There is a line running through health technology, and a great deal depends on which side of it a product sits. On one side you are giving people information. On the other you are making a clinical determination about a named individual, which is regulated as a medical device almost everywhere.
Where exactly the line falls
Explaining what a measurement is, what the range printed on a document means, and what a value outside that range is commonly associated with — that is information. Taking this person’s values and returning this person’s condition, or a treatment for it, is a determination.
The distinction is not about tone. A sentence that hedges carefully can still be a diagnosis, and a plain statement of what a test measures is not one.
What we will not do, even when asked directly
- Name a condition a person has, however strongly the numbers point.
- Recommend or adjust a treatment, and above all never a prescription.
- Tell someone they are fine, which is a clinical judgement wearing reassuring clothes.
- Rank urgency as though we had examined them.
What we do instead
We say what the values are and what the document says about them. We say what is worth asking about. And we say who to speak to and how soon — a category of person and a timeframe, never a specific clinic or number, because routing someone to a particular provider is its own kind of clinical decision.
Why hold a line that limits the product
Partly because it is the law, and we would rather design for it than discover it. Mostly because the alternative is a system confidently telling people what is wrong with them on the basis of a photograph, with no examination, no history and no accountability. That product would be easier to sell and we are not going to build it.
This article explains how our technology works. It is health information, not medical advice.