Not all AI health tools with regulatory authorization are clinically validated

Murphy, K. et al. BMC Med. Ethics 22, 14 (2021).Article 
PubMed 
PubMed Central 

Google Scholar 
Kim, J. Y. et al. In FAccT ’23: Proc. 2023 ACM Conference on Fairness, Accountability, and Transparency 1396–1417 (2023).Geis, J. R. et al. Can. Assoc. Radiol. J. 70, 329–334 (2019).Article 
PubMed 

Google Scholar 
Evans, B. J. J. Law Biosci. 10, lsad001 (2023).Article 
PubMed 
PubMed Central 

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

Google Scholar 
Center for Devices and Radiological Health. FDA https://go.nature.com/4dDbUct (6 September 2023).US Food and Drug Administration. https://go.nature.com/3YN8Civ (14 October 2016).US Food and Drug Administration. https://go.nature.com/3LYd32i (September 2023).US Food and Drug Administration. https://go.nature.com/3SOXHRw (accessed 17 September 2023).Lyell, D., Wang, Y., Coiera, E. & Magrabi, F. J. Am. Med. Inform. Assoc. 30, 1227–1236 (2023).Article 
PubMed 
PubMed Central 

Google Scholar 
US Food and Drug Administration. https://go.nature.com/3YwMt87 (accessed 14 June 2023).Kalantaridis, C. & Küttim, M. J. Technol. Transfer 46, 1487–1513 (2021).Article 

Google Scholar 
MIT News Office. https://go.nature.com/3LVzBkb (7 September 2017).Sandhu, S. et al. Patterns 4, 100710 (2023).Article 
PubMed 
PubMed Central 

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

Google Scholar 
Harris, P., Winney, I., Ashhurst-Smith, C., O’Brien, M. & Graves, S. Pathology 44, 583–585 (2012).Article 
PubMed 

Google Scholar 
Wu, E. et al. Nat. Med. 27, 582–584 (2021).Article 
CAS 
PubMed 

Google Scholar