Clinical Safety & Digital Health
Clinical safety in digital health is too often a folder of documents produced to be filed. This section is about the real thing: hazards as specific failure paths, mitigations that change the product, and safety cases that can be argued with.
Clinical Safety Is Not a Checkbox
The test of safety work is whether it changed the product. If the hazard log was written and nothing was redesigned, what happened was compliance theatre.
Hazard Is Not Risk — and Confusing Them Is How Digital Health Ships Harm
Two words that digital health teams use interchangeably mean very different things. The confusion isn't pedantic — it's the mechanism by which real harm gets reasoned away.
The Confident Wrong Answer: Safety Thinking for Clinical AI
Traditional clinical software fails in ways you can anticipate. AI fails differently — fluently, confidently, and most dangerously when it is wrong. Safety thinking has to change to match.
The Confident Wrong Answer: Safety Thinking for Clinical AI
Traditional clinical software fails in ways you can anticipate. AI fails differently — fluently, confidently, and most dangerously when it is wrong. Safety thinking has to change to match.
Who Is Your Clinical Safety Officer — and Why "Nobody, Really" Is the Wrong Answer
Many digital health products have a named clinical safety officer and no real one. The gap between the title and the function is where safety quietly stops happening.
Hazard Is Not Risk — and Confusing Them Is How Digital Health Ships Harm
Two words that digital health teams use interchangeably mean very different things. The confusion isn't pedantic — it's the mechanism by which real harm gets reasoned away.
A Safety Case Is an Argument, Not a Folder
Most "safety cases" in digital health are collections of documents that prove activity occurred. A real one is a reasoned, falsifiable argument that a specific system is acceptably safe — and the difference is everything.
Quiet Failures Are the Dangerous Ones
The failures that hurt patients in digital health are almost never the crashes. They're the silences — the result that never arrives and never announces it didn't.