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From EHR to PHR: Let’s Get the Record Straight

Journal: BMJ Open

Manuscript ID bmjopen-2019-029582.R1 ArticleFor Type: peerCommunication review article only Date Submitted by the 20-Feb-2019 Author:

Complete List of Authors: Symons, Joshua D; Imperial College London, Department of Surgery & Cancer Ashrafian, Hutan; Imperial College London, Department of Surgery & Cancer; Dunscombe, Rachel; Salford Royal NHS Foundation Trust Darzi, Ara; Imperial College London, Institute of Global Health Innovation

Primary Subject Patient-centred medicine Heading:

Secondary Subject Heading: Public health

Patient Health Record, Electronic Health Record, Patient Empowerment, Keywords: Digital, Digital Health

http://bmjopen.bmj.com/ on October 1, 2021 by guest. Protected copyright.

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1 2 3 4 From EHR to PHR: Let’s Get the Record Straight 5 6

7 a b c d 8 Joshua Symons , Hutan Ashrafian , Rachel Dunscombe , Ara Darzi 9 a Director, Big Data & Analytical Unit (BDAU), Centre for Health Policy (CHP), Institute of Global Health 10 11 Innovation (IGHI), Imperial College London

12 b 13 Chief Scientific Adviser and Honorary Senior Clinical Fellow in Surgery, Institute of Global Health 14 Innovation (IGHI), Imperial College London 15 c 16 Group Director of For Digital and peer Chief Information review Officer, Salford only Royal NHS Foundation Trust and 17 Northern Care Alliance 18 d 19 Director, Institute of Global Health Innovation (IGHI), Imperial College London 20 21 22 Corresponding author - Joshua Symons ([email protected]) 23 24 10th Floor QEQM (Queen Elizabeth the Queen Mother) Building 25 26 Room 1069 27 28 St Mary’s Hospital Campus 29 30 Imperial Health Care NHS Trust 31 32 Praed Street, W2 1NY 33

34 London, UK http://bmjopen.bmj.com/ 35 36 37 38 39 40 41

42 on October 1, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 9 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 Abstract 4 5 The importance of implementing integrated electronic health records as a route to enhance the quality 6 of health delivery has been increasingly understood. Electronic health records however carry several 7 8 limitations that include major fragmentation through multiple providers and protocols throughout the 9 NHS. Analysing the digital healthcare landscape, we identify that adopting a patient health record 10 system can empower patients and allow better harmonisation of clinical data at a national level. We 11 propose regional patient health record hubs to provide a universal interface that integrates digital heath 12 data at a regional level. This will reduce the complexity of connections, decrease governance challenges 13 14 and interoperability issues while also providing a safe platform for high-quality scalable and sustainable 15 digital solutions, including AI, across the NHS. 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33

34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41

42 on October 1, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 9 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 The importance of implementing integrated electronic health records (EHR) as a route to enhance the 4 quality of health delivery were outlined as early as 1998. The benefits of universal access for patients, 5 6 clinicians, policy makers and administrators include (i) increasing confidence and convenience through 7 streamlined access to information, (ii) improving clinical outcomes through enhanced care 8 communication, (iii) better decision making through access to real-time evidence and (iv) enabling 9 planning and productivity gains through increased efficiency.1 In 2014, it was proposed that by March of 10 2 11 2018, all individuals should have both viewing and editing capabilities for their own health record. This 12 proposal aligns with the recent definition of a personal health record (PHR) by the Royal College of 13 Physicians as “digital tools that allow a citizen to interact with health and social care services, have 14 access to the clinical content in their record, capture, record and if they wish, share their own data with 15 clinicians and others”.3 PHRs therefore provide an integral part of health record integration that is not 16 For peer review only 17 currently provided by EHR systems alone. Furthermore, PHRs have been shown to contribute to health 18 awareness and could be key in empowering patients to take direct control of their own healthcare.4 19 However, despite widespread availability of multiple PHR solutions in the UK, 2018 is now passing 20 without substantial adoption and patients able to meaningfully interact with their own healthcare data. 21 22 Although there has been growth in the number of PHR providers in almost all regions of the UK, PHR 23 uptake by patients and organisations is still remarkably slow.5 In response to a survey in 2016, less than 24 500,000 people were individually registered users of PHR while 1,377 organisations, including 122 NHS 25 26 Trusts, 16 Clinical Commissioning Groups (CCGs), 1,184 General Practice Surgeries (GPs), 33+ local 27 authorities, 15+ social care providers and 7 health boards were listed as organisational users of PHR.6 28 However, it is not clear if single organisations have integrated with multiple PHR providers thereby 29 conflating the totals and making them appear larger than they are, such as indicating that nearly half of 30 all NHS Trusts are organisational users.6 Slow uptake has been attributed to barriers in (i) governance 31 6 32 approval, (ii) clinical engagement, (iii) patient awareness and (iv) integration with local sytems. 33 Challenges in governance are being overcome by legislation changes informed by recent Caldicott

