NHS data: Maximising its impact on the health and wealth of the United Kingdom Saira Ghafur, Gianluca Fontana, Jack Halligan James O'Shaughnessy & ...
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NHS data: Maximising its impact on the health and wealth of the United Kingdom Saira Ghafur, Gianluca Fontana, Jack Halligan James O’Shaughnessy & Ara Darzi
Contents
02 ACKNOWLEDGEMENTS
04 FOREWORD
05 EXECUTIVE SUMMARY
08 INTRODUCTION: MAXIMISING THE IMPACT OF NHS DATA
12 PUBLIC OPINION AND ENGAGEMENT
16 DATA GOVERNANCE AND LEGAL FRAMEWORKS
20 DATA QUALITY AND INFRASTRUCTURE
24 CAPABILITIES
26 INVESTMENT
SUGGESTED CITATION
Ghafur S, Fontana G, Halligan J, O’Shaughnessy J, Darzi A. NHS data: Maximising its impact 28 VALUE SHARING
on the health and wealth of the United Kingdom. Imperial College London (2020) doi:
10.25561/76409 34 REFERENCES
Acknowledgements
We would like to thank the following people who contributed to this document
through interviews/ attendance at a round table and have agreed to be acknowledged:
NAME ORGANISATION
Dr. Natalie Banner * Understanding Patient Data
Professor Sir John Bell * The Academy of Medical Sciences
Kate Cheema British Heart Foundation
Professor Diane Coyle University of Cambridge
Douglas de Jager * Human.ai
Rachel Dunscombe * NHS Digital Academy
Dr. Andrew Elder Albion Capital
Lord Valerian Freyberg * House of Lords
John Godfrey * Legal & General
Joanne Hackett * Genomics England
Dr. Hugh Harvey * Hardian Health
Eleonora Harwich * Reform
A total of 26 one-to-one interviews were held with individuals with a strong
Geoff Heyes Mind
interest in this topic. Interviewees included representatives from government,
Dr. Dominic King Google Health the NHS, academia, industry (technology and life sciences), research
Dr. Jack Kreindler * Centre for Health & Human Performance institutions, charities and data privacy organisations. We have not consulted
the public or healthcare professionals for the purposes of this paper, as we
Michael MacDonnell * Google Health
chose to focus on experts in the data policy and governance space. Part of the
Dr. Mahiben Maruthappu * CeraCare rationale of the paper is to understand which issues should be explored with
Lord Parry Mitchell * House of Lords the public and how to do so.
Chris Molloy * Medicines Discovery Catapult
In addition to the interviews, a half-day workshop was held with the same
Professor Andrew Morris * Health Data Research UK (HDRUK) individuals to share insights from the interviews and to explore each topic in
Parker Moss Cancer Research Technology group discussion (the people marked with * above attended the workshop).
Questions covered during the interviews and the workshop included the
Annemarie Naylor * Future Care Capital
following (as the main headings):
Dr. Jean Nehme * Touch Surgery
Andrew Richards * Entrepreneur and investor • What are the key domains of action that the UK needs to take to
maximise the value of its health data, whether that is for better
Sam Smith medConfidential individual direct care, better healthcare delivery in the NHS, or
University College Hospital London better R&D?
Dr. Harpreet Sood *
and Health Education England
• How would you begin to value the potential of NHS data?
Martin Tisné Luminate
Lydia Torne * Simmons & Simmons • What investment is needed at national level? How do we realise
the potential of this investment?
Rakesh Uppal * Barts Life Sciences
Hakim Yadi * Closed Loop Medicine • What needs to be done to ensure public trust?
• What regulatory frameworks are required (e.g., legal, compliance,
We would also like to thank Vernon Bainton for the valuable comments he provided. security)?
2 BACK TO CONTENTS 3
Foreword
The UK is the best placed large economy in We hope that this paper acts as a catalyst
the world to use its health data assets for and framework for a much-needed national
transformative health, scientific and economic conversation on how the UK’s health data can
impact. Good progress is being made and all be best used to improve the health and wealth
levels of society – including the Government, of the entire nation. Following on from this, we
the NHS, academia, charities and industry – are need to generate additional evidence through a
committed to this agenda. However, there is a series of work programmes involving academics,
risk that this is being done in a piecemeal way. policy makers, industry, NHS leaders and most
No single organisation is unequivocally tasked of all the public. The Institute of Global Health
with leading the way, and the endeavour has Innovation intends to actively contribute to
lacked a comprehensive strategy. these efforts in the years ahead. These insights
will enable the UK to make the most of its
Our vision is to provide the public with better, advantages, with concomitant benefits for
more efficient care, driven by responsible patients, the NHS, the R&D community and the
innovation that is underpinned by the UK’s innovation economy. We hope that this work
extensive health data. Our goal in creating this will not only resonate in the UK, but also help
paper, therefore, is to fill that gap by proposing a governments and health systems internationally
single overarching framework to guide the proper to implement strategies to maximise the benefits
use of the UK’s health data assets. We have tried
to answer some of the essential questions this
of health data for their citizens.
