When I’m trying to explain to friends and family what I do, and I tell them that I work in Health IT and medical device software safety and regulation, they often ask me what sort of products I work with. They are then usually surprised that many of the businesses I support are small start-ups developing health apps. I think the assumption is that Health IT and medical devices are the realm of the big corporate organisations, and of course, everyone still assumes that medical devices are physical “things,” even if those “things” might be driven by software.
When is an app a medical device?
This depends on the intended purpose of the app, which is defined by the manufacturer. To me, this is the key to identifying the relevant legal and regulatory requirements that will need to be followed, and it doesn’t make much sense to develop an app without first defining what it is going to do. The intended purpose statement describes who the app will be used by (e.g. health professionals, patients, public), how it works, and where it is intended to be used (e.g. in healthcare settings, in the community, in people’s own homes on their own devices). Writing a solid intended purpose statement early in the development of an app will help to determine where the app sits in a specific care pathway, as well as whether it is classified as a medical device.
In the case of apps, a simplified version of the UK MDR 2002 definition for a medical device is software, which is intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
investigation, replacement or modification of the anatomy or of a physiological process, or control of conception
Note: please refer to The Medical Devices Regulations 2002 (legislation.gov.uk) for the full definition of a medical device.
Does an app (that the manufacturer has decided is not a medical device) still need to comply with the NHS DCB0129 Clinical Safety standard?
Once again, this depends on the intended purpose (which is why it is so important to get this right, and do it early). If you decide your app is not a medical device (often because it is a lifestyle app and is not directly influencing an existing disease, injury or handicap) then you don’t need to write a formal intended purpose statement. But beware; if you then start to make claims that your app “prevents obesity” or “reduces the risk of developing high blood pressure” then you are making claims that turn it into a medical device! Any claims that you make need to be supported by evidence to demonstrate that the app achieves its intended purpose. And if you can’t do this, then either the claims or the intended purpose are unsuitable.
If the app can still influence health or patient care, even if not meeting the definition of a medical device software, then the NHS Clinical Safety Standards (DCB 0129 and DCB 0160) still apply if the app is going to be marketed for use within the NHS in England and Wales. Of course, it is still a good idea to follow these standards if the app is only going to be used for private healthcare providers, or in other areas of the UK. Many private health organisations may require you to comply with specific safety requirements through commercial contracts, and as a patient or user, I would certainly be happier using an app that had been “gold stamped” as having adhered to this rigorous process and assessed by a qualified Clinical Safety Officer.
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