Document filename: PHR R1 Discovery Full Project / Programme Personal Health Record Project Domain A - PHR Project Document Reference PHR R1 Discovery Full Project Manager Status Final Owner Adam Lewis Version 1_0 Author Version issue date 23/02/2017 Personal Health Record Discovery Report Copyright 2017 Health and Social Care Information Centre Page 1 of 29 The Health and Social Care Information Centre is a non-departmental body created by statute, also known as NHS Digital.
Document management Revision History Version Date Summary of Changes V0.1 Initial Draft V0.2 Further internal peer review V0.3 Further internal peer review V0.4 Further internal peer review V1_0 Amended Principles & Up-issue for release Reviewers This document must be reviewed by the following people: Reviewer name Title / Responsibility Date Version Adam Lewis Programme Director Melissa Ruscoe Stewart Fishman Programme Manager Product Owner Approved by This document must be approved by the following people: Name Signature Title Date Version Adam Lewis Programme Director Melissa Ruscoe Stewart Fishman Programme Manager Product Owner 2
Glossary of Terms Term / Abbreviation CIO CCIO DOH GDE GDPR NHSD NHSE PHR RCP STP What it stands for Chief Information Officer Chief Clinical Information Officer Department of Health Global Digital Exemplars General Data Protection Regulation NHS Digital NHS England Personal Health Record Royal Collage of Physicians Sustainability and Transformation Partnerships Document Control: The controlled copy of this document is maintained in the NHS Digital corporate network. Any copies of this document held outside of that area, in whatever format (e.g. paper, email attachment), are considered to have passed out of control and should be checked for currency and validity. 3
Contents Purpose of this document 5 1. Programme brief and wider context 6 2. Our Approach to Discovery 7 3. Our Findings 9 3.1. Users & User Needs 9 3.2. Culture & business challenges 12 3.3. The Benefits of PHRs 15 3.4. Technology & Data 16 3.5. Policy & Legal 20 3.6. How PHRs are defined 22 3.7. Role of NHS Digital and other central bodies 23 4. Conclusions 26 5. Recommendations 27 4
Purpose of this document This document describes the the NHS Digital Personal Health Record (PHR) programme s discovery and research phase conducted between November and December 2017. It sets out: NHS Digital s working definition for PHRs the needs of current and future users of PHRs, focusing on health and care organisations how NHS Digital is responding to those needs ways to engage with the PHR programme The document is primarily aimed at those commissioning, developing or managing PHR-type tools in England. We believe it also has relevance to the wider UK and the international context. The PHR programme team wishes to thank all those who contributed insight, time, interest, expertise and experience, whether as authors of existing work on PHRs or as active participants in our primary research. What we mean by PHR? 1. It's secure, usable and online. 2. It's managed by the person who the record is about. 3. It stores information about that person s health, care and wellbeing. 4. Health and care sources can add information to the PHR. We explore the various different interpretations and use of the acronym PHR we discovered in the Findings section of this document. 5
1. Programme brief and wider context Aims and objectives The NHS Digital Personal Health Record (PHR) Programme is an initiative supported by NHS England, which aims to understand what is required for wider adoption of PHRs in England. We set out to understand what role the PHR Programme has in supporting this aim. This report is the output of the Discovery research phase of our project, which took place during November/December 2017. The overall Discovery aim was to understand what is required for wider of adoption of PHR tools in England, ultimately with a long term aim of every person in England benefiting from access to a PHR if needed. Out of scope Although not a primary focus of our Discovery, we acknowledge the growth of consumerfocussed non-clinically connected PHR tools, for example myfitnesspal and Strava. There are also a range of condition-specific tools that provide clinically-sourced information to patients and the wider public but do not support patients being able to input data (e.g. typing in, from their own apps and wearable technologies) to clinical systems (often referred to as patient write-in or patient -inputted data ). Policy context The Five Year Forward View 1 (under Chapter Four How will we get there? ) states that patients will have full access to fully interoperable electronic health records and be able to write into them; (including in social care contexts) and share them with carers or others they choose. The Secretary of State for Health and Social Care has also committed to Standards and interoperability capabilities [being] developed, enabling patients to access records for a range of conditions across multiple providers. The PHR landscape Documents such as the Royal College of Physicians (RCP) PHR Landscape Review (2016), and the PHR Interoperability Handbook 2 provide an overview of the current PHR landscape for NHS organisations and third-party app suppliers. However, the market is fast-moving and has developed since these were published. Many organisations have been on their own PHR journeys for several years. They have created their own PHRs and are now entering a new development phase focusing on the promotion and use of PHRs within specific patient cohorts, as well as the identification of clinical champions. At a Clinical Chief Information Officers (CCIO) event in London in 2018, research by Digital.health.net was shared, showing that many Sustainability and Transformation Partnership roadmaps cite PHRs as the next major step in transforming patient-facing services for healthcare organisations. The volume of third party suppliers is also expanding. Some are just entering the market, while others already have thousands of individual users such as Patient Knows Best and Evergreen Life. There are also a number of in-house developments such as at Queen Elizabeth Hospital 1 DOH (2014) Five Year Forward View. Available at: https://www.england.nhs.uk/wpcontent/uploads/2014/10/5yfv-web.pdf (Accessed 26 March 2018) 2 Personal Health Interoperability Handbook v.10 Draft Status (2016) NHS England, South Central and West Commissioning Support Unit. 6
