EDPB and EDPS support harmonisation of clinical trials under European Biotech Act, but call for specific safeguards for sensitive health data
Samenvatting
EDPB and EDPS support harmonisation of clinical trials under European Biotech Act, but call for specific safeguards for sensitive health data. Brussels, 12 March 2026 – The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have adopted a Joint Opinion on the European Commission’s Proposal for a European Biotech Act. The Proposal aims to strengthen Europe’s biotechnology and biomanufacturing sectors, particularly in the area of health, by streamlining the regulatory framework and updating the rules for clinical trials. The EDPB and the EDPS support the Proposal’s objective of fostering the EU’s competitiveness and addressing existing fragmentation in the application of the Clinical Trials Regulation (CTR). In particular, they welcome the aim to establish a single legal basis for the processing of personal data by sponsors and investigators, which will significantly improve legal clarity across Europe. At the same time, the EDPB and the EDPS underline that the sensitivity of health and genetic data processed in the context of clinical trials requires a high standard of protection. The Joint Opinion provides several recommendations to ensure that the proposed simplifications do not lower the level of protection for clinical trial participants. Key recommendations include: Clarifying controller roles: The Proposal should specify whether the actors involved in funding and conducting clinical trials act as sole or joint data controllers, to ensure a clear allocation of responsibilities. Limiting data retention: The mandatory 25-year minimum retention period should expressly apply only to the clinical trial master file, rather than to all personal data processed during a trial. Further processing for other clinical trials or for scientific research: As the Proposal aims to provide a legal basis under Union law for the further processing of trial data by the same controller, the ...
Waarom dit ertoe doet
Nieuwe regelgeving heeft directe gevolgen voor zorginstellingen die AI-systemen inzetten of plannen in te zetten.
Context (AI-duiding)
Klik op “Toon context” om AI-duiding op te halen.
Nieuwsbrief
Wekelijks dit soort signalen in je inbox
De nieuwsbrief bundelt nieuwe signalen, relevante verschuivingen en korte duiding zodat je minder afhankelijk bent van incidentele sitebezoeken.
Scores
De mate waarin dit signaal de Nederlandse gezondheidszorg kan beïnvloeden (1 = minimaal, 5 = transformatief).
Hoe snel actie of aandacht nodig is (1 = kan wachten, 5 = onmiddellijke aandacht vereist).
De mate van onzekerheid over de uitkomst of timing (1 = zeer voorspelbaar, 5 = zeer onzeker).
Tags
Bronnen
- EDPB and EDPS support harmonisation of clinical trials under European Biotech Act, but call for specific safeguards for sensitive health dataEuropean Data Protection Board (EDPB) —
Pipeline versie: 0.2.0 | Gegenereerd door: pipeline