Diagnosis, triage or clinical support in United States (federal): related rules
AI that helps diagnose, prioritize patients, recommend treatments, read medical images or draft clinical notes. Errors affect health, so clinical validation, medical oversight, patient transparency and, if it is a medical device, sanitary registration are required.
FDA for AI-enabled device software; Section 1557 (45 CFR 92.210): identify and mitigate discrimination risk in clinical decision support tools since May 1, 2025.
Texas
Transparency
January 1, 2026
TRAIGA: healthcare providers must disclose AI use in patient care.
California
Transparency
January 1, 2025
AB 3030: disclaimer on AI-generated clinical communications to patients unless reviewed by a clinician.
Colorado
Consequential decision
January 1, 2027
SB 26-189: health care is a consequential decision.
Obligations related to this use case
Risk assessment before using ADMT or other high-risk processing
Applies to CCPA-covered businesses (revenue threshold, 100,000 residents or 50% of revenue from selling data) that use ADMT for significant decisions, infer traits of employees, applicants or students through systematic observation, process sensitive data, or train ADMT or facial recognition. Training models on your own data is not enough by itself. For processing that began before 2026 the deadline is December 31, 2027.
What the rule provides
Conduct and document the assessment before starting the processing.
Describe the specific purpose, data, concrete benefits, negative impacts and safeguards; involve the staff who take part.
Have it approved by a person with authority over the processing.
Review it at least every three years and update it within 45 days of a material change.
Keep it while the processing continues or for five years after completion, whichever is later.
For processing that already existed before January 1, 2026, the deadline is December 31, 2027.
Pending confirmation in the official source (last checked: November 4, 2026)le.utah.gov refused the connection on Nov 4, 2026, so the official text is still unchecked. The wording after SB 226 still has to be confirmed in Utah Code § 13-75-103, and § 63I-2-213 has to show whether the Jul 1, 2027 repeal also covers what SB 226 added. Content per FPF and Perkins Coie.
Clear consumer notice of ADMT use
Colorado SB 26-189SB 26-189 (C.R.S. 6-1-17xx), obligaciones del deployerAdopted, applies later
Applies from January 1, 2027
When it relates
Applies if you use ADMT that materially influences decisions on employment, housing, health care, education, lending or insurance for Colorado consumers.
What the rule provides
Give a clear and conspicuous notice at the point of interaction that ADMT is used.
Typical evidence
Published notice and screenshots of interaction points
Verified in the official source on November 2, 2026Signing, dates and obligations checked on leg.colorado.gov on Nov 2, 2026. Exact content will depend on the Attorney General's rules, still pending.
Explanation within 30 days after an adverse decision
Colorado SB 26-189SB 26-189, obligaciones del deployerAdopted, applies later
Applies from January 1, 2027
When it relates
Applies to ADMT deployers in consequential decisions about Colorado consumers.
What the rule provides
Within 30 days of an adverse outcome, explain in plain language the decision and the role of ADMT.
Explain how to request information about the system, its data and the rights of correction and review.
Verified in the official source on November 2, 2026Checked on leg.colorado.gov.
Developer technical documentation for deployers
Colorado SB 26-189SB 26-189, obligaciones del desarrolladorAdopted, applies later
Applies from January 1, 2027
When it relates
Applies to those who develop or sell ADMT used in consequential decisions about Colorado consumers. Selling an AI product is not enough: in the assessment, select the type of decision your product supports.
What the rule provides
Give each deployer documentation on intended uses, training data categories, known limitations and instructions for use and human review.