Birmingham and My Medical Record at University Hospital Southampton which also have an established user base and have been available for a number of years. Current state of research and evaluation of PHR-type tools We have found academic research into PHRs within England to be at an early stage. This concurs with the RCP report 3 which stated that, at best there is only anecdotal evidence on PHR benefits, with little concrete evidence. The reports suggest that this is due to a lack of market research on what patients want and their wider use, coupled with the ways in which care professionals and service managers might find PHRs beneficial. 2. Our Approach to Discovery Focussing our Discovery research. The emerging PHR marketplace could be explored from many different angles, and our Discovery could have considered a wide range of problems. To understand which problems to focus on, and therefore have the greatest impact on as a NHS Digital Programme, the team first undertook a desk review of existing insight, described below. This review showed that in most cases, people currently gain access to clinical PHRs as part of a care pathway, with access granted by health and care professionals. So, to have the greatest chance of increasing PHR adoption, the team decided to focus on what might better enable health and social care organisations in their purchase, implementation, operations and development of PHRs that provide benefits to patients and the wider public. This is not to ignore the needs of patient groups and the wider public, but recognises that relatively robust research into this area pre-exists our Discovery. This has informed our User Needs section below. The team established key assumptions and problem statements to test through primary Discovery research with organisational stakeholders with an interest in PHRs. Stakeholder Identification We undertook a stakeholder-mapping exercise to identify our target audiences. It is expected that over the lifecycle of the project, the stakeholder map 4 will change. Discovery Research Methodology The Discovery phase was conducted by a small team of four full-time and two part-time members and was split into two phases: 3 Royal College of Physicians (2016) Personal health record (PHR) landscape review Final report. Available at: https://www.rcplondon.ac.uk/projects/outputs/personal-health-record-phr-landscape-review (Accessed: 26 March 2018) 4 Stakeholder Matrix Document (see Appendix) 7
1. Pre-discovery desk research exploring over 20 existing user insights, policy studies, advisory documents and other reports, from the UK, USA and Europe. Key documents included: o Royal College of Physicians PHR Landscape Review and User Insights o Patient Information Forum Learning from voices of experience: PHRs o NHS England / South Central and West CSU PHR Interoperability Handbook The outcome of this phase included a list of findings and assumptions which helped to form the basis of the lines of enquiries for the following discovery. 2. A 6-week discovery phase, in which we undertook primary research, based on a standardised research interview script 5 : o 19 in-depth interview sessions with individuals and teams within Sustainability and Transformation Partnerships (STP), Secondary Acute NHS Trusts, Global Digital Exemplars (GDE), vendors, NHS Digital and NHS England. Those with mature PHR tools, as well as those currently in development, or on a future roadmap were included. o Discussion and workshops at key events such as TechUK, Royal College of Physicians workshop, GDE PHR event discovery workshop and a Patient On Line (POL) meaningful digital access workshop. Discovery research participants The stakeholders interviewed during Discovery were: External and Internal DoH Organisations NHS England, NHS Digital Social Care Organisations Association of Directors of Adult Social Services Secondary Care NHS Providers and Services Imperial College Healthcare NHS Trust South London and Maudsley NHS Foundation Trust Salford Royal NHS Foundation Trust University of Southampton NHS Foundation Trust Newcastle Upon Tyne Hospitals NHS Foundation Trust North West Shared Infrastructure Services Professional Healthcare Bodies and Groups Royal College of Physicians Vendors Tiny Apps Patient Knows Best 5 See Appendix for PHR Interview Questionnaire. 8
Evergreen Life Ripple Foundation mhabitat Renal Patient View Get Real Health Marand Parsek 3. Our Findings This section sets out in detail what was learnt during Discovery. The sources for this section are the primary research we undertook, outlined above, combined with secondary findings based on primary research published by others working in the field (including by the Royal College of Physicians, Joined Up Leeds and The Patient Information Forum). Research findings from individual participants have been analysed and thematically grouped to create wider strategic themes. 3.1. Users & User Needs Different user groups have different needs from PHRs and look at PHRs from a different perspectives. A key purpose of discovery is to better understand the needs of key users in relation to the problem area. The high-level User Groups having interest in PHRs include: Care providers/ Health and care professionals/admin Staff Commissioners Vendors of PHR products Patients/ Carers This table sets out the user needs identified in discovery. Some relate to Integrated Digital Care Records, rather than PHRs, but remain relevant as they underpin adoption of PHRs: As a I need So that service provider commissioner an easy way to share information with other organisations a standard way of receiving information from other organisations I can provide better care to the patients it is easy for consumption...commissioner it to be easy to do the right thing about IG I reduce risk of failure commissioner commissioner I need systems to talk to each other and standards help me to do this I need to know that I am aligned with good practice in the areas of functional and technical design and architecture So that I am not moving away from everyone else 9
