The report, co-drafted by the ENVI rapporteur, Tomislav Sokol (EPP – Croatia), and LIBE rapporteur Annalisa Tardino (ID – Italy), emphasises several key topics within the EHDS, such as funding and the make-up of the EHDS board.
Compared to the Commission’s proposal, the draft puts more emphasis on the important role of real-world evidence for policy decision-making, research, clinical, and health technology assessment purposes. In this sense, the text introduces a recital highlighting the potential application of real-world evidence, including the benefits for patients with certain diseases, including respiratory and rare diseases.
The draft provides that health data access bodies shall only provide access to electronic health to a health data user where the processing of the data by the applicant is necessary for, inter alia, scientific research ensuring high levels of quality and safety of health care.
Of particular relevance for the in silico medicine community is that this shall extend to research on medicinal products or medical devices involving training, testing and evaluating of algorithms, including in medical devices, AI systems. The draft ultimately envisages an optout option for patients of sharing their data for secondary use. The EHDS proposed rules are now being examined and is set to be voted on by MEPs in July.
