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Important milestone in the path towards an EU AI Act
In mid-June 2023 the European Parliament voted in favor on its negotiating position on the proposed Artificial Intelligence (AI) Act. The next step towards a final legislative text are the three-way negotiations with the European Council and European Commission. The aim is to strike a deal in Q4 2023 under the Spanish Presidency.
The AI Act aims to ensure that AI developed and used in Europe is fully in line with EU rights and values including human oversight, safety, privacy, transparency, non-discrimination and social and environmental wellbeing. The Parliament text of the AI Act prohibits the use of real-time biometric identification systems as well those used for social scoring (classifying people based on their social behaviour or personal characteristics), as well as so-called emotion recognition systems in the workplace, schools and law enforcement.
Medical devices
The AI Act provides for specific requirements for high-risk applications, including AI medical devices (as software or as part of a physical medical device). These solutions would need to go through a conformity assessment to get a CE mark by meeting requirements for an adequate risk assessment, quality management and mitigation systems; high quality of the datasets feeding the system to minimize risks and discriminatory outcomes; logging of activity to ensure traceability of results; detailed documentation providing all information necessary on the system and its purpose for authorities to assess its compliance; clear and adequate information to the user; appropriate human oversight measures to minimize risk; high level of robustness, security and accuracy.
The implications for the IDERHA project:
• Needs to be taken into account for the development and use of medical devices including software as well as for the development of digital healthcare standards.
• Any AI system in the EU must meet the requirements of the AI Act and any AI system which qualified as a medical devices software, will fall under the scope of fort the AI Act and the Medical Devices Regulation.
• Medical device AI software must prove compliance with both AI Act and Medical Devices Regulation.
• Regulatory sandbox: tool allowing to explore innovative services under a regulator's supervision, e.g. services for predicting diseases.
IDERHA congratulates the European authorities for their work on the world’s first regulation of artificial intelligence.