Articles
Independent reporting and analysis for clinicians, regulators, and the people building these systems.
Woebot-style CBT chatbots, Talkspace-style hybrid platforms, suicide-risk detection, and the evidence base as of 2026 — plus the guardrails behavioral-health AI still routinely gets wrong.
Ambient scribes have moved from pilots to enterprise deployment across most large U.S. health systems. Where evidence, adoption, and the clinician-burnout signal actually sit mid-2026.
The 21st Century Cures Act CDS exclusion decides whether clinical software is a device. FDA guidance since 2022 has narrowed that line — and clinical LLMs are the wedge.
The Predetermined Change Control Plan is the FDA's answer to the update problem for AI/ML devices. Two years in, here is what the guidance means in practice and where it still falls short.
Three of the most-cited AI-governance programs in U.S. healthcare have published enough of their processes that patterns are visible. What mature looks like, and what most systems miss.
Which frontier-model vendors will sign a Business Associate Agreement, what their PHI-handling terms actually say, and what deployment architectures keep clinical LLMs on the right side of HIPAA.
The first year of RUAIH certification plus the growing MAUDE and MedWatch signal are starting to show how AI-enabled devices fail in production. What the data actually says.
Assort Health, Hippocratic AI, Innovaccer's voice suite, and the specialty and payer entrants — the products, deployment patterns, and ROI stories behind healthcare's biggest voice-AI wave.
Ambient AI scribes are expanding from pilot to nationwide deployment across all VA medical centers in 2026. The published evaluation is one of the most rigorous on any clinical-AI category to date.
Nearly 70% of health plans surveyed by PwC put AI-enabled documentation and coding in the top three inflators for 2027. That changes the political economy of clinical AI fast.
The new CMMI model pays for outcomes, not activities, in technology-supported chronic care — and explicitly names AI diagnostics as part of the ecosystem it is trying to build.
NHS England's £120 million Copilot deal is the largest healthcare AI deployment ever signed. The 43-minute-a-day claim is the headline; the trial methodology is what to read carefully.
A Mayo-owned, Microsoft-built foundation model for healthcare is a real strategic shift. Whether it lands depends on questions the June 2 announcement deliberately did not answer.
More than a thousand AI-enabled medical devices now carry FDA authorization. The headline is striking; the operational reality is more uneven.