commissioner I need a central data repository of information agreements So that organisations can query whether the data can be stored (Domain J) commissioner I need to understand the needs of my users So that I can do the right thing by them commissioner commissioner commissioner commissioner I need tools that help multiple health and care professionals work on a single patient s case I need guidance on a standard set of requirements I need support on IG issues for bi-directional portal for sharing information I don't want standards to dictate, but loose standards and guidance are helpful So that I can produce the right tool commissioner commissioner business case writer CEO organisation interested in PHR organisation interested in PHR organisation interested in PHR organisation interested in PHR I want any new tool to interoperate with existing systems I want NHS Digital to provide the direction of travel I need evidence of a wide range of benefits of PHRs I need evidence that PHRs provide cash releasing benefits I need to easily find what I need to do I need to be confident that available products comply with current standards I need to be confident that available products comply with current standards I need to know the national vision for PHRs So that I can share information with other organisations So that I can get my business case approved So that I can fund the PHR So that I avoid doing things wrong and avoid re-work So that I avoid creating silos So that I can save on resources, so that I don't need to reprocure a new solution too soon. So that I don't do the wrong thing and avoid re-work later service provider I need portability of information So that I can change vendors service using a PHR service using a PHR parent I need there to be an easy way of finding out if a patient has agreed to share their information with others, and who I need to know that the PHR product is compliant to relevant IG guidelines I need to manage my child s health as they are not able to So that patient data can be shared across organisations So that I am keeping patients data safe So that my child gets the best managed care 10
person facing access challenges person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition person with a/multiple health condition care provider care provider service providing care for all I need to designate another person to have the ability to help me manage my health I need to see all my dealings with the NHS and other care providers in one place I need an easy way to find information on my condition and treatment I need it to be easy to see information about my condition even if care is delivered by multiple services I need tools tailored for my condition I need to contribute own health and care information to discussions about me I need to to share health and care info with others I need to access more information within my PHR I need admin to do with my care to be simple and quick I need my care provider to know about my secondary conditions and preferences I need it to be easy and secure to communicate with care services I need to know about new approaches and medicines I need ways to monitor my condition and share my information if I wish I need a funding model that supports set up digital delivery of services I need funding models that support digital delivery I need all tools including digital to be accessible to all So that I don't repeat myself to multiple carers and I can contribute fully to my case So that I feel confident So that I save energy and have a complete view of my health and care So that I know information is relevant to me and save time searching So that I add value to care decisions So that people who care for me know what to do for me So that I can understand aspects of my care more fully So that I have more face to face with health and care professionals So that I can get the best care So that I can share or request information about my care So that I can get the best care So that I get better care because the care provider has a holistic view of me So that I don t lose out financially. So that I don't lose money on my tariff So no people are excluded from the best care 11
health and care professional health and care professional health and care professional health and care professional health and care professional health and care professional health and care professional health and care professional I need the PHR to be accessible to patients with impairments, low digital access or literacy I need to see all information relevant to my patients health and care I want to know the source of the information I need as complete a view as possible of my patient I need to view patients information prior to appointments I need evidence of the benefits of PHR use for me and my patients I need to have control over what information a patient sees I need to be confident I can trust the identity of patients accessing personal data So that I can deliver high quality timely care to the patient So that I can trust it and deliver high quality care So that I can make the safest care decisions So that I have more face to face time leading to better care So that I feel confident using a PHR So that I can meet safeguarding needs So that I can meet safeguarding needs and give the right medical advice PHR vendor I need to know the rules So that I can comply and sell more PHR vendor I need it to be easy to sell my products to NHS organisations So that I can sustain my business 3.2. Culture & business challenges Implementing PHRs can challenge existing cultures and mindsets for both health and care professionals and patients in terms of their interaction with each other. Through our research we have found that different user groups perceive various challenges and impediments regarding PHRs which have the potential to hinder adoption of PHRs. Health and care professionals: Enablers of adoption Clinical champions are seen as instrumental by one vendor with experience of working with multiple NHS Trusts. Having a credible and trusted voice within the organisation advocating PHR use can go a long way to overcoming any wider clinical resistance. We have learnt that many current PHRs started in a specific clinical pathway due to the enthusiasm and support of a single or a few health and care professionals. Barriers to adoption: 12
