The use of mobile apps as medical devices has received renewed interest lately, especially with the announcement of Apple’s HealthKit, a tool to monitor, record and recall your health and fitness information. Even before HealthKit, the question of what constitutes a medical device has been gradually evolving, and until recently clear guidance has been open to interpretation.
Here in the UK for example, MHRA guidance has gradually evolved since Cranworth released their first medical app (almost 4 years ago!). Transformation of clinical data, without the opportunity for the clinician to review the raw data, is a key ‘red flag’ that probably signifies that an app is likely to be considered a medical device. For example, MerseyBurns (the first CE-marked, MHRA-regulated app in the UK) is a tool that takes one form of information (a schematic of a burn) and turns it into another form of information (a prescription guide for fluid replacement therapy). The key here is that the clinician has no access to the underlying formulas and equations, and has to place faith in the correct performance of the app as a medical device.
On the other side of the Atlantic, however, things are getting a little clearer with the FDA providing lists of apps which are, are not and may be considered to require regulation. One item in particular stands out:
- Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014].
This item was added to the “maybe” list at the start of June, indicating that the FDA will exercise discretion in deciding whether or not such an app requires regulation.
The new guidance, from both the MHRA and FDA, is certainly welcome amongst the medical app development community, paving the way for a clearer regulatory process for developers that can (and should) result in improved confidence for consumers. If you are unsure, would like advice, or simply to discuss these issues feel free to Contact Us and we will be happy to help!