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healthcare-ai
5 posts with this tag.
Other tags:All postsacceptable-useacceptable-use-policyaccess-controlaccountabilityadministrative penaltiesAdobe FireflyadtechAfrican musicage gatingagent oversightagentic-aiai-acceptable-useai-adoptionAI Agent Safetyai-agentsai-apis
·9 min read
AI Medical Malpractice 2026: Who Is Liable When a Diagnostic AI Gets It Wrong?
Malpractice claims involving AI tools rose 14% between 2022 and 2024, with most in radiology, cardiology, and oncology. When an AI diagnostic recommendation leads to patient harm, liability may fall on the AI developer (product liability), the hospital (negligent implementation), or the physician (failure to exercise independent judgment). Here is how courts and state laws are distributing that risk.
·9 min read
Clinical AI Decision Support 2026: FDA January Guidance, Non-Device CDS Criteria, and Human Oversight Requirements
FDA issued updated Clinical Decision Support guidance on January 6, 2026, replacing the 2022 version. It clarifies which AI tools qualify as Non-Device CDS exempt from medical device regulation and which cross the line into regulated SaMD. Key change: enforcement discretion for singular-output CDS. Here is what the four-factor test means in practice.
·10 min read
FDA AI Medical Device Compliance 2026: SaMD Classification, 510(k), and Predetermined Change Control Plans
FDA has authorized more than 1,350 AI-enabled medical devices as of early 2026. The framework covers classification (Class I, II, III), the 510(k) vs PMA pathway, Good Machine Learning Practices, and Predetermined Change Control Plans for AI systems that update after clearance. A compliance guide for healthcare AI developers and deployers.
·8 min read
HIPAA and AI Vendors 2026: Which Tools Require a Business Associate Agreement (and What That Actually Covers)
ChatGPT Enterprise can sign a HIPAA BAA. ChatGPT Health cannot. Claude API can. Microsoft Copilot for Healthcare can. Getting this wrong is a reportable breach under HIPAA regardless of whether data leaked. A plain-English guide to BAA requirements for AI tools used in healthcare workflows.
·9 min read
Midjourney's 60-Second Body Scanner Claims to Beat MRI. Here's What FDA Clearance Actually Requires.
Midjourney announced a full-body ultrasonic scanner in June 2026, 60x faster and 10x cheaper than MRI, it claims. But it deliberately avoids diagnostic claims because those trigger FDA medical device clearance. Here is what the SaMD pathway requires, why the regulatory gate exists, and what it means for every team using AI tools that touch patient data.