The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has published a new guidance document intended to facilitate the development of medical device stand-alone software-a category which notably includes healthcare "apps" capable of running on smartphones.
The document, released on 19 March 2014, comes at a time when global regulators have been struggling to regulate the burgeoning field of medical software and apps.
The struggle lies between two opposing forces: to facilitate the development of new products that help consumers, and to protect those consumers from products that would do them harm.
To the latter, healthcare apps and software have the potential to make it easier to access healthcare than ever before. For example, a healthcare app that works with a smartphone's camera might prove instrumental in diagnosing a melanoma. An app that works with a smartphone attachment might similarly be able to test blood glucose levels, vital signs (blood pressure or heart rate) or any number of different health conditions.
But regulators have also been wary of apps, some of which have been peddling plainly false claims, incorrect information, or have otherwise not been proven to work properly. In several regulatory jurisdictions, such as the US, there has also been concern about how to classify not just the application, but each subsequent update to the application as well. Would updates to an app require a new regulatory application to first be approved?
MHRA's guidance offers a range of definitions which are in turn intended to clarify which regulatory pathways app and software makers should use to bring their devices to market.
Medical device software is defined as any software intended by the manufacturer to be used in the:
- 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
- control of conception
Apps aren't excluded from this definition, and those meeting MHRA's definition of "medical device" will need to undergo the conformity assessment (CE) process before being allowed on the market.
MHRA said certain words and phrases are likely to trigger the assessment process, including the following:
"Decision support" and "decision making" software/apps will "most likely" fall under the medical device directive as well, MHRA noted.
Examples of Regulatory Approaches
MHRA offered the following examples of devices which would and would not be regulated:
- "Apps acting as accessories to medical devices such as in the measurement of temperature, heart rate, blood pressure and blood sugars could be a medical device as are programmers for prosthetics."
- "Software that monitors a patient and collects information entered by the user, measured automatically by the app or collected by a point of care device may qualify as a medical device if the output affects the treatment of an individual."
- "Software that provides general information but does not provide personalised advice, although it may be targeted to a particular user group, is unlikely to be considered a medical device."
- "Software that is used to book an appointment, request a prescription or have a virtual consultation is also unlikely to be considered a medical device if it only has an administrative function."
As in the US, apps which only provide information to consumers will likely not be regulated by MHRA. "However, if the software or app performs a calculation or interprets or interpolates data and the healthcare professional does not review the raw data, then this software may be considered a medical device," MHRA added.
The app guidance does not make note of whether updates to software or an app will require a new conformity assessment determination.
MHRA App Guidance