Ministero della Salute
The Italian National Agency for Regional Health Services (AGENAS), within the framework of the functions provided for in Law No. 25 of March 28, 2022, through which it also assumes the role of the National Agency for Digital Health (ASD), will soon propose a public consultation on the document "Guidelines for the evolutionary path of Medical Systems for Telemonitoring".
The document aims to:
- specify the requirements that a Medical System needs to have in order to guarantee interoperability with the Italian Regional Telemedicine Infrastructure, as determined by the Ministerial Decree of September 21, 2022, ensuring appropriate levels of certification and security;
- provide a general framework of the characteristics, requirements, recommendations, and standards that have to be taken into account for the definition of an evolutionary path for Medical Systems.
The Guidelines are primarily intended for Manufacturers and Distributors of medical devices as well as Italian Health Authorities and Italian Regions/Public Authorities.
The aim of the consultation is to gather comments and additional knowledge elements to improve the quality of the document "Guidelines for the evolutionary path of Medical Systems for Telemonitoring".
Individual citizens, patients, caregivers, associations, decision-makers/programmers, responsible/managers of health services, healthcare professionals, and socio-health professionals with experience in the field of medical devices and health information systems will be called to participate in the consultation.