We heard from research participants working in some NHS Trusts, and from vendors, that some health and care professionals are sceptical about patient-inputted data being part of PHRs. The main scepticism is around the quality and relevance of data that patients will input. One participant suggested that there is need for national work on coding patient-inputted data to counter this concern and boost interoperability. Additionally, the RCP s Landscape Review of PHRs noted that levels of PHR adoption may be driven by healthcare professionals being wary of patient access to medical records. Since PHRs would have different data sets coming from different sources (internal/external systems, patients, health and care professionals, social care etc.) trust in data provenance becomes a key issue for health and care professionals, who need to make judgement calls about the usefulness of data. One respondent, seen as a leader on patient access to records, noted that some health and care professionals are concerned that patients may see information about themselves that causes them harm. There was also some worry that patients could view perceived inaccuracies which might lead to litigation. For these reasons, typically health and care professionals are able to redact certain information held within clinical systems before a version is viewed by a patient. Our primary research discussions with GP Practice Managers in a parallel project shows this can create a burden that can lead to reluctance to provide full record access. It is important to stress that this also means that the patient/person will not see ALL information held about them, but should see the most relevant and useful to their care. Research participants in NHS Trusts told us that some health and care professionals who do not yet use PHRs often anticipate increases in workload if patients start adding data to their records, or using secure communication channels within a PHR, and expect a swift response from services. Some health and care professionals also have concerns that patients may contact them via a PHR in emergency situations, which is not the appropriate route. However, research in the United States and some English NHS Trusts shows that these preconceptions typically do not become reality once PHR tools are adopted by services. The RCP s Landscape Review states there is some evidence that in fact time savings can result for patients and health and care professionals. Some of the clinical community feel that they are the owners, or at least guardians of patients data, and hence are cautious about sharing the data. Equally some of those spoken to felt the definition of PHRs put the patient as the data owner. However one prominent exponent of granting record access to patients stated We don t talk about ownership of records. Better 2 talk about #ResponsibleSharing and how it feels Initiators of PHR projects: Barriers to adoption: Some people stated that it could be a struggle to identify suitable benefits and best practice, to create a compelling business case to secure funds for PHR initiatives. In addition, they had to get buy-in from senior stakeholders in their organisations who need to understand these benefits before signing off potentially significant amounts of funding. One participant told us they deliberately set conservative benefits, such as a small reduction in GP appointments, from their pilot cohort of 300 users. Whilst understanding the need for information exchange, NHS organisations face the challenge of maintaining a common language of translation to allow interoperation between 13
clinical data systems. They currently do not have clarity regarding the ownership and exchange of data, and would look upon the centre to help them. NHS organisations are challenged about the commissioning payment disadvantage when they move from face to face appointments/consulting to digital appointments/consulting and would like the centre to help in resolving this challenge. Two trusts told us that the typical procurement process within Trusts can struggle to support PHR procurement, as the process expects a specific set of requirements and return on investment, which innovative or emerging products and technology may not yet have. Additionally, procurement does not always support the iterative and user-centred ways of working that many PHR projects adopt. Some Trusts we spoke to are concerned about vendor lock-in whilst procuring PHR solutions and are sometimes sceptical of claims made by vendors regarding the interoperability of their solutions. Similarly, they are also concerned about the solutions being aligned to wider national strategies and road maps. Some of those starting PHR projects feel it is hard to see what standards applicable to PHRs are being adopted elsewhere in the NHS or seen as best practice, which in turn makes them feel vulnerable whilst implementing new technologies. To be able to provide digital access to records to people, the records themselves have to be stored electronically, some organisations are still on a journey to complete this so cannot embark on PHRs until this completes. Commissioners have told us that for a PHR implementation project to be successful the health and care professionals, CCIOs and CIOs need to back it and actively participate. Furthermore, they ve stated that the difference in local, regional and national priorities have impacted the funding and adoption of PHRs. Vendors Barrier to adoption: Vendors told us they believe the certification process within NHS Digital/NHS England is a barrier to innovation, with some current processes taking a significant amount of time to complete, and also there can be duplication between differing certification processes causing further delays. We also heard that the procurement processes within NHS can be challenging for new startups looking to provide their solutions, lacking the track record that current procurement processes often require. They also lack the ability to navigate the NHS to make contact with influencers and decision-makers, compared to established vendors. Patients and the wider public from our desk research Barriers to adoption: Discovery revealed that patients and the wider public do not always know the art of the possible and this prevents innovation. In general they are not aware of the usage and benefits of PHRs and hence there is a need to raise awareness. People want to know what happens to the data they provide, and who can access/ view and use their data. They value data security and safety, and transparency of use, they fear that organisations (commissioners/ vendors etc) will monetise their healthcare data. Primary research by the Joined Up Leeds project highlighted that patients and the wider public wanted reassurance that data they input into a PHR would be seen and acted upon 14
