Consideration of health apps as medical devices
The mHealth (mobile health) market which covers health and medical practice with the support of mobile devices, including apps, is an expanding market.
Apps used in the field of medicine could be deemed to be medical devices. When considering whether or not an app is a medical product it is essential to take into account its intended use and the product’s mode of action.
Since there is currently no specific Spanish regulation on the use of software applications in medicine, in order to define which software applications used in the medical field can be considered medical devices, our main source of information is the guide published by the European Commission in January 2012 (“Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical device, Meddev 2.1/6, January 2012”). Although this guide is not legally binding, it can be viewed as a code of practice to be taken into account by companies when launching medical apps on the market. In any analysis of whether or not a software application as such used in the medical field can be considered to be a medical device, with the concomitant regulatory consequences deriving from that analysis, we need to ask the following questions:
- Is it a computer program?
- Does the software application act on the data or does it simply store them? Software applications that create or modify data in order to facilitate the work of interpretation by health care professionals should be considered as a medical product.
- Is the software application beneficial to patients? If the app only adds population data, provides generic diagnoses, or treatment options or scientific literature etc. it is not deemed to be beneficial to patients.
- What is the purpose of the software application? It would be necessary to analyze whether or not the software application fulfils any of the uses included in the definition of a medical device, pursuant to Council Directive 93/42/EEC concerning medical devices:
- 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.
In accordance with the aforementioned Meddev guide 2.1/6, in the event of an affirmative response to the first three questions, while excluding the last one, it would be appropriate to question whether it could be considered an accessory to medical devices, as these are treated in the same way as medical products.
Both at European and national level we need to address the challenge of ensuring that we have a legal framework capable of clarifying the present scenario, and which will protect data exchange, processing and analysis using software apps for mobile devices concerned with health.
José Fernández-Rañada
Jara A. Atienza
Garrigues Corporate/Commercial Law Department
