Triage-HF Plus: Cardiac Implantable Electronic Device Remote Monitoring Combined with Telephone Triage to Identify and Manage Worsening Heart Failure

Manchester University NHS Foundation Trust · NHS Trust

In term In term in the September 2026 edition: the latest version runs to 31 March 2028.

Reference: DARS-NIC-204376-Y0V5Y
Current version: v4.2
Term of current version: 5 December 2025 to 31 March 2028
Start date: 1 September 2019
Data controller: Sole Data Controller
Commercial purposes: No
Sublicensing: No
Files released to date: 44

Why the data was released

Objective for processing

Modern day pacemakers not only treat slow and fast heart rhythms but also have the ability to detect key changes in the patient’s overall condition that can help identify patients who may be sub-optimally managed or unwell. The health care team in this unit at Manchester University Hospital NHS Foundation Trust (MUFT) analyses data from patients with Medtronic implanted cardiac devices on remote follow-up. This is collected by transmitting downloads from home via CareLink, an internet-based service which allows doctors to remotely monitor an implantable cardiac device and monitor the care of patients managed by the service. MUFT use the results to improve the care delivered to patients. This process is called service evaluation. This particular service evaluation is called Triage-HF Plus and the purpose of the evaluation is to improve patient pathways and guide future models of care for patients followed up by remote monitoring.

‘Triage HF Plus’ is a new clinical pathway which was implemented at MUFT in June 2016. This evaluation was discussed with the Health Research Authority (HRA) at time of onset and was designated as a non-research study as the aim was to evaluate current care. The evaluation started in June 2016, and MUFT now have 3-years of cardiac device data available. The pathway dictates all patients who perform a transmission from home which is calculated to have a high ‘Heart Failure Risk Score (HFRS) are contacted by telephone to establish if they have any symptoms. If patients have symptoms of worsening heart failure after telephone assessment they are deemed ‘triage positive’, and if not, ‘triage negative’. Clinical action is then taken directly at the time of phone call. Patients with a low- or medium- HFRS are managed as per their usual care plan.

In order to provide essential outcome data to evaluate the impact of this new clinical pathway, MUFT require additional short– and medium- term health care utilisation and death data for all patients with devices facilitating remote-monitoring at MUFT during the evaluation period (21st June 2016 to 21st September 2018).

Using the existing clinical data from patients with a HFRS enabled device, linked to NHS England Hospital Episode Statistics (HES) data, MUFT and academic partners based at the University of Manchester (UoM) will examine:

i) adverse outcomes at 30- and 90-days (all-cause hospitalisation, heart failure hospitalisation, mortality)

ii) adverse outcomes at 12-months. This longer-term data will help MUFT evaluate the safety of the pathway and help guide future changes to the pathway (for example, intensifying monitoring for high HFRS patients, and relaxing face-to-face monitoring frequencies for low HFRS patients).

iii) Examine healthcare utilisation across the different Heart Failure Risk Score groups (this will require access to outpatient data as well as data for hospitalisation/death/use of outpatient services in the 12 months prior to implementation of the pathway.

(iv) Examine healthcare utilisation for ‘Triage-positive’ and negative cases

This falls under the medical purpose in s251 as defined as a ‘medical diagnoses’ for the provision of care and treatment.

The data received under this Data Sharing Agreement (DSA) will include a one-off drop of 2019/2020 HES Outpatients (OP) data, along with a one-off drop of 2021/22 HES Admitted Patient Care (APC), Outpatients (OP) and Emergency Care Dataset (ECDS) data.

A one-off drop of 2022/23 HES OP, APC and ECDS data will also be received. This is because COVID has significantly impacted Triage HF Plus hospitalisations and MUFT recently published data to indicate that there was a significant decrease in hospital admissions for Heart Failure during COVID, but this was associated with an increase in deaths from heart failure in the community (European Heart Journal-Quality of Care and Clinical Outcomes).

* Therefore, HES and mortality data for the period March 2020- June 2021 is likely to be tainted by the impact of COVID and is not an accurate representation of HF hospitalisation/ mortality data in non-COVID times.

* Due to the impact of COVID on HES and mortality data MUFT requires access to data until Sept 2023.

The data received from NHS England will be used solely for this project. Results will be published in a peer-review medical journal and presented at conferences. Results will likely feed into a bigger programme of service improvement by better use of cardiac device remote monitoring systems.

No elements of this work are taking place outside of England/Wales.

The data requested is justified under Article 6(1)e of the General Data Protection Regulation.

The collection of data from NHS England is essential to provide robust outcomes data for patients managed by the new pathway in order to establish if outcomes are improved. This is in the public interest as: (1) results from the Triage-HF Plus evaluation will advance academic and clinical knowledge regarding the true utility of health-related data, obtained from implanted devices, to complement the monitoring of heart failure stability, (2) whether managing patients using the Triage-HF Plus pathway results in improved care and outcomes for patients, (3) results from the Triage-HF Plus evaluation may lead to either further clinical studies or direct change in clinical service provision with the aim of improving patient care.

The data requested is justified under Article 9(2)h of the General Data Protection Regulation.

As laid out above, processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services (see processing activities).

Hospitalisation, healthcare utilisation and mortality data from NHS England will allow MUFT to investigate the impact of the Triage HF Plus clinical pathway.

NHS England data will provide dates and information about hospital attendances, admissions, Outpatient attendances and deaths. These events will be added to timelines at an individual record level to facilitate predictive modelling.