by clinical staff. If this was not the case, this lack of value from the PHR would become a barrier to further use. Research by the Royal College of Physicians strongly indicates that people with no long-term health conditions have little awareness and less uptake of PHRs. The health and care professional-focussed language used in many notes and records may also be a barrier to sharing of records with patients, who would prefer everyday language to be used in some cases (noting that many patients with long-term conditions do become expert in their condition and its terminology over time). Financial Constraints The Discovery showed that most existing clinically connected PHRs were procured by NHS organisations, as such these organisations have to find funding to get PHRs built. In terms of the various financial positions of healthcare organisations, one interviewee stated that NHS Digital should finance regional initiatives. The current payment mechanism (Payment By Results) prioritises face to face appointments and consultations and hence moving to digital channels is seen as a financial disadvantage. Involving organisations beyond the NHS Social care s representative observed that health projects and innovation remain siloed within the area of healthcare itself, whilst the engagement of social care occurred towards the end of the development lifecycle. For social care to innovate and provide insight, its involvement needs to be from the beginning of the programme of work. A number of research participants stated that involving national or condition-specific charities in PHR development was valuable, as it added credibility, insight and access to potential future PHR users during design. Geographic Barriers Some interviewees commented that, although federated models (of information sharing) work well for health and care professionals, they have boundaries, however these boundaries may not match the boundaries of patient care. Furthermore, several views suggested that PHRs shouldn t concentrate on patients in one Trust alone but should focus on capturing requirements at a regional level, currently within Sustainability and Transformation Partnership plans. One interviewee stated that they would go further and encourage a larger footprint than this, however within the current climate imagined that this wouldn t be acceptable. 3.3. The Benefits of PHRs Discovery revealed that stakeholders envisaged several benefits to adopting PHRs. Many of these benefits are assumed, or anecdotal, highlighting a lack of robust longitudinal evidence for PHR benefits (other than for cash releasing ones). Commissioners see PHRs as a vehicle to increase health awareness amongst the public and empower patients in the self-management of care provision 15
PHRs would provide accessible health care to everyone and all the time and enable people to better connect with their care providers PHRs provide health coaching and provide important content (personalised) related to people's own conditions which in turn leads to better self-management Using PHRs would reduce the burden on NHS by reducing front line physical interactions and re admissions PHRs help in providing continuity to an overall health-care as it is not just restricted to a single episode of care. In long term conditions or mental health issues this can be very useful. PHRs provide a mechanism to patients to capture their stories (mental health) and wellbeing details when outside of primary /secondary care setting and awaiting next interaction with the care provider. Cash-releasing benefits are the most commonly tracked and evidenced (that we are aware of). One Trust noted that unlike for example phone calls, which may not all be logged, every single interaction with a patient through a PHR is recorded and therefore revenues can be maximised. Another, operating a PHR that is shared by a large number of organisations, saw savings in postal costs of c 0.5m over a three-year period. 3.4. Technology & Data Today s marketplace of PHRs involves a disparate mix of technologies. A lot of PHRs have been built or procured in-house by single clinical organisations so often decisions have been made on a very localised basis. Vendors offering PHRs have often set up with a specific purpose and therefore have a very specific view on how PHRs should be built. NHS England commissioned a piece of work to look at the current estate of PHRs in their PHR Interoperability Handbook 6. This report showed significant variance in how PHRs have been implemented, looking at factors such as ownership, geographic footprint, proprietary or open technology underpinning the PHR. As technology has progressed some more mature PHRs have actually moved platforms to better meet need. 6 NHS England, HSCIC, South, Central and West Commissioning Support Unit (2015) Interoperability Handbook Available at: https://www.england.nhs.uk/wp-content/uploads/2017/03/interoperabilty-handbk.pdf (Accessed: 26 March 2018). 16
Figure 1- PHR Interoperability Handbook - PHR Maturity Model Based on needs established in research published by the Royal College of Physicians, Joined Up Leeds and The Patient Information Forum, as well as our own research, patients with longterm health conditions need it to be easy to see information for their condition when care is in multiple settings, and for all their dealings with the NHS in one place. This clearly requires PHR solutions to be interoperable too. A barrier to adoption is the lack of national approach to standards for health information exchange (HIE) and several regional initiatives for the same In the Next Steps on The NHS Five Year Forward View 7 there was a commitment to make patients medical information available to the right health and care professionals wherever they are. This is key to the delivery of the future vision of care in England, as described in the National Information Board s Personalised Health and Care 2020 A Framework for Action. 8 The future of interoperable Personal Health Records is heavily dependent on this vision and will have to be aligned to meet these user needs. 7 DOH (2016) Next Steps on the NHS Five Year Forward View. Available at: https://www.england.nhs.uk/wpcontent/uploads/2017/03/next-steps-on-the-nhs-five-year-forward-view.pdf (Accessed: 26 March 2018) 8 National Information Board (2014) Personalised Health and Care 2020 Using Data and Technology to Transform Outcomes for Patients and Citizens - A Framework for Action. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/384650/nib_report.pdf (Accessed: 26 March 2018 17
