Wednesday, August 19, 2026

1. Signal of the Day · Regulation & Policy Living page · read August 19

   Colorado opens formal rulemaking on its automated decision-making law, with health-care decisions inside the scope

   The Colorado Attorney General filed proposed Automated Decision-Making Technology and Chatbot Safety rules with the Secretary of State on August 11 and opened a formal comment window running through October 26, 2026. The statute itself, SB 26-189, defines a covered 'consequential decision' to include access to, eligibility for, or compensation related to health-care services, and sets deployer duties from January 1, 2027 — notice, plain-language explanation, record retention of at least three years, and a consumer right to meaningful human review after an adverse outcome. Per the Attorney General's page, comments submitted by September 4 are reflected in a revised draft circulating no later than September 23, ahead of the October 26 close. The Attorney General has separately committed not to enforce the statute until the rulemaking concludes, making this proceeding the clock on both enforcement and the pending industry challenge. (Corrected September 15; see Standards & Corrections.)

   HighBy Colorado Attorney GeneralRead at source ↗

2. AI Tech & Frameworks

   Oracle Health architect argues AI governance belongs at the workflow level, not the model level

   Manu Agrawal, chief architect for AI and machine learning at Oracle Health, speaking in a personal capacity, argues the useful question is no longer which model performs best but whether a system can be safe, useful, monitored, auditable and governed for the specific workflow where it is deployed. Three points translate directly into program design: human review should be risk-calibrated rather than universal, with documented reasoning for where it is required and how it is captured; auditability means being able to reconstruct a transaction later, including what evidence was retrieved, what the system produced, who reviewed it and what changed; and validation criteria should differ by workflow, since a documentation assistant and a prior-authorization tool carry different risks. Agrawal also flags repeatability, not only hallucination, as an underrated failure mode.

   MedBy Bill Siwicki · Healthcare IT NewsRead at source ↗

3. Regulation & Policy

   FTC makes investigative inquiries into Epic Systems over third-party access to patient data

   Reuters reported on August 14 that the Federal Trade Commission has sent investigative inquiries to health technology companies about whether Epic Systems restricts lawful access to patient data. Epic disputed the characterization, telling Healthcare IT News it does not engage in anticompetitive behavior and citing more than 1,000 published APIs, over 3,000 applications built on them, and more than 28 million patient records exchanged daily. The immediate subject is acute-care EHR competition rather than post-acute software, but the underlying theory concerns whether an EHR incumbent can gate third-party access to clinical data, which is the structural chokepoint every clinical AI vendor depends on regardless of care setting.

   MedBy Andrea Fox · Healthcare IT NewsRead at source ↗

4. Regulation & Policy

   The Fine Print No. 2 — The AI Question CLIA's Summary Doesn't Mention

   CMS and the CDC have opened the 1988 clinical-laboratory rules for comment (CMS-3485-NC, 91 FR 43586). The notice's summary lists four topics and artificial intelligence is in none of them — AI is subsection 6 of topic B, five questions on page 43588, alongside a sixth asking whether facilities that only interpret data need a CLIA certificate at all. The decode's finding, after a refutation pass: CLIA is not silent on AI. 42 CFR 493.1445(e)(1) already makes the laboratory director answerable for the postanalytic phase. What is missing is a validation method — the verification metrics in 493.1253(b)(2) are analyte metrics, and 493.1291, the only postanalytic standard, governs transmission rather than interpretation. Comments close September 14, 2026.

   MedBy thegovernancegazette.comRead at source ↗

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