Background to the evaluation

Triage HF Plus (Identifying and Managing Heart Failure Episodes In Ambulatory Patients With A Cardiac Implantable Electronic Device (CIED) Using Device Based Diagnostics and Automated CareLink Alerts) is a non-research, service evaluation project.

At the Trust, Medtronic CareLink transmissions from the ambulatory Cardiac Implantable Electronic Devices (CIED) population are routinely reviewed as part of standard clinical practice and this practice is endorsed by international guidelines. All patients have provided written informed consent ahead of enrolment onto the CareLink remote monitoring network and patients provide verbal informed consent to having their CareAlerts (capable of generating automatic alerts) enabled.

CareAlerts are a functionality of the device that need to be enabled in order for alerts about abnormal health-related data to be sent electronically to the clinical team. In patients where alerts have not been enabled, no alert will be sent to the clinical team. Patients will have attended a face-to-face visit to have these alerts enabled as part of routine care at some point during their follow-up.

Advances in heart failure diagnostics mean that it is also possible to identify patients at risk of worsening heart failure using health-related data recorded by the CIED. The Medtronic ‘Heart Failure Risk Score’ (HFRS) is an algorithm that uses input from health-related data recorded by the CIED stratify patients as low-, medium- or high-risk of a heart failure event in the next 30 days.

Since June 2016 MUFT have been using HFRS-based alerts for the remote identification of worsening heart failure in the population of CIED patients who are enrolled on the CareLink platform. The Research and Innovation department at Manchester Foundation Trust reviewed the service evaluation proposal to respond to Medtronic CareLink HFRS-based alerts and approved the use of the One Clinical Service database as a data collection tool to support the evaluation.

One Clinical Service (operated by Medtronic) is a secure care management service/ database that pulls data from the 'cloud' where device-related data sits. Using OCS clinicians can view physiological data and add clinical data in a secure environment. The hospital is the data controller, while Medtronic is the data processor on behalf of the Hospital.

On the basis that MUFT routinely respond to CareLink alerts in the existing practice, the Triage HF Plus service evaluation represents an extension of the existing clinical service. High-risk HFRS alerts prompt a telephone consultation with the patient, using the information provided by the remote transmission and patient reported symptoms appropriate clinical actions in line with clinical guidelines are instigated – this has become known as the ‘Triage-HF Plus pathway’.

Service evaluation has so far confirmed the Triage-HF Plus pathway appears to accurately identify patients who would benefit from a telephone assessment of heart failure stability and general health.

Purpose of Request

The purpose of this evaluation is to evaluate the Triage HF Plus pathway for the remote monitoring of heart failure stability and establish the accuracy of the pathway to predict adverse events and healthcare utilisation.

I. Data regarding (1) non-elective hospital attendances and (2) non-elective hospital admissions (3) Outpatient attendances and (4) death is required to provide the outcome data for this evaluation.

II. Information regarding the dates of these events is required to facilitate predictive modelling.

III. Data is required to be identifiable so MUFT can link events with each individual in order to facilitate predictive modelling.

IV. Data for the 12 months prior to date of enrolment in the pathway is required to examine healthcare utilisation associated with implementation of the Triage HF Plus clinical pathway.

V. There are no less intrusive ways of achieving this data reliably.

Proposed use of data

Recognising that remote monitoring of health-related data derived from CIEDs offers the potential to reconfigure clinical services based on their clinical condition, MUFT wish to examine health care utilisation (HCU) and mortality in the low-, medium- and high-HFRS groups to examine and validate the current care pathways and to assist in the development of future state care pathways. In view of this consideration, MUFT are applying to collect -12 month, +30 day, +90 day and +12 month outcome data (elective / non-elective hospital attendances and mortality) for the patients enrolled in the evaluation.

Cohort

MUFT have approximately 500 patients at the trust who are implanted with HFRS enabled devices capable of stratifying the risk of heart failure events based on health-related data, who have consented to remote monitoring using the CareLink platform.

Section 251 support is also in place to facilitate linkage with HES and Civil Registration Death data.

The section 251 approval allows the flow of the following identifiers to flow from Manchester University NHS Foundation Trust to NHS England.

NHS number

Date of birth

Sex

Postcode

As MUFT is a tertiary cardiac centre serving the wider area of Greater Manchester, East Cheshire and Lancashire, MUFT require central NHS England data to accurately establish local hospital attendances. MUFT also require civil registration data from NHS England as this is more reliable than mortality data collected at MUFT.

Support sought

MUFT are requesting time limited access to allow NHS England to undertake linkage of existing data held by the clinical team to HES /Civil registration data to collect follow-up / additional data on an existing dataset that is already held by the trust. By linking the two datasets MUFT will obtain additional information to help develop future state care models for CIED patients enrolled in remote monitoring programs.

The Confidentiality Advisory Group and Secretary of State for Health and Social Care have considered the application at the precedent set CAG and have authorised Time Limited Access to undertake the record linkage/ sample validation and to anonymise the data. MUFT have engaged informally with NHS England who will act as a third party to carry out data linkage and confirmed the minimum data identifiers required to undertake the linkage.

Organisations involved in evaluation

1. Manchester University NHS Foundation Trust (MUFT) - **note previously known as Central Manchester NHS Foundation Trust**

Role: (i) Sole data controller (ii) Data processor

Data remit: Provide Participant ID Numbers (PIDN) and patient identifiers to NHS England to facilitate linkage.

* NHS Number

* Date of Birth

* Gender

* Postcode

NHS England will return a pseudonymised extract linked HES-Civil Registration Deaths to MUFT.

The data sent by NHS England does not need to be re-identified once received back by MUFT.

