Health data from wearable devices and apps

Medical devices in the EU are currently regulated under the Medical Devices Directive (93/42/EEC). The Medicines and Healthcare products Regulatory Authority (MHRA) produced guidance in March this year on medical device software, including apps. Health apps are considered a medical device if they have a “medical purpose”. Where an app provides decision support or decision-making software, which applies some form of automated reasoning, such as calculations or symptom tracking, such software is very likely to meet the definition of a medical device and therefore be regulated by the MHRA Continue reading