34 reports.6 Some existing PHR systems give patients choice over sharing of their data addressing some of http://bmjopen.bmj.com/ 35 the governance concerns. Clinician and patient experience has been investigated to determine personal 36 3 37 barriers to PHR adoption. However, PHR integration with local systems, or PHR interoperability, 38 remains an unexplored challenge. Despite a large amount of research in EHR interoperability, there is a 39 paucity of evidence regarding barriers for EHR integration with PHR. The prospect of universally 40 connecting PHR systems is daunting considering individual CCGs, NHS Trusts, GPs, PHR and EHR vendors 41 and exchange protocols (Table 1 and Figure 1). Established node connection formulae demonstrates 42 on October 1, 2021 by guest. Protected copyright. 43 that just over 8,500 organisations could require over 36 million individual connections to provide real- 44 time connectivity of records for patients at any location.7 8 This doesn’t take into account additional 45 organisations such as laboratories, social and community care. Further addition of PHR providers, 46 personal devices and applications will exponentially increase this complexity. Solutions have been 47 proposed to deal with some of this complexity as part of national programmes but these fall short of 48 49 implementing the benefits of PHR. 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 9 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 Type Count 4 Care organisations (207) CCGs 5 6 (152) acute specialist and non-specialists trusts 7 (54) mental health trusts 8 (35) community providers 9 (10) ambulance trusts 10 (853) for-profit and not-for-profit independent sector organisations 11 (7,148) GPs 12 PHR providers (29) independent providers recorded by RCP 13 14 GP EHR providers (4) EMIS, TPP, INPS, Microtest 15 Trust EHR providers (7) Allscripts, Cerner, Epic, Intersystems, Lorenzo, Meditech, OpenEHR 16 Exchange protocols For(6) HL7, peerFHIR, IHE, CDA, review XDS, DICOM only 17 18 Table 1 Examples of different care providers, PHR and EHR providers and exchange protocols used within the UK. List is non-exhaustive. 19 20 Local Health and Care Record Exemplars (LHCREs) have been created with the same proposed benefits 21 outlined in 1998 through integration of care records, such as primary care with secondary, mental 22 health and social at a regional level.9 Although LHCREs aim to achieve real-time data sharing of both 23 identifiable and de-personalised data for direct care, the scope of these integrated records does not 24 25 universally include provision of linked data for research or patient access to read and write to integrated 26 records.9 Approaches to governance of data in LHCRE are not universal, with some initiatives putting 27 control of research and sharing permission with GPs and Academic Health Science Networks (AHSNs) 28 while others form independent research advisory groups. This creates regional variation in data sharing 29 30 practices, record access and approved uses of data. Furthermore, resources are limited, with some 31 LHCRE funding only covering £7.5 million of the estimated £90 million 5 year cost, making non-critical 32 features difficult to justify.10 This raises important questions around sustainability of LHRCEs which have 33 yet to be answered. Therefore, although LHCRE may provide integration of records to improve direct 34 care, patients will not necessarily benefit from access to these records, researchers may not be able to http://bmjopen.bmj.com/ 35 36 utilise these linked records to produce evidence and industry may not have access to the benefits of 37 real-time data access to develop new digital interventions. Digital innovation hubs will go some way in 38 addressing use of LHCRE data for innovative research but will not provide patient access or data input 39 into these records.11 40 41 At a national level, the National Record Locator Service (NRLS) has been proposed to achieve 42 harmonisation of individual health records across the U.K.12 This will be achieved by connecting NRLS to on October 1, 2021 by guest. Protected copyright. 43 various patient master index (PMI) systems at care providers which will keep care records up to date. 44 45 Although this important service will aim to provide a pointer to a single source of truth record for each 46 patient, it will not guarantee the quality of that record or provide integration of records for non-clinical 47 sources of patient data. The proof of concept for the service will also not include retrieval of the actual 48 patient records, therefore this service will not be able to provide real-time access to patient records at a 49 12 50 national level. NRLS will require that care provider services will be always available for querying using a 51 pull method, but services may not be available resulting in limited access to required records. 52 Connectivity to records at a national level will be dependent on the quality of local PMI and EHR 53 systems. Such connectivity issues could result in patient safety incidents due to missing records. 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 9 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 The newly released NHS App will allow patients to check symptoms, book GP appointments, manage 4 repeat prescriptions, view their own primary care record and manage data sharing preferences.13 5 6 Although this mobile application will create a baseline entry point for every NHS patient to view their GP 7 records, it does not include any ability to edit or even view the entire patient record. Other features will 8 allow patients to interact with portions of the health and social care system but listed benefits indicate 9 that this tool will provide a passive consumption service for commissioned digital services, not allow 10 11 patients to integrate digital services they have already chosen. Despite improving access to NHS services 12 and providing a starting point for universal primary care record access, the NHS application in its current 13 form will not provide a full universal PHR solution in its initial form and will overlap with functionality 14 provided by existing EHR portals and PHR platforms.14 15 16 Although the NHS App cannot replicate 15 existing PHR solutions and may not be designed to replace them it is unclear at this time how the 16 For peer review only 17 release of this application might impact the ability of PHR providers to market their products and 18 services. It is also unclear on how patient opt-out for data sharing in the NHS App will impact data 19 sharing at a regional level as patients might believe that using the application to opt-out of data sharing 20 will stop any sharing of their data in any system, resulting in a lack of clarity and transparency for 21 patients and organisations alike. 22 23 True PHR is the only current proposed health record solution which provides a choice to patients for 24 inputting into and controlling their own health records. Current PHR provider models are mainly centred 25 26 on integrating with local EHR systems at a care provider level, which has been shown to be more 27 beneficial than standalone PHR systems, although both models have been reported as offering 28 healthcare benefits.6 Although this meets the criteria of providing patients access, it does not provide 29 patients a choice in features of different PHR providers or join data across multiple providers. 30 Integration is also done using bespoke interoperability with local providers one solution at a time. To 31 32 provide choice in PHR features, integration with multiple PHR providers is required by single institutions. 33 This increases the burden and cost to these institutions to provide multiple PHR solutions and makes

34 universal adoption of PHR more difficult as patients and clinicians are unable to determine what benefit http://bmjopen.bmj.com/ 35 different PHR solutions may provide. Stand-alone PHR systems which enable patient input will not 36 37 necessarily be integrated with PMI systems and therefore data from these systems will not be available 38 to NRLS, making the patient responsible for communicating relevant information to clinicians and 39 exacerbating the existing burden for patients. 40 41 The dangers of trying to individually connect EHRs nationally and regionally while simultaneously

42 increasing adoption of PHR with the current system structure are substantial. This could lead to record on October 1, 2021 by guest. Protected copyright. 43 fragmentation which is an established concern and possibly lock data into another silo, unavailable to 44 the persons who need it. 17 Additionally, there could be an increasing disparity between the information 45 46 patients think is available to carers compared to what exists at the point of care. NRLS would need to 47 connect to more systems with less certainty over the range of standards which will be required to locate 48 records. Although the PHR adoption toolkit provides guidance for most standards, implementation of 49 these interoperability standards will inevitably vary.18 Currently there is also no solution for universal 50 integration of personal device data into most EHR systems. Some PHR systems provide this functionality, 51 52 but iterative evaluation of digital interventions will not be possible where personal device data is not 53 being integrated back into clinical records. A recent report by REFORM has recommended that 54 integration of such data should be explicitly included in NHS procurement contracts to ensure that 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 9 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 digital interventions can be tested for safety and efficacy. Universal integration of this form of patient 4 data into clinical records will be a large challenge for any EHR provider. 5 6 To overcome the barriers of universal record integration and PHR adoption, we propose a new model of 7 8 connecting systems with a PHR “hub” providing integration at regional levels for a single ‘source of 9 truth’ PHR (Figure 1). The PHR hub would consolidate data across EHR and PHR providers thereby 10 reducing complexity immensely while simultaneously moving towards universal choice and control for 11 patients. Complexity, barriers to interoperability and the potential for vendor lock-in would be further 12 reduced by requiring open standards in the PHR hub.19 Such an initiative would naturally complement 13 14 existing LHCREs, reducing variability for LHCRE implementation and enabling LHCREs to focus on critical 15 record integration. Patient controlled PHRs would decrease governance burden for organisations as 16 patients themselves For would control peer records orreview be able to delegate only this to care providers as needed. 17 Furthermore, each regional PHR would facilitate universal record validity by bridging local patient 18 master index (PMI) systems to keep patient details up to date. This would then ease requirements for 19 12 20 the National Record Locator Service (NRLS). PHR hubs could also separate care record service from 21 care settings allowing for better security and easier data migrations. PHR hubs would also provide a 22 single integration point between multiple PHR and EHR providers taking away the burden of integration 23 from the care provider. Finally, universal PHR accessibility would allow PHR vendors to market directly 24 to patients supported by clinician conversations around the benefits, possibly providing a far more 25 26 efficient method of increasing patient adoption and providing an easier path to self-care. 27 28 The ambition of achieving the potential of PHRs has long been established. Barriers such as a lack of EHR 29 systems, lack of PHR functionality in existing EHR systems, failed top-down implementation and 30 interoperability issues have presented formidable opponents to this ambition. Enabling true patient 31 empowerment requires that organisations are able to universally connect to PHR providers and that 32 patients are able to select the PHR provider they prefer. Only where PHR adoption is driven by patients 33

