The EU health community welcomes the agreement on the European Health Data Space (EHDS) proposal and provides key recommendations to ensure the EHDS will be implemented in a way that provides most added value for patients and European health systems.

The signatories of this statement, which are key stakeholder organisations representing patients, health professionals, researchers, industry and implementer actors in the healthcare ecosystem at both European Union (EU) and Member State level, welcome the provisional political agreement on the Regulation for the European Health Data Space (EHDS) reached on 15 March 2024.

Political negotiators have made substantial progress in the negotiation to agree on the key elements of EHDS. The stakeholder signatories are content to see a text that includes stronger wording on stakeholder involvement, a slightly more harmonised approach to opt-out mechanisms, and increased attention to capacity building in the member states and digital literacy among patients and health professionals. We recognise that the EHDS is an ambitious and innovative policy effort that will be built in a complex environment, and expectations will have to be managed to establish realistic outcomes and timelines. As we move towards the implementation and operation phases, delivering the elements of the EHDS will require EU institutions to involve relevant stakeholders in order to create effective policy tools, instruments, and delegated and implementing acts that will promote harmonised implementation and improve legal clarity.  Experience has shown that well-meant policies may fail when they do not reflect the real world that they strive to serve. Therefore, engaging stakeholders in this process is essential to ensure a feasible implementation path forward.

Our patients’, healthcare professionals’, researchers’, industry, and multi-stakeholder implementer organisations, have worked together since February 2023 to develop a set of key recommendations for the implementation phase of the EHDS that could address some of the challenges remaining in the draft document. At least eight elements need to be considered. They include preventing fragmentation in interpretation and implementation of the opt-out and opt-in provisions, appropriate information provision to patients, guidance for data holders, clarity on definitions and interaction with other legal frameworks, better interoperability in practice, enhancing public trust and structural stakeholder involvement. These recommendations are intended to help chart the path forward to a concrete implementation of the EHDS.

Recommendations:

• Address the risk of a fragmented interpretation and implementation of opt-out and opt-in mechanisms

Opt-out mechanisms to the primary and secondary use of data must be implemented in a harmonised manner across Member States to ensure a consistent approach to reduce barriers to cross-border health research.

For the secondary use of data, under article 33.1 Member States may introduce additional safeguards and measures at national level for data categories ‘e, ea, fa, and m’[1]. This provision, which may lead to the introduction of opt-in systems, must be accompanied with clear guidance to ensure harmonised approaches across Member States, to prevent a patchwork of approaches that may lead to the exclusion of certain patient groups or create obstacles for effective cross-border research.

• Provide clear information to patients

To facilitate patients’ understanding of the functioning of EHDS and to help them make informed decisions on the re-use of their health data, the information provided to patients must be sufficiently clear, concise, and shared in a harmonised manner across EU countries. Standardised EU templates should be developed to inform patients, ensure transparency, and establish clear EU guidelines for inferred data usage.

Access to health data by both public sector and private sector researchers is vital to facilitate research and improve patient outcomes. It is critical that patients understand the way their data is protected by relevant frameworks at EU and national level, and how patient confidentiality, prevention of unauthorised access and use of data, and maintaining data integrity are ensured.

• Limit the additional burden on healthcare professionals

The implementation of the EHDS must not add to the already high workload of healthcare professionals. There is a need for sufficient support, guidance, and tools to help healthcare professionals fulfil their additional roles and responsibilities under the EHDS and develop the required digital skills and competences, as well as investment in infrastructure and data as well as digital health literacy in general. Adequate resources and funding should be provided at the EU level to support training initiatives, streamline compliance procedures, and allocate resources efficiently. It is crucial to ensure that resources are properly and uniformly allocated at the national level to avoid discrepancies in implementation speed and capacity among Member States.

• Interoperability of EHRs in Practice

The interoperability of EHR systems is key for the functioning of the EHDS and needs to be strengthened because of the current diverse landscape of healthcare data sources. To address this issue, it is imperative to clarify and streamline the definitions and rules governing EHR systems within the EHDS framework and to use of fit-for-purpose standards for interoperability that are in line with existing best practices. It is also essential to co-create implementation or migration pathways with relevant stakeholder organisations.

• Enhance legal clarity & improve definitions

There is a need for additional guidance and legal clarity on the different definitions and the interplay with other legislations, to prevent a fragmented interpretation and implementation. The interplay between EHDS and other existing legal frameworks, such as the General Data Protection Regulation (GDPR), the Medical Devices Regulation (MDR),  the In Vitro Diagnostic Medical Device Regulation (IVDR), Artificial Intelligence Act and the Clinical Trials Regulation (CTR), presents challenges in ensuring coherence and compatibility across different regulatory regimes. This requires a careful assessment of the application of the different regulations, and guidance on their interaction. At the same time, implementation guidance related to the definitions and obligations of data holders and users can help the health community to better fulfil their foreseen roles in EHDS.

