For millions of people, smartwatches are more than just a piece of technology. They can use them to take control of their health in ways they never imagined.

While you go for a morning run, the smart watch can monitor the rhythmic pounding of your feet and the steady work of your heart. The watch can record the distance traveled and the intensity of your exercise, guiding you towards your fitness goals.

During lunch, you can use it to record calories for a BLT sandwich. As deadlines approach, I can offer gentle reminders to take a moment for yourself. And while you are napping, you might experience apnea or other sleep disorders.

But some users might also equate health advice with medical advice. Developers of devices and apps have consistently made it clear that their products cannot replace the advice or treatment of a professional physician.

A smart watch is not a medical device under the law. In the UK, medical devices are heavily regulated in a way that other devices such as smart watches are not. These regulations provide consumers with better legal protection and clarity, as well as a solution in the event of an accident.

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 the UK MDR, it is further classified, ranging from low risk (stethoscopes and wheelchairs) to high risk (pacemakers, heart valves, implanted cerebral simulators).

If the device is designed to enter the body or contains medicinal substances, it is more likely to be considered high risk. Depending on the risk classification, the law then imposes strict standards to protect users from harm. This includes the obligations of manufacturers and developers to ensure the security of their devices by conducting risk impact assessments, periodic audits and other actions.

All matters relating to medical devices in the UK fall under the jurisdiction of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA oversees medical devices available in the UK and has decision-making powers in relation to their marketing and distribution. It is also the MHRA’s duty to ensure that manufacturers and developers comply with the regulations.

Looking for wellness?

An important question is how to distinguish a device, digital tool or app as being used for medical purposes – which is how the UK MDR defines a medical device – versus those being used for general health and well-being. The latter would include, for example, meditation apps or step counters.

Traditionally, smartwatches have been treated as smart, wearable technology. At a glance, they offer users insight into their overall health and well-being, helping them make the necessary lifestyle adjustments to improve their health or fitness goals.

However, in recent years such technologies have advanced more and more. Tens of thousands of digital tools and apps have flooded the app stores. These include apps for mental health monitoring, symptom checkers based on data entered by patient users, or medical calculators for drug dosing.

Smart watches can have electrocardiogram (ECG) functions. An EKG is a test used to check a person’s heart rhythm and electrical activity. Medical professionals have traditionally used EKGs to look for signs of coronary heart disease or other cardiovascular conditions. The same functions on the watch may not have the appropriate sensitivity to detect medical conditions.

The latest version of the Apple Watch has built-in sensors that could detect atrial fibrillation, a type of irregular heart rhythm. In the US, Apple has received approval from the Food and Drug Administration (FDA) to use it for this purpose, marking a bold step into the regulated space of medicine and healthcare.

Biosensors, which were previously thought to be devices only applied in clinical settings, have now evolved in design into thin patches for consumer use. Take the Nix Biosensor device. When paired with Apple watches, it’s designed to measure the user’s optimal hydration level in real time by identifying molecular markers in sweat and determining fluid and electrolyte loss (substances that maintain the balance of fluids inside and outside cells).

Finally, new trends also show that more and more women are relying on fertility and cycle tracking in smart watches and sophisticated apps. However, there were concerns that users could use the information instead of actual birth control.

Therefore, as smartwatches and trackers develop, it is possible that they will approach the threshold for what authorities can consider a medical device.

Privacy protection

There is one more thing to consider. Users of devices and digital tools regularly submit their personal data. Companies 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”. This would fall under the application of Articles 6 and 9 of the UK GDPR and Schedule 1 of the DPA. This means that stricter standards are being imposed for the collection and use of such data (in its processing), including the potential obligation to carry out a comprehensive data impact assessment.

Indeed, the UK’s privacy watchdog, the Information Commissioner’s Office (ICO), issued a statement on 8 February 2024 reminding all app developers to ensure user privacy is protected following a regulatory review of menstruation and fertility apps.

Other potential protections for user privacy could come from the Medicines and Medical Devices Act 2021 (MMDA), the appointment of a patient safety commissioner and the National Health Service (NHS), which can now assess digital tools using a digital technology assessment. criteria (DTAC).

Clear guidelines in this area are not only necessary, they are imperative. Without them, we potentially risk stifling innovation and compromising customer care.