Fitness trackers, bodytech, wearables, smart watches and associated apps, also known as ‘Wearables’, range in sophistication from basic recording of activity levels like step counts to more advanced physiological indicators such as heart rate and blood pressure.
The wearables market was valued at $27.91 billion in 2019 and is expected to rise to $74.03 billion by 2025. Some of these devices are used by consumers with the intended purpose being to monitor their own general health and well-being and are not classified as medical devices. However, in light of the current pandemic the question has arisen as to whether these wearables can assist in the fight against COVID-19.
The role of wearables
These popular health and fitness wearables are very effective at monitoring a range of accessible physiological parameters including heart rate, body temperature, blood pressure, sleep, movement and even oxygen saturation levels. Most of these do not provide any form of actual diagnosis yet when the data is combined and cross-referenced, they are capable of completing a profile of a user’s overall health.
Depending on the intended use of the wearable and its functionality, it may be considered a medical device or it may instead be positioned as a general lifestyle/fitness product.
At present, technology has already proven an important contribution to the fight against COVID-19. Wearable manufacturers have begun creating or adapting their products so that they can assist with detecting early signs of COVID-19.
Some have developed algorithms that have been specifically tailored to catch the early symptoms associated with the virus. Some wearables utilising such software are now also enabled to continuously measure and interpret coughing and respiratory activity. Testimonials from healthcare providers have stated that this ability to monitor patients and being alerted to changing conditions in real time will give clinicians a new and important sword in the fight against COVID-19.
Additionally, the role of wearables against COVID-19, not only applies to monitoring patients and detecting the early signs of the virus but also in protecting our healthcare professionals. Given the highly contagious nature of the virus, by utilising wearables to continuously monitor suspected and confirmed cases of COVID-19, it is hoped that patient-to-caregiver contact can be reduced.
A wearable will generally be considered a medical device if it is intended by its manufacturer to be used for the diagnosis, monitoring, treatment or alleviation of a disease or the investigation of a physiological process, state or the anatomy. Wearables that fall within this scope cannot be placed on the market without a CE mark. Ireland’s Health Products Regulatory Authority (HPRA), has introduced derogations from some of the rules governing medical devices.
It is now permissible for non-CE marked medical devices relevant to COVID-19 to be placed on the market in certain limited circumstances with the prior approval of the HPRA. The HPRA will assess the product to determine whether its provision is in the interest of the protection of health, despite the fact it is not yet CE marked or CE marked for the particular use that is being proposed.
Even if a wearable is already CE marked as a medical device, companies need to be alive to pushing the boundaries of the existing intended use and the impact of making claims above and beyond the scope of the device’s existing certification. While companies may wish to assist with the fight against the pandemic, they also need to be extremely aware of the limitations of any existing certification they have for their device. Similarly, for wearable devices that are not classified as medical devices, manufacturers need to carefully consider the impact of their use in a health setting or in the fight against COVID-19, as this may trigger the application of the medical devices framework.
Additionally, the European Commission has published a notice to stakeholders relating to regulatory expectations. During COVID-19, the EU is permitting national marketing authorisations to be mutually recognised in other Member States who need these devices. Also, in instances whereby no national marketing authorisation exists, Member States can potentially make use of the exceptions within the Medical Device Directives, resorting to compassionate use or distribution of an unauthorised medicinal product in accordance with Article 5(2) of Directive 2001/83/EC.
As well as this, some Member States, like Italy, have also recommended the use of consumer wearable technology in remote consultations with suspected COVID-19 patients, through physician guidelines. Similarly, the UK’s NHS has urged health technology firms to provide digital technologies that can assist in remote consultations. Ireland’s Health Service Executive has also followed suit by approving an online portal to allow GPs and healthcare providers treat people remotely. Wearables will be able to provide initial indicators for healthcare providers monitoring these people through the platform. All of these steps go to demonstrate how valuable the use of wearables may be during this pandemic.
Another legal consideration with regard to using wearables during COVID-19 is that consumer laws continue to apply. The Irish Competition and Consumer Protection Commission (CCPC) have published a reminder that consumer law remains applicable during COVID-19. As a result, care should be taken to ensure any marketing statement is accurate and validly proven. As well as this, the CCPC are monitoring aggressive commercial practices or pressurised sales tactics towards consumers. Excessive ‘price gouging’ will not be accepted. They are also observing unfair contractual terms such as attempts to limit consumers’ legal rights directly or indirectly.
The Advertising Standards Authority for Ireland (ASAI) has also reported that any claims relating to preventing or the ability to cure COVID-19 should be supported by robust evidence. Under the ASAI Code, advertisers are required to adhere to the ASAI’s Code of Standards for Advertising and Marketing Communications in Ireland, which applies to all commercial marketing communications. As stated in this Code, any marketing communications should not mislead, or be likely to mislead, by inaccuracy, ambiguity, exaggeration, omission, or otherwise. The advertiser must be in a position to substantiate all claims, expressed or implied, that the advert or statement conveys to reasonable customers.
While the combination of multiple technologies in a compact, wearable platform can potentially offer users advanced capabilities especially during COVID-19, it can also expose them to a number of potential safety hazards. Consequently, wearables cannot be placed on the market if they are not considered ‘safe’ according to EU and Irish product safety rules. Wearables manufacturers should be aware of their liability to consumers who are harmed by defective products or the negligence of the manufacturer.
It is evident from the above discussion that wearables have the ability to provide a key tool in the battle against COVID-19. Despite this, they are still subject to significant regulatory regimes and compliance needs to be considered very carefully to prevent these products from falling foul of conformity with safety and consumer protection requirements. Crucially, manufacturers need to determine whether the wearable is a medical device or a general consumer product and ensure that they follow the appropriate regulatory framework to market.
Innovation and technology are what the governments are calling upon as the answer to help close the gap on exhausted national healthcare systems. However, in order for the wearables to be effective they must be safe, produced in compliance with regulations and properly functional to get placed on the market and be able to provide any assistance they claim to in the fight against COVID-19. Legal advice should be obtained if manufacturers are unsure of the regulatory risks involved in producing wearable technology or in extending a wearable’s existing use.
For more information, please contact a member of our Product Regulation & Consumer Law team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.