• Ensure systematic stakeholder involvement throughout the implementation and operation phases

We welcome the inclusion of new provisions on stakeholder involvement, including the creation of a new Stakeholder Forum. However, the involvement of patients, healthcare professionals, researchers, and industry representatives and implementer fora must be further defined to ensure this involvement in the implementation and governance of EHDS happens in a systematic manner. Establishing mechanisms for ongoing consultation, capacity-building initiatives, and transparent decision-making processes will enhance EHDS governance, foster trust and optimise stakeholder contributions. By empowering stakeholders and leveraging their expertise, policymakers can develop informed, responsive, and inclusive EHDS policies and initiatives, ensuring their success and sustainability.

In conclusion, we believe that the political agreement EHDS represents a significant step forward towards putting the patient at the heart of healthcare and improving proper data access and sharing. We look forward to continuing the dialogue and contributing to an effective implementation and governance of the EHDS to improve healthcare and research, while promoting effective and efficient patient-centric care through interoperability and innovation across the European Union.

[1] Human genetic, epigenomic, genomic data, other human molecular data, data from wellness applications, data from biobanks and associated databases

​6 September 2023, Brussels – OPTIMA, as part of a multi-stakeholder group consisting of 32 European patient organisations, medical associations, research organisations, data collaborations and industry associations met EU officials, including MEP Tomislav Sokol, Co-Rapporteur, as well as several permanent representations that will hold upcoming Presidencies of the Council of the European Union, to discuss how the European Health Data Space (EHDS) can facilitate health research and innovation to create tangible benefits for patients in the EU.

The meeting was held in follow-up to a joint statement issued by the group in June 2023 in which the organisations outlined the challenges of implementing an opt-out mechanism. In that statement, the group agreed that the Commission’s proposal strikes an adequate balance between delivering health-related benefits for patients in the EU and mitigating/eliminating any risks to their rights and interests.

The healthcare community remind that ensuring the trust of patients and other stakeholders in the healthcare system is vital. The group also call on legislators to adopt a consistent, EU-wide approach to unlock the potential value of using health-related data for research and innovation.

The 32 organisations raise their concerns that an opt-out or opt-in mechanism with regard to the secondary use of electronic health data under the EHDS may lead to health data disparities, where datasets underrepresent certain segments of the overall population. This would increase risks and undermine the reliability of data-driven health interventions. Instead of introducing more complexity, such as a general opt-out mechanism, more consideration should be given to ensure transparency and accountability regarding the processing operations performed on electronic health data and the results obtained from secondary use, and to the effectiveness of the safeguards in place.

On 6 June, OPTIMA joined together with 31 other health stakeholders to share views on specific recommendations for a potential opt-out mechanism in the future EHDS.

These organisations and initiatives have joined forces because they all share the view that health data are precious and renewable resources that can power decision-making for clinical care, deliver life-saving innovations, and strengthen health systems in the 21^st century.

Discussions in the EU policy-making process now include proposals for an opt-out mechanism for citizens to withdraw their data from secondary use purposes (that is, from research, regulatory purposes and evidence based policy making). The original European Commission proposal did not include this mechanism.

The group of stakeholders support the approach taken in the Commission’s original legislative proposal from May 2022 as it strikes a sensible balance between protection of personal data while enabling the use of data for research and innovation to create tangible benefits for patients and citizens. The stakeholders raise concerns about the real risk that data bias will form part of the EHDS from its inception and thus undermine its principal value for secondary use research purposes if an opt-out or opt-in mechanism is approved, and call for an impact assessment that will inform implementation of this policy option.

If the proposals for opt-out are approved in the final EHDS legislation, the group make six recommendations. They believe the opt-out mechanism should:

• be applicable across all Health Data Access Bodies in EU Member States, limiting the scope of national derogation and ensuring that the technical specifications are aligned.
• consider the impact on health and care professionals and for other data holders.
• be capable of implementation across the EU, without limiting lawful and ethical data sharing for secondary purposes.
• be routinely monitored as part of a regularly updated HealthData@EU data governance framework.
• have a limited, but well-defined, consistent and transparent scope.
• have necessary investment, infrastructure and budget to ensure sufficient transparency so that citizens are well informed of the opt-out.

Finally, the current debate on enabling secondary use of health data in Europe highlights the need to achieve stakeholder alignment where possible on the implementation journey ahead for the EHDS. It also speaks to the need for implementation decisions to be highly informed by those with experience and responsibilities for on-the-ground implementation. This reiterates a need for strong, balanced and inclusive stakeholder representation within the governance model of the EHDS such as its Board of Directors.

Click here for the full statement.