AGENAS, also in its role of the National Agency for Digital Health, launch an online public consultation on the draft of the “Guidelines on the Evolutionary Pathway of Medical Systems for Telemonitoring”.

The consultation aims to collect feedback and additional insights to enhance the quality of the document "Guidelines on the Evolutionary Pathway of Medical Systems for Telemonitoring."

The document aims 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.
  • to 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 organization/authorities and Regions/ Autonomous Provinces.

Individuals/citizens, patients, caregivers, associations, decision-makers/managers of health care organization and health care, health and social care professionals with experience in the field of medical devices and health information systems are invited to participate in the consultation.

The consultation will be open from 10th June 2024 to 29th June 2024. You can participate by completing a questionnaire available on the EUsurvey platform, in both Italian and English.

Italian version:
https://ec.europa.eu/eusurvey/runner/TeleMed
English version:
https://ec.europa.eu/eusurvey/runner/TeleMed?surveylanguage=EN
below is the guide to log - in to the EUsurvey platform in both Italian and English language.

Notes:
  • responses should focus on aspects relevant to the objectives of the guideline document.
  • only questionnaires submitted through the EUsurvey platform will be accepted.
  • no feedback will be provided for the questionnaires.
  • questionnaires received after the deadline will not be considered.
Proposals for integration or other comments will be reviewed for potential inclusion and revision of the guidance document.

The AGENAS HTA department will manage the completed questionnaires and the results of the consultation will be reported in anonymous (and if possible, aggregate) form in a special consultation report. This report will be published on the AGENAS institutional website. The consultation report may include the texts of the comments received (excerpts or full versions). Hence, it is recommended not to include personal data or information of your own or of a third party in your responses.

*The public consultation is carried out consistent with the guidance provided in the “Guidelines on Consultation,” developed by the Department for the Public Administration and the Department of Institutional Reform (2020).

Guide login EUsurvey (PDF)
Guidelines on the Evolutionary Pathway of Medical Systems for Telemonitoring (PDF)

 

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