i~HD joins coalition in raising concerns on draft European Health Data Space regulation

The coalition believes that the regulation has the potential to harness the benefits of the digital age for better health outcomes. However, the group is also raising ten fundamental issues that have not been addressed in the lead-up to the negotiations between the European Council, the European Parliament and the European Commission.

These ten issues are:

• The EHDS must set forth clearer and more coherent definitions (e.g. on ‘electronic health data’, ‘data holder’, ‘electronic health record system’)
• The EHDS must clarify its interaction with other applicable legal frameworks (including GDPR, Data Governance Act, Data Act, Medical Devices Regulation)
• The EHDS must harmonise rules, reduce legal fragmentation and ensure that the regulation can be implemented consistently across the EU
• The EHDS must specify the scope of electronic health data categories for secondary use.
• The EHDS should avoid any opt-in and only incorporate an opt-out mechanism as long as it does not lead to inconsistent implementation, increased health data disparities and excessive administrative burdens. The relevant legal bases under the GDPR should be leveraged and applied in a harmonised way across Member States
• The EHDS should safeguard and incentivise health research and innovation activities that are performed in line with the existing regulatory frameworks
• The EHDS should leverage existing health data infrastructures, set up by health institutions and stakeholders, to allow continuity and build on existing expertise
• The EHDS should avoid excessive data localisation and international health data transfer restrictions that go beyond the requirements of the GDPR’s framework
• The EHDS should involve all relevant health stakeholders from the outset of the implementation process and include them in its governance at both EU and Member State levels
• The EHDS must provide adequate resources and incentives to facilitate its successful implementation. It should be accompanied by policies promoting digital health skills and tools for health professionals, patients and citizens

For months now, i~HD has consistently been involved in different engagements and symposia together with the coalition to discuss the EHDS proposal. In 2022, the organisation provided feedback on the framework of the EHDS through “Towards European Health Data Space” or TEHDAS. Later that year, i~HD also co-signed a consensus statement by the same coalition. Last year, EHDS was one of the key topics in i~HD’s Annual Conference.