Makes high-risk automated decisions, in the United States

42 U.S.C. § 2000e-2; 29 U.S.C. § 623 · Read the law's page

• Do not use a hiring, screening, or promotion tool in a way that fails or refuses to hire, or otherwise discriminates against, an individual because of race, color, religion, sex, or national origin (Title VII section 703(a)(1)), or because of age (Age Discrimination in Employment Act section 4(a)(1)).
• Do not use a tool to limit, segregate, or classify applicants for employment in a way that would deprive or tend to deprive an individual of employment opportunities because of race, color, religion, sex, or national origin (Title VII section 703(a)(2)).
• If you procure employees for an employer, or procure for employees opportunities to work for an employer, do not fail or refuse to refer, or classify or refer, an individual because of race, color, religion, sex, or national origin (Title VII section 703(b)), or because of age (Age Discrimination in Employment Act section 4(b)).
• Be ready to demonstrate that a particular employment practice that causes a disparate impact on race, color, religion, sex, or national origin is job related for the position in question and consistent with business necessity; a disparate impact is also established where the complaining party demonstrates an alternative employment practice and the respondent refuses to adopt it (Title VII section 703(k)(1)).
• Base any differentiation by age on a bona fide occupational qualification reasonably necessary to the normal operation of the business or on reasonable factors other than age (Age Discrimination in Employment Act section 4(f)(1)).
• Apply these rules if you are an employer with fifteen or more employees under Title VII, or twenty or more under the Age Discrimination in Employment Act, for each working day in each of twenty or more calendar weeks in the current or preceding calendar year, if you are an agent of such an employer, or if you are an employment agency or an agent of one.

21 U.S.C. § 360j(o), read with 21 U.S.C. § 321(h) · Read the law's page

• This provision sets no duty of its own: it removes five kinds of software function from the definition of device in section 201(h), and a software function that meets the definition and falls outside those exclusions is a device under the Federal Food, Drug, and Cosmetic Act.
• Treat a software function as a device if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, and it meets none of the exclusions in section 520(o)(1) (administrative support of a health care facility, maintaining or encouraging a healthy lifestyle unrelated to disease, electronic patient records, displaying clinical laboratory test or other device data and results, and clinical decision support).
• Do not rely on the clinical decision support exclusion if the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system, or if it is not intended to let the health care professional independently review the basis for its recommendations so that the professional does not rely primarily on them to make a clinical diagnosis or treatment decision regarding an individual patient.
• Treat a software function described in section 520(o)(1)(C), (D), or (E) as a device from the date a final order of the Secretary identifies it, after notice in the Federal Register and at least 30 calendar days for public comment, on a finding that its use would be reasonably likely to have serious adverse health consequences.
• If you are required to register and propose to begin introducing a software function that is a device into interstate commerce for commercial distribution, report to the Secretary or an accredited person at least ninety days beforehand the class in which the device is classified and the action you took to comply with the requirements of section 514 or 515 that apply to it (section 510(k)).
• If your software function is a class III device that requires premarket approval, hold an approved application for premarket approval under section 515 before you market it, unless it is exempt under section 520(g).
• Do not introduce or deliver for introduction into interstate commerce a device that is adulterated or misbranded, and do not adulterate or misbrand a device in interstate commerce (section 301(a) and (b)).

45 CFR § 92.210 · Read the law's page

• 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.

Exec. Order No. 14365 (Dec. 11, 2025)

Discussion Draft, 119th Cong. (June 4, 2026)

S.2164, 119th Cong. (2025-2026)

• This measure is in committee and binds nobody yet; what follows is what it would require if it is enacted in this form.
• Conduct an impact assessment of an automated decision system used in a high-stakes context such as housing, employment, credit, or education.
• Disclose the impact assessment.
• Tell consumers when an automated decision system is being used to make a decision about them.
• Let consumers opt out of the use of an automated decision system.

45 CFR § 170.315(b)(11), as amended by 91 FR 67916 (Oct. 28, 2026) · Read the law's page

• This criterion binds a health IT developer whose Health IT Module is certified to it, in a program of voluntary certification of health IT.
• Enable a limited set of identified users to select, meaning activate, electronic decision support interventions that are evidence-based decision support interventions using the listed data, or predictive decision support interventions using that data together with Clinical Notes and Assessment and Plan of Treatment data.
• Enable interventions to be configured by a limited set of identified users based on a user's role.
• Enable a user to provide electronic feedback data for evidence-based decision support interventions, and make that feedback data available to a limited set of identified users for export in a computable format.
• Provide interventions to a user while the user is interacting with the technology.
• Update a Health IT Module certified to a revised certification criterion, and provide the update to your customers, in accordance with the dates identified for each revised certification criterion.