Page created by Michele Ortiz
Calls to Action
on Health Data
Raise the digital,
Digital Health                                     literacy & skills of all
Society & the                                      stakeholders

European Institute
for Innovation
                                                   Generate and value
Through Health                                     trustworthy Real
Data Calls to Action                               World Evidence

on Health Data
Ecosystems                                         Accelerate
This contribution summarises the outcomes          interoperability across
of two recent multi-stakeholder consultations      Europe and globally
to examine the acceptance criteria for societal
trust in the use of health data and a recipe for
trustworthy digital health: standards, architec-
ture and value.                                    Demonstrate
                                                   benefits to society
The Round Tables were developed and con-           from data access,
vened by DHS and i~HD neutrally and inde-          use and reuse
pendently from the event sponsors, Johnson &
Johnson and Microsoft. Each meeting was at-
tended by around 27 online participants from
EU institutions, national governments, industry,
academia, hospital management,, healthcare
                                                   Adopt a risk
professionals, regulators and patient represen-    stratification
tatives. DG Sante and Connect officials contrib-   approach
uted to both events.

The recommendations and calls to action aris-
ing from these events were presented to large
online audience at the Digital Health Society
                                                   Build a trustworthy
Summit in November 2020 and discussed by           framework for data
a multi-stakeholder panel. The recommenda-         access and use
tions, the calls to action and round table sum-
maries are documented in the accompanying
uploaded report, also available at
www.                                               Adopt a
The recommendations cover the following            approach to
key themes.                                        health data
     Raise the
     literacy &
     skills of all
Member States should set              Researchers, regulators, public
target standards for population       health and political decision
and professional digital, health      makers also need to be health
and data literacy and openly          data science literate.
share these targets at a European
                                      Healthcare funders (ministries,
                                      regions, insurers) should publicly
Literacy should cover, for the        declare an annual budget they will
public:                               invest in patient/citizen literacy
• becoming fluent data users          resources and initiatives, and
   for their own health               how they will cover age ranges,
• appreciating the importance         ethnicities and other population
   of the data they create            subgroups and leave no one
• understanding their rights and      behind.
   protections over data held by
   and used by others
• understanding the benefits          Education providers targeting
   their data can offer to society.   public and health professional
                                      education should be required
                                      to share digital health curricula
Literacy should cover, for            and learning objectives (not
existing and future health            course delivery materials). Equally
professionals and managers:           these points should be applied
• how to use digital health tools/    to curricula for health and data
   data science for patients and      literacy for the education of
   citizens                           children.
• how to educate and support
   patient/citizen users of health
   data and digital health tools      Industry should contribute to this
• how to respond to and               mission by sharing educational
   escalate issues, readings of       resources and the selective
   concern                            sponsorship of training places on
• the importance of RWE and its       literacy programmes.
• how to understand data
   science and its contribution to
   healthcare practice.
     and value
     Real World
National and Regional Health     •   education to raise the skills of those who
data infrastructure providers        need to generate real-world evidence, so
and coordinators, the research       they ask the right questions and generate
community, public health             comparable answers
agencies and European data       •   the kinds of research questions can be
infrastructure programmes            answered by distributed analytics, and
should increase and co-              which ones need to work on a dedicated
ordinate investments in:             patient level data extract
                                 •   improving data quality, starting with
                                     facilitating a more motivating culture within
                                     healthcare professionals and better EHR
                                     system user interfaces
                                 •   research into errors and statistical
                                     corrections for low quality data, and the
                                     generation of synthetic data e.g. for the
                                     training and validation of AI
                                 •   audit processes and traceability of the
                                     sources of data must be embedded into
                                     policies and architectures to ensure
 across Europe
 and globally
Member States should              Member States and the EC must
embrace an alignment of           support patients and citizens to
standards adoption with           become strong advocates of joined
other countries, such as on       up (interoperable) health data
the EEHRxF, and reflect those     balancing illness and wellbeing
as strong interoperability        (prevention) needs.
demands within national and
regional procurement policy and
specifications.                   The EC should more strongly
                                  encourage health data generated
                                  through its funded projects to be
Future standards                  more widely reusable via the EHDS.
development strategies
should involve representative
data creators and                 Interoperability between
users, especially health          consumer devices which
professionals and patients.       generate health data and
                                  EHRs will become increasingly
                                  important as this type of data
Healthcare providers              grows in volume and relevance
should demand, from their         and must therefore be ensured
EHR suppliers, explicit and       through regulation or soft law.
independently verified
interoperability against
prescribed standards through
procurement specifications and
renewal contracts.

The extent of the
interoperability a healthcare
organisation and its supplier
can deliver should be
measured and made public.
 benefits to
 society from
 data access,
 use and reuse
Data Permit Authorities and          Industry should support and
data sharing intermediaries          then adopt consensus practices
should:                              on how best to communicate
• publish lists of data uses they    the benefits to society from
   will normally support, and        their use of health data.
   those they would not
• require the intended benefit
   of data use to be stated with
   each data request
• define the terms and
   conditions they will require
   from data users
• publish annually the benefits
   they have enabled, and
   lessons learned from reusing
   health data
• consult with the public to
   define societal benefits and
• involve patients and citizens at
   decision making (board) levels
• promote and oversee good
   models of data altruism.
     Adopt a risk
The GDPR places too strong an      EU and national research
emphasis on the identifiability    funders should invest in further
of individuals from data           research on risk stratification
through explicit attributes        methods for health data sets so
and does not give adequate         that proportionate protections
recognition to unique data         such as appropriate codes of
patterns that may enable           conduct and suitable information
data subject identification.       security measures and can be
                                   applied consistently according to
                                   purpose and risk and not, as at
At an EU level a specific health   present, in a piecemeal way.
scientific and research basis
for reuse is needed.
                                   Data Protection Authorities
                                   and the European Data
Pseudonymisation should            Protection Board should indicate
not always be considered as        willingness to develop and adopt
personal data without taking       risk stratification guidance on the
into account the safeguards        use of data protection safeguards.
including the protection of
linkage keys.                      Member States and the EC
                                   should balance risks with the
                                   opportunity costs of not sharing
                                   health data.
 Build a
 framework for
 data access
 and use
Data Permit Authorities             All public and private
should:                             stakeholder should support
• promote the development           the adoption of standards and
   and adoption of multi-           Compacts for how data access
   stakeholder Compacts             requests are formulated and
   regarding responsible            transparently reported on.
   data use, transparency,
   communication, by including
   the public (patient and civil
   society organisations) health
   funders, providers and health
   data organisations (public
   bodies and industry)
• hold open public consultation
   when developing governance
   frameworks and decision-
   making rules for health data
   uses and reuses
• include members of the public
   in the constitution of the
   European, national or regional
   decision making bodies
• publish inventories of data
   use requests received,
   accepted, declined and of any
   investigations into misconduct
• conduct public awareness
   campaigns to explain to the
   public the research uses and
   benefits of using health data.
     Adopt a trans-
     approach to
     health data
All stakeholders should support      Synthetic data sandboxes
and promote treating repositories    should be developed to enable
of pooled anonymised health          research into novel security
data as a societal good.             approaches and the training of
                                     AI algorithms.

