Whilst many aimed at the public simply aim to support general health and fitness, some purport to assist both the public and the healthcare professionals in offering a medical diagnosis or treatment. For instance they may gather data such as diet, heartbeat, or blood glucose levels and then analyse and interpret the data to make a diagnosis, prescribe a medicine, or recommend treatment.
The question arises as to when an app could be considered a medical device. Under EU and UK laws a medical device is required to carry a CE marking to show that it complies with those laws and the ‘Essential Requirements’ they impose and to have affixed to the device a CE-marking as evidence of that compliance. The originating EU law (Directive 93/42) is due to be replaced and toughened up by a new Regulation 2017/745 soon to come into effect.
In broad terms the laws define a medical device to include software or other article intended by its manufacturer to be used specifically for:
To assist manufacturers in deciding whether their app falls within this definition and hence needs to comply with the EU medical device laws the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance by way of a step-by-step interactive PDF to help identify the health apps which are medical devices and make sure they comply with regulations. These updated MHRA guidelines were issued just a month after the July 2016 European Commission guidance on stand-alone software. The US Food and Drug Administration also issued revised guidance In February 2015 on the regulation of mobile medical apps.
There is a broad consensus between these guidelines whereby an app is a regulated app if it fits within the definition of medical device (ie, it is intended to diagnose disease or other conditions; cure, mitigate, treat, or prevent disease; or affect the structure or function of the body). Intended uses may be established through labeling claims or advertising by the manufacturer or its representatives. The formal labeling of a product is not necessarily the end of the story when determining intended use - how the product actually is marketed is the key.
More recently the Advocate General at the European Court of Justice (ECJ) issued an opinion regarding software that supports prescribing physicians with information on contra indications, doses, and interactions between medicinal products. Perhaps unsurprisingly, the software was determined to be a medical device as it was specifically intended for diagnostic or therapeutic purposes and to help physicians with what medicines to prescribe, predict possible allergies, and assess treatment options. The Advocate General effectively adopted the principles set out by the European Commission. The Advocate General is commonly, but not invariably, followed by the ECJ itself. Read the decision here.