MUFT have already prepared a pseudonymised clinical dataset (device and medical record data) which will be analysed along side the pseudonymised datasets returned from NHS England.

Both datasets use a unique random 6-digit PIN that can be used to link the two datasets. This avoids the need to re-identify any data. MUFT will only be handling pseudonymised (de-identified) data from this point forwards.

MUFT will also facilitate the transfer of pseudonymised data to and from NHS England, storage, processing and (in part) analysis of data.

2. University of Manchester

Role: Data processor

Data remit: Analysis of pseudonymised database.

UoM will receive pseudonymised NHS England data and this will be transferred via MUFT (data controller).

3. Medtronic Inc

Role: Providing patient level data concerning health-related data from Medtronic CareLink platform prior to linkage by NHS England.

Data remit: Medtronic have no access to any of the NHS England data. It is not involved in this aspect of the data processing. Medtronic's role in the evaluation is to provide Heart Failure Risk Status (HFRS) data to MUFT. As such Medtronic is neither a data controller or data processor within this DSA. Should their role change the DSA will require an amendment to NHS England and necessary approvals sought.

This DSA covers data for the cohort of participants covered by Section 251 approval.

Processing activities

NHS England data will be linked with individual patients in the study cohort by Participant ID Number (PIDN). Both datasets use a unique random 6-digit PIDN that can be used to link the 2 datasets. This avoids the need to re-identify any data.

Manchester University NHS Foundation Trust (MUFT) will act as the co-coordinating organisation. MUFT will provide NHS England with identifiers alongside corresponding PIDN for each patient in the cohort, and receive in return NHS England data linked with PIDN.

All organisations party to data sharing must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by Personnel (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

Sharing of a minimal identifiable data set from participants with NHS England is outlined in the approved CAG Section 251 application. Using information booklets and posters in waiting rooms MUFT have stated the plans to use routinely collected health-data from implanted devices to inform the development of new data-driven, technology enabled remote monitoring pathways for patients with heart failure who also have implanted devices.

Data Flows

Information transferred to NHS England will be record-level, directly identifiable patient data. Data received from NHS England will be record-level pseudonymised data.

Personal data for each study participant will be provided to NHS England by the data controller (Manchester University NHS Foundation Trust, MUFT). Data transfer will occur via an encrypted data transfer service. This data will be PIDN (unique random 6-digit number) and personal identifiers only: NHS Number, Date of Birth, Gender, Postcode.

Linked NHS England data will then be provided to the data controller (MUFT) via an encrypted transfer system. The output of NHS England data received will be record-level. Data will be analysed with PIDN only. Disseminated pseudonymised data from NHS England will only be shared with named individuals working at MUFT, and the academic collaborators at UoM. Data will not be transferred to any other organisation. A dataset with aggregated data with small numbers suppressed will be made available and will be viewed by collaborators from MUFT and UoM for the purpose of supporting the analysis. The collaborator is Medtronic, who are supporting the health-economic analysis of the new clinical pathway.

Data Safe Haven (DSH)

Pseudonymised NHS England data processed by the data controller (MUFT) will be received via the DSH at the University of Manchester (UoM) where additional processing and analysis can be undertaken. Access to the DSH is only granted to substantive employees of the University of Manchester or postgraduate students enrolled with MuFT whom have completed the University's Data Protection Training and authorised by the Research Governance, Ethics and Integrity team (RGEIT). Each DSH user has a project file within the DSH, which is accessible to that user only.

Data will be accessed by students enrolled for a postgraduate course (e.g. Masters and/or PhD) with MUFT. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to MUFT's policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of MUFT. MUFT would be responsible and liable for any work carried out by students. These students may only work on the Data for the purposes described in this DSA.

The postgraduate students will not be accessing the data remotely.

Access to the DSH is restricted to on-campus connectivity only. Only named individuals are authorised to move data in or out of the DSH. No personnel outside the direct employment of the University of Manchester will have access to the processed NHS England data.

NHS England data is downloaded into the DSH via a single point - a static IP addressed laptop within the RGEIT office.

For this evaluation, NHS England data will be received by the data controller (MUFT). The data controller will create a separate password-protected sub-folder within their project folder on the MUFT server, which can only be accessed by named individuals. Once the data is stored; this will be manually reviewed to ensure there are no obvious issues with the data. Here it will be combined with other evaluation data to create a pseudonymised database for analysis. This data includes:

NHS England data for each participant. This will be combined with data collected from (1) Cardiac device data and (2) Data from medical records (stored in pseudonymised database) to create a pseudonymised database.

The pseudonymised database will be used for all analysis.

Once this pseudonymised data file is checked and authorised the original NHS England data file will be destroyed.

The pseudonymised database will be transferred from MUFT to UoM via the DSH. After logging on to the laptop with their UoM username and password, the named academic analysts will access the DSH using the University’s 2-factor authentication Service (Duo) to verify their identity. Data is transferred into the separate password-protected sub-folder in PIs project folder within the DSH using the Secure Transfer Service.

The pseudonymised NHS England data file will be stored within a secure project file in the DSH. Data will be stored in the DSH until such time that all peer-reviewed publications have been disseminated and the clinical team are confident that no further analysis will be required (maximum storage 10 years).

Data analysis will be performed using software within the DSH (mainly Excel, SPSS, R, GraphPad).

Processed pseudonymised data may be transferred back to MFT from the DSH to facilitate analysis/checking by substantive employees from Manchester University NHS Foundation Trust during different stages of the analysis process. Researchers at University of Manchester have no access to the pseudonymisation key, rendering the dataset effectively anonymised. This data transfer will be undertaken in line with processes outlined in this DSA - i.e., secure file transfer directly onto the MFT server. This has been discussed and approved by the HRA Confidentiality Advisory Group.

No NHS England data will be transferred outside England and Wales.

NHS England data will be combined with data collected as part of the TRIAGE evaluation project as stated above. It will not be linked with any other databases.

Outside MUFT, it will not be possible to re-identify individuals based on data provided. Access to the key linking PIDN and patient identifiers will be kept securely at MUFT with access granted to named individuals only. This file will be destroyed once all data analysis is complete, and results disseminated and peer review complete.

There will be no data linkage undertaken with NHS England data provided under this DSA that is not already noted in the DSA.

Access is restricted to employees or agents of Manchester University NHS Foundation Trust.

Expected output

Results will be submitted to peer-review journals and presented locally at meetings, and at national/international conferences.

Local meetings, held in Greater Manchester, will be attended by clinicians, healthcare practitioners, healthcare scientists, clinical managers, heart failure charities and patients.

No data presented will be identifiable. Small numbers will be suppressed in all outputs in line with the HES analysis guide to avoid risk of re-identification – any data with less than 5 patients will not be shown.

Interested audiences will be health professionals – but will not be restricted i.e. results will be available to the public.

Dissemination of Results

When processing is complete, outputs will include:

1. Submission to peer review journal.

2. Presentations at:

a) Internal meetings at UoM and MFT

b) Seminars and workshops at academic events (where appropriate)

c) National and international academic conferences

d) Patient engagement events

3. A lay summary of results for patients and interested non-academic parties will be placed on the Research Webpage for Manchester Heart Centre. a) letters/emails to study participants

b) MFT, Health Innovation Manchester, UoM and on publicly accessible websites

c) Results may be disseminated in the form of progress reports for interested parties (may include the PhD student's thesis and external collaborators).

A manuscript for peer review publication is currently in the final stages of writing, with the aim to publish mid 2024. An additional manuscript will follow 2023/2024, Interim results have been disseminated at the following academic conferences;

(1) European Society of Cardiology Congress 2022, platform presentation. Use of a device-based remote management heart failure care pathway is associated with reduced hospitalization and improved patient outcomes: TriageHF Plus real-world evaluation.

(3) American Heart Association Scientific Sessions 2021, platform presentation. Use of a Novel Cardiac Implantable Electronic Device Digital Care Pathway (TriageHF-Plus) is Associated With a Reduction in All-Cause Unplanned Hospitalizations.

Of note, these presentations have received significant media exposure:

(1) The Telegraph article: The ‘game-changing’ heart implant that can slash hospital admissions, August

2022.

(2) British Heart Foundation webpage news article: Remote heart alert system saves heart failure patients

from hospitalisation, August 2022

(3) The Times article: Heart implant transmits patient data to hospital for instant care alerts, August 2022.

(4) British Heart Foundation Heart Matters magazine, June 2022.

(5) The Telegraph article: How advances in technology and data from pacemakers alert doctors about

heart failure patients who may benefit from medical attention. February 2022.

All study participants have been made aware of the he study website (https://research.cmft.nhs.uk/research/manchester-royal-infirmary/manchester-heart-centre/clinical-studies/triage-hf-plus-evaluation). The interim results have not yet been published on this webpage, but this will be done following peer-review process of results.

The PhD student’s thesis has been submitted and she has been awarded her PhD.

Level of data contained in outputs

All outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide. Some case study timelines for individual participants may be published to visualise the association between health-related device data and non-elective hospital admission/attendance events however all dates will be removed (dates replaced with timeline of day e.g. 0-365) and no data will be presented which could directly identify the individual e.g. specific details of reasons for hospital attendance/admission or multiple co-morbidity data. This is considered essential for displaying the clinical significance of device data.

Dissemination and communication approach

Through the outputs stated above, the results of this evaluation will be disseminated to target audience of researchers, data scientists, academic groups, innovative technology-focused organisations and research participants. Health Innovation Manchester (HInM) has established links with a wide variety of communities and will help ensure output is brought to the attention of policy makers and industry collaborators.

Communication channels will include

Academic channels peer review journal manuscripts, presentation at conferences

Website and newsletters via UoM, (Health Innovation Manchester (HInM) and MFT

Open lectures and talks public promotion of results via HInM public engagement meetings. MFT clinicians and academics will present the results of this Triage-HF Plus evaluation at at least one cardiology congress.

Exploitation of results/outputs

MFT has a research collaboration Agreement in place with Medtronic outlining data and knowledge ownership and access rights. Results will be shared with all stakeholders (including Medtronic who have supplied the health-related data from implanted devices) but Medtronic will only see aggregated outputs of the NHS England data.

Stakeholders will have no influence on the evaluation results.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

Expected measurable benefits

The main benefit of this evaluation study will be a greater understanding of the utility of a combined HFRS/telephone triage service i.e. the Triage HF Clinical Pathway to identify patients at risk of 30-day hospitalisation or death. If results show good diagnostic utility (and the health economics evaluation confirms low burden on implementation) – this may contribute to a change in national guidance – upgrading recommendations to more strongly supporting this strategy is incorporated into routine clinical practice. If results show poor diagnostic utility, this may contribute to a downgrading of current guidance.

On a local level, results will help MFT to adapt the current service provided to cardiac device patients to improve care. For example, if patients are being admitted to hospital within 30 days of a high alert despite feeling well at the time of alert, MFT may implement a new pathway streamlining all patients to have a face-to-face clinical review.

