Tag
healthcare-ai
10 posts with this tag.
·9 min read
Illinois HB 1806 AI Therapy Law: Checklist for Small Teams
Illinois HB 1806 bans therapy offered without a licensed professional and sets a written consent test for AI notes. Checklist, Maine table, notice draft.
·8 min read
Maine LD 2082: AI Therapy Ban and AI Notes Consent Rules
Maine LD 2082 (Public Law 2025, ch. 687) bans unlicensed AI therapy and sets a written notice and consent test for AI session notes. I read all 22 pages.
·7 min read
FDA AI Device Orders Compared: Rules vs. Real Accuracy
Four FDA orders put algorithm-based devices in class II. I compared what each rule requires with the accuracy the first product in each type showed.
·7 min read
Healthcare AI Enforcement Actions Tracker (2026)
Every US regulator action against a health AI product we can source to an official document, the legal theory each one used, and the check it implies.
·9 min read
HTI-5 Drops AI Model Cards: 31 Questions for Your EHR Vendor
HTI-5 ends the AI model card rule for certified EHRs on Dec 28, 2026. The 31 fields it deletes, the bias duty that stays, and how to keep both in a contract.
·9 min read
AI Medical Malpractice: Who Is Liable for Diagnostic AI
14% more malpractice claims involve AI diagnostics. AI medical malpractice liability in 2026 -- developer, hospital, or physician, who pays?
·9 min read
Clinical AI Decision Support: FDA CDS Guidance Explained
Check FDA's four-factor test to see if your clinical AI decision support tool is exempt Non-Device CDS or regulated SaMD under the January 2026 guidance.
·10 min read
FDA AI Medical Device Compliance: SaMD, 510(k) and PCCP
1,350+ AI medical devices are FDA-cleared. Which SaMD class, 510(k) or PMA pathway, and PCCP rules govern your 2026 compliance plan?
·8 min read
HIPAA and AI Vendors: Which Tools Need a BAA
Which AI vendors can sign a HIPAA business associate agreement in 2026? ChatGPT Enterprise and Claude API qualify, ChatGPT Health does not.
·9 min read
Midjourney Body Scanner Claims: What FDA Clearance Requires
One word keeps Midjourney's 60-second scanner out of FDA AI medical device clearance in 2026. Here's what the SaMD pathway actually requires.