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
mHealth applications for smartphones are increasingly employed in everyday life, providing information on treatment options, tips on managing illness, and helping to monitor conditions from high blood pressure to diabetes. The market is growing to such an extent that it has been estimated that by next year some 500 million people will be using healthcare apps.
We are all aware that the world is becoming more connected. It is estimated that there will be around 26 billion internet connected devices worldwide by 2020 –a large proportion of which are related to health and healthcare. According to research – students are spending between 9 – 10 hours per day ‘engaged’ with their mobile device managing their banking, fitness and retail in addition to communication. If we are relying more and more on our devices to manage our lifestyle, including our health, what are the risks?
Is there a potential risk for insurers as a result of the Consumer Rights Act 2015 (CRA) bringing digital content into the mainstream of product liability? Alternatively, does it create an opportunity for insurers to develop a new insurance product?