This will benefit patients by improving patient care, and the NHS by evaluating the best service delivery. MFT anticipate it would take 2-3 years to fully implement and evaluate significant new changes.

Another benefit of this study will be improved knowledge of the utility of the Triage-HF Plus clinical pathway as a pragmatic screening tool to identify patients at increased risk of hospitalisation. This will be of benefit to health and social care as outlined below:

Researchers: Improved knowledge in this research area opens up new avenues of research within the field of device/heart failure research. If device data is shown to accurately identify patients at increased risk of heart failure hospitalisation, then this may justify modifying clinical pathways and facilitate the rapid scale up implementation of this pathway across the UK. Interim results have been presented and the aim is to disseminate comprehensive results in 2023/2024. Discussions across other sites are already taking place to scope out rapid scale up across the UK.

Clinicians: A greater understanding of the significance of health-related data from cardiac devices will help health professionals make the best use of cardiac device data to serve their patients. For example, this study may lead to a greater emphasis on enrolling patients onto remote monitoring platforms to enable abnormal results to be reviewed by clinical teams. Target date: Dissemination of work to improve knowledge of relevant health professionals: 2023/2024.

Patients: This work will hopefully lead to improved patient care. This may not occur as a direct result of this evaluation, rather further down the line as results inform service improvement projects.

2023 update: NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data in people with cardiac implantable electronic devices” is currently underway, demonstrating how this research is directly contributing to review of national guidance. Results are expected in 2024.

Benefits reported so far

Yielded benefits to date as a result of preliminary data are summarised here.

It has been identified that the TriageHF Plus pathway is:

1. Associated with reduced risk of all-cause hospitalisation

(2024) Association of a device-based remote management heart failure pathway with outcomes: TriageHF Plus real-world evaluation. ESC Heart Failure, 11: 2637–2647. https://doi.org/10.1002/ehf2.14821.

2. Cost-effective

Data submitted to NICE review in 2024, and used as part of the evaluation to recommend remote monitoring as an option in routine care:

https://www.nice.org.uk/guidance/dg61

Economic modelling has also been presented at an international conference (European Cardiology Congress August 2025) and a paper is currently in peer-review with Heart.

In view of this, TriageHF Plus is now being rolled out across sites in the UK.

Datasets on the current version

Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Datasets approved under DARS-NIC-204376-Y0V5Y-v4.2
Dataset	Type of data	Sensitivity	Frequency	Confidential data
Civil Registrations of Death - Secondary Care Cut	Identifiable	Sensitive	One-Off	Section 251 NHS Act 2006
Emergency Care Data Set (ECDS)	Identifiable	Non-Sensitive	One-Off	Section 251 NHS Act 2006
HES:Civil Registration (Deaths) bridge	Identifiable	Non-Sensitive	Ongoing	Section 251 NHS Act 2006
Hospital Episode Statistics Accident and Emergency (HES A and E)	Identifiable	Non-Sensitive	One-Off	Section 251 NHS Act 2006
Hospital Episode Statistics Admitted Patient Care (HES APC)	Identifiable	Non-Sensitive	One-Off	Section 251 NHS Act 2006
Hospital Episode Statistics Critical Care (HES Critical Care)	Identifiable	Non-Sensitive	One-Off	Section 251 NHS Act 2006
Hospital Episode Statistics Outpatients (HES OP)	Identifiable	Non-Sensitive	One-Off	Section 251 NHS Act 2006

Files released

Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.

Patient opt-outs were applied to all 44 files released under this agreement, across every version. About opt-outs

No files recorded as released under the current version. 44 were released under earlier versions, shown in the version history.

Version history

The register lists each renewal of this agreement as a separate row. This site has 5 versions.

DARS-NIC-204376-Y0V5Y-v4.2 5 December 2025 to 31 March 2028

Title: Triage-HF Plus: Cardiac Implantable Electronic Device Remote Monitoring Combined with Telephone Triage to Identify and Manage Worsening Heart Failure
Commercial: No
Sublicensing: No
Datasets: 7
Files released: 0

Datasets: Civil Registrations of Death - Secondary Care Cut; Emergency Care Data Set (ECDS); HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP)

What changed from DARS-NIC-204376-Y0V5Y-v3.3

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-204376-Y0V5Y-v3.3
Field	Was	Became
Start date	~~2024-04-05~~	2025-12-05
End date	~~2026-03-31~~	2028-03-31

Objective for processing

[66 paragraphs unchanged] Data remit: Analysis of pseudonymised ~~research~~ database. [5 paragraphs unchanged]

Processing activities

[14 paragraphs unchanged] For this evaluation, NHS England data will be received by the data [48 words unchanged] it will be combined with other evaluation data to create a pseudonymised ~~research~~ database for analysis. This data includes: NHS England data for each participant. This will be combined with data [8 words unchanged] Data from medical records (stored in pseudonymised database) to create a pseudonymised ~~research~~ database. [2 paragraphs unchanged] The pseudonymised ~~research~~ database will be transferred from MUFT to UoM via the DSH. After [38 words unchanged] in PIs project folder within the DSH using the Secure Transfer Service. [8 paragraphs unchanged]

