Together with other 11 European healthcare stakeholders ranging from patients to healthcare professionals and medical technology industry, UEHP endorsed the joint statement on access to innovative healthcare under the AI Act.
The statement provides our joint views on how the AI Act can give citizens the confidence to embrace AI-based solutions, including AI-enabled digital health services and tools.
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 joint statement we offer four considerations to be taken into account during the trilogue negotiations. 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.
In April 2021, the European Commission proposed the first EU regulatory framework for AI. It says that AI systems that can be used in different applications are analysed and classified according to the risk they pose to users. The different risk levels will mean more or less regulation. Once approved, these will be the world’s first rules on AI.
On 14 June 2023, MEPs adopted Parliaments negotiating position on the AI Act. The talks began with EU countries in the Council on the final form of the law. The aim is to reach an agreement by the end of this year.