It confirmed that, in the review period, analyses were still conducted on the held identifiers and over the full period of retained HES. For MHMDS, no use had been made of 2008/09 and 2009/10 data and a decision was taken to delete these years from the system. These years of MHMDS data will be removed from this Data Sharing Agreement in the next iteration, by which time deletion will have taken place.

CQC’s use of identifying data is subject to CQC’s statutory Code of Practice on Confidential Personal Information (the code). The purpose of the code is to provide transparency on CQC’s use of information for data subjects and other stakeholders and as a guide for staff on the practices CQC will follow. Practice 1 of the code (‘Obtaining confidential personal information’), clarifies that CQC ‘only obtain confidential personal information where it is necessary to do so to enable CQC to perform CQC’s functions. CQC will obtain only the minimum necessary confidential personal information’. The CQC are satisfied the substance of this agreement meets this requirement.

CQC is the sole data controller and also processes the data. Atos is a data processor for CQC. Atos is CQC’s ICT service provider and was engaged through the IMS3 framework contract, let by the Department of Health. The data from NHS Digital will only be processed by substantive employees of CQC and ATOS (note that the local patient identifier may be shared with the originating Trust to identify patient notes to review, as detailed below in the Benefits section). CQC wish to flag that the IMS3 contract will be expiring at the end of the 2019/20 financial year. A new supplier(s) for these services will be agreed over the course of the next 12 months. Any such change will result in an amendment of this Data Sharing Agreement before the new changes can take effect.

There are no other organisations involved in the wider project nor any commissioners involved.

On-going produced outputs include risk-based monitoring through CQC insight:

-incorporates data indicators that align to CQC’s key lines of enquiry for that sector

-brings together information from people who use services, knowledge from CQC’s inspections and data from CQC’s partners

-indicates where the risk to the quality of care provided is greatest

-monitors change over time for each of the measures

-points to services where the quality may be improving

Outputs are produced on an ongoing basis and shared with the specific provider as well as granting access to key arms-length partners; for example, NHS England/ NHS Improvement. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

Pre-inspection data evidence grids: used by the inspections teams and shared with providers. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities. For example, 'Same-day procedure' indicator within HES sets out the proportion of elective admissions where the patient’s primary procedure was on the day of admission and provides high-level information to the inspection team for planning/ review purposes.

Outliers Programme : analysis of certain metrics derived from these data are shared with trusts who have hit a statistical threshold that is regarded as being of concern. A trust receives analysis only of patients admitted at that trust with a comparison to overall national rates. For example, indicators have been generated on ‘Perinatal mortality and neonatal readmissions’ used to monitor the care of new-borns; 'therapeutic endoscopic procedures on biliary tract' raised in response to an alert raised by Dr Foster Intelligence Ltd - investigated death rates for endoscopic procedures. This is aggregate information with small numbers suppressed in line with the CQC suppression rules as specified in processing activities.

National Reporting: used to support the creation and population of national reports providing a qualitative review of health and care supported by aggregated information. The nature of these reports varies year on year depending on CQC's topics of interest. This is aggregate information with small numbers suppressed in line with NHS Digital’s HES Analysis Guide. For example, MHMDS was used within CQC’s annual ‘Monitoring the Mental Health Act’; the 2017/18 publication appeared in February 2019.

Thematic reviews: used internally to inform CQC's regulatory activities. They provide an in-depth review of selected areas of care, for example dementia care. This is aggregate information with small numbers suppressed. This will use both the CQC suppression rules as specified in processing activities as well as NHS Digital’s HES Analysis Guide rules and judgement will be determined by CQC on whether it is felt a slightly nuanced version for circulation internally within CQC or externally to care providers/arms-length bodies partnering CQC would be of more benefit via the CQC rules. A further example being a review of urgent care in which the indicator of ‘death within 30 days of stroke, neck of femur, acute myocardial infarction’ was used from HES. They are shared publicly, however some contribute to CQC’s internal understanding of a subject and are not released publicly.

In the monitoring of organisations for ongoing compliance against essential quality and safety standards, CQC uses screening techniques in its CQC insight tools, which analyse a wide variety of data sources to highlight possible outlying concerns that trigger actions where concerns are raised. Such screening methods are aided by a more local approach to information gathering and analysis, which is being developed in consultation with appropriate stakeholders. These techniques, currently along with national surveys of patients, help to create a more holistic understanding in informing its work with ongoing compliance, investigations, and thematic reviews.

In addition, the data will also be used in the CQC’s remit to investigate serious concerns about the quality of public services. These data will be a vital pillar in both a national system of monitoring registered organisations, and the development and publication of reliable performance indicators.

CQC has been embedding its new insight programme over the last two years. Core data from this data sharing agreement were used in the production of indictors that align to CQC’s key lines of enquiry for a particular sector (e.g. hospitals). The indicators have been used to highlight the greatest risks to the quality of care and, through monitoring change over time, have pointed to services where the quality of care may be improving.

These data are also used in the regulatory planning meetings (RPMs) as well as in the production of pre-inspection data evidence grids. These have allowed lead inspectors to decide which core services to inspect. The data have provided the groundwork for inspectors to approach identified areas with an appropriate set of questions providing a clear focus during the intensive inspection process. The data used in these products help to derive an ongoing assessment of the quality of core services. Areas of concern are highlighted and remedial action is monitored to follow up improvements. Additionally, areas of good practice are also flagged with the specific aim of using quality benchmarks to raise standards both within and across organisations.

Side-by-side with this process, CQC’s outliers programme has continued to monitor and review potential outliers of high mortality and readmission rates. CQC received data from Dr Foster Intelligence Ltd that provided an additional route for identification in addition to CQC’s own. Where concerns were identified, these were taken up by the relevant relationship owner in conjunction with appropriate analytical support to understand whether an issue existed and, where this might have been the case, whether the trust were aware of the concern and what remedial action had been put in place. The mortality data are therefore used to provide a fundamental resource in the understanding of the quality of the provision of care and provide a tool to highlight where possible concerns may exist and where further investigation is required.

CQC has made extensive use of NHS Digital data within its insight pre-inspection reports within the hospital/ MH sectors. Over the previous 12 months, CQC have produced approximately 150 of these reports, which provide a breakdown of analysis by highlighted service (for example, surgery) and allow the inspection team to determine where to focus the inspection. The reports provide trust-level indicators and national comparisons from the most-readily available data and so allow the inspection team to hone in on particular areas of interest. An inspection report and associated ratings are then published.

The published reports included recommendations for improving the quality of care provision and examples of good practice that other organisations could adopt. The NHS Digital data are therefore critical in this process for driving up the quality of care provision both within each organisation and more widely across England.

Further reviews of the ratings and analyses of NHS Digital featured in the 2017/18 State of Care report that is designed to provide a high-level commentary on year-on-year changes to care provision within England. This year, it highlighted the ‘safety’ domain as a particular concern with the aim of creating debate and policy changes to make long-term improvements in this area.