Stakeholder joint statement on access to innovative healthcare under the Artificial Intelligence Act (AI Act)

14 June 2023

As representatives of the healthcare sector, ranging from medical technology manufacturers to healthcare professionals and patient groups, we have a shared goal of improving health outcomes and healthcare systems. We welcome the intent of the proposed AI Act, which has the potential of giving individuals the confidence to embrace AI-based solutions, including AI-enabled digital health services and tools. These tools and services support the safe continuity of care and access to innovative, state-of-the-art healthcare across Europe.

We would like to highlight four considerations that are pertinent to healthcare, such as those requiring alignment with existing and forthcoming legislation, definitions, data and data governance, human oversight and requirements for third-party-conformity assessment for high-risk AI systems.

Download joint statement from Related Files.