News
16 October 2025

Medical community proposes new recommendations to simplify the regulatory framework for digital health

On 14 October 2025, BioMed Alliance published a new document highlighting the recommendations of healthcare professionals and researchers on the digitalisation of healthcare and the simplification of the relevant regulatory framework. The document was based on an internal survey, and summarises medical societies views on the implementation of relevant legislations, the use of health data and AI in healthcare, and related challenges and opportunities. The document was prepared in the context of the European Commission’s call for evidence on the Digital Omnibus (Digital Package on Simplification).

The Alliance underscores the urgent need to simplify digital rules in healthcare while upholding high safety standards. It calls for sector-specific guidance, regulatory clarity, and strong collaboration with healthcare professionals, patients, and researchers in shaping digital initiatives, including the European Health Data Space (EHDS) and the Artificial Intelligence Act (AI Act). Reforms must be forward-looking and designed to empower, not burden, those at the forefront of care and research, promoting the sustainable use of digital health and AI innovation.