Executive summary
enterprise poses but acknowledge that there are We would like to thank the many outstanding
many questions that need further research and contributors who have given their time and
inquiry. Our main message is this: the goal of any energy so generously to this work. We look The NHS occupies a special place in the psyche community, offers the best hope of turning the
strategy must be to deliver benefits to people forward to their continued contribution as we of the British nation. It is one of our most tide on the rising cost of healthcare. Further,
in the UK, and specifically to the NHS. Benefits move forward. treasured institutions, and while trust in other there will be a premium for the country that
to other parties will come as a corollary and are parts of the national infrastructure has fallen, cements its position at the head of the pack.
important considerations for the strategy. the public still overwhelmingly believes in the
purpose and benefits of our health service. The Government is well aware of the scale
To achieve the greatest benefit for British Among its many strengths is the NHS’s ability and urgency of the opportunity, and in the last
citizens and patients, it is essential to adhere to bring together a comprehensive, longitudinal 15 years it has undertaken some important
to three main principles: dataset for 65 million people in the UK. In a initiatives to improve the breadth, depth and
world where big data has increasing value, the quality of the UK’s health data assets. These
1. Patients must feel a sense of agency Lord Ara Darzi
Co-Director UK has an opportunity to leverage its health include the creation of the UK Biobank and
and control over what happens to their data; multiple disease registries, especially in the
Institute of Global Health Innovation data assets to benefit people in the UK and
Imperial College London across the world – both through better health field of cancer care, and the Global Digital
2. Health data must always be used in a way
and through the generation of more research Exemplars programme in hospitals. The key
that is safe, secure, legal and ethical; and
and development and economic growth. ambition is to keep the UK at the forefront of
3. There must be a concerted effort to fairly world class research.
distribute benefits to people across the UK. Ensuring that we maximise the benefits of this
opportunity is non-negotiable. The UK, like most To take advantage of this increasingly rich data
We believe these are the sine qua non of a developed nations, faces significant long-term environment, a number of organisations –
successful UK health data strategy. Get it challenges in healthcare, both from an ageing including NHS Digital, HDR-UK and Genomics
right, and we can generate enormous value for Lord James O’Shaughnessy population – the number of people aged 85 or England– have been created to both improve
patients, clinicians, taxpayers and the economy. Visiting Professor older in the UK will double in the next ten years curation and provide greater access to data for
Get it wrong, and the public will withdraw their Institute of Global Health Innovation research purposes. The current Secretary of
– and the growing cost of new kinds of precision
support. By following our proposals, the NHS Imperial College London State for Health and Social Care has created a
medicine. Using health data to improve the
can remain the most trusted institution in the UK quality and efficiency of care delivery, and new body, NHSX, to provide the overall strategic
while maximising the extraordinary potential give new therapeutic insights to the research direction for efforts to digitise healthcare, with
of its data assets.
4 BACK TO CONTENTS 5concomitant benefits for the UK’s health data Centre of Expertise to focus on this topic and is are acceptable or not. This is sure to require data” includes and an open debate on specific
assets. Further, organisations such as the developing a full programme of work for 2020. an investment in the tens of millions over the uses of health data, the kinds of organisations
Academic Health Sciences Networks (AHSNs) This organisation should have a mandate to coming years. with which the NHS should collaborate, and the
and the Accelerate Access Collaborative create the conditions to deliver the vision, such role each should play. It should also include
(AAC) aim to drive the adoption and spread of as appropriate levels of government investment Finally, to maximise the potential of NHS data the principles that organisations should adhere
products, services and businesses that can and clarity on challenges regarding data assets to improve the health and wealth of to around transparency, accountability and
improve care within the NHS and elsewhere. protection and patient confidentiality. the nation, the Government needs to make a fairness in data use. This paper puts forward a
These efforts, and related initiatives in Northern substantial upfront investment, many multiples value-sharing framework that lays out a number
Ireland, Scotland and Wales, combine to enable It is equally important to make sure that the greater than what we currently see and of arrangements the NHS can explore and
an ecosystem in the UK that promotes the governance of the UK’s health data policy estimated to be billions of pounds. As a starting the risks and benefits of each. This includes
development of solutions and technologies properly reflects the views of patients, their point, all health data must be digitised. Data arrangements such as revenue- and equity-
within the NHS and in close collaboration with families and NHS staff. Efforts to involve the quality must improve dramatically and so must sharing, or one-off payments for data licenses
partners from academia, life sciences and the public in the conversation regarding what be refined or “curated” at scale to maximise the (where appropriate).
technology industry. constitutes acceptable uses of their health data benefits for people in the UK. This requires a
have been piecemeal. This lack of transparency huge amount of investment to enable machine- The purpose of this document is to create
It is important, however, to be realistic about fuels suspicion of the NHS – one of the most readable data to be collected at source; a first step towards establishing a vison,
the challenges that remain. The NHS is the most trusted institutions in the UK – and damages provide technological infrastructure required strategic framework and underlying principles
trusted organisation in the UK when it comes to public trust. Certain aspects of how health data for storage, manipulation and linking, ensure to underpin how health data should be used
looking after confidential personal information; can be processed remain in a legal “grey area”, mainstream medical staff are appropriately to improve patient care. We need to agree:
yet a previous attempt to corral the UK’s health particularly with regard to secondary uses of skilled; and attract and retain the necessary the areas of action needed to maximise the
data for research purposes through the Care. health data (the use of data beyond the reason data science and engineering capability. On its value of NHS data; the current situation and
Data programme experienced significant it was originally collected, such as secondary own, this investment should more than deliver a existing barriers for each of these areas;
problems and had to be curtailed. Furthermore, research). The NHS also lacks the capacity – for return for the UK population in terms of clinical recommendations to explore further; and
the salience of data issues among the general example, data scientists and engineers, clinical benefit and improved service delivery. There outstanding questions that should be resolved
public is rising, as is scepticism about the use informatics experts – to combine, clean and is a significant question about who should using evidence-based research. Answering
of such data by private sector organisations. package data at scale to the point where it is provide this investment. The case for public these questions will be the focus of the next
Proving that NHS and other health data are useful and of most value. funding is strong, but there may also be a role stage of our work.
