From step counters to heart-rate monitors, health apps are becoming increasingly sophisticated. As advertisers promote new health-monitoring features, they should take care not to overstate what their technology can actually do.
Three recent ASA rulings highlight why advertisers should think carefully about both the capabilities of their apps and the impressions created by their advertising.
Although the apps appeared similar, the rulings turned on different issues, illustrating the importance of both robust substantiation and understanding when software may fall within the scope of medical-device regulation.
More than a digital notebook
The MHRA's guidance distinguishes between software that simply records health information and software that measures, analyses or interprets physiological data. While software that acts as a digital notebook is unlikely to be regulated as a medical device, more advanced functionality may bring it within the UK medical devices framework.
As health apps continue to evolve, advertisers should understand where their products sit on that spectrum and ensure they meet any applicable regulatory requirements.
It's not just what you say
Consumers form impressions from more than just headline claims. Images associated with blood-pressure monitoring, demonstrations showing users placing a finger on a smartphone screen, and references to health metrics can all suggest that an app is capable of measuring physiological data.
Advertisers should consider the overall impression created by their marketing, not just the wording of individual claims. Where advertising suggests that an app can perform a particular health-monitoring function, marketers should hold robust evidence to support that impression.
Small differences, big consequences
The three ASA rulings demonstrate how relatively small differences in functionality can have significant regulatory consequences.
One app used photoplethysmography (PPG) technology to measure heart rate, bringing it within medical-device territory (Novabeyond Ltd t/a Blood Pressure-Monitor Tracker App, 17 June 2026). Another appeared to analyse users' blood-pressure readings through colour-coded indicators, moving beyond simple record-keeping (HealthTracker Apps t/a Blood Pressure Monitor App, 17 June 2026). The third case was different again: there was no clear evidence of medical-device functionality, so the issue centred on misleading and unsubstantiated advertising rather than medical-device regulation (P&L Studio t/a Blood Pressure, 17 June 2026).
Although each case turned on different facts, together they highlight the importance of understanding both what software actually does and what consumers are likely to believe it does. As health apps become increasingly sophisticated, features that measure, analyse or interpret health data may require not only careful substantiation but also compliance with the relevant medical-device framework.
The takeaway
As digital health technologies continue to develop, advertisers should consider not only what their apps do but also what consumers are likely to think they do.
Claims, demonstrations and visual cues should accurately reflect an app's functionality and be supported by appropriate evidence. Where software measures, analyses or interprets health data, advertisers should also consider whether medical-device regulation may apply.
When it comes to health apps, the line between a wellness tool and a regulated medical device may be only a few features wide.
For further information, see the MHRA's guidance on stand-alone medical device software.
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