The EU Health Coalition, with the support of BioMed Alliance, EAU, EFPIA and COCIR organised a hybrid workshop with stakeholders and policy makers on 18 May to 'Maximise EHDS impact on better health data sharing'. The event provided an opportunity to discuss different aspects of the Commission Proposal on a European Health Data Space (EHDS), which intends to facilitate health data sharing for healthcare, research and policy making. The event was attended by around 40 persons present in the venue and more than 200 online and was moderated by Magda Chlebus from EFPIA. The slides that were presented during the event are available here and the recording is available here.

Welcome

Nathalie Moll, co-chair of the EU Health Coalition

Nathalie emphasised that the EHDS can be truly revolutionary if it succeeds to coordinate research efforts across Europe to be able to jointly tackle emerging complex health challenges. Putting in place a common consistent, trustworthy and efficient framework across the EU to use health data for research, innovation, policy-making and regulatory activities, while ensuring full compliance with the EU's high data protection standards will strengthen the European health research landscape and fulfil EU health policies’ objectives. To be successful, the proposed EHDS legislation needs to lay the foundation for the building of trust in health data sharing among EU citizens which is linked to a greater digital literacy, transparency and understandings of the benefits of unlocking the value of data. Removing the barriers to health data for scientific research will mean patients can benefit from the discovery of innovative treatments, medical devices and diagnostics but also allow to create a sustainable, resilient healthcare system paving the way for more preventive, personalised healthcare.

Towards the European Health Data Space

Guillaume Byk, Legislative Officer - Digital Health, European Reference Networks, European Commission and Laurent Saunier, European Commission

The European Commission presented the European Health Data Space (EHDS) proposal for a Regulation. The goals are threefold; empowering citizens to access and control their personal electronic health data, ensuring a consistent framework for the use of individual’s data for research, innovation, policy making and regulatory activities (secondary use) and creating a genuine single market for digital health services and products (EHR).

There will be two infrastructures – one for primary care MyHealth@EU, and one for the re-use of health data (HealthData@EU), with mandatory national agencies appointed for both. MyHealth@EU already exists and builds on voluntary work that is already ongoing between member states. There will be new rules for the interoperability of Electronic Health Records in line with the European Commission’s Recommendations on a European EHR Exchange Format, including a self-assessed conformity assessment procedure and market surveillance agencies to monitor conformity of products on the market.

The Commission wants to address the challenges of sharing data through addressing legal/ governance issues, enhancing the quality of data and developing infrastructure and capacity building/ digitalisation.

Better data sharing for better health research & care

Chris Walker, EFPIA Chair of the Digital Health Expert Group

The experience of COVID has shown that effective and efficient use of multiple datasets condensed work into a matter of weeks rather than years in terms of understanding around the disease.

EFPIA welcomes the EHDS proposal especially its ambition to address current legal and technical fragmentation that hinders the ability to bring forward the innovation.

The EHDEN project funded by the IMI is a private -public partnership which has grown the ecosystem and community working around the use of Real-World Evidence (RWE) and Big Data for health research. The project has explored what it means to develop ‘FAIR’ systems, but also what is involved in ensuring the data is ready to be used for research through the application of common data standards. Common data models are central to this work – organising data into a common model even though it comes from multiple formats, studies and medical specialties.

Claudia Pansieri, Researcher at CVBF - Consorzio per Valutazioni Biologiche e Farmacologiche

Ms. Pansieri presented opportunities of better data sharing of clinical trials data for health research and care in paediatrics through the development of a data centre and sharing Clinical Trials data. The CRC data centre, presented as the example, uses 20 repositories and the data is used from multiple sites and clinical trials to understand therapeutic medicines and their impact on children.

Barriers to achieving better cooperation for clinical excellence have been seen in lack of commitment to the FAIR principles. Data is not always ‘findable’ as publication of negative results is not mandatory. Data is not ‘Accessible’ due to low knowledge of how to build a database. The standards and systems are not ‘Interoperable’ and the willingness of sponsors to share data is often based on their own economic strategies - Reusable. However, there are many compelling scientific, ethical and economic reasons why it makes sense to share data for individual and societal health benefits.

European Health Data Space: challenges and opportunities

Panellists:

Peter Arlett, Head of Data Analytics and Methods Task Force (EMA), Co-chair of Big data steering group
Shona Cosgrove, Project Researcher at Sciensano, TEHDAS WP4 and WP5
Hans Juul Hedegaard, Head of Data Service Strategy, The Danish Health Data Authority
Giedre Kvedaraviciene, COCIR Digital Health Director
James N’Dow, Adjunct Secretary General of Education of the European Association of Urology, Professor of Urological Surgery at the University of Aberdeen, Co-Chair Biomed Alliance Health Data taskforce
Gözde Susuzlu Briggs, Project Coordinator Data Saves Lives

What do you want EHDS to enhance and how to get there?

Peter Arlett shared the EMA’s experience of exploring the opportunities of secondary use of data for all steps in the regulatory process – supporting better decision making, and therefore quicker and more effective access to innovative therapies, and better patient health. The DARWIN EU network is the backbone of this work, and is already onboarding data partners using a ‘data protection by design’ model similar to the EHDS. The Erasmus University Medical Center (EMC) Rotterdam will be the service provider delivering the DARWIN EU Coordination Centre.