Investments should promote
the uptake of federated              A transformation towards
data models to facilitate            cross-organisational and
interoperability, connectivity       independently run health data
and FAIR data access while           repositories will require radical
upholding GDPR compliance.           change in ICT products and
                                     procurement, for which policy
                                     enablers must now be enacted.
Europe should now consolidate
efforts on one or a small number
of common data models so that        Regional and national early
data harmonisation methods,          adopters should be encouraged
tools and skills can be scaled up    to collaborate across borders to
to become a readily available and    develop best practices, lessons
affordable resource.                 learned and accelerate the reuse
                                     of data and the development of
                                     benefits from it, sharing with other
Stakeholders should focus            Member States and stimulating
eHealth governance models,           European competitiveness.
trust mechanisms and research
infrastructures to contribute data
to large-scale independent health
data repositories that provide
real-time continuity of data
access for individuals, healthcare
delivery and for population
level analysis, with appropriate
DHS Summit
The above calls to action were presented and
discussed by an expert panel which com-
prised Nicola Bedlington, Chair of Data Saves
Lives, Jesper Kjaer, Danish Medicines Agen-
cy and Nigel Hughes Project Lead EHDEN &
Janssen and Ioana-Marie Gligor, Head of Unit
DG Sante. They agreed the two most import-
ant calls were upskilling digital, data and
health literacy, and generating and valu-
ing trustworthy Real World Evidence.

We conducted a poll of Summit attendees
and the results were:

  50%                                           82%
                     thought the most                 thought if health
                     important call                   data is to be a
                     was adopting a                   societal good it
                     transformational                 should be defined
                     approach to                      by a group formed
                     health data.                     of multiple

  72%                                           73%
                     thought a list of                thought that, to
                     data uses that would             develop trust in
                     normally be                      data access and use,
                     supported and those              they would prefer to
                     that would not be                see a combination
                     supported should be              of written laws/
                     developed by a group             regulations and
                     formed of multiple               multi-stakeholder
                     stakeholders.                    codes of conduct.

