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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.

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References

  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); https://www.bundesgesundheitsministerium.de/elektronische-patientenakte.html

Download references

Acknowledgements

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

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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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