CPME Feedback on Commission Proposal for a Regulation on Artificial IntelligenceComments Off on CPME Feedback on Commission Proposal for a Regulation on Artificial Intelligence

CPME commends the European Commission for developing a ground-breaking legislation on artificial intelligence (AI).

European doctors welcome the overall risk-based approach for AI, the creation of the European Artificial Board, the development of the EU database for high-risk AI and the proposed risk management system.

European doctors also welcome the proposed definition of the AI system as it will ensure that where an AI system is a safety component of a medical device, or is by itself a medical device (software), subject to third-party conformity assessment under the medical devices framework, then the AI system is considered of high-risk for the purpose of the AI proposal. This high-risk classification is needed to guarantee patient utmost safety.

CPME provides specific comments in relation to the stand-alone high-risk AI list of Annex III; data and data governance, highlighting the need to conduct regular audits by an AI external auditor and where the AI EU Board could serve as audit standardisation and harmonisation body; transparency and provision of information to users; human oversight; quality management system; conformity assessment; CE marking of conformity; transparency obligations for certain AI systems; AI systems already placed on the market or put into service; and designation of national competent authorities and specificities of AI use by healthcare professionals.

Please see CPME Feedback on Commission Proposal for a Regulation on Artificial Intelligence.