Acceptance criteria for
societal trust in the use
of health data
Round Table
This report summarises the topics, discussions      ever, there is less public understanding
and conclusions of a multi-stakeholder Round        and therefore trust for uses of data that
Table held on Thursday 3rd September 2020           are not directly applicable to the indi-
on acceptance criteria for societal trust in the    vidual and performed by organisations
use of health data. Its aim was to propose          who seem less familiar within the health
criteria for building and retaining socie-          ecosystem. Participants considered the chal-
tal trust in the uses and reuses of health          lenge of societal acceptance criteria from three
data, across a spectrum across direct care,         perspectives: the who, what and why of data
public health, health system improvement and        use and reuse; technical and organisational
research. 27 participants, comprising patient       safeguards; transparency and trust about use
organisations, healthcare providers, payers,        and value. Through breakout group and plena-
ministries, data protection authorities, industry   ry discussions, the following themes emerged.
and industry associations and representatives
from the European Commission participated in        There is a big difference conceptually between
a highly interactive half-day meeting designed      data use to benefit the individual and larg-
and run by the Digital Health Society and the       er scale data reuse that has the potential to
European Institute for Innovation through           benefit many (but might not include individual
Health Data, sponsored by Microsoft and             data subjects). The public, and individual
Johnson and Johnson. The Round Table sought         data subjects generally support data re-
to consolidate what society and decision mak-       use if it clearly explained to them what
ers would regard as acceptable conditions           the beneficial objective is. It was recognised
and terms for access to large scale data            that there is no universally accepted definition
resources. It has been timed and offered as         of beneficial use, but that illustrative lists of
input to the scope, design and governance           purposes that would normally be support-
framework being developed for the European          ed by decision making bodies, and pur-
Health Data Space.                                  poses that would not be supported, are
                                                    helpful for guiding the public and guiding
Right across the learning and innovation eco-       decision makers. It would additionally be
system, there is a growing need for large scale     reassuring and strengthen public support if
access to health data. A momentum for Eu-           list of approved uses, and denied uses, would
ropean cohesion on data access, harmonised          periodically be published. This is in effect a
criteria and governance, has been accelerated       combination of transparency of intention
by the European Health Data Space. How-             and transparency of action.
It has been found by a number of patient and       Decision-making bodies, and the governance
public perception studies that ensuring that       frameworks that they operate under, are more
the use purpose will deliver a benefit to health   likely to operate at Member State and/or re-
systems and that this benefit will be afford-      gional level rather that EU level, for legal, polit-
able, without excessive profit taken, is the       ical and practical reasons, but the governance
most important criterion for support. Whether      frameworks they utilise should be as consistent
the bodies involved are commercial or public,      as possible, across Europe. The public must
whether they are classically associated with       be involved in developing their gover-
healthcare or not, are less important factors.     nance frameworks and decision-making
COVID -19 has demonstrated the level of public     rules and should be included in the constitu-
engagement and support that is possible if the     tion of the bodies themselves.
purpose for data collection and use is clear and
in society’s interest.                             Public fears about misuse, including fears
                                                   that information will be used in some way
The importance of transparency to the              to disadvantage or discriminate against
public as well as to individuals whose data        individuals or minority sub-populations,
might be reused was a dominant theme               must also be addressed by such bodies.
throughout the event, across all of the three      These fears are very powerful and if they are
breakout groups. This was perhaps considered       not addressed, they risk dominating over the
to be the most important success factor. It was    perceived benefits of using health data. And
emphasised that this transparency must be          important mitigation for this fear is, again,
inclusive, including vulnerable groups of peo-     transparency. The public have to know how
ple whose data are equally important and who       their data is being used, and how it is not
should be inclusive beneficiaries of the out-      used. Even when it is not feasible to give in-
comes from using data (a potential adaptation      dividual level control over all possible uses of
of the concept of reasonable accommodation         data, the public then need to have confi-
was discussed). Inclusivity may have economic      dence in the organisations that are mak-
challenges in a single market, but on the Euro-    ing decisions on their behalf. In cases where
pean scale and through the use of European         data have been anonymised it is not easy to
standards, inclusivity can be made economical-     provide personalised feedback, but collective
ly viable. Greater public and health work-         published feedback about how data have been
force education, including data literacy,          used to populations may prove sufficient.
digital literacy and health literacy, are
therefore essential success factors as well.
Many of the reuses of data, especially for          Synthetic data, in which noise (perturbation) is
research, public health and health service          added to the data in order to prevent individu-
improvement do not need identifiable                als being recognised even from very rich data
data, but they do often need fine-grained,          patterns, is a method that is gaining recogni-
close to real-time, data including longitudi-       tion as a method for some kind of population
nal histories and increasingly including special-   level research.
ised data types such as genomics. The biggest
concern for citizens is whether they could be       It is usually fruitful to think about the inter-
identified from a dataset that is being shared      play between what we construct by means of
or accessed. The GDPR strongly distinguish-         technology and our social constructions (laws,
es pseudonymised from anonymised data,              codes of conduct, organisations, behaviour).
but it was argued that fine-grained data            Law should not be made without thinking
can never be truly anonymous.                       about how technical constructs can help en-
                                                    able compliance and enforcement. Technology
                                                    initiatives should not be developed without
                                                    considering how and by whom these initiatives
                                                    will be governed. A third, psycho-social (people
                                                    oriented), dimension is also important.
This historic distinction is perhaps
                                                    There was considerable discussion about a
no longer viable, and a risk                        code of conduct. Although a formal and pos-
                                                    sibly legally enforceable code might be devel-
stratification approach which takes                 oped at a European level, there was support
into account the way in which the                   for organisations, especially health and
                                                    health-related companies, to come togeth-
data are being processed and                        er and to develop voluntary codes of prac-
protected and the benefits of                       tice that they agree to adopt: known as a
                                                    compact. The public would be most assured
use through information security                    if this is a single code developed through
measures is more appropriate.                       multi stakeholder engagement including
                                                    patients and the public, and was adopted by
                                                    all health data user organisations (commercial
                                                    and public, and including patient and civil soci-
                                                    ety organisations themselves when they collect
                                                    and use data).

This report summarises the topics, discussions     The Round Table was an invitation-only,
and conclusions of a multi-stakeholder Round       multi-stakeholder and highly interactive half-
Table held on Thursday 3rd September 2020          day online event with 27 participants, dividing
on Acceptance criteria for societal trust in       for some of the time into three virtual break-
the use of health data.                            out rooms for deep dive topics. The agenda is
                                                   given in Appendix 1. The participants included
Its aim was to propose criteria for building and   patient organisations, healthcare providers,
retaining societal trust in the uses and reuses    payers, ministries, data protection authorities,
of health data, across a spectrum from direct      industry and industry associations and rep-
care, public health and health system improve-     resentatives from the European Commission
ment to research. The Round Table sought           who are architecting the European Health Data
to identify what society and decision makers       Space. The list of meeting participants is given
would regard as acceptable conditions and          in Appendix 2.
terms for access to large scale data resources.
This report is therefore intended to help frame    The event was jointly run by the Digital Health
future European initiatives to develop better      Society (represented by Bleddyn Rees) and
formalised models for data provision, use and      the European Institute for Innovation through
governance, to better position new actors          Health Data (represented by Dipak Kalra). It
(e.g. industry) in roles such as healthcare de-    built on the Digital Health Society’s Summit in
livery partner, care pathway redesign partner,     Helsinki with the Finnish Presidency last De-
analytics partner and knowledge partner. In        cember when both organisations collaborated
particular, this Round Table and report have       on the data and digital content.
been timed and offered as inputs to the scope,
design and governance framework being de-          It was sponsored by Microsoft and Johnson and
veloped for the European Health Data Space. It     Johnson, who contributed financially for pre-
may guide the development of any necessary         paring and running the event but did not con-
enabling legislation and policy instruments,       trol the structure, hosting, content or reporting
industry promoted standards or codes and           of the event.
innovations in information security safeguards.
No individual stakeholder is able to solve the
challenges and now more than ever we need a
deep collaboration which strikes fair balances
for all to enable the common good.