34 will PHR access fully satisfy the requirements of its intended users. We have proposed a new call for http://bmjopen.bmj.com/ 35 regional PHR hubs to provide an universal PHR interface and integrate EHR systems at a regional level. 36 This will reduce the complexity of connections, decrease governance challenges and interoperability 37 issues while also providing a safe platform for high-quality scalable and sustainable digital solutions, 38 including AI, across the NHS. Achieving standardised universal PHR adoption in the NHS will unlock the 39 40 true value of the UK’s integrated healthcare records. 41

42 on October 1, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 9 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 Figure Legend 4 5 Figure 1: PHR hubs would transform the complex ecosystem (left) including high patient and provider 6 burden to a simpler ecosystem (right) centred around the patient increasing choice and system flexibility 7 8 9 10 Funding: This research had infrastructure support provided by the NIHR Imperial Biomedical Research 11 Centre (BRC) 12 13 14 15 Competing Interests: None 16 For peer review only 17 18 19 Authorship statement: All authors (JS, HA, RD, AD) all contributed to the conception/ design/ 20 acquisition/ analysis/ interpretation of data for this work. They all contributed to the drafting/ 21 intellectual content and gave final approval for publishing. 22 23 24 25 26 27 References 28 1 29 NHS Executive. Information for health: an information strategy for the modern NHS 1998-2005. 30 Department of Health 1998. 31 http://webarchive.nationalarchives.gov.uk/20120503231618/http://www.dh.gov.uk/prod_consum_dh/ 32 groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4014469.pdf 33

34 2 Kelsey T, Cavendish W. Personalised Health and Care 2020: Using Data and Technology to Transform http://bmjopen.bmj.com/ 35 Outcomes for Patients and Citizens. National Information Board 2014. 36 37 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/38 38 4650/NIB_Report.pdf 39 3 40 Wyatt J, Hoogewerf J, Quinn N. Personal health record (PHR) User insights. RCP 2017. 41 https://www.rcplondon.ac.uk/projects/outputs/personal-health-record-phr-user-insights (accessed 3

42 Sep 2018). on October 1, 2021 by guest. Protected copyright. 43 44 4 Ozok AA, Wu H, Garrido M, Pronovost PJ, Gurses AP. Usability and perceived usefulness of personal 45 health records for preventive health care: A case study focusing on patients' and primary care providers' 46 perspectives. Applied ergonomics. 2014 May 1;45(3):613-28. 47 48 5 PHR locations map - NHS Digital. NHS Digital. 2018. https://digital.nhs.uk/services/personal-health- 49 records-adoption-toolkit/phr-locations-map (accessed 3 Sep 2018). 50 51 6 Wyatt J, Sathanandam S, Rastall P. Personal health record (PHR) landscape review Final report. RCP 52 53 2016. https://www.rcplondon.ac.uk/projects/outputs/personal-health-record-phr-landscape-review 54 (accessed 3 Sep 2018). 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 9 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 7 NHS statistics, facts and figures. Nhsconfed.org. 2017.http://www.nhsconfed.org/resources/key- 4 statistics-on-the-nhs (accessed 3 Sep 2018). 5 6 8 Benson T. Principles of health interoperability HL7 and SNOMED. 2nd ed. London: : Springer 2012. 7 8 9 Farenden J, Singh I. Local Health and Care Record Exemplars: A summary. NHS England. 2018. 9 https://www.england.nhs.uk/wp-content/uploads/2018/05/local-health-and-care-record-exemplars- 10 11 summary.pdf

12 10 13 Personal communication 14 11 £37.5m investment in Digital Innovation Hubs to tackle Britain’s biggest health challenges - Health 15 16 Data Research UK. HDRFor UK. 2018. peer https://www.hdruk.ac.uk/news/37-5m-investment-in-digital- review only 17 innovation-hubs/ (accessed 26 Nov 2018). 18 12 19 National Record Locator Service - Health Developer Network. Health Developer Network. 2018. 20 https://developer.nhs.uk/library/systems/national-record-locator-service/ (accessed 3 Sep 2018). 21 22 13 NHS App - NHS Digital. NHS Digital. 2018. https://digital.nhs.uk/services/nhs-app (accessed 26 Nov 23 2018). 24 25 14 Patient Access – GP services at your fingertips. EMIS Health. 2018. 26 https://www.emishealth.com/products/patient-access/ (accessed 26 Nov 2018). 27 28 15 Patient portal software – About us – Patients Know Best. Patients Know Best. 2018. 29 https://www.patientsknowbest.com/about-us.html (accessed 26 Nov 2018). 30 31 16 Who Evergreen Life are & our mission for people powered health. Evergreen Life. 2018. 32 https://www.evergreen-life.co.uk/who-we-are (accessed 26 Nov 2018). 33

34 17 Beard L, Schein R, Morra D, Wilson K, Keelan J. The challenges in making electronic health records http://bmjopen.bmj.com/ 35 accessible to patients. Journal of the American Medical Informatics Association. 2011 Nov 25;19(1):116- 36 20. 37 38 18 Guidance for developing Personal Health Records - NHS Digital. NHS Digital. 2018. 39 40 https://digital.nhs.uk/services/personal-health-records-adoption-toolkit/guidance-for-developing- 41 personal-health-records (accessed 3 Sep 2018).

42 on October 1, 2021 by guest. Protected copyright. 19 43 Open Standards principles. GOV.UK. 2018. https://www.gov.uk/government/publications/open- 44 standards-principles/open-standards-principles (accessed 3 Sep 2018). 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

Page 9 of 9 BMJ Open

1 2 3 152 4 5 Acute 64 6 Trusts Other 6 7 Trusts 8 Protocols 9 10 29 11 11 PHR HUBS 12 For peer review29 PHR only PHR EHR

13 GP http://bmjopen.bmj.com/ 14 EHR 15 Protocols 16 Trust Patients 17 EHR 18 Patients 19 20

21 on October 1, 2021 by guest. Protected copyright. 207 22 CCGs 216 23 Trusts 24 25 26 27 28 207 Clinical Commissioning 7,148 General 29 Groups Practices 7,148 GP 30 31 Practices 32 33 34 35 36 37 38 39 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

From EHR to PHR: Let’s Get the UK Record Straight

Journal: BMJ Open

Manuscript ID bmjopen-2019-029582.R2 ArticleFor Type: peerCommunication review only Date Submitted by the 09-May-2019 Author:

Primary Subject Patient-centred medicine Heading:

Secondary Subject Heading: Public health

Patient Health Record, Electronic Health Record, Patient Empowerment, Keywords: Digital, Digital Health

http://bmjopen.bmj.com/ on October 1, 2021 by guest. Protected copyright.

