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Regulating AI in medicine in the United States and Europe

Nature Machine Intelligence volume 3, pages 738–739 (2021)Cite this article

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The regulatory landscape for artificial intelligence (AI) is shaping up on both sides of the Atlantic, urgently awaited by the scientific and industrial community. Commonalities and differences start to crystallize in the approaches to AI in medicine.

In the United States, the US Food and Drug Administration (FDA) published a regulatory framework for AI applications in medicine in April 2019 and an action plan in January 2021 (ref. 1). The FDA’s leadership role in formulating regulatory guidance is a manifestation of the broader US national approach to the regulation of AI. In contrast to the European Union (EU), the US policy sustains from broad and comprehensive regulation of AI and instead delegates responsibilities to specific federal agencies, with an overarching mandate to avoid overregulation and promote innovation2.

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References

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Acknowledgements

This study was partially funded by the Swiss National Science Foundation (SNSF).

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Authors and Affiliations

  1. Institute of Law, University of Zurich, Zurich, Switzerland

    Kerstin N. Vokinger

  2. Berkman Klein Center for Internet and Society, Harvard University, Cambridge, MA, USA

    Kerstin N. Vokinger & Urs Gasser

  3. TUM School of Social Sciences and Technology, Technical University of Munich, Munich, Germany

    Urs Gasser

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  1. Kerstin N. Vokinger
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  2. Urs Gasser
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Correspondence to Kerstin N. Vokinger or Urs Gasser.

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Vokinger, K.N., Gasser, U. Regulating AI in medicine in the United States and Europe. Nat Mach Intell 3, 738–739 (2021). https://doi.org/10.1038/s42256-021-00386-z

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