Scene setting

Bleddyn Rees and Dipak Kalra welcomed partici-                 taking a deeper dive on societal acceptance
pants.                                                         factors for data reuse that might be taken on
                                                               board when developing the EHDS governance
Bleddyn set the scene for this Round Table,                    framework. A future event is planned by Digital
which has built on prior related events over                   Health Europe on the perspectives of patient
the past several months, starting with a Digi-                 organisation representatives on this topic.
tal Health Society Summit in December 2019,                    These events have some organisers and partic-
which highlighted many of the issues and chal-                 ipants in common, and are sharing outputs so
lenges that impact on how the public and pa-                   that their progression is complementary and
tients understand and indicate preferences for,                additive.
or control over, the uses made of health data.
In the spring of this year DG Santé has run a                  Dipak reminded the audience that there is an
series of consultation workshops with strong                   explosion of the opportunity space to learn
DPA participation, moderated by Petra Wilson.                  more from health data, as more and more
In May, the DigitalHealthEurope project ran a                  kinds of data are being captured about and by
virtual focus group for industry about compa-                  patients and citizens, and are potentially com-
ny aspirations and potential contributions to                  binable if this is permitted to build up rich pic-
the European Health Data Space (EHDS). The                     tures of healthcare, health outcomes, wellness
industry participants highlighted the special op-              and wider influences on health etc. We must
portunity for architects of the EHDS to develop                take a future looking vision on the availability of
a coherent governance framework that could                     data. We should especially note the most rapid
be adopted by other European data initiatives,                 growth area will be citizen generated data, and
thereby helping to harmonise approaches                        our approaches to governing data use must
adopted across Europe. This Round Table was                    actively win citizens’ trust in sharing their data.
designed to contribute to that aspiration, by

                                             Population registries,Clinical
                 Geomic data                      trials databasees                         Care apthways, decision
                                                                                           support, trends and alerts

        Transport,                                              Ditigal
                                                                                                         Mobile devices
     environment ect.                                           Citizen

                         Bio-sensors                  Social networks                Clinical applications

  “Personal sensor data is expected to grow to 90%                            “By 2021 there will be almost as many personal
  of all stored information within the next decade”                                   assistant bots on the planet as people”

  “90% of the data in the world today has                                                   “> 1billion have access to mobile
  been created in the last 2 years”                                                                      broadband internet”
Right across the learning and innovation eco-        This has included important for the collection
system, there is a growing need for large scale      of personal data by a range of organisations
access to health data. Many of the innovations       (such as restaurants) that would not normally
we are developing or foreseeing need to ben-         have this and allowing location data to be used
efit from vast volumes of health data. This may      by agencies that do not normally have this
be from conventional healthcare sources (e.g.        either. However, it would be wrong to assume
detailed EHRs), patient and citizen generated,       that this societal goodwill is going to be perma-
medical devices and non-health sources such          nent or can now be relied upon for many other
as pollution. The analysis needs are for this to     desired uses of health data.
be fine grained, individual level data (normally
anonymised) so that precise and novel analy-         A momentum for European cohesion on data
ses can be undertaken. Pre-compiled aggre-           access has been accelerated by the European
gated data sets, or data warehouses refreshing       Health Data Space (EHDS). The details of how
their data every few months, are no longer           this space will be designed, what data sources
adequate. There is also an increasing demand         it will contain and which ones it will network to,
for the data to be close to real time (so that       and how it will be governed including its uses
real time feedback systems, for example driv-        as well as the terms of use are still being de-
en by AI, can be developed), and for this to be      fined. However, the following concept diagram,
longitudinal, reflecting health, wellness, disease   developed by DigitalHealthEurope, seems to
trajectories and outcomes.                           be a plausible concept model. Europe already
                                                     has several existing data network infrastruc-
This growing data need has stimulated national       tures that might be interconnected through the
and EU level (and international) investments in      space, which could then offer a single portal
large scale data resources and networks that         for access to permitted data extract from these
offer these opportunities. The different exist-      networks. This includes the eHealth Digital Ser-
ing and emerging infrastructures comprise a          vice Infrastructure (which presently exchanges
mixture of eHealth (digital health) services and     patient summaries and electronic prescrip-
research infrastructures. They are implement-        tions between some member states, but has
ed via a mixture of centralised and federated        a roadmap to extend the range of electronic
architectures. These different infrastructures       health record data sets to be communicated),
are often set up quite differently. They may         the DARWIN network being developed by the
process different kinds of data, from different      EMA and the national medicines agencies for
sources, serve different purposes and user           the exchange of medicines information in-
types and have different governance frame-           cluding for pharmacovigilance, the European
works. This makes it difficult to win public trust   Reference Networks that especially connect
at a European level.                                 centres across Europe caring for patients or
                                                     conducting research in rare diseases, and the
The COVID-19 pandemic has stimulated public          life sciences research infrastructures. There are
awareness and support for generating rapid           additionally, stakeholder groups which have
insights from data, and the attitude to data col-    data accumulations that could be contributed
laboration amongst data using organisations.         into the space, as physical data or as network
connections, subject to suitable agreement and                       to scale up. Personalised medicine and AI, for
terms. This includes industry, such as Pharma,                       example, will become increasingly important.
MedTech, Telecos and large ICT companies,
and public health agencies that are starting to                      However, when shifting from left to right on
accumulate data in response to emergencies                           the diagram there are several challenges that
such as COVID-19. Patients and citizens are an                       are faced by the public when it comes to ac-
important potential data contributor, as well as                     cepting and supporting these data uses. This
data user, as mentioned earlier. These different                     includes the more limited widescale public
data sources span healthcare, research, tech                         understanding of the right-hand side uses,
and regulation, and the uses of the space may                        how they are undertaken, with what kinds of
cover any or all of these areas. Data quality,                       data. Additionally, the kinds of organisation that
interoperability, collaboration and governance                       become involved in undertaking those uses
have to be right. The public have to be on                           are less familiar as health stakeholders to the
board for this to succeed.                                           public. Knowledge derived from populations of
                                                                     patients may take a long time to feed back to
The diagram below illustrates, in the upper                          visible public benefit, and the benefit may be
portion of the diagram, many examples of the                         perceived by different people from the ones
potential agreed uses of health data that occur                      whose data was needed to generate a knowl-
at an individual level (close to the patient or citi-                edge. This all creates a progressive disconnect
zen), at the level of regional and national health                   between patients and the public and the uses
systems (for public health or health service                         and uses of data, with reducing direct engage-
improvement purposes) and at an even larger                          ment and choice, making it harder to win public
scale for the conduct of research. All of these                      trust and provide public assurance. We need
example uses occur today, but some of them                           to develop a new consensus on acceptance
are relatively local and are only just beginning                     criteria for the uses of data.

