Smartwatches are tools for managing health and wellness. They can monitor heart rhythms, workout distance, and even provide reminders for personal care. However, they cannot replace professional medical advice.
Smartwatches are not just a piece of technology, but they can be used to take control of health in ways never thought possible. They can monitor rhythmic pounding of feet and heartbeat, record distance covered and intensity of workout, guide fitness goals, log calories for a BLT sandwich, offer gentle reminders to take a moment for yourself, and pick up instances of apnoea or other sleep disturbances. However, some users could also conflate health tips with medical advice, as device and app developers have consistently made it clear that their products cannot replace a professional medical doctor’s advice or treatment.
In the UK, medical devices are strictly regulated in a way that other devices such as smartwatches are not. The key legal framework in the UK is the Medical Devices Regulations 2002 (UK MDR). Once a product has been identified as a medical device under UK MDR, further classification of it takes place, ranging from low risk (stethoscopes and wheelchairs) to high risk (pacemakers, heart valves, implanted cerebral simulators). If a device is designed to go inside the body or if it contains medicinal substances, it is more likely it is treated as high risk. Depending on the risk classification, the law then imposes stringent standards to protect users from harm. These include obligations on the manufacturers and developers to ensure their devices are safe, through conducting risk impact assessments, periodic audits, and other actions.
All matters relating to medical devices in the UK fall under the responsibility of the Medicines and Healthcare Products Regulatory Agency (MHRA), which conducts surveillance of medical devices available in the UK and has the authority to make decisions regarding their marketing and distribution. It is also the MHRA’s duty to ensure that manufacturers and developers are complying with the regulations.
An important question is how one distinguishes a device, digital tool, or app as one used for a medical purpose versus one that is used for general health and wellness. As smartwatches and trackers evolve, it is possible that they may approach the threshold for what authorities could consider a medical device.
Privacy protections are another important consideration for users of devices and digital tools. Businesses must ensure compliance with the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018 (DPA). Personal health data is a “special category of data” that falls under the application of Articles 6 and 9 of the UK GDPR and Schedule 1 of the DPA. Other potential safeguards for users’ privacy could come from the Medicines and Medical Devices Act 2021 (MMDA), the appointment of the Patient Safety Commissioner, and the National Health Service (NHS), which can now evaluate digital tools using the digital technology assessment criteria (DTAC).
