FEAM and the European Academies’ Science Advisory Council (EASAC) are collaborating on a project to evaluate how AI-incorporated health products and services can be evaluated for adoption into healthcare use. Key areas of exploration include evidence measurement, randomized clinical trials (RCTs), and health systems research, with use-cases illustrating the added value of AI.
The project will assess the need for new guidance or regulations, considering existing frameworks, including revised EU regulations on medical devices, the AI Framework, European Health Data Space, and Product Liability Directive. The project will also address barriers related to data federation and interoperability across healthcare systems, and emphasize ethical considerations such as data protection, privacy, transparency, public trust, and equity in health access. Consent governance and model explainability will be highlighted. In addition, the project will focus on education and capacity building, stressing the need to upskill the broader workforce in digital awareness and integrate these skills into early education.
The joint scoping paper between EASAC and FEAM was finalised in January 2023 and presented at a FEAM Forum conference in Sweden in May. The event was co-organised by FEAM under the auspices of the Swedish Presidency of EU Council and with interventions from the European Parliament rapporteur for the European Health Data Space, the DG Sante legal lead on AI, and members of the Swedish Parliament and Health Authority.
The project will deliver a detailed report with actionable recommendations, along with articles in scientific and policy journals and a communications plan. A multidisciplinary workshop is also being considered to discuss our findings and further enhance understanding of AI’s role in healthcare.
The working group has been set and comprises 20 members: 9 from FEAM and 11 from EASAC, reflecting a higher number of women candidates from EASAC. The first WG meeting will take place online on September 30, with future meetings planned in person. This project will be overseen from the FEAM side by Prof. Luis Martí Bonmatí with the support of Louise Abboud and Sara Ekabiki Ossete, who will bring their expertise and guidance to ensure its success.
For any inquiries, please contact FEAM Forum Policy Officer Louise Abboud or EASAC Biosciences and Public Health Programme Director Rosa Castro.
Working Group members:
