Public consultation on the telemonitoring guidelines open in Italy

On June 10, 2024, the National Agency for Regional Health Services (AGENAS) announced an online public consultation on the draft of the “Guidelines on the Evolutionary Pathway of Medical Systems for Telemonitoring” aiming to collect feedback and additional insights to enhance the quality of the document and to achieve the following objectives:

• Outline the requirements that a Medical System must meet to ensure interoperability with the Regional Telemedicine Infrastructure, as mandated by the Ministerial Decree of September 21, 2022. This includes ensuring appropriate levels of certification and security;
• Provide an overview of the characteristics, requirements, recommendations, and standards that need to be considered when defining an evolutionary path for Medical Systems.

The Guideline is intended primarily for manufacturers and distributors of medical devices as well as health organizations/authorities and regions/autonomous provinces.

The consultation is open from June 10, 2024, to June 29, 2024. Participants should complete a questionnaire available on the EUsurvey platform in Italian and English.

More details in Italian and English can be found here.

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