United StatesSection 1557 final rule, nondiscrimination in the use of patient care decision support tools
In force since .
An AI sector rules rule binding public and private bodies.
- Obligation class
- Prohibition, DPIA
As of .
What it requires
- This rule binds the covered entity that uses a patient care decision support tool (a recipient of Federal financial assistance, the Department of Health and Human Services, or an entity established under title I of the Affordable Care Act), not the developer that supplies the tool; a developer's own duties for predictive decision support interventions sit in a separate rule of the Office of the National Coordinator for Health Information Technology.
- Do not discriminate on the basis of race, color, national origin, sex, age, or disability in your health programs or activities through the use of a patient care decision support tool, meaning any automated or non-automated tool, mechanism, method, technology, or combination thereof used to support clinical decision-making.
- Make reasonable efforts, on an ongoing basis, to identify uses of patient care decision support tools in your health programs or activities that employ input variables or factors that measure race, color, national origin, sex, age, or disability.
- For each patient care decision support tool you identify that way, make reasonable efforts to mitigate the risk of discrimination resulting from the tool's use in your health programs or activities.
These lines are LexLint's reading of the law's text, as of .
What this law does
A covered entity must not discriminate on the basis of race, color, national origin, sex, age, or disability in its health programs or activities through the use of patient care decision support tools. A covered entity has an ongoing duty to make reasonable efforts to identify uses of patient care decision support tools in its health programs or activities that employ input variables or factors that measure race, color, national origin, sex, age, or disability.
For each tool identified, a covered entity must make reasonable efforts to mitigate the risk of discrimination resulting from the tool's use in its health programs or activities. A patient care decision support tool is any automated or non-automated tool, mechanism, method, technology, or combination thereof used by a covered entity to support clinical decision-making in its health programs or activities.
A covered entity is a recipient of Federal financial assistance, the Department of Health and Human Services, or an entity established under title I of the Affordable Care Act. The regulations in the part are effective beginning . The identification and mitigation duties apply within 300 days of .
The section applies to covered entity users of patient care decision support tools, while the separate requirements of the Office of the National Coordinator for Health Information Technology rule apply to health information technology developers.
When LexLint raises it
When your app profile says your app makes health care decisions.