Joint Statement: health organisations define EHDS’ opt-out required for life-saving research

On 6 June 2023, a joint statement of 32 European patient organisations, medical associations, research organisations, data collaborations and industry associations was published to share their common views on specific recommendations for a potential opt-out mechanism in the 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 (i.e. health research, regulatory purposes and evidence-based policy making). The European Commission’s original 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.

Download the full statement