Only a few weeks remain for stakeholders to comment on the initial impact study published by the European Commission at the end of 2020 on the future European Health Data Space. The Commission will in fact end this exercise on 3 February 2021, before a wider referral and a proposal for a regulation at the end of 2021.
The European Health Data Space (EHDS) is one of the priorities outlined by the European Commission in its European Data Strategy (see EUROPE 12429/5). It aims to “harness the full potential of digital health to provide high-quality healthcare and reduce inequalities.” In particular, it seeks to promote access to health data for research and innovation, with a view to establishing new preventive strategies, as well as improving the diagnosis and treatment of diseases, while ensuring that citizens have control over their own personal data.
In its initial impact study, the Commission considers that the future proposal for a Regulation could be based on Article 114 of the Treaty on the Functioning of the EU (TFEU), potentially combined with Article 16 on data protection.
Among the ideas in this document are governance mechanisms for the primary and secondary use of health data, with the possibility of revising the mandate of the voluntary eHealth network and the establishment of national sectoral bodies. The document also talks about a right to portability of health data and rules on legal liability for the use of digital services using artificial intelligence.
Link to the call for comments: http://bit.ly/38H4OVM (Original version in French by Sophie Petitjean)