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1 2 3 4 From EHR to PHR: Let’s Get the UK Record Straight 5 6

12 b 13 Chief Scientific Adviser and Honorary Senior Clinical Fellow in Surgery, Institute of Global Health 14 Innovation (IGHI), Imperial College London 15 c 16 Group Director of For Digital and peer Chief Information review Officer, Salford only Royal NHS Foundation Trust and 17 Northern Care Alliance 18 d 19 Director, Institute of Global Health Innovation (IGHI), Imperial College London 20 21 22 Corresponding author – Hutan Ashrafian ([email protected]) 23 24 Institute of Global Health Innovation 25 26 10th Floor QEQM (Queen Elizabeth the Queen Mother) Building 27 28 St Mary’s Hospital Campus 29 30 Praed Street, W2 1NY 31 32 London, UK 33

34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41

42 on October 1, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 10 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 Abstract 4 5 This article reflects on the changing nature of health information access and the transition of focus from 6 electronic health records (EHRs) to personal health records (PHRs) along with the challenges and need 7 8 for alignment of national initiatives for EHR and PHR in the National Health Service (NHS) of the United 9 Kingdom (UK). 10 11 The importance of implementing integrated EHRs as a route to enhance the quality of health delivery 12 has been increasingly understood. EHRs however carry several limitations that include major 13 fragmentation through multiple providers and protocols throughout the NHS. Questions over ownership 14 and control of data further complicate the potential for fully utilising records. Analysing the previous 15 initiatives and the current landscape, we identify that adopting a patient health record system can 16 For peer review only 17 empower patients and allow better harmonisation of clinical data at a national level. We propose 18 regional PHR “hubs” to provide a universal interface that integrates digital heath data at a regional level 19 with further integration at a national level. 20 21 We propose that these PHR “hubs” will reduce the complexity of connections, decrease governance 22 challenges and interoperability issues while also providing a safe platform for high-quality scalable and 23 sustainable digital solutions, including artificial intelligence (AI) across the UK NHS, serving as an 24 25 exemplar for other countries which wish to realise the full value of healthcare records. 26 27 28 29 30 31 32 33

34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41

42 on October 1, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 10 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 Background 4 5 The importance of implementing integrated EHR, increasingly referred to as electronic patient records 6 (EPRs), as a route to enhance the quality of health delivery in the UK NHS were outlined as early as 7 1 8 1998. The benefits of universal access for patients, clinicians, researchers, policy makers and 9 administrators include (i) increasing confidence and convenience through streamlined access to 10 information, (ii) improving clinical outcomes through enhanced care communication, (iii) better science 11 and decision making through access to real-time evidence and (iv) enabling planning and productivity 12 gains through increased efficiency.1 In 2014, it was proposed that by March of 2018, all individuals 13 2 14 should have both viewing and editing capabilities for their own health record. This proposal aligns with 15 the definition of a personal health record (PHR) by the Royal College of Physicians as “digital tools that 16 allow a citizen to interactFor with healthpeer and social review care services, have only access to the clinical content in their 17 record, capture, record and if they wish, share their own data with clinicians and others”.3 PHRs 18 therefore provide an integral part of health record integration that is not currently provided by EHR 19 20 systems alone. Furthermore, PHRs have been shown to contribute to health awareness and could be key 21 in empowering patients to take direct control of their own healthcare.4 However, despite widespread 22 availability of multiple PHR solutions in the UK, 2018 has now passed without substantial adoption of 23 PHRs and empowerment of patients through meaningful interaction with their own healthcare data. 24 25 Although there has been growth in the number of PHR providers in almost all regions of the UK, PHR 26 uptake by patients and organisations is still remarkably slow.5 In response to a survey in 2016, less than 27 28 500,000 people were individually registered users of PHR while 1,377 organisations, including 122 NHS 29 Trusts, 16 Clinical Commissioning Groups (CCGs), 1,184 General Practice Surgeries (GPs), 33+ local 30 authorities, 15+ social care providers and 7 health boards were listed as organisational users of PHR.6 31 However, it is not clear if single organisations have integrated with multiple PHR providers thereby 32 conflating the totals and making them appear larger than they are, e.g. counts reflecting that nearly half 33 6

34 of all NHS Trusts are organisational users. Slow uptake has been attributed to barriers in (i) sharing of http://bmjopen.bmj.com/ 35 data at a local level, (ii) clinical aversion and reluctance, (iii) patient awareness and (iv) technical 36 integration with local information sytems.6 Despite improvements in data sharing mandates, namely 37 through the Caldicott principles, the first challenge remains heavily influenced by the second and third 38 challenges as sharing of data is inhibited where there is a lack of clinician and patient endorsement.6 39 40 Furthermore, PHR solutions have the ability to address the first 3 challenges through patient control of 41 records and bringing value for clinicians and patients yet this ability is hampered by the formidable

42 challenge of local integration. Given that the majority of existing UK PHR solutions are reliant on direct on October 1, 2021 by guest. Protected copyright. 43 integration with existing EHR solutions, local information exchange remains a key inhibitor to gaining 44 value from PHRs.6 45 46 Despite a large amount of research in EHR interoperability, there is a paucity of evidence regarding 47 48 barriers for EHR integration with PHR, i.e. PHR interoperability. The prospect of universally connecting 49 PHR systems is daunting considering the sheer number of individual CCGs, NHS Trusts, GPs, PHR and 50 EHR vendors and exchange protocols (Table 1 and Figure 1). Established node connection formulae 51 demonstrates that 8,500 organisations could require over 36 million individual connections to provide 52 real-time connectivity of records for patients at any location.7 8 This doesn’t take into account additional 53 54 organisations such as laboratories, social and community care. Further addition of PHR providers, 55 personal devices and applications will exponentially increase this complexity. Solutions have been 56 proposed to deal with some of this complexity as part of national programmes but these fall short of 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 10 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 implementing the benefits of PHR. Therefore, both technical and socio-technical barriers for information 4 exchange between health record systems continue to present the biggest barrier for enabling these 5 6 benefits. 7 8 Type Count 9 Care organisations (207) CCGs 10 (152) acute specialist and non-specialists trusts 11 (54) mental health trusts 12 (35) community providers 13 (10) ambulance trusts 14 (853) for-profit and not-for-profit independent sector organisations 15 (7,148) GPs 16 For peer review only 17 PHR providers (29) independent providers recorded by RCP 18 GP EHR providers (4) EMIS, TPP, INPS, Microtest 19 Trust EHR providers (7) Allscripts, Cerner, Epic, Intersystems, Lorenzo, Meditech, OpenEHR 20 Exchange protocols (6) HL7, FHIR, IHE, CDA, XDS, DICOM 21 22 Table 1 Examples of different care providers, PHR and EHR providers and exchange protocols used within the UK. List is non-exhaustive. 23 24 Reducing Barriers for Information Exchange 25 26 Local Health and Care Record Exemplars (LHCREs) have been created in the NHS with the same 27 proposed benefits outlined in 1998 through integration of care records, such as primary care with 28 secondary, mental health and social at a regional level.9 Although LHCREs aim to achieve real-time data 29 30 sharing of both identifiable and de-personalised data for direct care, the scope of these integrated 31 records does not universally include provision of linked data for research or patient access to read and 32 write to integrated records.9 Approaches to governance of data in LHCRE are not universal, with some 33 initiatives putting control of research and sharing permission with GPs and Academic Health Science 34 http://bmjopen.bmj.com/ Networks (AHSNs) while others form independent research advisory groups. Some LHCREs are 35 36 implementing PHR repositories at a regional level but this is not universal and different LHCREs are 37 embracing different technologies.10 This creates regional variation in data sharing practices, record 38 access and approved uses of data. Furthermore, resources are limited, with some LHCRE funding only 39 covering £7.5 million of the estimated £90 million 5 year cost, making non-critical features difficult to 40 10 41 justify. This raises important questions around sustainability of LHRCEs which have yet to be answered.

