Digital health technologies under the new EU Medical Devices Regulation: monitoring and governing intended versus actual use

The functionality of digital health technologies (DHTs), such as wearable devices and virtual assistants, is being promoted as essential tools to empower people to take control and responsibility of their own health and wellness. Examples of wearable devices referred to in this article include devices that track health-related and fitness-related data such as heart rate, activity level, sleep cycles and caloric intake. An example of a virtual assistant includes Amazon Echo with its technology to analyse the user’s voice to detect and determine ‘physical or emotional abnormality’ and provide targeted content related to a particular medicine sold by a particular retailer to address the detected problem.1 There is significant literature on the potential benefits of DHTs in reducing costs and the burden on the healthcare system, for example, by offering the public ways to self-manage health from home.2 DHTs are also attributed with the ability to help detect early warning signs of potentially serious health conditions that may otherwise go unnoticed.3 While healthcare providers generally recognise DHTs as useful tools, there is evidence that these technologies are increasingly being used by the public in a manner that potentially increases healthcare costs in the long run.4 5 One study reported an increase in physician–‘digital chondriac’ interaction where patients demand immediate attention from medical professionals based on troubling health indicators detected by wearable devices, which may or may not be accurate.6 On the other end of the spectrum, some patients elect to bypass traditional health service structures and take medical and health decision into their own hands at great risk to themselves instead of consulting a medical professional.7 8 The medical literature also echoes concerns regarding the accuracy and unsubstantiated scientific claims of DHTs which may mislead consumers about their health and lead to potentially harmful …