being used to benefit the wider public is for the “right” kind of private money targeted
critical to retaining trust in this endeavour. We need a national conversation with at specific projects that require additional
locally delivered engagement involving all financial support; this needs to be explored
There remains some confusion about who is stakeholders to address these issues, as further.
responsible for overseeing the UK’s emerging this topic is too important to solely involve
health data strategy. Any strategy must not senior government and NHS leaders. First and An additional consequence of this investment
only cover separate NHSs in each of the four most critically, we must seek input from both will be a dataset that is more attractive for
home nations, but also include a number of the public and from clinicians – as trusted academia and the life sciences and technology
organisations – some of which are listed above guardians – regarding what they believe to industries to license and use, facilitating the
– that are involved in setting policy. There also be acceptable uses of health data, and this creation of technologies that will directly benefit
remains confusion around which organisation must be done on an ongoing basis. This people in the UK. The resulting economic growth
is ultimately responsible for developing public involvement should build on excellent and job creation is likely to generate billions of
and delivering the vision for maximising the local efforts such as the “citizen juries” by pounds for the UK economy. It is imperative that
potential value of NHS data for people in the Connected Health Cities and Understanding we create the right mechanisms for technology
UK. Important first steps and shared learning Patient Data and the engagement efforts of the and science to thrive, and equally important
have been made by the UK Health Data HDR UK Public Advisory Board and OneLondon to make sure that the NHS realises fair value
Research Alliance, but this remains a major programme. These should be combined with from the data or capability that is contributed.
challenge. It needs to involve senior decision- a national communications strategy regarding We must also make sure that the benefits are
makers across government and especially the use of health data in partnership with the shared across the UK, and not simply in those
the NHS, united behind an official narrative Association of Medical Research Charities areas that are already doing well.
that all stakeholders – including the public, (AMRC). We must be much more transparent
clinicians, the NHS, government, academia, about current uses. We need a dialogue to In doing so, it is essential to engage with the
charities, and the life sciences and technology ensure people’s views and concerns are public on a continual basis to understand what
industries – can support. In an encouraging reflected in decisions about which uses of data, arrangements are acceptable to them. This
sign, NHSX has committed to develop a National and benefits generated form these, should include an explanation of what “health
6 BACK TO CONTENTS 7bringing together 22 research institutes problem with intangible assets. While valuation
Introduction: Maximising across the UK, which has in turn funded
seven Digital Innovation Hubs, through
methodologies exist and have been recently
used by the Government,6 their applicability to
the impact of the UK’s health data the Industrial Strategy Challenge Fund
(ISCF), to enable a UK-wide life sciences
the NHS context needs further development.
ecosystem that provides responsible and While progress has been made, the UK still
safe access to health data, technology and lacks a clear strategy to maximise the impact
OPPORTUNIT Y payer system under a common legal framework, science, research and innovation services. of health data. Such a strategy will need to be
could create a single longitudinal dataset for a underpinned by a clear framework that robustly
While the NHS is considered one of the best • Genomics England has been allocated addresses questions of privacy, ethics, security
health systems in the world, there is still large and diverse population. In addition, other
more than £250 million for the introduction and what value is provided to the NHS in the
room for improvement in UK health outcomes.1 complementary strengths include:
of whole genome sequencing in the NHS, sharing of these data.
Achieving a step-change in the nation’s health • A health service that is the most trusted including towards projects such as the
outcomes requires a broad range of measures institution in the UK; 100,000 Genomes Project that enables Public involvement in the use of their health
including, but not limited to, more spending. research into treatments for rare diseases data has been piecemeal and inconsistent, and
One of the opportunities open to the NHS is to • A strong record of innovation in health and common cancers.5 past efforts have attracted criticism. Both the
use data-driven solutions and technologies to and life sciences and a vibrant technology NHS Connecting for Health Agency (responsible
improve direct care, make the delivery of care industry; • UK Biobank, established by the for delivering the National Programme for IT)
more efficient and promote the development Wellcome Trust and partially funded by and Care.Data received widespread criticism for
• World leading research universities and the Government, aims to improve the
of new therapies. issues such as a lack of clear objectives, data
other research assets; prevention, diagnosis and treatment of a security and failure to deliver clinical benefit. 7, 8
In healthcare, huge amounts of data are wide range of serious and life-threatening
• The strategic importance of R&D
collected, but the potential benefits they could illnesses. Data quality needs to improve dramatically.
investment for the Government, especially
deliver have not been fully realised. If used There is wide variation in data quality across the
in the life sciences;
effectively and appropriately, health data can NHS, as data is captured across a huge number
generate huge value for people in the UK. • A stable, balanced and well-respected CHALLENGES of systems with bespoke data structures and a
These benefits can be categorised as follows: legal and regulatory system. While well positioned to take advantage of the significant number of hospital records are still
opportunities generated by health data, the UK paper-based. Machine-readable data needs to
• Health and social value (primary goal): Numerous efforts to deliver benefits for people be collected to improve both direct clinical care
and the NHS also face significant challenges.