Benefits reported

[2 paragraphs unchanged] 1. Associated with reduced risk of all-cause hospitalisation ~~(results presented at academic conference, publication submitted for peer-review)~~ ~~2. Cost-effective (preliminary results submitted to NICE Diagnostics Assessment Programme, not yet presented/published)~~ (2024) Association of a device-based remote management heart failure pathway with outcomes: TriageHF Plus real-world evaluation. ESC Heart Failure, 11: 2637–2647. https://doi.org/10.1002/ehf2.14821. ~~In addition, the TriageHF algorithm can:~~ 2. Cost-effective ~~1. Discriminate between patients at high and low risk of cardiovascular and non-cardiovascular hospitalisation in real-time.~~ Data submitted to NICE review in 2024, and used as part of the evaluation to recommend remote monitoring as an option in routine care: ~~2. Discriminate between ambulatory patients at high and low risk of death- i.e., stratify risk remotely and predict all-cause mortality.~~ https://www.nice.org.uk/guidance/dg61 In view of these considerations, remotely monitored data is now being used (in Greater Manchester and other centres) to identify high-risk patients to clinical care teams for focused review to ensure that evidence-based treatments are optimised, in order to reduce risk of unplanned hospitalisation and mortality. Interim results across three sites suggest this is the case and these results has been presented in conferences. Economic modelling has also been presented at an international conference (European Cardiology Congress August 2025) and a paper is currently in peer-review with Heart. Analysis is ongoing to provide robust analysis of healthcare utilisation (changes to clinical coding to account for COVID-19 have led to some delays). The aim is to provide comprehensive results by 2023/2024. In view of this, TriageHF Plus is now being rolled out across sites in the UK.

Unchanged: Expected output, Expected measurable benefits.

DARS-NIC-204376-Y0V5Y-v3.3 5 April 2024 to 31 March 2026

Title: Triage-HF Plus: Cardiac Implantable Electronic Device Remote Monitoring Combined with Telephone Triage to Identify and Manage Worsening Heart Failure
Commercial: No
Sublicensing: No
Datasets: 7
Files released: 8

What changed from DARS-NIC-204376-Y0V5Y-v2.8

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-204376-Y0V5Y-v2.8
Field	Was	Became
Start date	~~2023-02-03~~	2024-04-05
End date	~~2023-11-07~~	2026-03-31
Civil Registrations of Death - Secondary Care Cut: legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Emergency Care Data Set (ECDS): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
HES:Civil Registration (Deaths) bridge: legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Hospital Episode Statistics Accident and Emergency (HES A and E): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Hospital Episode Statistics Critical Care (HES Critical Care): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Hospital Episode Statistics Outpatients (HES OP): legal basis	~~Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Objective for processing

Modern day pacemakers not only treat slow and fast heart rhythms but [9 words unchanged] the patient’s overall condition that can help identify patients who may be ~~suboptimally~~ sub-optimally managed or unwell. The health care team in this unit at Manchester [88 words unchanged] guide future models of care for patients followed up by remote monitoring. [2 paragraphs unchanged] Using the existing clinical data from patients with a HFRS enabled device, linked to NHS ~~Digital~~ England Hospital Episode Statistics (HES) data, MUFT and academic partners based at the University of Manchester (UoM) will examine: [5 paragraphs unchanged] The data required under this Agreement will include a request for HES A&E 19/20 which was originally omitted from the previous agreement. In addition, there is also a request for ECDS 20/21 annual data to enable a 2 year follow up, after the last eligible patient had been identified. Patients were under active evaluation at MUFT between June 2016 and Sept 2018. However, remotely monitored cardiac device data was available for patients for a total of 3 years (i.e., up to September 2019). The data received under this Data Sharing Agreement (DSA) will include a one-off drop of 2019/2020 HES Outpatients (OP) data, along with a one-off drop of 2021/22 HES Admitted Patient Care (APC), Outpatients (OP) and Emergency Care Dataset (ECDS) data. ~~Therefore, the 21/22 HES annual refresh data and the latest mortality data is also required.~~ A one-off drop of 2022/23 HES OP, APC and ECDS data will also be received. This is because COVID has significantly impacted Triage HF Plus hospitalisations and MUFT recently published data to indicate that there was a significant decrease in hospital admissions for Heart Failure during COVID, but this was associated with an increase in deaths from heart failure in the community (European Heart Journal-Quality of Care and Clinical Outcomes). COVID has significantly impacted Triage HF Plus hospitalisations and MUFT recently published data to indicate that there was a significant decrease in hospital admissions for Heart Failure during COVID, but this was associated with an increase in deaths from heart failure in the community (European Heart Journal-Quality of Care and Clinical Outcomes). [1 paragraph unchanged] * Due to the impact of COVID on HES and mortality data MUFT ~~is now requesting~~ requires access to data until Sept ~~2022.~~ 2023. The data ~~requested~~ received from NHS ~~Digital~~ England will be used solely for this project. Results will be published in [16 words unchanged] of service improvement by better use of cardiac device remote monitoring systems. [2 paragraphs unchanged] The collection of data from NHS ~~Digital~~ England is essential to provide robust outcomes data for patients managed by the [82 words unchanged] change in clinical service provision with the aim of improving patient care. [2 paragraphs unchanged] Hospitalisation, healthcare utilisation and mortality data from NHS ~~Digital~~ England will allow MUFT to investigate the impact of the Triage HF Plus clinical pathway. NHS ~~Digital~~ England data will provide dates and information about hospital attendances, admissions, Outpatient attendances [6 words unchanged] added to timelines at an individual record level to facilitate predictive modelling. [21 paragraphs unchanged] The section 251 approval allows the flow of the following identifiers to flow from Manchester University NHS Foundation Trust to NHS ~~Digital.~~ England. [4 paragraphs unchanged] As MUFT is a tertiary cardiac centre serving the wider area of Greater Manchester, East Cheshire and Lancashire, MUFT require central NHS ~~Digital~~ England data to accurately establish local hospital attendances. MUFT also require civil registration data from NHS ~~Digital~~ England as this is more reliable than mortality data collected at MUFT. [1 paragraph unchanged] MUFT are requesting time limited access to allow NHS ~~Digital~~ England to undertake linkage of existing data held by the clinical team to [34 words unchanged] future state care models for CIED patients enrolled in remote monitoring programs. The Confidentiality Advisory Group and Secretary of State for Health and Social [22 words unchanged] validation and to anonymise the data. MUFT have engaged informally with NHS ~~Digital~~ England who will act as a third party to carry out data linkage and confirmed the minimum data identifiers required to undertake the linkage. [3 paragraphs unchanged] Data remit: Provide Participant ID Numbers (PIDN) and patient identifiers to NHS ~~Digital~~ England to facilitate linkage. [4 paragraphs unchanged] NHS ~~Digital~~ England will return a pseudonymised extract linked HES-Civil Registration Deaths to MUFT. The data sent by NHS ~~Digital~~ England does not need to be re-identified once received back by MUFT. MUFT have already prepared a pseudonymised clinical dataset (device and medical record data) which will be analysed along side the pseudonymised datasets returned from NHS ~~Digital.~~ England. [1 paragraph unchanged] MUFT will also facilitate the transfer of pseudonymised data to and from NHS ~~Digital,~~ England, storage, processing and (in part) analysis of data. [3 paragraphs unchanged] UoM will receive pseudonymised NHS ~~Digital~~ England data and this will be transferred via MUFT (data controller). [1 paragraph unchanged] Role: Providing patient level data concerning health-related data from Medtronic CareLink platform prior to linkage by NHS ~~Digital.~~ England. Data remit: Medtronic have no access to any of the NHS ~~Digital~~ England data. It is not involved in this aspect of the data processing. [17 words unchanged] such Medtronic is neither a data controller or data processor within this ~~Agreement.~~ DSA. Should their role change the ~~Agreement~~ DSA will require an amendment to NHS ~~Digital~~ England and necessary approvals sought. This ~~Agreement~~ DSA covers data for the cohort of participants covered by Section 251 approval.

