In the joint statement, healthcare stakeholders representing patients, healthcare professionals and industry, share their views on how the AI Act can give citizens the confidence to embrace AI-based solutions, including AI-enabled medical technologies.

Most existing AI solutions that are being used in national healthcare systems are integrated in medical technologies and regulated under MDR/IVDR. As medical technologies constitute an integral component of healthcare systems, it is essential that the AI Act will facilitate the delivery of innovative healthcare.

In the statement, four considerations to be taken into account during the trilogue negotiations are presented. The AI Act must:

• align with all relevant horizontal and sectoral European laws and concepts;
• provide more clarity on the definitions;
• provide a clear data and data governance framework as data is indispensable for AI;
• ensure uniform application and implementation of its provisions across Member States regarding its governance structure to avoid unnecessary fragmentation within the Single Market.