Interoperability Barriers to adoption: The majority of the interviewees (both commissioners and vendors) have emphasised the need for interoperability and acknowledged the related challenges. Today s public are mobile and move across regional boundaries and hence their health and care information needs to follow them thus warranting a need for a PHR that is both portable and mobile. Humans are complex and illnesses do not respect organisational boundaries (Ayesha Rahim, 2018) There is a lack of a single language for the translation of information across different care settings. The software systems being used by various care settings are disparate with information held in silos and in different formats, coupled with a lack of widely used standards for data exchange makes information exchange challenging. The current structures of the NHS records limit the addition of external data i.e. patient contributed information. Several initiatives are in play to build Health Information Exchanges (HIE) which not only provide regional platforms to enable exchange of data but also provide comprehensive and consolidated sharing agreements. Commissioners have expressed their keen desires to extend the HIE networks beyond local regions by connecting with other HIEs thus creating a national network for Information exchange. NHS Digital is currently working on the National Record Locator Service (NRLS) which will enable the locating of records. NRLS will provide a strategic data sharing component within health & care architecture. PHRs could in future use this service to surface relevant records. There is a need for a single source of truth for people s records that can be drawn upon by Personal Health Record solutions in order to provide clinically safe care to the patient. Data provenance: In addition to having the patient s clinical and care information sourced from health & care systems, both health and care professionals and patients are keen for having patient-provided information in PHRs, as long as it is actionable, valuable to all involved in the care setting and timely. Increasingly this will include information from personal apps and wearables. With such an array of information being fed into the PHRs, the provenance, and subsequent assessment of the information becomes key for health and care professionals to make high quality decisions in patient care. Use and control Health and care professionals are keen that the right level of information is made available on the PHRs for people to view, ensuring it provides a holistic view, without having any damaging impact on the person s emotions and care. Therefore any PHR solution must have capabilities to extract only the relevant information from all relevant sources. For example, for a condition 18
specific PHR, patients would only see clinically relevant information to support them with management of their condition. Data standards There is a need for a structured mechanism of exchanging data using open standards, and Fast Healthcare Interoperability Resources (FHIR) seems to be direction of travel. Data privacy and guidance relating to of the impact of General Data Protection Regulation (GDPR) is a topic of keen interest for the majority of interviewees. There are misconceptions and hence a lack of clarity in terms of the storage, access, ownership, control and processing of health and care information of a person. Whilst both people and care providers want the ability to input information into a PHR once, so it can be reused numerous times, there is confusion around the end to end flow of the information. Most vendor interviewees expressed the need for guidance and standards from the centre, as awareness of these will help them future-proof their products. They also have concerns over the possible creation of very stringent standards that could make their solutions non-compliant or also inhibit innovation. Some suppliers stated that they found the current NHS Digital and NHS England certification process as a barrier to innovation, due to the amount of work required to complete as well as duplication between differing areas and would like to have an simplified process. They would like to input to the development of standards and the overall direction of travel. Key findings in this area include: There is need for a common set of standards which indicate a direction of travel and are aligned to their international counterparts Standards for Data sharing and exchange and FHIR seems to be direction of travel. OpenEHR was also noted. Standards for a common clinical language - SNOMED CT is the chosen clinical coding model that has been agreed upon and is currently being implemented across the NHS. Standards and guidelines in areas of IG, GDPR and consent models Standards around data involving privacy, security, access, storage, hosting Accessibility and usability standards for a wider adoption across the population with varied needs and challenges Standardised presentation and measurement models of information Specific standards mentioned as being used: FHIR SNoMED HL7 PathLab for laboratory data transfers OpenEHR LOINC (LIONC?) for laboratory results data transfer ORCHA organisation to help with apps approval Desired future standards and related developments: FHIR Open APIs with GP data systems 19
CareConnect Standardised Role-Based definitions to manage who gets to see what in shared records e.g. what does a social worker get to view? 3.5. Policy & Legal Patient Health Record Commitment and related policies Although our Discovery research has found that there still exists ambiguity over the precise definition of what a PHR is, there are references to the delivery of PHRs in current NHS policy documentation. In the National Information Board s Delivering the Five Year Forward View Personalised Health and Care 2020 under Domain One: enabling citizens and patients to make the right health and care choices. PHRs will be accessible via nhs.uk, a fully integrated health and care digital platform 9. In Personalised Care 2020: Using Data and Technology to Transform Outcomes for Patients and Citizens A Framework for Action, people are to have full access to their care records. Under workstream 1.1 in this Framework there is a commitment that from March 2018 all individuals will be enabled to view their care records and to record their own comments and preferences on their record, with