"The Joint Opinion broadly supports the EU's ambition to strengthen its biotechnology sector, but it emphasizes that data protection safeguards must be tightened, particularly where health data is involved."
"The proposed Biotech Act would introduce specific requirements where AI is used in clinical trials, requiring sponsors to assess risks to patient safety and data integrity."
"These obligations would apply in addition to those under the EU AI Act, and any guidance developed by the European Medicines Agency should be prepared in consultation with the EDPB and EDPS."
The EDPB and EDPS issued a Joint Opinion on the proposed European Biotech Act I, supporting its aim to enhance the EU biotechnology sector. They emphasize the necessity for stricter data protection measures, particularly concerning health data. The Biotech Act, while not amending the GDPR directly, will significantly impact personal data processing in clinical trials. Specific requirements for AI use in clinical trials are introduced, mandating risk assessments and protocol descriptions. Compliance with GDPR and collaboration with the EDPB and EDPS is essential for organizations involved in clinical trials.
Read at Data Matters Privacy Blog
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