42 Therefore, although LHCRE may provide integration of records to improve direct care, patients will not on October 1, 2021 by guest. Protected copyright. 43 necessarily benefit from access to these records, researchers may not be able to utilise these linked 44 records to produce evidence and industry may not have access to the benefits of real-time data access 45 to develop new digital interventions. Digital innovation hubs, funded through Health Data Research UK 46 47 (HDR UK) and aiming to increase research using local integrated records, will go some way in addressing 48 use of LHCRE data for innovative research but will not provide patient access or data input into these 49 records.11 50 51 At a national level, the National Record Locator Service (NRLS), not to be confused with the same 52 abbreviation used for the National Reporting and Learning System, has been proposed to achieve 53 harmonisation of individual health records across the U.K.12 This will be achieved by connecting NRLS to 54 various electronic patient master index (EPMI) systems at care providers which will keep care records up 55 56 to date. Although this important service will aim to provide a pointer to a single source of truth record 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 10 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 for each patient, it will not guarantee the quality of that record or provide integration of records for 4 non-clinical sources of patient data. The proof of concept for the service will also not include retrieval of 5 6 the actual patient records and early features are aimed at providing access for direct care, therefore this 7 service will not be able to provide real-time access to patient records at a national level.12 NRLS in its 8 current iteration, will require that care provider services will be always available for querying using a pull 9 method, but services may not be available resulting in limited access to required records. Connectivity 10 11 to records at a national level will be dependent on the quality of local EPMI and EHR systems. Such 12 connectivity issues could result in patient safety incidents due to missing records. Furthermore there is a 13 need to consider other sources of data relevant to personal health such as income, education and other 14 data which patients may be able to share easily given the right mechanism. This has given rise in “smart 15 cities” to the concept of a person master index (PMI) as an alternative to an EPMI. 16 For peer review only 17 The newly released NHS App will allow patients to check symptoms, book GP appointments, manage 18 repeat prescriptions, view their own primary care record and manage data sharing preferences.13 These 19 20 features are enabled through a “broker” system which translates individual health record provider 21 implementations.14 Although this mobile application will create an excellent baseline entry point for 22 every NHS patient to view their GP records, it does not include any ability to edit or even view the entire 23 patient record. Other features will allow patients to interact with portions of the health and social care 24 system but listed benefits indicate that this tool will provide a passive consumption service for 25 26 commissioned digital services, not allow patients to integrate digital services they have already chosen. 27 Despite improving access to NHS services and providing a starting point for universal primary care 28 record access, the NHS application in its current form will not provide a full universal PHR solution in its 29 initial form and will overlap with functionality provided by existing EHR portals and PHR platforms.15 16 17 30 Although the NHS App cannot replicate existing PHR solutions and may not be designed to replace them 31 32 it is unclear at this time how the release of this application might impact the ability of PHR providers to 33 market their products and services. It is also unclear on how patient opt-out for data sharing in the NHS

34 App will impact data sharing at a regional level as patients might believe that using the application to http://bmjopen.bmj.com/ 35 opt-out of data sharing will stop any sharing of their data in any system, resulting in a lack of clarity and 36 37 transparency for patients and organisations alike with potential loss of trust across all stakeholders. 38 PHR which enables full two-way integration of both care provider health record data and patient 39 40 generated data with patient control of data sharing, is the only current proposed health record solution 41 which provides a choice to patients for inputting into and controlling their own health records. PHRs also

42 provide benefit by providing digital intervention data generated by patients to clinicians as well as on October 1, 2021 by guest. Protected copyright. 43 providing a missing piece of research data necessary to evaluate the true patient journey. Current PHR 44 provider models are mainly centred on integrating with local EHR systems at a care provider level, which 45 46 has been shown to be more beneficial than standalone PHR systems, although both models have been 47 reported as offering healthcare benefits.6 Although this meets the criteria of providing patients access, it 48 does not provide patients a choice in features of different PHR providers or join data across multiple 49 providers. Integration is also done using bespoke interoperability with local providers one solution at a 50 time. To provide choice in PHR features, integration with multiple PHR providers is required by single 51 52 institutions. This increases the burden and cost to these institutions to provide multiple PHR solutions 53 and makes universal adoption of PHR more difficult as patients and clinicians are unable to determine 54 what benefit different PHR solutions may provide. Stand-alone PHR systems which enable patient input 55 will not necessarily be integrated with PMI systems and therefore data from these systems will not be 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 10 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 available to NRLS, making the patient responsible for communicating relevant information to clinicians 4 and exacerbating the existing burden for patients. 5 6 Learning from the Past 7 8 The dangers of trying to individually connect EHRs nationally and regionally while simultaneously 9 increasing adoption of PHR with the current system structure are substantial. This could lead to record 10 11 fragmentation which is an established concern and possibly lock data into another silo, unavailable to 12 the persons or systems which need it. 18 Additionally, there could be an increasing disparity between the 13 information patients think is available to carers compared to what exists at the point of care. NRLS 14 would need to connect to more systems with less certainty over the range of standards which will be 15 required to locate records. Although the PHR adoption toolkit provides guidance for most standards, 16 For peer review only19 17 implementation of these interoperability standards will inevitably vary. Currently there is also no 18 solution for universal integration of personal device data into most EHR systems. Some PHR systems 19 provide this functionality, but monitoring of digital interventions such as prescribed mobile applications 20 will not be possible where personal device data is not being integrated back into clinical records. As 21 22 suggested in a 2018 REFORM report on data value, integration of such data should be explicitly included 20 23 in NHS procurement contracts to ensure that digital interventions can be tested for safety and efficacy. 24 Furthermore, the benefits of integrating patient generated data into clinical records have been clearly 25 outlined in the Topol review.21 Universal integration of this form of patient data into clinical records will 26 be a large challenge for any EHR provider. 27 28 A Potential Solution 29 30 To overcome the barriers of universal record integration and PHR adoption, we propose a new model of 31 connecting systems with a PHR “hub” providing integration at regional levels for a single ‘source of 32 truth’ PHR (Figure 1). The PHR hub could operate in a similar fashion to the “broker” system used by the 33

