When digital tech becomes a medical device has been saved
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When digital tech becomes a medical device
Many tech companies could soon face a raft of regulatory compliance challenges
Wearables and other digital tech have enormous potential for enabling personalized and preventative healthcare but their adoption into the clinical environment has been relatively slow due to data quality, privacy and cyber safety concerns. The industry should embrace the new EU regulations for medical devices to address these concerns and to unlock the full potential of their products for healthcare.
Many tech companies could soon face a raft of regulatory compliance challenges
Healthcare is going digital, personal and persistent. As they monitor heart rates and other vital signs, the latest wearables and other digital tech can give individuals an almost continuous stream of data about their health. That is driving demand for smart watches and other personal devices, but also steering them into a heavily regulated part of the consumer economy – medical devices – and raising a raft of compliance challenges. As they typically don’t have a compliance culture, tech companies face a steep learning curve.
If they are harnessed well, wearable devices could play a major role in enabling more proactive, personalized and preventative healthcare. The Apple Watch, for example, can alert wearers to an irregular heart-beat and allow them to conduct an ECG and record their symptoms. Apple says the waveform, results, date, time and any symptoms can be exported as a PDF to share with a clinician.
Deloitte Global predicts that 320 million consumer health and wellness wearable devices will ship worldwide in 2022. By 2024, that figure will likely reach nearly 440 million units as new products hit the market and more healthcare providers become comfortable with using them. At the same time, thousands of smartphone apps now offer personalized wellness and fitness advice, while connected sensors and cameras are increasingly being used to monitor the health of elderly and frail in their homes2 .
New devices, new regulations
As these new devices and services enter the European market, the European Commission is revising EU laws and regulations to try ensure a high level of safety for consumers without stalling innovation. In May 2021, a new regulation3 expanding the definition of a medical device came into effect. That definition focuses on the intended medical purpose of the product or service. Defining and properly describing the intended purpose of the device is the starting point for all decisions, including the qualification as a medical device or not. In essence, if the provider claims their offering is intended for a specific medical purpose, then they need to comply with medical device rules. The product or service will need to be certified by the appropriate regulatory body/ authority – self-certification is no longer acceptable in many cases. But any product or service that steers clear of such medical claims may not require regulatory approval as a medical device.
As of May 2022, a further EU regulation4, covering medical devices used to examine in vitro samples of human body specimens (such as wearable biosensors that monitor analytes in sweat or blood), also applies. This regulation introduces stricter controls for high-risk in vitro diagnostic medical devices, which will be scrutinized by experts at an EU level before they are launched on to the market.
As such regulations can’t possibly anticipate every scenario, there will be grey areas. One tricky challenge is how to regulate technology that aims to help people with mental health issues, which can range from mild anxiety to serious phobias, depression and schizophrenia. As example, in the US of the thousands of mobile apps that are designed to help people manage their mental health, some have been approved by The Food and Drug Administration5, but this process can take years.
As well as complying with medical device rules, providers of wearable devices and other personal healthcare tech in the EU will need to comply with the General Data Protection Regulation (GDPR)6, cyber-security regulations7
and the forthcoming AI Act8, governing the use of artificial intelligence.
To help tech companies get to grips with the rules, the European Commission is issuing extensive guidance. But for consumers, the fine line between a medical device and an app for wellbeing or lifestyle may not be clear. Although a web search could generate advice on how to manage a bad back, the search service wouldn’t be considered a medical device under the new regulation. Yet, a smartphone app that dispenses similar information based on patient data, could be in the scope of the new rules - if the software performs an action on information for the benefit of the individual that goes beyond storage, communication or simple search.
The pandemic drives digital health adoption
At the same time, the lines between wellness and healthcare have further blurred during the pandemic. Traditionally used to measure activity levels, wearable devices are increasingly been harnessed to help detect the early signs of an infection or other health condition (figure). For example, smart watches can detect subtle changes in heart rates, activity levels and sleep patterns - all indicators that the wearer may have caught COVID.
Indeed, much of the software and sensors being integrated into smart watches and other wearables could be useful in clinical environments. While adoption has been relatively slow in the face of medics’ skepticism, data privacy concerns and cyber-security threats, the social distancing required by the pandemic has prompted many healthcare providers to take a closer look at using digital technologies for diagnosis or therapeutic purposes. If patients are unable or unwilling to visit a doctor in person, the data collected by wearable devices could help enable remote diagnosis or therapy.
The new EU regulations could help to build clinicians’ and consumers’ trust in medical devices and the value of the health data they collect. Although many tech companies may find regulatory compliance an onerous challenge, it could help their products gain traction and ultimately unlock the full potential of digital tech for healthcare.
1.https://www2.deloitte.com/global/en/insights/industry/technology/technology-media-and-telecom-predictions/2022/wearable-technology-healthcare.html
2. A catalogue developed by HumanFirst lists than 1,200 digital sensors that are used for remote patient monitoring. UK consumer group Which provides a good overview of telecare options.
3. Regulation (EU) 2017/745, https://eur-lex.europa.eu/legal content/EN/TXT/PDF/?uri=CELEX:32017R0745
4. Regulation (EU) 2017/746, https://eur-lex.europa.eu/eli/reg/2017/746/oj
5. Source: https://www.verywellmind.com/fda-approval-and-mental-health-apps-5193123
6. https://eur-lex.europa.eu/eli/reg/2016/679/oj
7. https://eur-lex.europa.eu/eli/reg/2019/881/oj
8. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0206
9. Source: https://www.nature.com/articles/s41551-020-00640-6
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