 EHDS                               Inno
                                        vation                   Research              Regulation             Continuity of
                                                                            Cross                        EU RD
                                                   Puplic                  sectional                    Registries
                                                 health crisis               EDS                        Platform

                                     Industry                          Common European                                             research
                                  research and                         Health Data Space                                       infrastructures
                                                                                                                                 (e.g. ELIXIR)
                                   innovation                         - Data Governance
                                                                      - Data Interoperability and Quality
                                                                      - Infrastructural Building Blocks

  Non-Federated                           Patients &                                                                  & regional
  Netwoks                                  citizens                                                                  networks (e.g.
                                                                   eHDSI                Regulators
Individual level health data                    Population level health data                 Big health data
  EHR systems, apps, sensors, genomics,           EHR systems, regional & national             national & international research infra-
  Clinical Decision Support, AI guidance +        eHealth infrastructures                      structures, federated query research
  health impacting data e.g. pollution                                                         platforms + cross-sectoral infrastruc-
                                                                                               tures & services
  Used for:                                       Reused for:                                  Reused for:
  •   Health status monitoring                    •   Healthcare provider performance and      •   Epidemiology
  •   Continuity of care (including the patient       planning                                 •   Digital innovation: devices, sensors,
      and caregivers)                             •   Quality and safety, care pathway opti-       apps
  •   Care pathway tracking, clinical workflow        misation                                 •   AI development
      management                                  •   Medical device and algorith refinement   •   Personalised medicine and bio-marker
  •   Real-time feedback and guidance to          •   Pharmacovigilance                            research
      patients and clinicians                     •   Public health surveillance               •   Diagnostics development
  •   Personalised medicine                       •   Public health strategy                   •   Drug development
  •   Disease interception, prevention and        •   Health services and resources planning   •   Disease understanding and
      wellness                                                                                     stratification
  •   Healtcare provider reimbursement

                                    Decreasing public understanding of why and how data are used
                                                     Increasingly unfamiliar data users
                                         Increasing distance from data results from the patient
                                          Increasing time from data use to demostrated value
                               Perceived lessening choice and greater cybersecurity risk = harder trust

Europe has seen many public attitude and                                identify some ground rules for building and
patient attitude surveys in recent years, which                         retaining societal trust in the uses and reuses
have been conducted by many different or-                               of data. This should be across the spectrum of
ganisations, using different methods and espe-                          purposes and users, consider different access
cially using differently framed questions (some                         and governance models, how transparency
of which have not been well worded to yield                             should be demonstrated and what acceptable
precise answers). The result is possibly a more                         societal benefit should look like. It is hoped that
confused picture of public opinion than a help-                         an eventual set of endorsed acceptance criteria
ful one, and we need to recognise that public                           would give greater confidence to data provid-
confidence and trust in the uses of data they                           ers and data users about data availability and
understand less well, such as genomics infor-                           what access arrangements are permissible,
mation, is lower than for classical clinical data.                      acceptable and serve to catalyse greater data
However, there is a general consensus that the                          availability and data use.
public does support the use of health data for
quality improvement at research that is target-                         Participants were divided into three breakout
ing new or better solutions for diagnosis, treat-                       groups to discuss specific facets of this chal-
ment and prevention, but not for non-health                             lenge:
                                                                        1. The who, what and why of data use and
This was the starting point for the Round Table.                           reuse
Its objective, through three breakout groups                            2. Technical and organisational safeguards
and subsequent plenary discussion, was to                               3. Transparency and trust about use and value

The who, what and why of
data use and reuse
Moderators: Dipak Kalra and Zoi Kolitsi                 »  It was stressed that, as experienced
                                                        through COVID-19, people understand

1. Individual level health                              that putting data into a pool contributes to
                                                        the greater good. They do not need to get
data v. Big health data                                 personal benefit in order to participate (a
                                                        crowd-sourcing spirit). They are nervous
General observations                                    and much less trusting if the benefits can-
                                                        not be clearly explained.
•   There is a big difference conceptually be-
    tween data use and big data reuse (“is my       •   The paradigm of rare diseases (RD), which
    data being used for my care or in a research        was agreed to be a situation where patients
    setting?”). Dividing the data use landscape         do not see a hard divide between care and
    in more ways, as in the figure shown earli-         research. They want their data used to
    er, might not be helpful when it comes to           improve diagnosis and treatment. This gave
    acceptable data use.                                rise to the following questions:

•   It is very important for people to be able to       »  How far are we from extending the ap-
    trust the people who use the data. Lines get        proaches we adopt for RD patients, in which
    blurred when citizens don’t know what will          research is an integral part of care, to other
    happen to their data → transparency was             patients and conditions? Might RD patients
    agreed to be key in order to build the nec-         help to champion the research agenda for
    essary trust.                                       other patient groups?