34 NHS App to communicate with different implementations of GP systems, translating data across EHR http://bmjopen.bmj.com/ 35 and PHR providers thereby reducing complexity immensely while simultaneously moving towards 36 universal choice and control for patients. Complexity, barriers to interoperability and the potential for 37 vendor lock-in would be further reduced by requiring open standards in the PHR hub.22 Such an initiative 38 39 would naturally complement existing LHCREs, especially if implemented at a regional level, reducing 40 variability for LHCRE implementation and enabling LHCREs to focus on critical record integration. 41 Combining this with patient controlled PHRs would decrease governance burden for organisations as

42 patients themselves would control records or be able to delegate this to care providers as needed. on October 1, 2021 by guest. Protected copyright. 43 Furthermore, each regional PHR would facilitate universal record validity by bridging local patient 44 45 master index (PMI) systems to keep patient details up to date. This would then ease requirements for 46 the National Record Locator Service (NRLS).12 PHR hubs could also separate care record service from 47 care settings allowing for better security and easier data migrations. PHR hubs would provide a single 48 integration point between multiple PHR and EHR providers taking away the burden of integration from 49 the care provider. Finally, universal PHR accessibility would allow PHR vendors to market directly to 50 51 patients supported by clinician conversations around the benefits, possibly providing a far more efficient 52 method of increasing patient adoption and providing an easier path to self-care. 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 10 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 Conclusion 4 5 The ambition of achieving the potential of PHRs has long been established. There have been major 6 achievements towards understanding value of increased information flow, especially for patients, based 7 23 8 on recommendations of the Wachter report. This includes the appointment of Clinical Chief 9 Information Officers across the NHS, the launch of the NHS App and new training initiatives such as the 10 NHS Digital Academy.24 Despite these achievements, barriers such as a lack of EHR systems, lack of PHR 11 functionality in existing EHR systems, the controversial legacy of top-down implementations such as the 12 costly UK National Programme for Information Technology (NPfIT) and continuous interoperability 13 24 14 issues have presented formidable opponents to this ambition. Enabling true patient empowerment 15 requires that organisations are able to universally connect to PHR providers and that patients are able to 16 select the PHR providerFor they prefer.peer Understanding review and addressing only facilitators and barriers of PHR 17 adoption along with barriers for PHR interoperability should be a key focus for the NHS and researchers. 18 Only where PHR adoption is driven by patients will PHR access fully satisfy the requirements of its 19 20 intended users. This requires facilitating a market place for PHR providers who can address patient 21 demand using their own data. We have proposed a new call for regional PHR hubs to provide an 22 universal PHR interface and integrate EHR systems using the existing broker system already provided by 23 the NHS App as an example.10 As suggested in the Watcher report, we propose that such hubs should be 24 implemented in regional settings to encourage local ownership.23 This will reduce the complexity of 25 26 connections, decrease governance challenges and interoperability issues while also providing a safe 27 platform for high-quality scalable and sustainable digital solutions, including AI, across the NHS. 28 Achieving standardised universal PHR adoption with EHR data in an integrated record in the NHS will 29 unlock the true value of the UK’s integrated healthcare records and can serve as an example to other 30 countries which wish to unlock the true potential of their healthcare records. 31 32 33 34 Figure Legend: http://bmjopen.bmj.com/ 35 36 37 38 Figure 1- PHR hubs would transform the complex ecosystem (left) including high patient and provider 39 burden to a simpler ecosystem (right) centred around the patient increasing choice and system flexibility 40 41

42 on October 1, 2021 by guest. Protected copyright. 43 Author contributions: 44 45 46 47 JS – Conception, Design, Final Draft, Approval and Agreement to be Accountable 48 49 HA– Conception, Design, Final Draft, Approval and Agreement to be Accountable 50 RD–Design, Final Draft, Approval and Agreement to be Accountable 51 52 AD–Design, Final Draft, Approval and Agreement to be Accountable 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 10 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 Funding Statement: Infrastructure support for this research was provided by the NIHR Imperial 4 Biomedical Research Centre (BRC). 5 6 7 8 Conflicts of Interest: None 9 10 11 12 References 13 14 1 NHS Executive. Information for health: an information strategy for the modern NHS 1998-2005. 15 Department of Health 1998. 16 http://webarchive.nationalarchives.gov.uk/20120503231618/http://www.dh.gov.uk/prod_consum_dh/For peer review only 17 groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4014469.pdf 18 19 2 Kelsey T, Cavendish W. Personalised Health and Care 2020: Using Data and Technology to Transform 20 21 Outcomes for Patients and Citizens. National Information Board 2014. 22 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/38 23 4650/NIB_Report.pdf 24 25 3 Wyatt J, Hoogewerf J, Quinn N. Personal health record (PHR) User insights. RCP 2017. 26 https://www.rcplondon.ac.uk/projects/outputs/personal-health-record-phr-user-insights (accessed 3 27 Sep 2018). 28 29 4 Ozok AA, Wu H, Garrido M, Pronovost PJ, Gurses AP. Usability and perceived usefulness of personal 30 health records for preventive health care: A case study focusing on patients' and primary care providers' 31 32 perspectives. Applied ergonomics. 2014 May 1;45(3):613-28. 33 5 PHR locations map - NHS Digital. NHS Digital. 2018. https://digital.nhs.uk/services/personal-health- 34 http://bmjopen.bmj.com/ 35 records-adoption-toolkit/phr-locations-map (accessed 3 Sep 2018). 36 6 Wyatt J, Sathanandam S, Rastall P. Personal health record (PHR) landscape review Final report. RCP 37 38 2016. https://www.rcplondon.ac.uk/projects/outputs/personal-health-record-phr-landscape-review 39 (accessed 3 Sep 2018). 40 41 7 NHS statistics, facts and figures. Nhsconfed.org. 2017.http://www.nhsconfed.org/resources/key-

42 statistics-on-the-nhs (accessed 3 Sep 2018). on October 1, 2021 by guest. Protected copyright. 43 44 8 Benson T. Principles of health interoperability HL7 and SNOMED. 2nd ed. London: : Springer 2012. 45 46 9 Farenden J, Singh I. Local Health and Care Record Exemplars: A summary. NHS England. 2018. 47 https://www.england.nhs.uk/wp-content/uploads/2018/05/local-health-and-care-record-exemplars- 48 summary.pdf 49 50 10 Personal communication 51 52 11 £37.5m investment in Digital Innovation Hubs to tackle Britain’s biggest health challenges - Health 53 Data Research UK. HDR UK. 2018. https://www.hdruk.ac.uk/news/37-5m-investment-in-digital- 54 innovation-hubs/ (accessed 26 Nov 2018). 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 9 of 10 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 12 National Record Locator Service - Health Developer Network. Health Developer Network. 2018. 4 https://developer.nhs.uk/library/systems/national-record-locator-service/ (accessed 3 Sep 2018). 5 6 13 NHS App - NHS Digital. NHS Digital. 2018. https://digital.nhs.uk/services/nhs-app (accessed 26 Nov 7 8 2018). 9 14 NHS Digital. Personal communication. 24 Apr 2019. 10 11 15 Patient Access – GP services at your fingertips. EMIS Health. 2018. 12 13 https://www.emishealth.com/products/patient-access/ (accessed 26 Nov 2018). 14 16 Patient portal software – About us – Patients Know Best. Patients Know Best. 2018. 15 16 https://www.patientsknowbest.com/about-us.htmlFor peer review (accessed 26 Novonly 2018). 17 17 Who Evergreen Life are & our mission for people powered health. Evergreen Life. 2018. 18 19 https://www.evergreen-life.co.uk/who-we-are (accessed 26 Nov 2018).

