Clinical Algorithms, Antidiscrimination Laws, and Medical Device Regulation
Abstract
This Viewpoint discusses recent legal directives by the DHHS and FDA that could increase health care entities’ liability for possible discriminatory biases of clinical algorithms and the need for additional legal clarity to avoid adverse effects on algorithm development and use.
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More recent research has highlighted the potential presence of skin pigmentation biases in research-grade and consumer PPG-based wearable devices.
“More recent research has also highlighted the potential presence of these biases in research-grade and consumer PPG-based wearable devices [4,27-29]”
From Impact of skin pigmentation on pulse oximetry blood oxygenation and wearable pulse rate accuracy: systematic review and meta-analysis (2024) · cites this paper as [29]
Cites
Dissecting racial bias in an algorithm used to manage the health of populations
Obermeyer, Z., Powers, B., Vogeli, C., & Mullainathan, S. (2019) · Science · doi:10.1126/science.aax2342 · Cited by 7,137 · see citing works
Adams, R., Henry, K. E., Sridharan, A., Soleimani, H., Zhan, A., Rawat, N., Johnson, L., Hager, D. N., Cosgrove, S. E., Markowski, A., et al. (2022) · Nature Medicine · doi:10.1038/s41591-022-01894-0 · Cited by 365 · see citing works
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Preparing Physicians for the Clinical Algorithm Era
Goodman, K. E., Rodman, A. M., & Morgan, D. J. (2023) · New England Journal of Medicine · doi:10.1056/nejmp2304839 · Cited by 56 · see citing works
Self-citationComeau, D. S., Bitterman, D. S., & Celi, L. A. (2025) · npj Digital Medicine · doi:10.1038/s41746-025-01443-2 · Cited by 44 · see citing works
Singh, S., Bennett, M. R., Chen, C., Shin, S., Ghanbari, H., & Nelson, B. W. (2024) · Journal of Medical Internet Research · doi:10.2196/62769 · Cited by 36 · see citing works
“More recent research has also highlighted the potential presence of these biases in research-grade and consumer PPG-based wearable devices [4,27-29], leading to calls to address inequity, bias, and discrimination in wearable health technology and clinical practice algorithms [30,31].”
- Authors
- Goodman, K. E., Morgan, D. J., & Hoffmann, D. E.
- Affiliations
- University of Maryland, Baltimore (US)
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2023-01-24
- Volume
- 329
- Issue
- 4
- Pages
- 285
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W4313544796
- Cited by
- 48
- References
- 2
- Citations by year
- 2026: 3 · 2025: 21 · 2024: 12 · 2023: 12
- FWCI
- 11.98
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Agency for Healthcare Research and Quality (K01HS028363)
- Topics
- Social Sciences › Safety Research › Ethics and Social Impacts of AI
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Social Sciences › Law › Digitalization, Law, and Regulation
- Keywords
- clinical algorithms, algorithmic discrimination, anti-discrimination law, medical device regulation, medical liability, algorithmic bias, algorithm development
- MeSH terms
- Algorithms, Delivery of Health Care, Prejudice, United States, Liability, Legal, Medical Device Legislation
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