Provide benefits to patients and to the in the UK through the use of health data are and R&D. Legacy infrastructure and tools are also
public by using data to improve preventive already under way and can be built upon: What we call “NHS data” is in reality a very hindering attempts to move to the cloud.9
measures and enable better, faster, diverse set of datasets, with varying value and
more cost-effective provision of care. For • NHSX, with investment of more than £1 utility. Electronic health records, where they The NHS currently lacks the capacity to curate
example, by enabling patients to access billion per year, is responsible for setting exist, while useful to support clinical practice, data at scale. It requires data science and
their health records to improve care national policy for NHS technology, provide largely unstructured data that is often engineering talent on a very large scale. The
delivery or by accelerating development of digital and data (including data-sharing difficult to link to other care settings. Data from NHS needs to invest in people – including the
drugs. and transparency).2 Of note, NHSX have pathology (e.g., blood test results), radiology doctors and nurses providing everyday care,
recently announced a £250 million (e.g., mammogram images), and molecular as identified in the Topol Review – and talent
• Economic value: Create jobs and investment to create the NHS Artificial studies (e.g., genome sequencing) are already to ensure the system has an appropriate
economic growth by enabling the life Intelligence Lab in collaboration with the showing significant promise, for example workforce of skilled experts and form ambitious
sciences and technology industries Accelerated Access Collaborative (AAC).3 helping identify new targets for a drug therapy. partnerships with the most innovative
to develop data-driven solutions,
Datasets like Hospital Episode Statistics (HES) technology vendors to leverage the best cross-
technologies and therapeutic interventions • NHS Digital, with a budget of around
can be useful to inform population health industry expertise in data management.
that directly benefit people in the UK. £500 million per year, designs, builds and
operates the core national infrastructure, analyses and the allocation of resources across
We currently lack the investment to make
• Financial value: Provide direct financial platforms and applications on which the health and social care services. However, joining
this happen. This investment is required to
flows for the NHS through appropriate NHS and social care system relies. An these varied data together into clean, curated
attract and retain talent, provide education
licensing and value-sharing arrangements example of their recent work is the NHS and useful forms is not straightforward.
and training, upgrade data infrastructure, and
with the right partners. App, that allows patients to manage GP Estimating the value of and potential benefits improve data quality.9
appointments, order repeat prescriptions from the data is very difficult, which makes
The UK is well placed to capture the opportunity and view their records.4 While there are a number of NHS organisations
of using the data to prevent disease and the development of robust business cases
with differing accountabilities with regard to
improve how we deliver health and social care • Health Data Research UK is an and the negotiation of fair value sharing
NHS data, it is unclear which organisation
services. This is because the NHS, as a single- independent, non-profit organisation agreements a big challenge. This is a common
8 9would be responsible for developing the UK’s • Ensure arrangements entered into by Exhibit 1: Learning from other countries
strategy to maximise the impact of health data NHS organisations agree fair terms for
and overseeing its delivery. This needs to be their organisation and for the NHS as a
addressed urgently. A single organisation should whole. In particular, the boards of NHS US: Digital health companies have ESTONIA: Estonia has been CHINA: China has significantly
be accountable for developing and delivering a organisations should consider themselves attracted significant investment an early adopter of using digital boosted its investment in big
vision, co-produced with the public and with key ultimately responsible for ensuring that through venture capital, with technologies across the public data and advanced analytics. For
analytics and big data companies sector, and each citizen has example, an investment of 60 billion
stakeholders in the system. any arrangements entered into by their
attracting almost $2 billion of access to their own health record, yuan (£6.7 billion) is funding the
organisation are fair, including recognising funding by Q3 of 2019.15 In the China Precision Medicine Initiative
Finally, while the UK has an opportunity to be the which is linked by a unique citizen
and safeguarding the value of the data public sector, the Government identifier.10 Datasets are linked, in a bid to sequence 100,000,000
global leader in this area, other countries have that is shared and the resources that are has allocated close to $2 billion genomes by 2030.12
and all interactions are logged
made notable achievements and could leapfrog generated as a result of the arrangement.16 in funding to precision medicine and visible to the patient through
the UK. Some notable efforts are summarised in initiative All of US. This research blockchain technology.
the exhibit. • Ensure arrangements agreed by NHS programme is engaging 1,000,000
organisations fully adhere to all applicable volunteers of all life stages, health
national level legal, regulatory, privacy and statuses, races and ethnicities,
BASIC PRINCIPLES security obligations, including in respect of
and geographic regions, using data
from electronic health records, bio
In recent years, a number of organisations the National Data Guardian’s Data Security specimens, physical evaluations,
have proposed principles that should guide Standards, the General Data Protection sensors, and other technologies.12
the appropriate use of NHS data. These include Regulation (GDPR) and the Common Law
those currently being drafted by Health Data Duty of Confidentiality.16
Research UK and those published in the Life
Sciences Sector 2 Deal and the DHSC’s Code
AREAS OF ACTION
of Conduct for Data-Driven Technologies. The
following principles, based on previous efforts, Through our research, we have identified six
are most relevant for the purposes of this paper: areas of action to maximise the impact of NHS
data on the health and wealth of the United
• Ensure any use of NHS data aims to improve Kingdom:
the health, welfare and/or care of patients
in the NHS, or the operation of the NHS. 1. Public opinion and engagement
This may include the discovery of new
2. Data governance and legal frameworks
treatments, diagnostics, and other scientific
breakthroughs, as well as additional wider 3. Data quality and infrastructure
benefits.16
4. Capabilities
• Demonstrate active and ongoing
engagement with patients and the public 5. Investment
in the design, development and governance 6. Value sharing
of their activities involving health data to
provide assurance that these activities are For each area, we have described the current
in the public interest. state (including successes and challenges) and
put forward recommendations to explore further.
• Encourage the availability and use of FRANCE: The French Government ISRAEL: The Government has AUSTRALIA: The Government
data for research and innovation that has recently mandated the creation invested almost $300 million to allocated $374.2 million in 2017
serves public interest, by making data of a ‘Health Data Hub’ which is create a national unified dataset towards a digital health record
Findable, Accessible, Interoperable and aimed at boosting and facilitating that will take millions of individual to which every Australian would
Reusable by adopting the FAIR Guiding the use of health data for research patients’ information and help have access (“My Health Record”).
by public and private entities, with collect and curate it in a uniform Following an opt-out period in
principles for scientific data management
the ambition of making France a manner to maximise its utility.14 2019, approximately 90% of the
and stewardship.17 global leader in the innovative uses population have access to a digital
of health data.13 health record.11 While data available
• Ensure arrangements agreed by NHS
through My Health Record is
organisations are transparent and clearly somewhat limited, the underlying
communicated in order to support public policy and infrastructure changes
trust and confidence in the NHS and wider are in place.
government data policies.
