Artificial Intelligence in Breast Cancer ScreeningEvaluation of FDA Device Regulation and Future Recommendations

Accepted for Publication: September 13, 2022.

Published Online: November 7, 2022. doi:10.1001/jamainternmed.2022.4969

Corresponding Author: Ilana B. Richman, MD, MHS, Yale School of Medicine, 367 Cedar St, Room 301a, New Haven, CT 06511 (ilana.richman@yale.edu).

Author Contributions: Mr Potnis and Dr Richman had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Potnis, Ross, Gross, Richman.

Acquisition, analysis, or interpretation of data: Potnis, Ross, Aneja, Richman.

Drafting of the manuscript: Potnis, Richman.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Richman.

Obtained funding: Richman.

Supervision: Gross, Richman.

Conflict of Interest Disclosures: Mr Potnis reported grants from the US National Institutes of Health (NIH) and grants from the American Society of Hematology outside the submitted work. Dr Ross reported grants from the US Food and Drug Administration, Johnson & Johnson, the Medical Devices Innovation Consortium, Agency for Healthcare Research and Quality (AHRQ), grants from the NIH and Arnold Ventures outside the submitted work; and serving as an expert witness at the request of Relator’s attorneys in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen, all outside the submitted work. Dr Aneja reported grants from the US National Science Foundation, from the US National Cancer Institute (NCI), Patterson Family Trust, American Society of Clinical Oncology, the Radiation Society of North America, the American Cancer Society, and AHRQ, and nonfinancial support from Amazon, all outside the submitted work. Dr Gross reported grants from Johnson & Johnson, funding from AstraZeneca, and personal fees from Genentech outside the submitted work. Dr Richman reported funding from the NCI and salary support from the Centers for Medicare & Medicaid Services outside of the submitted work. No other disclosures were reported.

Funding/Support: Dr Richman received funding for this study from the US National Institutes of Health (No. K08 CA248725).

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.