Processing activities

NHS ~~Digital~~ England data will be linked with individual patients in the study cohort by [17 words unchanged] link the 2 datasets. This avoids the need to re-identify any data. Manchester University NHS Foundation Trust (MUFT) will act as the co-coordinating organisation. MUFT will provide NHS ~~Digital~~ England with identifiers alongside corresponding PIDN for each patient in the cohort, and receive in return NHS ~~Digital~~ England data linked with PIDN. [1 paragraph unchanged] Sharing of a minimal identifiable data set from participants with NHS ~~Digital~~ England is outlined in the approved CAG Section 251 application. Using information booklets [28 words unchanged] monitoring pathways for patients with heart failure who also have implanted devices. [1 paragraph unchanged] Information transferred to NHS ~~Digital~~ England will be record-level, directly identifiable patient data. Data received from NHS ~~Digital~~ England will be record-level pseudonymised data. Personal data for each study participant will be provided to NHS ~~Digital~~ England by the data controller (Manchester University NHS Foundation Trust, MUFT). Data transfer [16 words unchanged] number) and personal identifiers only: NHS Number, Date of Birth, Gender, Postcode. Linked NHS ~~Digital~~ England data will then be provided to the data controller (MUFT) via an encrypted transfer system. The output of NHS ~~Digital~~ England data received will be record-level. Data will be analysed with PIDN only. Disseminated pseudonymised data from NHS ~~Digital~~ England will only be shared with named individuals working at MUFT, and the [46 words unchanged] Medtronic, who are supporting the health-economic analysis of the new clinical pathway. [1 paragraph unchanged] Pseudonymised NHS ~~Digital~~ England data processed by the data controller (MUFT) will be received via the [15 words unchanged] Access to the DSH is only granted to substantive employees of the ~~UoM~~ University of Manchester or postgraduate students enrolled with MuFT whom have completed the ~~Universities~~ University's Data Protection Training and authorised by the Research Governance, Ethics and Integrity [7 words unchanged] project file within the DSH, which is accessible to that user only. Access to the DSH is restricted to on-campus connectivity only. Only named individuals are authorised to move data in or out of the DSH. No personnel outside the direct employment of the University of Manchester will have access to the processed NHS Digital data. Data will be accessed by students enrolled for a postgraduate course (e.g. Masters and/or PhD) with MUFT. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to MUFT's policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of MUFT. MUFT would be responsible and liable for any work carried out by students. These students may only work on the Data for the purposes described in this DSA. ~~NHS Digital data is downloaded into the DSH via a single point - a static IP addressed laptop within the RGEIT office.~~ The postgraduate students will not be accessing the data remotely. For this evaluation, NHS Digital data will be received by the data controller (MUFT). The data controller will create a separate password-protected sub-folder within their project folder on the MUFT server, which can only be accessed by named individuals. Once the data is stored; this will be manually reviewed to ensure there are no obvious issues with the data. Here it will be combined with other evaluation data to create a pseudonymised research database for analysis. This data includes: Access to the DSH is restricted to on-campus connectivity only. Only named individuals are authorised to move data in or out of the DSH. No personnel outside the direct employment of the University of Manchester will have access to the processed NHS England data. NHS Digital data for each participant. This will be combined with data collected from (1) Cardiac device data and (2) Data from medical records (stored in pseudonymised database) to create a pseudonymised research database. NHS England data is downloaded into the DSH via a single point - a static IP addressed laptop within the RGEIT office. For this evaluation, NHS England data will be received by the data controller (MUFT). The data controller will create a separate password-protected sub-folder within their project folder on the MUFT server, which can only be accessed by named individuals. Once the data is stored; this will be manually reviewed to ensure there are no obvious issues with the data. Here it will be combined with other evaluation data to create a pseudonymised research database for analysis. This data includes: NHS England data for each participant. This will be combined with data collected from (1) Cardiac device data and (2) Data from medical records (stored in pseudonymised database) to create a pseudonymised research database. [1 paragraph unchanged] Once this pseudonymised data file is checked and authorised the original NHS ~~Digital~~ England data file will be destroyed. [1 paragraph unchanged] The pseudonymised NHS ~~Digital~~ England data file will be stored within a secure project file in the [23 words unchanged] confident that no further analysis will be required (maximum storage 10 years). [1 paragraph unchanged] Processed pseudonymised data may be transferred back to MFT from the DSH [37 words unchanged] data transfer will be undertaken in line with processes outlined in this ~~agreement~~ DSA - i.e., secure file transfer directly onto the MFT server. This has been discussed and approved by the HRA Confidentiality Advisory Group. No NHS ~~Digital~~ England data will be transferred outside England and Wales. NHS ~~Digital~~ England data will be combined with data collected as part of the TRIAGE evaluation project as stated above. It will not be linked with any other databases. [1 paragraph unchanged] There will be no data linkage undertaken with NHS ~~Digital~~ England data provided under this ~~agreement~~ DSA that is not already noted in the ~~Agreement.~~ DSA. Data will only be accessed and processed by substantive employees of Manchester University NHS Foundation Trust and will not be accessed or processed by any other third parties not mentioned in this Agreement. Access is restricted to employees or agents of Manchester University NHS Foundation Trust.

