Clinical Algorithms, Antidiscrimination Laws, and Medical Device Regulation

Katherine E Goodman; Daniel J Morgan; Diane E Hoffmann

doi:10.1001/jama.2022.23870

Clinical Algorithms, Antidiscrimination Laws, and Medical Device Regulation

JAMA. 2023 Jan 24;329(4):285-286. doi: 10.1001/jama.2022.23870.

Authors

Katherine E Goodman¹, Daniel J Morgan^{1

2}, Diane E Hoffmann³

Affiliations

¹ Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.
² VA Maryland Healthcare System, Baltimore.
³ University of Maryland School of Law, Baltimore.

PMID: 36602795
DOI: 10.1001/jama.2022.23870

No abstract available

Plain language summary

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.

Publication types

Research Support, U.S. Gov't, P.H.S.

MeSH terms

Algorithms*
Delivery of Health Care* / legislation & jurisprudence
Delivery of Health Care* / methods
Liability, Legal
Medical Device Legislation*
Prejudice* / legislation & jurisprudence
Prejudice* / prevention & control
United States

Grants and funding

K01 HS028363/HS/AHRQ HHS/United States