He strongly supported the standardisation work in terms of putting data into a common data format that makes data ready for research. EMC has been awarded the contract to deliver this for DARWIN. This will need public and private partners to work together to convert to common data models. EMA is committed to supporting the EHDS both by piloting (with DARWIN) and sharing expertise.

Hans Juul Hedegaard represented the Danish Health Data Authority which is responsible for the collection and storage of national health data in national registries. He saw the EHDS proposal as an important step in addressing some of the challenges for better collaboration across the EU. He highlighted the key of working in a collaborative way and sharing experience between EU member states. He again highlighted the need for collective work on standardisation, for example OMOP. EHDS can be an enabler of this collaboration. There is still quite a lot that will need to be worked out by Member States, and the Danish model for providing data secondary use can be shared with others as in inspiration.

James N’Dow reminded us that the key job as a clinician and researcher, and for medical societies in general is to promote better care for patients. The EAU learned through their experience of developing Clinical Practice Guidelines (CPGs) to guide healthcare professionals in the best way to treat patients that there are significant challenges with the published evidence even from randomised clinical trials. Much of what is published is not fit for purpose for CPGs, so in the end guidelines not underpinned by the best evidence. They discovered that alongside clinical trials, use of Real World Evidence or Big Data needs to be embraced – it is in linking with multiple data sources that you understand more about patient outcomes with greater variables, like comorbidities, obesity etc. This is why the EAU has led to IMI Big Data projects (PIONEER and OPTIMA). How we harmonise data in a common data model is crucial for this work, and is currently costly and takes a lot of resource. Leveraging this what EHDS plans to do, but also the EU can leverage what has been achieved by IMI Big Data projects to ensure the success of its plans.

Shona Cosgrove has been working as a member of TEHDAS Joint Action which brings together 25 member states, supporting the development of the concepts for the secondary use of health data in the EHDS. In that sense, she highlighted that she has a slightly different perspective than the other speakers (who mainly represent data users and data providers), as TEHDAS is helping the European Commission and the Member States to build the EHDS, and to help member states to prepare and to meet the challenges of implementation. As part of the work, they will be visiting 12 countries to understand what is already in place, but also to understand what still needs to be put in place in various national contexts. The needs and expectations for the EHDS vary across Member States.

Gözde Susuzlu Briggs echoed the positive value of data sharing for patients as demonstrated by Data Saves Lives. The EHDS plays an important role in leveraging this. Patients need to be engaged from the very beginning, and to be able to give real value, time and resource will need to be invested to ensure they understand key concepts so their contributions can be meaningful rather than tokenistic. Patient communities are channels to citizens at national levels and to reach out and gain trust and the EHDS will need to leverage these networks.

Giedre Kvedaraviciene focused on the need to continue to listen to the needs of all stakeholders in order to build a common understanding and trust development for a workable legislation. The legislation itself should provide clarity of definitions and approach – one understanding across MS and stakeholders. It should also make clear where the value of the action is and how we measure it. The legislation should also consider the costs – whatever we do, aim to measure balance between value and costs. In terms of implementation of the EHDS, the focus should be on establishing meaningful and effective continuous cooperation amongst all actors and building competencies and capacity of different actors.

What would be the challenges?

Panellists identified the following challenges:

• The possibility of misalignment and an unclear legal basis. Particularly considering the interplay between different pieces of legislation and harmonisation of different Member State initiatives.
• Different barriers are experienced by different stakeholders and there can be a different understanding of what solutions are needed. Multistakeholder collaboration will be key.
• Member State capacity to develop and implement the IT infrastructure. This will take time and resource and a gradual approach may be needed, with prioritisation.
• EHDS must be able to demonstrate value and benefits to citizens and health. Relevant stakeholders must be able to focus on delivering benefits and creating opportunities for health and innovation rather than struggle with excessive compliance barriers.
• EHDS is delivering a profound change from business as usual, for example on those researchers used to working on clinical trials. Education, information, collaboration and lots of resources to enhance the collaboration between clinical and data scientists will be needed.
• For data reuse, it will be important to agree a common data model.
• If clinicians working on the front line of health care or patients are left behind, then we run the risk of losing EU citizens from this endeavour. Co-creation can mitigate this.
• Need to protect values while remaining competitive, ensuring innovation is not stifled. Therefore, trust and ethics in respecting and protecting the rights of all stakeholders will also be critical.

Take home messages from panellists

• Important to build on political will in all EU member states (MS). MS need and want to collaborate.
• No one should be left behind. We need to work together. This means not only EU member state agencies, but also patients, clinicians and researchers on the ground, and industry stakeholders. They all need to be part of the development and implementation of EHDS to ensure a true European ecosystem that can collaborate to bring genuine and lasting change.
• The EHDS is requiring a mechanism for structural and inclusive involvement of stakeholders throughout the implementation and operation of EHDS. There should be effective formal mechanisms for hearing concerns from the different stakeholders and work on them together.
• A focus must be on building trust of citizens and a gradual approach – starting with what works well and developing consensus on how to approach more sensitive matters to manage risks in the acceptable manner.
• Simplifying the ‘how’ as much as possible – leveraging what has happened and is happening already without adding unnecessary layers of complexity.