10 BACK TO CONTENTS 111. Public opinion
and engagement
SUMMARY:
• The NHS is one of the most trusted • As trusted guardians in the NHS, there
institutions in the UK and this trust has needs to be more proactive engagement
been built over decades. with clinicians and other front-line staff on
this topic.
• Work has been done to understand what
people in the UK think about health data use • Citizens have not been involved in setting
but a much more detailed understanding is the rules and principles by which decisions
needed. about data use are made.
• There is limited understanding of opinions
across demographic and socio-economic
groups.
The NHS is one of the most trusted institutions UK generally accept the use of health data for
in the United Kingdom, with a recent survey provision of individual care and are open to
by the Open Data Institute reporting that the some secondary uses of data by the NHS, for
majority of respondents were confident that the example, the use of properly anonymous patient
NHS would use their data ethically. This research data where there is a clear public benefit (e.g.,
also showed that people are more likely to share research).20, 21 On the other hand, people tend
personal data with the NHS than any other UK to be against sharing health data where it is
organisation and that satisfaction with the NHS perceived to solely benefit the private sector,
compared favourably with the opinions of other where health inequalities may be exacerbated
similar European countries.18, 19 This trust has or where data-sharing may distract from
been built over decades and underscores the delivering quality patient care.
importance of public engagement and support
for the success of any effort that involves the Our understanding of the public’s view on
use of health data. sharing data with commercial organisations
is improving, but there is more work to be
A detailed understanding of what the public done. Wellcome Trust surveys show a decline
thinks about data being used and shared is in support for “Health data being accessed
critical to the effort to maximise the impact by commercial organisations if they are
of health data. We know that people in the undertaking health research” (53% in 2016
12 NHS data: Maximising its impact on the health and wealth of the United Kingdomvs. 39% in 2018).22, 23 A recent workshop are required to understand the views of people
showed that people are more likely to accept that are underrepresented in existing studies,
anonymised patient data being shared with including people from the devolved nations
industry when the NHS receives a benefit and of the UK, from rural areas, from Black, Asian
when the NHS is involved in the development of & Minority ethnic groups (BAME) and of lower
the resulting data-driven solution. Participants socio-economic status. R ECO M M E N DAT I O N S :
were also more likely to accept data being
shared with industry after being “exposed to We also need to consider the thoughts and
attitudes of clinicians and other front-line 1. Better engage with citizens and NHS staff on the topic of health
information and discussion about particular data. There are a number of ways that we can promote the sense that this
ways that commercial organisations might be NHS staff. In the past, their objections were a
is something done with people in the UK, not something done to them.
involved in developing healthcare products and significant factor in the failure of programmes
For example:
services” (18% vs. 45%).21 Similarly, deliberative such as Care.Data. The Wachter Review (2016)
research in Scotland in 2013 suggested recommended a long-term national engagement
strategy to obtain buy-in from leaders of NHS a. Understand which data licensing d. Ensure we understand the
consensus was that private sector access to and value-sharing models are the attitudes and concerns of all
personal data should only be granted where trusts (e.g., Chief Clinical Information Officers,
most appropriate/ethical, building segments of the UK population.
this is likely to result in some form of public CCIOs) and clinicians, and to engage and
on existing regional initiatives.
benefit.24 Specific concerns have been raised listen to front-line workers. The review also
e. Ensure that these efforts are all
about access to data by insurance companies, recommended the campaign focus on meeting b. Involve citizens or citizen bodies brought together to form a more
leading to coverage being denied or premiums the needs of “patients, their families, healthcare in decisions regarding the use of cohesive narrative.
being more expensive. Some legislation already professionals and the entire nation”, not simply health data, for example, through
exists to prevent this, such as the Code on cost savings.26 public representation on decision-
Genetic Testing and Insurance, which forbids making boards.
It is not enough to understand and take into
insurance companies asking for or taking into
account public attitudes. Citizens must be c. Engage early with NHS staff,
account the result of a predictive genetic test.25
actively involved in setting the rules and including senior trust leaders
Legislative mechanisms such as this can be
principles by which decisions about data use (e.g., CCIOs) and clinicians to
used to protect against other perceived and
are made. This shouldn’t be a one-off exercise understand their opinions and
real risks.
but embedded into governance. In addition to concerns.
Aside from understanding acceptable uses of involving citizens, there is a clear opportunity to
health data, it will be important to more deeply be proactive about how information regarding
understand the trade-offs citizens are prepared the use of health data is relayed to the public.
