Weighty issues for diet app developers
January 2022, like every January, sees many people planning to diet after indulging on mince pies, mulled wine and seconds of turkey curry. But this year, the traditional time of abstinence involves a technical twist: 2022 is forecast to be the year of the diet app. Developers and their insurers have a lot to chew over when assessing the risks of these products.
One size does not fit all
There is mounting evidence to show that each person's metabolism is different; meaning that generalised approaches towards dieting do not work. Instead, developers are increasingly leveraging consumers' personal health data to provide bespoke diet plans. Like a suit cut in celebration of losing a few pounds around the waistline, diet plans and advice can be tailored to the individual user. These apps sit in the grey area between lifestyle products, that are subject to general product safety requirements, and medical devices, that are tightly regulated.
Red tape measures
To determine whether a diet app should be regulated as a "medical device", developers should assess their product against the definition set out in the Medical Devices Regulations 2002. A "medical device" is a product, "together with any software necessary for its proper application" that is used to diagnose, prevent, monitor, treat or alleviate a disease, or is used to investigate a physiological process. A similar definition applies to products placed on the EU market under Regulation 2017/745 on medical devices. A diet app may fall within the definition if it includes elements that monitor health data such as heart rate or blood sugar levels.
In addition, guidance by the Medicines and Healthcare products Regulatory Agency (the MHRA) is intended to help developers determine whether apps should be regulated as medical devices. According to the guidance, if an app has just one function that is captured by the 2002 Regulations, such as investigating a physiological process, then it should be classified as a medical device. On the other hand, the guidance sets out a list of functions that will not amount to a medical purpose per se, such as allowing users to monitor their "wellbeing" or simply to transmit medical data without changing it.
Establishing whether an app is a medical device is only part of the battle. App developers may also want to provide users with dietary advice, to complement the app's other functions and improve users' health.
However, developers should be aware of the risks associated with offering unqualified professional advice. Users could act upon advice in a way that adversely affects them, which could provide the basis for litigation. Developers should consider choosing to provide the service via clinicians or registered healthcare professionals.
Developers who market their products with claims that users will receive advice from "dietitians" should ensure that the advisers are qualified and registered as such. In the UK, "dietitian" is a professional title that is protected by law. "Dietitians" are held to high standards under the Health Professions Order 2001, by the Health & Care Professions Council (HCPC) and the British Dietetic Association (BDA).
The risk of losing more than a few pounds
Developers whose apps should be classified as medical devices but fail to seek registration of the product are at risk of investigation by the MHRA, and financial or criminal penalties.
Claimants could also bring claims under the Consumer Protection Act 1987, alleging that a defect in the app caused an injury. This could arise where an app fails to deliver correct data on a user's health, such as based on calculations combining exercise and physiological readings, and the user acts on the data in such a way that their health is affected.
The scope of apps that can target the dietary and healthcare market ranges from fitness trackers that monitor exercise and calorie intake, through to those that analyse physiological data such as glucose levels and blood pressure, accompanied by professional and bespoke nutritional advice.
Judging the difference between what is a mere lifestyle app and what should in fact be a regulated medical product or service can be difficult. In a booming market, the developers who get it right can look forward to making a healthy profit.