As healthcare and research continue to embrace digital transformation, navigating the complex regulatory landscape is more challenging than ever. To address this, BioMed Alliance has released a position statement with key recommendations on the European Commission’s Digital Omnibus Proposals. Built on feedback from healthcare professionals and researchers across Europe, our statement calls for improvements to the General Data Protection Regulation (GDPR), the AI Act, and other regulatory simplifications.
While we welcome the opportunities presented by the Digital Omnibus Proposals to advance digital health, it is crucial to carefully consider their implications for data-driven healthcare, AI integration, and the protection of sensitive patient data. The Alliance calls for clearer guidelines on pseudonymisation and health data processing for AI, as well as sector-specific guidance on GDPR compliance for health research. It also advocates for stronger safeguards to protect health data, post-market monitoring of AI systems to ensure patient safety, measures to reduce AI bias, and clearer definitions of roles and responsibilities to promote AI literacy in healthcare.
