案例库 · 广告与公关 · 市场决策 · 2026
这条还没译成中文，下面是英文原文。
An app ad said your iPhone monitors blood pressure — it was not a medical device
'Your iPhone now supports blood pressure monitoring', the Google ad said. The app measured heart rate only, was unregistered, and could make no medical claims.
Novabeyond · 2026-06-17
怎么回事
Novabeyond's 'Blood Pressure-Monitor Tracker' app measures heart rate through the phone's camera (photoplethysmography) and lets users log blood-pressure readings taken elsewhere. A Google video ad showed a finger on a screen with SYS/DIA readings fluctuating under the text 'Your iPhone now supports blood pressure monitoring'; an in-app ad said 'Record your heart rate daily — tap your finger'.
The ASA judged that the app's PPG heart-rate function made it a Class IIa medical device — and it was not registered with the MHRA or conformity-marked. For an unregistered device, no medical claims can be made at all. The video ad also directly misled: the visuals implied the phone itself measured blood pressure, which the app cannot do.
On 17 June 2026 the ASA upheld both complaints under CAP rules 3.1, 3.7 and 12.1. The ads must not appear again, and Novabeyond was told not to make medical claims for an unregistered device or imply blood-pressure monitoring it cannot deliver.
为什么会这样
- The claim was the product's whole pitch: 'your iPhone monitors blood pressure' described a capability the app does not have.
- Health functionality changes what the app legally is — PPG heart-rate monitoring makes it a medical device, and without registration every medical claim becomes a breach.
- The ad's visuals did the misleading work: fluctuating SYS/DIA numbers under a fingertip say 'measurement' whatever the small print allows.
教训
Health claims turn an app into a medical device in regulators' eyes: without registration, no medical claims at all, and the ad carries the liability for the gap.
后来呢
Novabeyond was told its ads must not reappear in the investigated form and that medical claims require MHRA registration and conformity marking. The ruling sits in a growing line of ASA decisions on wellness apps whose marketing outruns their clinical status.
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