An Assessment on Innovator's Ability for Consent-Free Health Data Reuse, In the Context of the GDPR and EHDS: The Netherlands Case Study.

Abstract

Considering the difficult procedure of obtaining consent, consent-free health data reuse is believed to be one major contributor towards the creation of thriving health innovation ecosystem. While classic researchers are supported by the GDPR to reuse health data without consent, the innovator's situation remains unclear, and this uncertainty continues to exist upon the introduction of the EHDS. To shed light on grey areas, positions of GDPR and EHDS on the ability of innovators for consent-free health data reuse were assessed. The study concludes that, while academicians are able to reuse health data without consent, a private company's ability has been impeded by individual member states' deviations from Article 9(2) GDPR. Furthermore, in contracts to EHDS (2022) which appeared in favour of innovators through the elimination of consent mechanism, EHDS (2024) with the inclusion of opt-out mechanism, and exclusion of private sector bodies from the Article 35(f), has negatively affected private companies.