Protocols for the implementation of a Register for health related APPS

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


The Ministry of Health launced an action area considering:

  • The wide distribution of “Health Apps”, largely following unregulated modality;
  • The results of the Study on health Apps distribution, risks and opportunities for the establishment of a “Register of health Apps”, defining requirements, features and organisational aspects for their management throughout time.

The project, led by Fondazione FORMITin collaboration with Rome University of International Studies (UNINT), is based on the following phases:  

  • Development of an internal laboratory for validation of software and contents supporting procedures indicated in subsequent phases.
    This first phase aimes at:
      • Designing the “Register of Health Apps” in accordance with current legal requirements and highlighted needs
      • Designing an experimental version of the “Register of Health Apps”, to be used during the trial period. The aim of such period is to customise the Register from an informational and operational point of view, thanks to interaction with possible stakeholders (Ministry, Producers, Control bodies).
  • Communication and dissemination activities.
    Design and conduct of several information actions. A monthly newsletter containing technical and practical information is prepared with manufacturers. A detailed communication plan is outlined making use of targeted activities on social networks and on information platforms devoted to health sector.