For millions of people, smartwatches aren’t just a piece of technology. They can use them to take control of their health in ways never thought possible. As you go on your morning run, a smartwatch can monitor the rhythmic pounding of your feet and your heart’s steady beat. The watch can record the distance covered and the intensity of your workout, guiding you towards your fitness goals.
During lunch, you can use it to log calories for a BLT sandwich. As deadlines loom, they can offer gentle reminders to take a moment for yourself. And as you doze off, they might pick up instances of apnoea or other sleep disturbances.
But some users could also conflate health tips with medical advice. Device and app developers have consistently made it clear that their products cannot replace a professional medical doctor’s advice or treatment.
A smartwatch is not a medical device as defined by law. In the UK, medical devices are strictly regulated in a way that other devices such as smartwatches are not. These regulations provide users with better legal protections and clarity as well as providing for resolution in the event of a mishap.
What qualifies
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). The MHRA 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.
Pursuit of wellness?
An important question is how one distinguishes a device, digital tool or app as one used for a medical purpose – which is how the UK MDR defines a medical device – versus one that is used for general health and wellness. The latter would include, for example, meditation apps or step counters.
Traditionally, smart watches have been treated as smart, wearable technology. On the face of it, they offer users insight into their general health and wellness, helping them make necessary lifestyle adjustments to improve their health or fitness goals. Source: PTI