Link: The dangerously blurry line between wellness and medical tech

On July 15th, the FDA told Whoop that its Blood Pressure Insights feature hadn't been properly cleared. In response, Whoop used the term "wellness" to avoid regulatory scrutiny.

The word "wellness" can often bypass FDA regulations, meant for simpler, non-diagnostic tech features. However, Whoop's feature suggests blood pressure levels, blurring these boundaries.

Although labeled as a beta, Whoop's feature could lead users to assume they have health issues like hypertension. As a result, this could prompt unadvised medical decisions.

Other companies, like Samsung and Apple, are also exploring similar health features that skate close to needing FDA approval. This underscores the ambiguity and potential risks of using "wellness" as a catch-all term.

The FDA's current framework struggles to categorize increasingly complex tech features cleanly. It’s critical to define what truly constitutes a wellness versus a medical feature more distinctly.

Despite the convenience of these tech advancements, consumer awareness remains low. Hence, the need for clearer guidelines and marketing honesty in promoting such features is becoming more pressing.#

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