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

Abstract

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 …