to make between sharing data for clinical or For example, we can make better use of real-
other benefits and the risks in terms of potential world examples where people in the UK have 2. Use what we already know combined with what we can learn through better
loss of privacy. The benefits from the use of benefited from data-driven solutions, and public engagement to develop and implement a communications strategy led by
health data for individual direct care and for we can provide ongoing transparency on the the NHS on the use of health data, prioritising communications that foster trust,
certain secondary purposes are clear (e.g., to organisations that are involved and the role they not just information transfer. For example:
inform a patient’s course of treatment, or for will play. For example, in Scotland the Public
research to yield new treatments). However, Benefit and Privacy Panel is a publicly-convened a. Describe tangible benefits for data releases and as part of the
benefits from other secondary uses, such as for panel that streamlines governance processes citizens using real world examples. UK Health Data Research Alliance
service planning, can be less obvious, creating for the scrutiny of requests for access to NHS Innovation Gateway.30
a challenge when engaging with the public. Scotland originated data to benefit the citizens b. Develop a communications
Some benefits from secondary uses of data may of Scotland for purposes other than direct care.27 strategy for mass and social media, d. Train NHS staff to involve patients
including an approach to tackling in decisions about how their health
not accrue despite the best efforts from parties
Efforts to engage with the public are misinformation. data can be used. NHS staff should
involved. For example, attempts to develop
complicated by the fact that the words used be aware of resources outlining
new interventions using NHS data might be best practice use of health data
to describe patient data and its uses can c. Communicate more clearly how
unsuccessful. We need to better understand the health data is used, by which and, where appropriate, how and
be confusing, as evidenced by research
public’s view of these trade-offs even at the risk organisations and for what kinds of when to seek consent for secondary
commissioned by Understanding Patient Data
of limiting the uses to which these data can projects. For example, by improving uses of health data.
who have published their own guidance on
be put. the visibility and usability of NHS
terminology.28, 29 Terms such as “anonymised”
and “consent” can have different meanings in Digital’s register of approved
We still don’t know what large segments of the
UK population think about health data usage different contexts.
and sharing. More engagement and research
14 BACK TO CONTENTS 15GDPR requires a legal basis to exist in order to research into a medical condition the data
to permit the processing of personal data. In subject suffers from, as well as the impact of
addition, it prohibits the processing of “special the related right for a data subject to withdraw
categories” of personal data (including data consent and request erasure of the data.
concerning health, as well as genetic and
biometric data) unless a specific exemption Consequently, there will likely be an increased
applies.32 Such exemptions include where: reliance on the other statutory exemptions
2. Data governance 1. Explicit consent has been given by the
listed rather than consent, which in turn may
be subject to public challenge as exemptions
and legal frameworks data subject to processing for one or more
specified purposes;
may be perceived as “loopholes” for using
personal data. Additional laws regarding the
confidentiality of patient medical records and
2. Processing is necessary for medical the sharing of identifiable patient medical
diagnosis, the provision of health or social records will also need to be navigated (for
care or treatment or the management of example, implied consent to sharing only if
SUMMARY:
health or social care systems and the sharing is for the purposes of ongoing
• Data governance standards in the NHS have • Some exemptions that provide a legal basis to services; or treatment).
been significantly improved in the past ten process personal data are unclear, and there
years thanks to efforts such as the National is a risk of such exemptions being perceived 3. Processing is necessary to protect the vital The final two exemptions regarding data
Data Guardian. as “loopholes” . interests of the data subject or another processing for reasons of public interest in
person where the data subject is physically public health and scientific research both
• However, the legal framework governing the • Exemptions regarding data processing for or legally incapable of giving consent; require a basis in UK or EU laws. Notably, the
use of personal data in healthcare remains “reasons of public interest in public health” ICO has recently stated that this legal basis
complex and creates a number of legal and and “scientific research purposes” both 4. Processing is necessary for reasons of
for data processing is provided by the Data
societal challenges. require a basis in UK or EU law. public interest in public health, such as
Protection Act 2018 itself. This appears to
protecting against serious cross-border
differ from the position taken in the EU, which
threats to health on the basis of EU/UK
has tended to look to other legislation as the
laws (provided there are suitable and
The standards for data governance in the NHS UK’s independent authority set up to uphold legal basis for permitting data processing for
specific measures to safeguard the rights
have been significantly developed in the past information rights in the public interest, research purposes. For example, in early 2019
and freedoms of the data subject, in
ten years – thanks in part to the creation of promoting openness by public bodies and the European Data Protection Board considered
particular professional secrecy);
the National Data Guardian (NDG) role, held data privacy for individuals. whether the Clinical Trials Regulation could
by Dame Fiona Caldicott – and introduced to 5. Processing is necessary for scientific be an appropriate legal basis for permitting
ensure that the health data of patients and the While it might be possible to perform
research purposes based on EU/UK laws processing of special category data under
public is safeguarded. To improve the security research using anonymised data, often the
(which shall be proportionate to the aim the public interest or scientific research
of healthcare data, the NDG recommended anonymisation removes some, or a significant
pursued, respect the essence of the right exemptions.33 The European Data Protection
ten data security standards for all healthcare part, of the value of that data. Many uses of
to data protection and provide for suitable Supervisor (EDPS) also notes in its preliminary
organisations to implement. This resulted in health data involve mining big datasets to
and specific measures to safeguard the opinion on data protection and scientific
the Data Security and Protection Toolkit (DSPT), obtain insights, whether regarding public health
fundamental rights and the interests of research34 that Exemption 5 above is “a new area
requiring all organisations that have access more widely or in respect of specific diseases,
the data subject). and requires adoption of EU or member state
to NHS patient data to use this online self- targets, drug discovery or drug development.
law before the use of special categories of data
assessment tool to demonstrate their capability For example, it is often necessary to know if This legal framework may create a number of for research purposes can be fully operational”,
in implementing the security standards.31 a disease outbreak is more prevalent in men legal and societal challenges. Exemptions 2 and that “[the exemption] in principle provides
or women, of a particular age range, in a and 3 are drawn narrowly and therefore may for processing of special categories of data for
The legal framework governing the use of particular geographic area, or with particular only apply in very limited circumstances. scientific research but only on the basis of EU or
personal confidential data in healthcare is socio-economic considerations. However, As such, it is likely that the most applicable member state law. However, such laws have yet
complex and, in some instances, unclear. retaining these identifiers increases the exemptions for secondary uses of health data to be adopted.”
