Research collaboration for the Study on Health Apps distribution – opportunities, risks and legal requirements

Contracting Party: Italian Ministry of Health –Department of National Health Service planning and organisation – Directorate General of medical devices, pharmaceutical service and safety in healthcare)

Period: 2014 - 2015

Description:

The Italian Ministry of Health launced an action area which, deriving from a research project, can contribute to the reduction and containment of risk factors deriving from unappropriate use of Health Apps.

The project, led by FORMIT Foundation, is based on the following phases:

• Analysis and scouting of the status quo of best practices and of excellences in use or being activated;

This first phase aims at:

• scanning best practices in use and possible excellences in use or being activated (both in Italy and in Europe);
• defining a taxonomy of health apps and their classification into macro categories, corresponding to their application.

• Realisation of a “Technical-organisational model” defining the verification and validation processes of best practices and assuming their implementation;
  Based on the results coming from the first phase, on the basis of collected examples and best practices , a “technical-organisational model” is set up, which defines their verification and validation processes, at least at National level, under direct coordination of the Ministry of Health.

• Erogation of the verification and validation service.
  Based on the results deriving from the previous two phases, a road map for experimental activities is outlined, defining terms and modalities for the erogation of an “onoing serivce of verification and validation of health apps contents” and a corresponding “ongoing verification serivce of quality, security and free of bias” of the software.