                                                        »  Can these RD concepts be easily under-
                                                        stood as we present the benefits to society?
A common viewpoint participants                         »   Is it productive still to separate primary
had encountered is that if patients                     and secondary uses as we do today (care
                                                        vs. research) or can we make things easier
are told clearly how a particular
                                                        by looking at the bigger picture? Would it
data use will lead to a direct benefit                  be realistic to progressively blur the bound-
to them (e.g. for a new type of                         aries between primary and secondary uses
                                                        for commoner conditions?
treatment for them) or a benefit to
others (e.g. treatments for other                       »   It was agreed that the area of rare dis-
                                                        eases shines a positive light on the use of
patients, but might not include
                                                        data for research, given that the medical
the patient him or herself), they                       need is so high. Patients are much more
willingly give their consent.                           willing to make their data available, but also
                                                        are contributors to finding the solutions.
»   RD should not be completely separated        The fear that data is being held to a
    from commoner disease research. These            patient’s disadvantage
    should be linked: common disease research
    will progressively be based on smaller pop-
                                                     •   Testimonies of patients have shown that
                                                         in spite of various explanations offered to
    ulations of patients, which might eventually
                                                         them, they fear that data they have shared
    be applicable to a single patient.
                                                         will then be used to their personal disad-
    »   We all agree there has to be a link be-          vantage (whether this be penalising by in-
    tween care and research but there are sep-           surance companies, for marketing, discrimi-
    arate demarcation lines – a single patient is        nation, preventing their career progress e.g.
    of no interest to the research data user, but        at work, cyber-criminality: blackmail after
    care needs to have nominative (identifiable)         the hacking of private information).
                                                     •   It was agreed that it is difficult to fight these
•   Can we use these different groupings of              fears about health data misuse due to a
    purpose to better understand the worries             lack of faith in policy making and political
    that patients have about how their data is           decisions, as well as a deep-rooted fear
    used? Would it be productive to look at the          about big private companies/industry tak-
    groupings their acceptance in a different            ing advantage of the data but then pushing
    way, to understand the worries and the               excessive pricing of products onto health-
    solutions to those worries?                          care systems. There may be value in listing
                                                         as prohibited those misuses that the public
Concerns expressed                                       have greatest concern about.
                                                     Monetising data
•   Preventing the misuse of data, having trans-
    parency about proper uses and the reason-        •   The topic of monetising data isn’t something
    ing behind these uses is important. There            that is spoken about much these days but
    must be understanding and awareness                  was rumoured in the past to be lucrative.
    about what it means to have access to a              However, it was agreed that this issue has
    patient’s data and for this to be used for the       not gone away. It was agreed that this also
    broader good.                                        links to data ownership. Some ICT compa-
                                                         nies (e.g. app developers) offer their cus-
“Fear is the strongest emotion”                          tomers free services in exchange for per-
                                                         mission to use their health data. Another
•   As seen and concluded from the enquires              point was made that many hospitals don’t
    run at the European Commission over the              understand – but sometimes overestimate
    last three years in data sharing, fear is the        - the value of their data. (A comparison was
    strongest of the emotions relating to data           drawn with the data of an individual being
    protection, rather than the potential for            of little value in that regard).
•    We need to use a lot more data efficiently                                                   »  The public has to understand why, how
     and effectively and safely, and to bring the                                                 and by whom data can be usefully used.
     public along. We can only overcome the
     fears mentioned above by showing the
                                                                                           •      The issue of trust enablers and transpar-
                                                                                                  ency was discussed alongside a criticism of
     public the benefits from making good uses
     of data.
                                                                                                  »   Although GDPR is a means towards
Assurance principles/core                                                                         achieving trust, it was discussed that the
principles                                                                                        Regulation is still in infancy when it comes
                                                                                                  to helping to ensure that citizens can find
•    It was agreed that it is important to illustrate                                             out “what the system knows about me”.
     the positive examples of how using the data
     of large populations can lead to more effec-
     tive treatments, with concrete case studies.
                                                                                           With regard to matters of control,
     »  There was a recent Belgium consultation
     on genomic data undertaken with engage-                                               citizens should be able to decide
     ment of students and teachers and a wider                                             (authorise) who may use data and
     engagement of citizens which highlighted                                              for what purpose. Citizens cannot
     what the fears are. We need comparative
     qualitative studies to better understand
                                                                                           easily find this out. Although this
     what the issues are, and then to see what                                             is an area that GDPR tackles, it is
     the impact of education is on those fears.                                            pragmatically not happening in real
     Patients may then become actors, not just
     passive data donors.
                                                                                           life. If data is used under a public
                                                                                           interest legal basis the citizen is
     »   The example of Citizens’ Juries, conduct-
     ed by the UK Connected Health Cities pro-
                                                                                           not asked, does not decide, does
     gramme, was discussed1. In order to under-                                            not control and is not normally
     stand the scenarios for which participants                                            informed about that use.
     would agree to the use their data for re-
     search, they were offered a three-day edu-                                            A third important trust enabler
     cation course, which encouraged people to
                                                                                           is the need for greater public
     be engaged in understanding data use and
     to voice informed decisions. This helped to                                           knowledge and access to education
     highlight what aspects of a proposed data                                             and literacy (health, data and
     use influenced decision making the most.                                              digital) – from primary school
     However, this brought up the question as
     to how feasible it would be to carry out a                                            upwards, about how to treat your
     similar exercise on a whole population.                                               own health data, about how to deal
                                                                                           with common health conditions.

1 Tully, MP, Hassan, L, Oswald, M, Ainsworth, J. Commercial use of health data—A public “trial” by citizens’ jury. Learn Health Sys. 2019; 3:e10200.
»     These are three empowering enablers.

•    However, how realistic is it for patients and     We need education showing the
     the public to be able to read and digest
                                                       public how their data can be useful
     about all of the different possible uses of
     health data, and to understand these well         without their identity ever being
     enough to be able to make informed deci-          divulged to researchers. This could
     sions? We cannot ignore the role of govern-       be through lists of example uses
     ments here, to create integrated and co-or-
     dinated governance frameworks, where              and more detailed case study
     citizens can see the principles, the values       examples. With the evolution of
     that governments respect, and what are the        analytical methodologies, we can
     monitoring measures being taken.
                                                       do virtually everything researchers
•    It was agreed that there is an interesting        need with data without making
     dynamic between citizen responsibility and
     government assistance. It was concluded
                                                       personally-identifiable data
     that a citizen needs to be active and to lo-      accessible.
     cate/find if there is a governance framework
     that they can be part of designing or influ-
     encing, part of which is transparency.