Expected output

[8 paragraphs unchanged] a) Internal meetings at UoM and ~~MUFT~~ MFT [4 paragraphs unchanged] b) ~~MUFT,~~ MFT, Health Innovation Manchester, UoM and on publicly accessible websites c) Results may be disseminated in the form of progress reports for interested parties (may include the PhD student's ~~thesis).~~ thesis and external collaborators). [2 paragraphs unchanged] ~~(2) Europhysiology conference 2022, poster presentation. Physical activity measured by cardiac devices predicts frailty, hospitalisation and death in older people.~~ [10 paragraphs unchanged] ~~The~~ All study participants have been made aware of the he study website (https://research.cmft.nhs.uk/research/manchester-royal-infirmary/manchester-heart-centre/clinical-studies/triage-hf-plus-evaluation) is up to date and letters were recently sent to participants with a reminder of this webpage for information. (https://research.cmft.nhs.uk/research/manchester-royal-infirmary/manchester-heart-centre/clinical-studies/triage-hf-plus-evaluation). The interim results have not yet been published on this webpage, but this will be done following peer-review process of results. The PhD student’s thesis has been ~~submitted.~~ submitted and she has been awarded her PhD. [6 paragraphs unchanged] Website and newsletters via UoM, (Health Innovation Manchester (HInM) and ~~MUFT~~ MFT [2 paragraphs unchanged] ~~MUFT~~ MFT has a research collaboration Agreement in place with Medtronic outlining data and [21 words unchanged] implanted devices) but Medtronic will only see aggregated outputs of the NHS ~~Digital~~ England data. [2 paragraphs unchanged]

Expected measurable benefits

[1 paragraph unchanged] On a local level, results will help ~~MUFT~~ MFT to adapt the current service provided to cardiac device patients to improve [13 words unchanged] of a high alert despite feeling well at the time of alert, ~~MUFT~~ MFT may implement a new pathway streamlining all patients to have a face-to-face clinical review. This will benefit patients by improving patient care, and the NHS by evaluating the best service delivery. ~~MUFT~~ MFT anticipate it would take 2-3 years to fully implement and evaluate significant new changes. [4 paragraphs unchanged] 2023 update: NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data in people with cardiac implantable electronic devices” is currently underway, demonstrating how this research is directly contributing to review of national guidance. Results are expected in 2024.

Benefits reported

~~The main benefit to patients is that, as a result of preliminary data the applicant has synthesised evidence to support the broader use of this technology.~~ Yielded benefits to date as a result of preliminary data are summarised here. ~~Yielded benefits to date are summarised here.~~ It has been identified that the TriageHF Plus pathway is: ~~MUHFT have identified that routinely monitored data, automatically collected on a daily basis can~~ 1. Associated with reduced risk of all-cause hospitalisation (results presented at academic conference, publication submitted for peer-review) 2. Cost-effective (preliminary results submitted to NICE Diagnostics Assessment Programme, not yet presented/published) In addition, the TriageHF algorithm can: [2 paragraphs unchanged] ~~a. Higher percentages of time spent in a ‘high’ risk status, and less time in a ‘low’ risk status, was associated with increased risk of death.~~ In view of these considerations, remotely monitored data is now being used (in Greater Manchester and other centres) to identify high-risk patients to clinical care teams for focused review to ensure that evidence-based treatments are optimised, in order to reduce risk of unplanned hospitalisation and mortality. Interim results across three sites suggest this is the case and these results has been presented in conferences. In view of these considerations, remotely monitored data is now being used (in Greater Manchester and other centres) to identify high-risk patients to clinical care teams for focused review to ensure that evidence-based treatments are optimised, in order to reduce risk of unplanned hospitalisation and mortality. Interim results across three sites suggest this is the case and these results has been presented in conferences. Analysis is ongoing to provide robust analysis of healthcare utilisation (changes to [8 words unchanged] to some delays). The aim is to provide comprehensive results by 2023/2024.