Your smart watch isn’t a medical device – but it surely is tracking all of your health data

For thousands and thousands of individuals, smartwatches aren’t just a bit of technology. They can use them to take control of their health in ways never thought possible.

As you go in your morning run, a smartwatch can monitor the rhythmic pounding of your feet and your heart’s regular beat. The watch can record the distance covered and the intensity of your workoutguiding you towards your fitness goals.

During lunch, you need to use it to log calories for a BLT sandwich. As deadlines loom, they’ll offer gentle reminders to take a moment for yourself. And as you nod off, they might pick up instances of apnoea or other sleep disturbances.

But some users could also conflate health suggestions with medical advice. Device and app developers have consistently made it clear that their products cannot replace knowledgeable medical doctor’s advice or treatment.

A smartwatch just isn’t a medical device as defined by law. In the UK, medical devices are strictly regulated in a way that other devices equivalent to smartwatches are usually not. These regulations provide users with higher legal protections and clarity in addition to providing for resolution within the event of a mishap.

What qualifies

The key legal framework within 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, starting from low risk (stethoscopes and wheelchairs) to high risk (pacemakers, heart valves, implanted cerebral simulators).

If a tool is designed to go contained in the body, or if it comprises medicinal substances, it’s more likely it’s treated as high risk. Depending on the danger classification, the law then imposes stringent standards to guard users from harm. These include obligations on the manufacturers and developers to make sure their devices are protected, through conducting risk impact assessments, periodic audits and other actions.

All matters referring to medical devices within the UK fall under the responsibility of the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA conducts surveillance of medical devices available within the UK and has the authority to make decisions regarding their marketing and distribution. It can be the MHRA’s duty to be sure that manufacturers and developers are complying with the regulations.

Pursuit of wellness?

An vital query is how one distinguishes a tool, digital tool or app as one used for a medical purpose – which is how the UK MDR defines a medical device – versus one which is used for general health and wellness. The latter would come with, for instance, meditation apps or step counters.

Traditionally, smart watches have been treated as smart, wearable technology. On the face of it, they provide users insight into their general health and wellness, helping them make mandatory lifestyle adjustments to enhance their health or fitness goals.

In recent years, nonetheless, such technologies have change into increasingly advanced. Tens of 1000’s of digital tools and applications have flooded app stores. These include monitoring apps for mental health, symptom checkers based on information entered by patient users, or medical calculators for drug dosing.

Smartwatches can have electrocardiogram (ECG) functions. An ECG is a test used to envision an individual’s heart’s rhythm and electrical activity. Medical professionals have traditionally used ECGs to search for signs of coronary heart disease or other cardiovascular conditions. The same functions on a watch may not have the appropriate sensitivity to select up on medical conditions.

The latest version of the Apple watch has embedded sensors that will have the ability to detect atrial fibrillationa form of irregular heart rhythm. In the US, Apple has obtained clearance from the Food and Drug Administration (FDA) allowing it for use for this purpose, marking a daring move into the regulated medicine and healthcare space.

Biosensors, previously regarded as devices that were administered only in clinical settings have now evolved by design into slim patches for consumer use. Take the Nix Biosensor device. When paired with Apple Watches, it’s designed to measure a user’s optimal hydration level in real time by identifying molecular markers in sweat and determining the lack of fluid and electrolytes (substances that maintain a balance of fluids inside and outdoors cells).

Finally, emerging trends also indicate that increasingly more women are counting on fertility and cycle trackers in smartwatches and complex apps. However, there have been concerns that users might use the data rather than actual contraception.

Hence, as smartwatches and trackers evolve, it’s possible that they could approach the brink for what authorities could consider a medical device.

Privacy protections

There’s something else to think about too. Users of devices and digital tools commonly hand over their personal data. 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 information”. This would fall under the applying of Articles 6 and 9 of the UK GDPR and Schedule 1 of the DPA. This signifies that more stringent standards are imposed for the gathering and use of such data (in its processing), including potentially an obligation to conduct an in depth data impact assessment.

Indeed, the UK’s privacy watchdog, the Information Commissioner’s Office (ICO) issued an announcement on February 8 2024 reminding all app developers to make sure they protect users’ privacy following the regulator’s review of period and fertility apps.

Other potential safeguards for users’ privacy could come from the Medicines and Medical Devices Act 2021 (MMDA)from the appointment of the Patient Safety Commissioner and from the National Health Service (NHS), which might now evaluate digital tools using the digital technology assessment criteria (DTAC).

Clear guidelines on this area are usually not just mandatory, they’re imperative. Without them, we potentially risk each stifling innovation and compromising user care.