20 18 21 Beard L, Schein R, Morra D, Wilson K, Keelan J. The challenges in making electronic health records 22 accessible to patients. Journal of the American Medical Informatics Association. 2011 Nov 25;19(1):116- 23 20. 24 25 19 Guidance for developing Personal Health Records - NHS Digital. NHS Digital. 2018. 26 https://digital.nhs.uk/services/personal-health-records-adoption-toolkit/guidance-for-developing- 27 personal-health-records (accessed 3 Sep 2018). 28 29 20 Harwich, E. and Lasko-Skinner, R., 2018. Making NHS data work for everyone. 30 31 21 Topol E, Health Education England. The Topol Review. Preparing the Healthcare Workforce to Deliver 32 the Digital Future. Health Education England, editor. London, Unitied Kingdom: NHS. 2018:1-48. 33

34 22 Open Standards principles. GOV.UK. 2018. https://www.gov.uk/government/publications/open- http://bmjopen.bmj.com/ 35 standards-principles/open-standards-principles (accessed 3 Sep 2018). 36 37 23 Wachter R. Making IT work: harnessing the power of health information technology to improve care in 38 England. Report to the National Advisory Group on Health Information Technology in England. London: 39 40 The Stationery Office. 2016 Sep 7. 41 24 Public Accounts Committee. The dismantled National Programme for IT in the NHS. Nineteenth Report 42 on October 1, 2021 by guest. Protected copyright. 43 of the Session. 2013;14. 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

BMJ Open Page 10 of 10

1 2 3 152 4 5 Acute 64 6 Trusts Other 6 7 Trusts 8 Protocols 9 10 29 11 11 PHR HUBS 12 For peer review29 PHR only PHR EHR

13 GP http://bmjopen.bmj.com/ 14 EHR 15 Protocols 16 Trust Patients 17 EHR 18 Patients 19 20

From EHR to PHR: Let’s Get the UK Record Straight

Journal: BMJ Open

Manuscript ID bmjopen-2019-029582.R3 ArticleFor Type: peerCommunication review only Date Submitted by the 12-Aug-2019 Author:

Primary Subject Patient-centred medicine Heading:

Secondary Subject Heading: Public health

Patient Health Record, Electronic Health Record, Patient Empowerment, Keywords: Digital, Digital Health

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 10 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 4 From EHR to PHR: Let’s Get the UK Record Straight 5 6

12 b 13 Chief Scientific Adviser and Honorary Senior Clinical Fellow in Surgery, Institute of Global Health 14 Innovation (IGHI), Imperial College London 15 c 16 Group Director of For Digital and peer Chief Information review Officer, Salford only Royal NHS Foundation Trust and 17 Northern Care Alliance 18 d 19 Director, Institute of Global Health Innovation (IGHI), Imperial College London 20 21 22 Corresponding author – Hutan Ashrafian ([email protected]) 23 24 Institute of Global Health Innovation 25 26 10th Floor QEQM (Queen Elizabeth the Queen Mother) Building 27 28 St Mary’s Hospital Campus 29 30 Praed Street, W2 1NY 31 32 London, UK 33

34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41

42 on October 1, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 10 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41

42 on October 1, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 10 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 for each patient, it will not guarantee the quality of that record or provide integration of records for 4 non-clinical sources of patient data. The proof of concept for the service will also not include retrieval of 5 6 the actual patient records and early features are aimed at providing access for direct care, therefore this 7 service will not be able to provide real-time access to patient records at a national level.12 NRLS in its 8 current iteration, will require that care provider services will be always available for querying using a pull 9 method, but services may not be available resulting in limited access to required records. Connectivity 10 11 to records at a national level will be dependent on the quality of local EPMI and EHR systems. Such 12 connectivity issues could result in patient safety incidents due to missing records. Furthermore there is a 13 need to consider other sources of data relevant to personal health such as income, education and other 14 data which patients may be able to share easily given the right mechanism. This has given rise in “smart 15 cities” to the concept of a person master index (PMI) as an alternative to an EPMI. 16 For peer review only 17 The newly released NHS App will allow patients to check symptoms, book GP appointments, manage 18 repeat prescriptions, view their own primary care record and manage data sharing preferences.13 These 19 20 features are enabled through a “broker” system which translates individual health record provider 21 implementations.14 Although this mobile application will create an excellent baseline entry point for 22 every NHS patient to view their GP records, it does not include any ability to edit or even view the entire 23 patient record. Other features will allow patients to interact with portions of the health and social care 24 system but listed benefits indicate that this tool will provide a passive consumption service for 25 26 commissioned digital services, without allowing patients to integrate digital services they have already 27 chosen. Despite improving access to NHS services and providing a starting point for universal primary 28 care record access, the NHS application in its current form will not provide a full universal PHR solution 29 in its initial form and will overlap with functionality provided by existing EHR portals and PHR 30 platforms.15 16 17 Although the NHS App cannot replicate existing PHR solutions and may not be designed 31 32 to replace them it is unclear at this time how the release of this application might impact the ability of 33 PHR providers to market their products and services. It is also unclear on how patient opt-out for data

34 sharing in the NHS App will impact data sharing at a regional level as patients might believe that using http://bmjopen.bmj.com/ 35 the application to opt-out of data sharing will stop any sharing of their data in any system, resulting in a 36 37 lack of clarity and transparency for patients and organisations alike with potential loss of trust across all 38 stakeholders. 39 40 PHR which enables full two-way integration of both care provider health record data and patient 41 generated data with patient control of data sharing, is the only current proposed health record solution

