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Worldwide interest in artificial intelligence (AI) applications is growing rapidly. In medicine, devices based on machine/deep learning have proliferated, especially for image analysis, presaging new significant challenges for the utility of AI in healthcare. This inevitably raises numerous legal and ethical questions. In this paper, the authors analyse the state of AI regulation in the context of medical device development, and strategies to make AI applications safe and useful in the future.

Teaching Points:

  • AI applications are medical devices supporting detection/diagnosis, work-flow, cost-effectiveness.
  • Regulations for safety, privacy protection, and ethical use of sensitive information are needed.
  • EU and U.S. have different approaches for approving and regulating new medical devices.
  • EU laws consider cyberattacks, incidents (notification and minimisation), and service continuity.
  • U.S. laws ask for opt-in data processing and use as well as for clear consumer consent.

Article: Artificial intelligence as a medical device in radiology: ethical and regulatory issues in Europe and the United States

Authors: Filipp Pesapane, Caterina Volonté, Marina Codari and Francesco Sardanelli

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