access through multiple routes including NHS Choices. Th e Framework expanded upon this in a second point, to give care professionals and carers access to all the data, information and knowledge they need real-time digital information on a person s health and care by 2020 for all NHS funded services 10. Consent: Through our Discovery we have discovered that consent is a key component as more and more digital integrated services are introduced e.g. a PHR platform, app or a patient portal. There are various consent models currently in play and there is a need to extend these further whilst standardising them to bring in uniformity and transparency. With the onset of the General Data Protection Regulation (GDPR) setting high standard for consent there was some concern as to how that would affect Personal Health Records. Whilst GDPR is clear on the use of data for direct care with the processing of personal data being generally prohibited 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 on the basis of Union or Member State law or pursuant to 9 DOH (2015) Policy Paper Delivering the Five Year Forward View. Available at: https://www.gov.uk/government/publications/implementing-personalised-health-and-care-2020/delivering-thefive-year-forward-view#domain-one-enable-me-to-make-the-right-health-and-care-choices-supporting-digitalservices-for-patients-and-citizens (Accessed: 26 March 2018) 10 National Information Board (2014) Personalised Health and Care 2020 Using Data and Technology to Transform Outcomes for Patients and Citizens - A Framework for Action. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/384650/nib_report.pdf (Accessed: 26 March 2018) 20
contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3 ; 11 With PHRs bringing the ability for people to directly add information which might then be seen by a health and care professional, people need to be made aware how that data will be used. With consumer focused PHRs, users need to be able to control how and where that information is shared. Currently certain systems allow people to choose what part of their information is shared, this has to be done at a level which is usable to the person, whilst also maintaining a level of granularity that provides the person with confidence that their data will not be shared inappropriately. One supplier informed us that previous initiative had looked at sharing by data type (meds/labs etc) but this did not work for patients, so they had adopted a privacy model which allowed information to be categorised into one of four thematic groups which can be turned on or off. Many interviewee s have expressed the importance of a robust Consent Model that works for all. Dame Fiona Caldicott, (appointed National Data Guardian in 2014) stated at a King s Fund event that she wanted people to have a simple choice for consent and opt-outs. One area of interest, which a number of people had, was the opportunities created by consent for research, some of the local initiatives allow you to control data sharing to research organisations. Consent is applicable for an initial start of sharing data and to stop the share. Consent is required at a granular level within organisations i.e. data is shared with which organisation. Consent is required to the type or category of data that is shared. Sharing of patient inputted data should be based on consent provided by the patient. Consent can be extended not just for the care team involved in care provision and NHS bodies but may be also outside of NHS i.e. police and council. Some authorities currently follow a model of implied consent and only when a person explicitly denies the sharing of data is it stopped. The stopping of data sharing can become a barrier to ongoing care provision. Data Protection and Sharing One of the emerging debates around PHRs is who acts as data controller and data processor when the patient is inputting personal data to a PHR. Under the Data Protection Act 12 medical information is classed as sensitive personal data, as PHRs can contain this type of information, it is incumbent on the data controller to ensure that data has been processed lawfully. In order for the healthcare organisation to share 11 REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) Article 9(2)(h) 12 Information Commissioner s Office Key Definitions of Data Protection Act. Available at: https://ico.org.uk/fororganisations/guide-to-data-protection/key-definitions (Accessed 26 March 2018) 21
information between healthcare organisations, privacy impact assessments (PIA) need to be carried out, and information sharing agreements (ISA) drawn up and agreed. Furthermore under the GDPR guidance on the individuals right to be informed, individuals must be provided with privacy information; the purpose for data processing, the retention periods and who it is shared with. This would also be applicable to Data Sharing Agreements (DSAs) that PHR organisations chose to share it with in the future. Most organisations who have started the PHR journey told us that information governance (IG) has played an important role in their journey. Involvement of IG teams from the start has been very helpful. Most contributors to our research see the value in sharing data across organisations. Up to date and complete data about a patient enables better care provision. One contributor noted they have never met a person who needs help, who worries about their information being shared if it will improve their care. Organisations are looking at a structured and standardised mode of sharing data. This includes not just data within their internal or national systems but also sharing of documents and images. Some organisations have raised their challenges in sharing of images across organisations Organisations are looking to NHSD or NHSE to publish standard benefit statements for data sharing which would have more organisations open up for sharing data held by them Barriers to adoption: One of the barriers to data sharing is not having the clarity over the roles of data processor/controllers when multiple organisations provide data to create a longitudinal record, who can grant clinical authorisation so that people can see this shared data. Some heaklth and care professionals cite protecting patients from harm as a barrier to full, transparent sharing of clinical records with patients. These health and care professionals wish to keep control over which details i.e. not just system data but what notes are exposed to the patient/carer. The current financial model within the NHS National Tariff Payment System 2017/18 13 doesn t reimburse digital e-consultations (supplemented by patient information sharing), therefore there are no financial incentives to support digital channel shift in primary and secondary NHS services. 3.6. How PHRs are defined What is a PHR: a spectrum of opinion. We uncovered a number of definitions of PHRs, alongside local names for these tools (e.g. patient portals ). This is our chosen definition: 1. A secure, accessible, online space, managed by individual people. 2. It stores information about people s health, care and wellbeing. 13 NHS Improvement 2017/18 and 2018/19 National Tariff Payment System. Available at: https://improvement.nhs.uk/resources/national-tariff-1719 (Accessed at: 26 March 2018) 22