It includes the NHS Act (2006), the Health likelihood that this data is deemed to be merely are 1, 4 and 5 above. However, it may be difficult
and Social Care Act (2012), and the Data ‘pseudonymised’ rather than ‘anonymised’ to rely on Exemption 1 (consent) for a number If this type of systematic data
Protection Act (DPA, 2018). The Data Protection meaning that GDPR will apply to its use. of reasons, including difficulties obtaining commercialisation is adopted, further
Act 2018 is the UK’s implementation of the The deployment of more complex privacy- consent at the time of collection for secondary consideration will be needed to ensure the
General Data Protection Regulation (GDPR). enhancing technologies is necessary to enable (potentially then unknown) uses of data, the NHS can comply with its obligations as a
Legislation in the DPA is covered by the sophisticated data obfuscation, amongst extent to which consent is able to be freely given data controller generally. These include
Information Commissioner’s Office (ICO), the other things. (as required under GDPR) if the data use relates duties around data subjects’ right of access,
16 17rectification, restriction and objection under This includes potential causes and treatments
GDPR, which may only be derogated from in a for a huge range of health problems such as
scientific research context if certain conditions back pain, bladder cancer and even bedbugs.35
are met. Compliance with data subjects right This is one of many useful public resources
to information (or the relevant exemption to that is freely available under what is called
that right) will also need to be considered. the Open Government License (OGL) for public
Ensuring such compliance might be costly from sector information. The OGL allows anyone
a technical and legal perspective, however the to copy, publish, distribute, adapt and to
potential sanctions if the NHS fails to do so are “exploit the Information commercially and non-
also significant (up to €20m or 4% of global commercially”. However, where any of the above
turnover, whichever is higher). is done, the user must “acknowledge the source
of the Information in your product or application
Some forms of non-personal health data are by including or linking to any attribution
already available to the public and not subject statement specified by the Information
to GDPR. This includes anonymised aggregated Provider(s)”.36 Further, this information is meant
information created by the government, for to be made available under the same terms to
example, the evidence-based information on everyone, as governed by the Re-Use of Public
common health conditions on the NHS website. Sector Information Regulations 2015.37
R ECO M M E N DAT I O N S :
Clarify the legal frameworks relevant to health data
usage and sharing by seeking guidance from the ICO on:
1. Discrepancies and misunderstandings as would the data controller need to identify
envisaged by the EDPS on a pan-EU level, a new and separate legal basis for the
by increasing dialogue with the research processing of that data if it is compatible
community. with the purpose of the original
processing?
2. Data usage and data-sharing in
healthcare, for both primary and 4. The scope of the “public interest in
secondary uses. This could be done the area of public health” exemption
in conjunction with the National Data in Data Protection Act 2018, Schedule
Guardian and NHSX and should involve 1, Part 1. Likewise, clarity on the scope
industry, academia and research of Exemption 4 above when it is relied
institutions. Notably, the EDPS has on in conjunction with the legal basis
suggested EU codes of conduct and of processing special category data for
certifications in respect of a variety of the performance of a task carried out
matters requiring clarification. in the public interest (Article 6(1)(e) of
the GDPR), would be welcomed and has
3. The extent to which a new legal basis been suggested by the European Data
for processing is required where the Protection Supervisor.
purpose of subsequent processing is
compatible with the purpose of the 5. The DHSC should instruct the ICO
original processing. For example, if data to provide this guidance as soon as
is initially collected and processed for possible, and fund it to do so.
the purposes of a specific clinical trial
and the data controller wishes to reuse
that data for other scientific research,
18 BACK TO CONTENTS NHS data: Maximising its impact on the health and wealth of the United Kingdom3. Data quality, standards Health Record System
and infrastructure
Cerner
DXC Technology
System C
Intersystems
SUMMARY:
Allscripts
• Outside of primary care, there is a marked • In recent years there have been positive
Meditech
difference in data quality, standard efforts to improve data quality and define
adherence and interpretation, and standards, such as through the NHS IMS Maxims
infrastructure. Digital’s Data Quality Maturity Index. Graphnet
• Data often requires significant effort to be • Across the NHS, there are examples EMIS Health
post-processed, as accurate data are very where data curation is being done well, Teleologic
often not captured real-time. for example, NHS Digital’s Hospital Episode
Kainos
Statistics (HES), the Clinical Practice
• Legacy technology and infrastructure are Research Datalink’s (CPRD) primary care TPP
delaying the ability to move to the cloud, data and the SAIL databank in Wales.
Advanced
further holding data quality back.