42 which provides a choice to patients for inputting into and controlling their own health records. PHRs also on October 1, 2021 by guest. Protected copyright. 43 provide benefit by providing digital intervention data generated by patients to clinicians as well as 44 providing a missing piece of research data necessary to evaluate the true patient journey. Current PHR 45 46 provider models are mainly centred on integrating with local EHR systems at a care provider level, which 47 has been shown to be more beneficial than standalone PHR systems, although both models have been 48 reported as offering healthcare benefits.6 Although this meets the criteria of providing patients access, it 49 does not provide patients a choice in features of different PHR providers or join data across multiple 50 providers. Integration is also done using bespoke interoperability with local providers one solution at a 51 52 time. To provide choice in PHR features, integration with multiple PHR providers is required by single 53 institutions. This increases the burden and cost to these institutions to provide multiple PHR solutions 54 and makes universal adoption of PHR more difficult as patients and clinicians are unable to determine 55 what benefit different PHR solutions may provide. Stand-alone PHR systems which enable patient input 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 10 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 will not necessarily be integrated with PMI systems and therefore data from these systems will not be 4 available to NRLS, making the patient responsible for communicating relevant information to clinicians 5 6 and exacerbating the existing burden for patients. 7 8 Learning from the Past 9 The dangers of trying to individually connect EHRs nationally and regionally while simultaneously 10 11 increasing adoption of PHR with the current system structure are substantial. This could lead to record 12 fragmentation which is an established concern and possibly lock data into another silo, unavailable to 13 the persons or systems which need it. 18 Additionally, there could be an increasing disparity between the 14 information patients think is available to providers compared to what exists at the point of care. NRLS 15 would need to connect to more systems with less certainty over the range of standards which will be 16 For peer review only 17 required to locate records. Although the PHR adoption toolkit provides guidance for most standards, 18 implementation of these interoperability standards will inevitably vary.19 Currently there is also no 19 solution for universal integration of personal device data into most EHR systems. Some PHR systems 20 provide this functionality, but monitoring of digital interventions such as prescribed mobile applications 21 22 will not be possible where personal device data is not being integrated back into clinical records. As 23 suggested in a 2018 REFORM report on data value, integration of such data should be explicitly included 24 in NHS procurement contracts to ensure that digital interventions can be tested for safety and efficacy.20 25 Furthermore, the benefits of integrating patient generated data into clinical records have been clearly 26 outlined in the Topol review.21 Universal integration of this form of patient data into clinical records will 27 28 be a large challenge for any EHR provider. 29 A Potential Solution 30 31 To overcome the barriers of universal record integration and PHR adoption, we propose a new model of 32 connecting systems with a PHR “hub” providing integration at regional levels for a single ‘source of 33

34 truth’ PHR (Figure 1). The PHR hub could operate in a similar fashion to the “broker” system used by the http://bmjopen.bmj.com/ 35 NHS App to communicate with different implementations of GP systems, translating data across EHR 36 and PHR providers thereby reducing complexity immensely while simultaneously moving towards 37 universal choice and control for patients. Complexity, barriers to interoperability and the potential for 38 22 39 vendor lock-in would be further reduced by requiring open standards in the PHR hub. Such an initiative 40 would naturally complement existing LHCREs, especially if surfaced or directly integrated at a regional 41 level, reducing variability for LHCRE implementation and enabling LHCREs to focus on critical record

42 integration. Combining this with patient controlled PHRs would decrease governance burden for on October 1, 2021 by guest. Protected copyright. 43 organisations as patients themselves would control records or be able to delegate this to care providers 44 45 as needed. Furthermore, each regional PHR could facilitate universal patient validated PMI by bridging 46 local PMI systems to keep patient details up to date. This would then ease requirements for the National 47 Record Locator Service (NRLS).12 PHR hubs could also separate care record service from care settings 48 allowing for better security and easier data migrations. PHR hubs would provide a single integration 49 point between multiple PHR and EHR providers taking away the burden of integration from the care 50 51 provider. Finally, universal PHR accessibility would allow PHR vendors to market directly to patients 52 supported by clinician conversations around the benefits, possibly providing a far more efficient method 53 of increasing patient adoption and providing an easier path to self-care. 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 10 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

1 2 3 4 5 Conclusion 6 7 The ambition of achieving the potential of PHRs has long been established. There have been major 8 achievements towards understanding value of increased information flow, especially for patients, based 9 on recommendations of the Wachter report.23 This includes the appointment of Clinical Chief 10 11 Information Officers across the NHS, the launch of the NHS App and new training initiatives such as the 12 NHS Digital Academy.24 Despite these achievements, barriers such as a lack of EHR systems, lack of PHR 13 functionality in existing EHR systems, the controversial legacy of top-down implementations such as the 14 costly UK National Programme for Information Technology (NPfIT) and continuous interoperability 15 issues have presented formidable opponents to this ambition.24 Enabling true patient empowerment 16 For peer review only 17 requires that organisations are able to universally connect to PHR providers and that patients are able to 18 select the PHR provider they prefer. Understanding and addressing facilitators and barriers of PHR 19 adoption along with barriers for PHR interoperability should be a key focus for the NHS and researchers. 20 Only where PHR adoption is driven by patients will PHR access fully satisfy the requirements of its 21 22 intended users. This requires facilitating a market place for PHR providers who can address patient 23 demand using their own data. We have proposed a new call for regional PHR hubs to provide an 24 universal PHR interface and integrate EHR systems using the existing broker system already provided by 25 the NHS App as an example.10 As suggested in the Watcher report, we propose that such hubs should be 26 implemented in regional settings to encourage local ownership.23 This will reduce the complexity of 27 28 connections, decrease governance challenges and interoperability issues while also providing a safe 29 platform for high-quality scalable and sustainable digital services, such as personal artificial intelligence 30 (AI), across the NHS. Achieving standardised universal PHR adoption with EHR data in an integrated 31 record in the NHS will unlock the true value of the UK’s integrated healthcare records and can serve as 32 an example to other countries which wish to unlock the true potential of their healthcare records. 33

34 http://bmjopen.bmj.com/ 35 36 Figure Legend: 37 38 39 40 Figure 1- PHR hubs would transform the complex ecosystem (left) including high patient and provider 41 burden to a simpler ecosystem (right) centred around the patient increasing choice and system flexibility

42 on October 1, 2021 by guest. Protected copyright. 43 44 45 Author contributions: 46 47 48 49 JS – Conception, Design, Final Draft, Approval and Agreement to be Accountable 50 HA– Conception, Design, Final Draft, Approval and Agreement to be Accountable 51 52 RD–Design, Final Draft, Approval and Agreement to be Accountable 53 54 AD–Design, Final Draft, Approval and Agreement to be Accountable 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 10 BMJ Open: first published as 10.1136/bmjopen-2019-029582 on 18 September 2019. Downloaded from

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1 2 3 4 5 6 7 8 152 9 Acute 64 10 Trusts Other PHR HUBS 11 Trusts 12 For peer review only 13 14 29 PHR 15 29 PHR 16 GP 17 EHR

LHCRE http://bmjopen.bmj.com/ 18 19 Trust Patients 20 EHR Patients 21 22 23 24 25 7,148 GP on October 1, 2021 by guest. Protected copyright. 26 Practices 216 27 Trusts 28 29 207 Clinical Commissioning 7,148 General 30 Groups Practices LHCRE 31 207 11 32 CCGs EHR 33 34 35 36 37 38 39 40 41 42 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60