Compliance risks need to be considered to harness the power of wellness apps

Health and wellbeing apps and wearable devices, such as FitrWoman and Oura, are good examples of apps that collect personal health and activity data to support elite sports stars and everyday athletes alike to optimise their training capabilities and performance, as well as improve their health and fitness levels.

A recent article in The Times (registration required) reported on a new study by University College London showing that women’s reactions and mental agility can improve during their periods, and found that tracking the menstrual cycle to dictate how women exercise could be key to shaping how women approach sport. It said that many Team GB Olympians will be using apps like FitrWoman and Oura this summer.

Health law expert Louise Fullwood of Pinsent Masons said that this type of technology has great potential and can contribute to the much needed ‘female-specific’ data required for health research to adequately support and advance women’s health. However, app providers should give careful consideration to compliance – not just from a legal and regulatory perspective, but also an ethical one.

“This is particularly critical for apps and devices which collect this highly sensitive information. The algorithms and bases for reports and advice given need to be solidly evidenced and verifiable in order to provide value and avoid harm by giving misleading advice,” she said.

From a legal perspective, developers need to consider whether the technology or software could constitute a ‘medical device’, for the purposes of compliance with the Medical Devices Directive and Regulation.

According to guidance by the Medicines and Healthcare Regulatory Agency (MHRA), developers of health apps are required to reassess their compliance and the classification of their products under new UK medical devices regulations. Apps such as symptom checkers, those that aid diagnosis and those that track reproductive cycles could potentially be caught by the regulations, increasing compliance requirements and data collection rules for such businesses.

“It is also of critical importance to have strong data security, information governance and clear data protection consents. For example, looking at the privacy policies of some providers of period or fertility tracking systems, whilst there are statements about data never being ‘sold’, there is a degree of opacity as to whom and when data might be otherwise ‘shared’ with third parties,” said Fullwood.

The guide to good practice for digital and data-driven health technologies, published by the UK’s Department of Health and Social Care, is one of the resources available to app developers and providers on ethical operations, good practices, principles and regulatory requirements, such as on data protection and data transparency.

Commenting in a recent report on the UK fitness industry by data provider Leisure DB, corporate law expert Samantha Treleaven of Pinsent Masons said that the growth of wellness apps was "nowhere near its peak".

"Consumers will continue to challenge existing systems to gain a more in-depth understanding of their health status and overall wellness," she said. "The goal now has to be an even more personalised approach, with cross-sector collaboration to embrace and analyse all aspects of physical, mental, financial and medical health. It appears investors agree."