EU Artificial Intelligence Act

The EU Artificial Intelligence Act (Regulation (EU) 2024/1689) is the first comprehensive legal framework for regulating artificial intelligence (AI). Since becoming law on August 1, 2024, the AIA aims to ensure AI is safe, respects fundamental rights, and promotes trustworthy innovation across the EU. [digital-strategy.ec.europa.eu]

Core Approach

The AIA takes a risk-based approach and classifies AI systems into four risk levels (like a pyramid):

  • Unacceptable risk — Banned outright
  • High risk — Strictly regulated with obligations
  • Limited risk — Transparency requirements
  • Minimal/no risk — Largely unregulated (vast majority of AI applications)

[digital-strategy.ec.europa.eu]

Prohibited Practices (Unacceptable Risk)

Eight specific practices are banned because they threaten safety, livelihoods, or rights.

  • Harmful manipulation or deception (e.g., subliminal techniques distorting behavior).Exploitation of vulnerabilities (e.g., targeting children or disabled people)
  • Social scoring (leading to unfair treatment)
  • Individual criminal risk prediction based solely on profiling (with exceptions)
  • Untargeted scraping of internet/CCTV for facial recognition databases
  • Emotion recognition in workplaces or education (with medical/safety exceptions)
  • Biometric categorization inferring sensitive traits (race, politics, etc.)
  • Real-time remote biometric identification in public spaces by law enforcement (narrow exceptions).

[https://ec.europa.eu/newsroom/dae/redirection/document/112367]

About the author

Partner and General Manager, Brian Pate is ISO 1385:2016 Lead Auditor certified for Medical Device Quality Management Systems (MD), and ISO 19011:2018 Management Systems Auditing (AU) and Leading Management Systems Audit Teams (TL). Brian started his medical device career in anesthesia clinical research in 1985 and has since worked both academia and industry including many years with Johnson & Johnson, Baxter Healthcare, and GE Medical. Brian’s roles have included software engineering, systems engineering, quality assurance, and regulatory affairs. Brian has served on multiple AAMI TIR working groups, including TIR32-2008 (Application of ISO 14971 Risk Management to Software; now IEC 80002-1) and TIR45-2012 (Guidance on the use of Agile practices in the development of medical device software) and served as a reviewer for the 2nd edition of TIR45. Brian serves on the AAMI Software Committee and as an AAMI instructor for the software, design controls, and agile methods courses. Brian also is a member of the Underwriters’ Laboratories (UL) Standards Technical Panel for UL1998 (Software in Programmable Components) and or UL5500 (Remote Software Updates).

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