Regulatory frameworks for mobile medical applications

Abstract

A mobile application (app) is a software program that runs on mobile communication devices such as a smartphone. The concept of a mobile medical app has gained popularity and diffusion but its reference regulatory context has raised discussion and concerns. Theoretically, a mobile app can be developed and uploaded easily by any person or entity. Thus, if an app can have some effects on the health of the users, it is mandatory to identify its reference regulatory context and the applicable prescriptions.

Keywords:

• European directives
• FDA guidelines
• medical device
• mobile application
• regulatory framework

Financial & competing interests disclosure

The authors are co-owners of Cardionica srl, a spin-off of the Instituto Superiore di Sanita, Roma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• A mobile application (app) is a software program that runs on a mobile communication device such as a smartphone or a tablet.

• Since the market of the medical device is far different from that of the mobile apps, an effort is needed to implement the medical device regulations to the mobile app market.

• Worldwide, there is a lack of legal awareness amongst the parties involved in the mobile medical app ecosystem, which may create data protection and health safety risks for app users.

• In Europe, it is of utmost importance to ‘map’ the entities involved in the mobile app market into the entities defined within the European regulatory framework.

• In the USA, the FDA issued a guidance containing non-binding recommendations and a list of examples of mobile apps to assist manufacturers in determining if a product is a mobile medical app and follow the associated controls established by the regulation.

• It is important to increase the awareness about the medical regulatory framework by promoting education initiatives for all the players involved in the development and commercialization of mobile medical apps.

• The additional risks posed by the medical mobile apps must be identified and properly managed in the risk analysis process.

Notes