3. People can add information to it, as can other health and care sources. 4. People decide what data items in the PHR are seen by others. There is a spectrum of types of PHR, as shown below, between the extremes of a Personal Health Record that the individual person controls, to Integrated Digital Care Records (IDCR) that the service provider controls. At present patient-ownership of the record isn t what most NHS organisations are considering when giving record access. PHR is not a term used by all those we interviewed, for example one preferred to use the term Care Information Exchange, another Patient Portal. However, in these cases, the tools did fit with our definition of PHR, except for patient users having low levels of control over the data items. In general, the defining factors for PHRs, in interviewees' views, include: portability aggregation of multiple data sources a degree of patient control over the data items in the tool, the ability for patients to contribute information to the tools. Some noted that PHRs are a longitudinal record of someone s health and care, rather than a snapshot. A minority stressed the need to include social care information in a PHR, and one city operates on the assumption that future use of PHRs will extend into other public services, and therefore uses PHR as an acronym for Person Held Record. There were different views on whether PHRs are, or should be, best used on a specific condition pathway, or as more generalist user-driven tools. However, most felt that without some clinical connections, PHR tools have less value to all stakeholders. 3.7. Role of NHS Digital and other central bodies Organisations looking at adopting a PHR, and those that have completed this journey, consistently see a key role for NHS Digital in enabling the wider adoption of PHRs at a local level, helping align good practice across the NHS estate and helping improve networking and knowledge transfer for those involved in PHR implementation. However, it was also clear that imposition of systems or solutions from the centre would be unwelcome and potentially counter-productive. 23
A few participants in reseach gave unprompted descriptions of a future central repository of various resources that they can access at various stages of their PHR implementation project. These resources include - PHR Initiatives in the country Vendors providing PHR Solutions Best Practices and experiences. Further, when prompted as to whether such a resource would be desirable, those participants that didn t volunteer this concept themselves felt it would be helpful to those looking to implement PHRs. Some of the stated requirements from NHS Digital include: PHR implementers would like to learn from those organisations that are further along in the PHR implementation journey, and hence would like the knowledge and learning to be shared. This could be enabled by creating a central database of organisations with experience of a similar journey, along with the solution being implemented, and the challenges being faced by them. A central library of endorsed good practice from all such initiatives would be a helpful tool. As there are several innovations being made at local and regional levels, a community to share the findings and the outputs of the innovations could help the NHS as a whole which could be facilitated by NHS Digital. As PHRs are a new technology, the expectation is that NHS Digital will come forward and share its direction of travel in terms of technology, roadmap and impact on the NHS system, such that organisations can ensure they are aligned with the strategy. NHS Digital and NHS England might enable a wider adoption of PHRs by creating more awareness of the concept, the benefits and the use of PHRs. To make the procurement and interoperation of PHRs easier, NHS Digital might create a set of standards that all solutions should comply with, and similarly a set of guidelines that will enable a better implementation. It was suggested that these standards and guidelines should not be so rigid that they are difficult to comply with, and hence inhibit innovation and have an adverse effect on current implementations. Some interviewees feel that, after publishing a list of standards and guidelines, NHS Digital can further help in maintaining a list of quality suppliers who provide PHR solutions which are compliant. Some feel this might be achieved by a kitemarking process. An up to date list of vendors and solutions not only gives the ease of selection, but also ensures a process of continuous learning from the overall community. A minority of participants in the research would like PHR solutions to be built on open standards to take away the risk of vendor lock-in. Alongside this there needs to be centrally defined standards for interoperability to allow this movement data between systems. Most organisations wish NHS Digital to provide access to the necessary IG guidance, to help organisations remain compliant with necessary DPA/ GDPR legislation. In addition, NHS Digital can also help shortcut the process of drafting an Information/Data Sharing Agreement (ISA/DSA), for example, promoting existing successful examples (e.g. in North London, Lancashire and elsewhere) to be used by other organisations, reducing the associated process, time, cost and overheads. Some participants told us that it can be hard to create a compelling business case to secure funds for PHR initiatives and would like NHS Digital to play a role in aiding the creation of business case by providing a set of use cases, benefits and impact on users. 24