Skip to main content

Thank you for visiting You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Regulating AI in medicine in the United States and Europe

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.

This is a preview of subscription content

Access options

Buy article

Get time limited or full article access on ReadCube.


All prices are NET prices.


  1. Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (FDA, 2021).

  2. Executive Office of the President: Guidance for Regulation of Artificial Intelligence Applications (The White House, 2020).

  3. Proposal for a Regulation Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) (European Commission, 2021).

  4. Vokinger, K. N., Feuerriegel, S. & Kesselheim, A. S. Lancet Digit. Health 3, 337–338 (2021).

    Article  Google Scholar 

  5. Oren, O., Gersh, B. J. & Bhatt, D. L. Lancet Digit. Health 2, 486–488 (2020).

    Article  Google Scholar 

  6. Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) (FDA, 2019).

  7. Lavizzo-Mourey, R. J., Besser, R. E. & Williams, D. R. NEJM 18, 1681–1684 (2021).

    Article  Google Scholar 

  8. Canto, J. G., Rogers, W. & Goldberg, R. J. JAMA 8, 813–822 (2012).

    Google Scholar 

  9. Parikh, R. B., Teeple, S. & Navathe, A. S. JAMA 322, 2377 (2019).

    Article  Google Scholar 

  10. Kausha, A., Altman, R. & Langlotz, C. JAMA 324, 1212 (2020).

    Article  Google Scholar 

  11. Muehlematter, U. J., Daniore, P. & Vokinger, K. N. Lancet Digit. Health 3, 195–203 (2021).

    Article  Google Scholar 

  12. Rajkomar, A. et al. NPJ Digital Med. 1, 18 (2018).

    Article  Google Scholar 

  13. Toscano, F., O’Donnell, E. & Unruh, M. et al. Eur. J. Publ. Health 28, cky213.401 (2018).

    Google Scholar 

  14. Die elektronische Patientenakte (Bundesministerium für Gesundheit, accessed 13 June 2021);

Download references


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

Author information

Authors and Affiliations


Corresponding authors

Correspondence to Kerstin N. Vokinger or Urs Gasser.

Ethics declarations

Competing interests

The authors declare no competing interests.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Vokinger, K.N., Gasser, U. Regulating AI in medicine in the United States and Europe. Nat Mach Intell 3, 738–739 (2021).

Download citation

  • Published:

  • Issue Date:

  • DOI:


Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing