Tag
healthcare-ai
5 posts with this tag.
·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.
·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.
·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?
·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.
·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?