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Not all AI health tools with regulatory authorization are clinically validated

Nature Medicine volume 30, pages 2718–2720 (2024)Cite this article

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An Author Correction to this article was published on 16 September 2024

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Devices that lack adequate clinical validation pose risks for patient care. A new validation standard is proposed to evaluate FDA authorization as an indication of clinical effectiveness in medical AI.

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Fig. 1: Validation methods for FDA-authorized AI devices by specialty.
Fig. 2: Validation methods for FDA-authorized AI devices over time.

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References

  1. Murphy, K. et al. BMC Med. Ethics 22, 14 (2021).

    Article  PubMed  PubMed Central  Google Scholar 

  2. Kim, J. Y. et al. In FAccT '23: Proc. 2023 ACM Conference on Fairness, Accountability, and Transparency 1396–1417 (2023).

  3. Geis, J. R. et al. Can. Assoc. Radiol. J. 70, 329–334 (2019).

    Article  PubMed  Google Scholar 

  4. Evans, B. J. J. Law Biosci. 10, lsad001 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  5. Vellido, A. Kidney Dis. 5, 11–17 (2018).

    Article  Google Scholar 

  6. Center for Devices and Radiological Health. FDA https://go.nature.com/4dDbUct (6 September 2023).

  7. US Food and Drug Administration. https://go.nature.com/3YN8Civ (14 October 2016).

  8. US Food and Drug Administration. https://go.nature.com/3LYd32i (September 2023).

  9. US Food and Drug Administration. https://go.nature.com/3SOXHRw (accessed 17 September 2023).

  10. Lyell, D., Wang, Y., Coiera, E. & Magrabi, F. J. Am. Med. Inform. Assoc. 30, 1227–1236 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  11. US Food and Drug Administration. https://go.nature.com/3YwMt87 (accessed 14 June 2023).

  12. Kalantaridis, C. & Küttim, M. J. Technol. Transfer 46, 1487–1513 (2021).

    Article  Google Scholar 

  13. MIT News Office. https://go.nature.com/3LVzBkb (7 September 2017).

  14. Sandhu, S. et al. Patterns 4, 100710 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  15. Tierney, W. M., Meslin, E. M. & Kroenke, K. J. Gen. Intern. Med. 31, 228–233 (2016).

    Article  PubMed  Google Scholar 

  16. Harris, P., Winney, I., Ashhurst-Smith, C., O'Brien, M. & Graves, S. Pathology 44, 583–585 (2012).

    Article  PubMed  Google Scholar 

  17. Wu, E. et al. Nat. Med. 27, 582–584 (2021).

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgements

For their consultation, comments and mentorship, the authors thank M. R. Patel, W. Ratliff, Z. Hussain, J. Castillo, I. Yüksel, H. Chen, P. Guo, H. McInnis, J. E. Hancock, B. J. Evans and A. Merlo.

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Author notes

  1. These authors contributed equally: Adonis Abdullah, Ying Fang.

Authors and Affiliations

  1. UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    Sammy Chouffani El Fassi, Adonis Abdullah, Ying Fang & Naya Kayali

  2. Duke Heart Center, Duke University School of Medicine, Durham, NC, USA

    Sammy Chouffani El Fassi

  3. University of South Carolina School of Medicine, Columbia, SC, USA

    Ying Fang

  4. Department of Pharmacology, University of Oxford, Oxford, UK

    Sarabesh Natarajan

  5. Columbia University Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA

    Sarabesh Natarajan

  6. Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    Awab Bin Masroor

  7. ECU School of Dental Medicine, East Carolina University, Greenville, NC, USA

    Naya Kayali

  8. University of Miami Miller School of Medicine, University of Miami, Miami, FL, USA

    Simran Prakash

  9. Department of Social Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    Gail E. Henderson

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  1. Sammy Chouffani El Fassi
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Correspondence to Sammy Chouffani El Fassi.

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Chouffani El Fassi, S., Abdullah, A., Fang, Y. et al. Not all AI health tools with regulatory authorization are clinically validated. Nat Med 30, 2718–2720 (2024). https://doi.org/10.1038/s41591-024-03203-3

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