•    On the other hand, we must get away from          B RE AK /////////////
     the notion that everything must be put onto
     the shoulders of the citizen. There must be       2. Purposes and people
     an agency that they can trust to make deci-
     sions about data use on a collective behalf,      •   It was agreed that the ways forward for
     and that they can monitor.                            encouraging people to be fear-free and to
                                                           share their data is through transparency
•    Some of these ideas were seen to be mostly            about having done the right things with
     applicable to situations in which personally          data. This is paramount. The conversation
     identifiable information is being used. We            then focused in that regard on the purpos-
     also need to make more transparent use of             es and players.
     solutions that don’t include identifiable data
     or patient level data. Distributed networks       Purposes
     and analytics hold promise for removing
     that need.                                        •   An increasing number of organisations are
                                                           becoming part of the health data ecosys-

                                                       •   Similarly to the growing number of food in-
                                                           gredients, a list of acceptable purposes may

help to address the need for transparency          Organisations/Players
    and trust building. It may be illustrative.
                                                       •   An illustrative list was shown through the
•   It was agreed that there is no need for a              slides and the discussion showed that pub-
    comprehensive list of purposes. It may be              lic surveys have come down against having
    too generic (or would need to be infinite!).           a fixed list of approved organisations.

•   The need remains for ethic committees              •   The conversation led to questions such as
    and local government bodies to approve or              whether any kind of organisation should not
    disapprove a research data use, as well as             be granted access to health data and how
    educating citizens about the role of such              the public perceives their data is being used
                                                       •   To address this, the findings of a recent
•   A blacklist of the purposes for which data             Citizens’ Jury in Scotland were touched on.
    will never be used would also be useful.               The most important decision-making factor
                                                           was the purpose for which the data would
    »  Attention was brought on the Guidance
                                                           be used, but not with whom the data would
    note for researchers and evaluators for
                                                           be shared. There was support for improve-
    social sciences and humanities research
                                                           ments to their own health, the heath of
    2010 – which sets boundaries through a list
                                                           others or the health system, but not use for
    of what data may not be used for.
                                                           a purely financial purpose.
    »   It was also mentioned that a list such as
                                                           »   Specifically, it was mentioned that par-
    this exists in France2. This includes prohib-
                                                           ticipants asked, “Why is my data not already
    ited examples such as marketing about a
                                                           used (like in banking, to improve experi-
    pharma product and insurance purposes.
    In France public interest is also a ground
    for allowing data use (though this is not              »  On the topic of data donations, if the
    enacted by written law) – but this should be           purpose is to save a life or to serve public
    formally defined and ideally then enacted/             good, the common answer in the Jury was
    adopted into written law. There is patient             definitely yes, we would be very keen to
    organisational involvement in that decision            share our data.

    »   Within this context, it was also men-
    tioned that perhaps the Declaration of Hel-
    sinki could also contribute to determining a

    »   A list of purposes that would be prohib-
    ited is also useful as it is illustrative of the
    boundaries a decision-making body would
    not cross.

Organizational approaches:
Safety and Acceptance
Moderators: Paul Timmers and Nathan Lea                                                   •     Main risk is of citizens handing over control
                                                                                                of their data if they can be identified again.

1. What standards should                                                                        »  Maybe many citizens would like to do-
be set around anonymisa-                                                                        nate fully personal data – perhaps altruistic
                                                                                                plus personal benefits (different motives).
tion, given the challenges                                                                      »  Citizens would likely be more ready to
with genomics, fine grained                                                                     hand over detailed data if they knew how it
location data, rich clinical                                                                    was protected, where it was going and who
                                                                                                would see it.
profiles, rare diseases…?
                                                                                          •     If citizens knew it could be used for advanc-
•    Are we getting to the stage where tech is                                                  ing medical innovations, they may be happi-
     moving so fast that it is difficult to make                                                er to share, but they may be worried about
     anything pseudonymous/anonymous?                                                           insurance company interests and how data
                                                                                                may be used against their interests.
     »     Rare disease

     »     Is this true of synthetic data?
                                                                                                »   But each of us is different – what level
                                                                                                of risk will you tolerate? May have a generic
     »  Avoiding the wicked question: how do                                                    risk band we opt into, for health data shar-
     we define a consent-based model?                                                           ing. Anything out of someone’s band needs
        • Need an open and honest dialogue                                                      special permission.
           with citizens
        • They raise different concerns to med-
                                                                                                »  Near real time use – real time man-
                                                                                                agement decisions. Recognition of social
           ical professionals
                                                                                                determinants of health may be increasingly
•    Transparency of how citizens’ data is used                                                 important for guiding care.

     »  If you can give them a basis to consent                                                 »  Decisions are made on trusted data –
     and be aware of data use it builds trust                                                   currently about 16% of that which is avail-
     »   Need to have a risk framework around
     different kinds of data – e.g. time limited                                                »   Blending of citizen data with health ser-
     trust, certain data like family history of rare                                            vice data in a single environment is key.
     disease. If shared more widely can cause
     issues and have implications for others.

     »     Truly synthetic data3.

3 The term synthetic data is used variably, at present. In this context the term was used to describe real health data extracts that have been modified to a sufficient extent that
individuals could not be identified from the data. Techniques include blurring, rounding, date shifting, making coded terms less granular… An alternative meaning is when data is
generated entirely by a computer algorithm that has parameters which ensure the fictitious data value ranges resemble real population norms but resemble no specific individuals.
2. When and how (even, if)   • GDPR created to develop common rules
                               within the digital single market (and beyond)
pseudonymised data can be
                               » Rule harmonisations
safeguarded enough to be
                               » Definitions of trust – are these culturally
considered effectively to be   bound to different jurisdictions?
anonymised to a data recipi-   » Can we have common rules?
ent/user?                    • The wild west – trading privacy for conve-
•   Risk stratification, where there is no binary   nience
    yes / no. Unlikely to hard code anything in     »  Some discomfort with what convenient
    particular because all data is so different.    use implies for wider data use.
    »   Could we develop tool sets to test that:    »  How can you - the citizen - use your data
    e.g. could the data be reassembled?             as well as for the common good? Can you
•   Aggregated data implies the need for less       yourself use your data to negotiate insur-
    protection. GDPR still applies to pseud-        ance? Trade your data for health? You can
    onymized data, so that determines how you       defend your own interests, since you define
    proceed.                                        them.

•   This is hard – an issue is that anonymous       »  COVID-19 Apps – to what extent is that
    data has a use but in many cases it is next     choice enforced?
    to useless. This is about a world that is       »  Look for game changers in the privacy /
    evolving – the big games are now in person-     convenience trade-off
    alised prevention where anonymous data is
    not useful

•   Who makes the determination?

