AI law and regulation
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AI used in medical products and medical writing raises questions of legal scope, regulatory oversight and control of its outputs. The parts divide by regulatory setting: the EU AI Act, medicines, medical devices and writing tools, followed by arguments about regulation and innovation. Practical tool use, data protection, general software qualification as a medical device and copyright belong to neighbouring concerns.
- The EU AI Act: scope, risk classes and timetable — system definitions, actors in scope, risk classes, the research exemption and the application timetable
- AI in medicines regulation and submissions — regulatory frameworks, explaining AI in submissions and product information, and the European network’s AI workplans
- Regulating AI in medical devices — overlapping EU requirements and conformity assessment, data and oversight, liability and adaptive changes, and comparison with the FDA approach
- Are AI writing tools regulated medical devices? — device qualification, AI Act applicability and controls on AI-assisted regulatory documents
- AI regulation and the case for slowing innovation — dated arguments for oversight or a development pause and competing views on regulation’s effects on innovation