Epic Systems
Single-trust vendor systems
Multiple systems
DATA SYSTEMS Outside of primary care there is large diversity
in clinical systems, data quality, IT investment, ‘In-house’ systems
Data systems and infrastructure have evolved
timeliness of data and interoperability of
to varying degrees across the NHS. In primary Paper records
systems. While all providers have a patient
care, practice management software has been
administration system, a recent survey showed
in use since the early 90s.38 The majority
approximately 23% of patient records in acute
of hospitals and secondary care providers,
hospitals are entirely paper-based, and there
however, remained paper-based until the start
was limited regional alignment of the systems
of the 21st century. In the past two decades,
used to process and store these records. Of
a multitude of policy and technology changes
the 117 trusts using electronic records, the vast
resulted in a complex ecosystem of electronic ds
majority (79%) employed one of 21 different or
health records (EHRs).39 ec
commercially available systems, and 10% were
rr
pe
Pa
Today all GP settings are digitised, and there using multiple different EHRs within the same
is a route to convergence on standardised data hospital. However, of those that used a single
for all GP systems. The GP IT Futures programme system, almost half (42%) were using one of
in England and similar programmes in the three identified systems. Making these three
devolved administrations are helping to reform systems interoperable would improve access to
the commercial landscape in primary care and information for more than one million hospital
to enable a move to open, modern, cloud native encounters every year, with international as
Figure 1: Frequency of use of
records
architectures with consistent technical and well as national benefit, where internationally- health record systems by trusts
data standards.40 Nevertheless, local GP usage established data coding and interoperability
ouse
and distribution of health record
and data structure remain varied, existing standards are used.39
In h
systems in NHS England. Each LSOA
proprietary IT system providers are resistant to region in England was assigned the
Legacy technology and infrastructure are
moving towards open standards and Clinical health record system of the hospital
delaying the ability to move to the cloud,
Commissioning Groups (CCGs) must employ trust patients from that LSOA most
holding data quality back. Cloud computing frequently attended during the study
Multiple
staff and still use Commissioning Support systems
allows large-scale, cost-efficient analysis of period. LSOA, Lower Layer Super
Unit (CSU) resources to clean data for returns
medical data to support healthcare services, Output Area; NHS, National Health Single trust
purposes. vendor systems
especially when combined with artificial Service.39
20 21intelligence.31 When integrated properly, interactions generate some form of electronic
the security of cloud-based solutions has record or footprint.49 A single patient typically
the potential to exceed that of on-premise generates close to 80 megabytes of data each
solutions.41 Furthermore, the costs of on- year in imaging and electronic medical record R ECO M M E N DAT I O N S :
demand cloud computing and storage are data.50 Every GP holds electronic records
lower, which is supportive of the push for of every consultation, in coded form, many 1. Enable codified, real-time data to be captured at source,
increased access to EHRs, digital health stretching back decades. However, despite improving data quality in the NHS.
solutions and the analysis of medical data for significant improvements in collecting near-
research purposes.42 - 44 NHS Digital has issued real time data, such as with the Emergency a. Enforce common standards for c. Ensure that NHS staff that use
a guidance document approving healthcare Care Data Set (ECDS) collected by NHS Digital, data capture across the NHS, existing systems are properly
organisations’ use of cloud computing accurate data is very often not captured real- signalling as early as possible trained to do so, improving the
(provided that appropriate safeguards are put time.51 Significant efforts to post-process the to suppliers of systems such as quality of data captured in the
in place).45 However, local service agreements data are often required. Curating datasets EHRs. first instance.
for cloud have not been standardised, causing involves the organisation and integration of
b. Increase digital maturity and
confusion regarding the responsibilities of the data collected from various sources such that
shift away from paper-based
NHS organisation versus the supplier. the value of the data is maintained over time.
processes. The Wachter Review
This is particularly difficult in the NHS given the (2016) recommended “all NHS
variation in data quality and structures. trusts to reach a high degree of
STANDARDS
In recent years there have been positive digital maturity by 2023, after
Across the NHS, there are examples where
which government subsidies
efforts to improve data quality and define data curation is done well. For example, NHS should no longer be made
standards. NHS Digital is working to improve Digital’s Hospital Episode Statistics (HES), the available.” 26
data quality through the Data Quality Clinical Practice Research Datalink’s (CPRD)
Maturity Index, which provides CCGs with the primary care data and the SAIL databank in
opportunity to investigate and engage in data Wales.52-54 For years these datasets have been
quality improvement with providers, and NHS employed for secondary uses, such as academic
England’s Digital Maturity Self-Assessment, research, planning health services and
which helps providers measure how well they informing health policy. A number of individual 2. Invest in standards-based infrastructure and cloud-based
are making use of digital technology.46, 47 HDR NHS trusts and CCGs have also invested in the services across the NHS.
UK has convened a data officers group that capability to curate data at scale in order to
brings together expertise from across all UK better plan their own services. In addition, many a. Invest in standards-based Agreements should also avoid
Health Data Research Alliance members. There of the 15 Academic Health Science Networks infrastructure across the NHS vendor lock-in by ensuring
has been a concerted effort to drive supplier (AHSNs) – established by NHS England to with a minimum of availability providers can lift and shift data
behaviour to ensure systems support returns support the adoption and spread of existing and reliability. from one cloud provider to another
and standards. Open standards such as the Fast innovations at pace and scale across regional at the end of a contract period.
Health Interoperability Resources (FHIR) have networks – have invested in data curation b. Outline in local service
improved interoperability of systems. NHSX capabilities. The seven Data Research Hubs agreements the scope of
and NHS Digital are working to encourage and also have a major focus on data curation.55 cloud services, including who
enforce data and interoperability standards, is responsible for what, who
holding providers to account for implementing holds insurance and who’s
FUNDING
standards, and driving usability of systems to indemnifying whom.
increase data quality at source.48 There are ongoing concerns that the NHS
cannot afford to divert funding from direct
Nonetheless, there is still a marked difference provision of care towards IT. KLAS Research’s
in data quality, standard adherence and Arch Collaborative measured feedback from 200
interpretation, and infrastructure across provider organisations around the world and
providers, making it difficult and costly to recommended an annual investment of 3-4% of
3. Review the mechanisms for funding IT in the NHS.
combine and curate datasets. revenue to run a digitally safe environment.56 For example,encourage a move towards capital funding of
However, few NHS providers meet this Software-as-a-Service (SaaS) solutions, such as cloud, and
standard and the Information Management & away from funding on-site legacy technologies.
CURATION
Technology (IM&T) investment survey to look at
NHS services see approximately one million organisational spend on IT disbanded almost a
patients every 36 hours and almost all decade ago.
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