    »   Data Trust – a third arbiter that rep-
    resents that patients’ say. The right con-
    struct. Political cycles make them less ap-

    »  Can Data Trusts/arbiters keep big plat-
    forms under control?

    »  Trust brokers – independent of all play-
    ers but ensuring data subjects’ concerns are
    addressed in their determinations. Charities
    and patient organisations may play a role

    »   Data Permit Authorities…?
3. Rules regarding authori-                                » Is individual more secure if they know
                                                           how data is secured and across a more har-
sation and access controls,                                monized framework?
restricting indiscriminate                                 »   Avoid shopping around where there are
“internal reuse” of the data                               variations in protection.

by large (public & private)
organisations?                                         4. Concluding points
•   Endgame is that the citizen controls their         •   Architecture is the enabler if supports ev-
    data, or it is controlled on their behalf with a       erything we have covered, and it is feasible.
    full audit trail
                                                           »   Tech is malleable
    »  There would be exceptions under
    consent                                            •   Codified real time data for life – clean. Obli-
       • Study consent – use only as long as               gation to citizens to make this data available
          consent and participation permits                to support their care and care of others
       • Where are these scoped by contract?           •   Keen to see a more harmonious and har-
    »  Dynamically withdraw data for wider                 monized health regime in Europe.
    healthcare access

•   The nature of a study is different. Right to
    be forgotten may not be realistic given the        Great potential especially with AI to
    seemingly contractual nature of studies            revolutionize medicine – find a way
    and participant responsibilities as an active
                                                       to strike the balance with concerns
                                                       around privacy and sensitive data.
    »  Find mechanisms for changing minds as

•   Ethical determinants around non-punitive           •   This is about better tech and organisational
    opting out and cannot force people to give             safeguards. What is “better” in this case? Is it
    their data                                             faster?
    »   Issues are often covered by GDPR                   »   Make it possible
    »  Is it more useful to have something at              »  Tying ourselves in knots in the status
    EU level harmonizing the selection of legal            quo
                                                           »   Opportunity to make things smoother
    »    Harmonized interpretations? Probably…
    There are variations on use of consent, pub-           »   Fairness relates to how data is acquired
    lic task or others for collection.                     and its accuracy, but it is hard to find what
                                                           is fair.

Transparency & Trust
about data use and value
Moderators: Bleddyn Rees and Carina Dantas          •   Health and societal value should be seen
                                                        in the perspective of “common good” – But
Context for the session                                 does common good apply only to the entire
Many studies have suggested that the                    population or specific groups/segments
overriding discriminating characteristics               of the population (e.g. rare diseases). How
in the eyes of the public about the use                 large does a segment have to be or serious/
of health data mainly refer that the use                valuable the challenge being tackled?
should deliver clear public benefit, espe-          •   Information should be provided to citizens /
cially benefits to the health system and                patients not only at the beginning and end
to citizens, and should not primarily be                of a study but throughout its duration.
used for personal or organisational gain of
the organisation using the data. Although           •   When a study fails, the results should also
deeper dive research has danced around                  be shared – lessons learned has real value
this topic, it has so far proved difficult to           and failure can avoid future failings. Failure
formally specify ways of defining public                should not be stigmatised and can be as
benefit and health benefit.                             important as success in terms of learning.

                                                    •   The value of published research, product
                                                        and services was discussed; they are all
1. Demonstrating health or                              valuable and understood as diverse but all

societal value                                          forming different parts of the chain of inno-
                                                        vation. Value will vary but as long as passes
•   Do we need a definition of health or societal       a minimum value of benefit to patients/peo-
    benefit? A definition is challenging.               ple that is acceptable.

Engaging patients/citizens for                      Value is also seen differently
co creation and public-private                      depending on the type of
partnerships (extending IMI to                      organisations (e.g. research,
other industries e.g. tech, MedTech,                industry and patient). Criteria to
automotive and energy etc.) on                      judge value might be helpful e.g.
projects to meet unmet need has                     reducing, inequalities, improving
real value.                                         outcomes, improving financial
                                                    stability of health systems.
2. Earning trust
•   Can we, should we, incentivise citizens or      Messaging needs to be clear and
    patients to share data and build trust? Pa-     balanced – clear information,
    tients are usually more willing to share data
    than a “common” citizen – this distinction
                                                    transparency and consents in
    needs to be addressed. Also, incentive is a     order to develop data trust and
    term that may be misunderstood. Need to         altruism.
    consider what incentives or benefits might
    be possible and desirable.

•   It is important to know/understand main-        •   Trust can be guaranteed by which mea-
    stream opinions but also the different              sures? Legislative, information, (some
    segments/minorities. Can the concept of             countries have evolved systems e.g. data
    “reasonable accommodation” (taken from              altruism, data protection), others – is there
    disability legislation) be adapted for data         the need for concerted actions in multiple
    sharing? Use of facial recognition might not        perspectives? Insurers use of health data
    be 100% compliant with GDPR but its use             appears to raise concerns especially in
    for persons with disabilities/vulnerable peo-       countries with insurance funded systems
    ple may be justified as “reasonable accom-          which could be controlled via legislation.
    modation” and an alternative to consent. A
    form of exemption allowing societal benefit     3. Missing further informa-
    to override compliance (think public interest
    justification).                                 tion citizen perspective on
                                                    data sharing
                                                    •   Information to citizens, that are not only
Literacy (digital & health) is                          misinformed but sometimes also suspicious
essential to empower people (they                       – this is a key element to be addressed

need to understand) and it is also •                    Why health data is secure and its use safe.
key to provide strong safeguards   •                    What data is being shared and the benefits.
that assure people their data will
                                   •                    Dynamic consent was discussed as a poten-
not be misused. More work needed                        tial tool. It was highlighted it is necessary to
on these possible safeguards.                           understand what it implies, so that it is not
                                                        a burden to citizens/patients [ very short
                                                        discussion as ran out of time].
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