AI in Healthcare Has Its Own Rulebook
Health care never got the memo that AI was supposed to be unregulated. AI tools that diagnose, triage, or recommend treatment can fall under FDA oversight as medical devices. Federal health officials have pushed transparency requirements for predictive models used in care decisions. And behind all of it sits the oldest duty in medicine: do no harm.
What does that mean in plain English? If your AI touches patient care, document everything: what data trained it, what it was validated against, and where its limits are. Make sure clinicians understand what the tool is actually saying — a risk score is not a diagnosis. And keep a human clinician as the decision-maker, not the decoration.
Health care shows the future of AI regulation everywhere else: existing duties of care, applied to new tools, with documentation as the proof.
I explain frameworks; I don't give legal counsel.
Related consulting: Business systems diagnostics · All services
I explain frameworks; I don't give legal counsel.
