Data watchdogs seek safeguards in biotech law
Regulators urge limits on data retention and clearer responsibility lines.
The European Data Protection Board and the European Data Protection Supervisor have issued a joint opinion on the proposed European Biotech Act. Both bodies support efforts to streamline biotech regulation and modernise clinical trial rules.
Regulators welcome plans to harmonise the application of the Clinical Trials Regulation and create a single legal basis for processing personal data in trials. Greater legal clarity for sponsors and investigators is seen as a key benefit.
Strong safeguards are urged due to the sensitivity of health and genetic data. Recommendations include clearer definitions of data controller roles and limiting the proposed 25-year retention rule to essential trial files.
Further advice calls for defined purposes when reusing trial data, alignment with the AI Act, routine pseudonymisation, and lawful frameworks for regulatory sandboxes under the GDPR.
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