Across a crowded landscape of phone apps that promise to help people understand their bodies, a quieter distinction is being drawn: software that has been tested, approved and bound by regulators is asked to take only what it needs and to use it only for the purposes it was approved for. Health leaders in England speak of this as a discipline of restraint, a promise that data gathered in the service of care should not wander into other uses. Yet the promise is tested by the reality that such tools rarely stand alone, and that information passing between connected systems is only as safe as the
Digital Therapeutics Promise Tighter Data Controls Than Wellness Apps, Experts Say
It wouldn't make sense to collect additional data for the sake of it
Mark
Why does the line between a wellness app and a digital therapeutic matter for privacy?
Mimi
Regulation. A digital therapeutic is clinically approved and tested, so the data it collects has to serve purposes regulators have signed off. A wellness app can be a free-for-all.
Mark
What does that look like in practice?
Mimi
Williams uses a sleep disorder service. It tracks sleep duration and night wakings, and that data shouldn't be used to treat other conditions.
Luke
Worth noting that this is how the system is meant to work, according to two people from an NHS innovation network. The piece doesn't show a case where it was tested or enforced.
Mark
So the claim is about design, not track record?
Luke
Largely, yes. Checketts says these products "generally" have stricter controls. That's a hedge, not a guarantee.
Mimi
And Williams admits the risk is real, because these tools often sit alongside other digital health systems, generating large amounts of data that could be breached.
Luke
The UCL and King's report concerned female health apps, not digital therapeutics. It's context, not a comparison between the two.
Mark
What's the unresolved part?
Mimi
Interoperability. Williams says a lack of it can disrupt data flow, and that makes meeting obligations harder as adoption grows.
El Pulso
- Unregulated wellness apps have drawn alarm after researchers warned of unnecessary privacy and safety risks in women's health tracking.
- Digital therapeutics are being positioned as a stricter, clinically approved alternative, raising the stakes for how their data is handled.
- Regulators' approved purposes, data-sharing agreements and impact assessments are being used to fence in what patient information can be used for.
- Interoperability gaps and the movement of data across connected health systems remain an unresolved pressure point as adoption accelerates.
Across a crowded landscape of phone apps that promise to help people understand their bodies, a quieter distinction is being drawn: software that has been tested, approved and bound by regulators is asked to take only what it needs and to use it only for the purposes it was approved for. Health leaders in England speak of this as a discipline of restraint, a promise that data gathered in the service of care should not wander into other uses. Yet the promise is tested by the reality that such tools rarely stand alone, and that information passing between connected systems is only as safe as the weakest link that carries it.
Wellness apps have multiplied quickly, from period trackers to sleep monitors and mental health chatbots. Their ease of use has come with growing unease about what happens to the personal data they collect, and a recent report from University College London and King's College London warned of privacy and safety risks in female health apps.
Digital therapeutics aim to set themselves apart. These are software treatments that have been clinically approved and tested before reaching a patient's phone or laptop. Officials at Health Innovation Oxford & Thames Valley explain that because regulators approve them, they operate under tighter controls, using only the data needed for good outcomes and for refining the treatment. A sleep-disorder tool, for example, should not repurpose its sleep data to treat other conditions without breaching its regulatory agreements.
Developers are expected to rely on population-level data to check that the tools work and to fix faults, while clinicians watch individual patients to ensure they stay within expected limits. Because these products often sit alongside other digital health systems, large volumes of data move between them, which is why data protection rules under UK law are enforced closely.
Organisations must put comprehensive data-sharing agreements, protocols and impact assessments in place, and those agreements must be reviewed over time. Penalties for breaches are significant. Still, managing this flow is difficult, and as adoption grows, the real test will be whether patient data stays secure as it travels between connected systems.
Wellness apps are easy to find. There are period trackers, sleep monitors, mental health chatbots and digital weight loss diaries, all promising to help people understand their own bodies. Alongside them have come worries about what happens to the data they collect. A recent report from University College London and King's College London warned that users of dozens of female health monitoring apps face "unnecessary privacy and safety risks through poor data handling practices."
Against that backdrop, a newer category of health technology is trying to set itself apart. Digital therapeutics use software to deliver clinically approved treatments directly to a patient's phone or laptop. Unlike off-the-shelf wellbeing apps and fitness trackers, they go through rigorous testing and approval. When used properly, the data they generate lets healthcare practitioners tailor care more closely to the individual.
Two figures from Health Innovation Oxford & Thames Valley, part of an NHS network that encourages the spread of innovation, laid out how this is meant to work. Guy Checketts, the organisation's head of evaluation and transformation, says digital therapeutics do collect and use personal data. But because regulators assess and approve them, they generally operate under stricter privacy and usage controls than unregulated wellness apps. As part of their regulatory obligations, they should use only the personal data needed to achieve good patient outcomes and to refine the medical intervention.
Matt Williams, the organisation's senior programme manager for mental health, offered an example: a digital therapeutic built to treat sleep disorders by tracking how long a patient sleeps and how often they wake at night. That data, he says, should not be repurposed to treat other conditions, since doing so could breach the agreements struck with regulators. In his words, the data would be used as part of the treatment or to enable communication with a patient, and it would make no sense to gather extra data for its own sake unless it was part of a study.
Checketts adds that both the companies building these products and the professionals prescribing them can use the technology and its datasets only for purposes and outcomes that regulators have approved, and those must be spelled out during the regulatory process. Developers, he says, should use population-level rather than individual data to check that people are using the tools correctly and to fix technical faults. Healthcare professionals would typically monitor individual patients to confirm outcomes are staying within "expected limits."
The picture is complicated by the fact that digital therapeutics are often used alongside other digital health systems. Williams says this produces large volumes of patient data that could be breached or misused, which is why the Data Protection Act is applied and enforced so rigorously in this area.
To comply with that act and the UK GDPR, Checketts says organisations developing and using these products must put comprehensive data-sharing agreements in place. Everyone sharing the data is expected to follow them, and Checketts says they must also produce a data-sharing protocol and a data protection impact assessment specific to the data being shared and processed. Williams says the agreements clarify who may share or use health data, what kind of data is gathered and why. He notes that penalties for breaches are significant and that such agreements should be reviewed and revised over time.
Managing the flow of data is central to running these services, and Williams says it is not easy. A lack of interoperability within a health system, for instance, can disrupt it. Checketts says he senses a broad and growing recognition of the value of health data, along with rising interest in digital therapeutics, particularly as an alternative to pharmaceutical treatment for mental health conditions. As adoption grows, the test will be whether data stays secure as it moves between connected systems.
Citas Notables
The data collected by the digital therapeutic would be put to good use as part of the treatment, or used to enable communication with a patient.— Matt Williams, Health Innovation Oxford & Thames Valley
Digital therapeutics generally have stricter data privacy and usage controls than non-regulated wellness apps because regulators assess and approve them.— Guy Checketts, Health Innovation Oxford & Thames Valley (paraphrased)
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