The American College of Radiology® (ACR®) filed comments with the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and Centers for Medicare and Medicaid Services (CMS) about a proposal regarding nondiscrimination by covered entities in the medical use of clinical algorithms. The College urged OCR and CMS to engage with the Food and Drug Administration (FDA) to better understand the current landscape and limitations of commercially available AI-enabled software devices.
The proposal was a subcomponent of the Biden Administration’s sweeping notice of proposed rulemaking (NPRM) to reinterpret the scope of the Affordable Care Act (ACA) Section 1557. The OCR and CMS proposed to penalize covered entities for discrimination on the bases of race, color, national origin, sex, age or disability through use of clinical algorithms in medical decision making.
While well-intentioned, the clinical algorithm proposal does not fully consider AI generalizability issues. For example, some AI algorithms were developed and cleared for use with specific subpopulations, such as adult-aged patients. Under the proposal, medical use of such an algorithm in accordance with device labeling could be perceived by HHS investigators as discriminatory decision making based on age.
The ACR also recommended enhanced public transparency of AI software devices to appropriately enable compliance with the OCR/CMS proposal by end-users. The College referenced comments filed with the FDA in 2021 on AI transparency needs.
For more information about ACR comments, please contact Michael Peters, ACR Senior Government Affairs Director, Regulatory Policy.