Saturday, June 22, 2024

Italy Sets Stage for Advanced Telemonitoring in Healthcare: Public Consultation Begins

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The Italian National Agency for Regional Health Services (AGENAS), functioning under its role as the National Agency for Digital Health (ASD), is set to initiate a public consultation regarding the document titled “Guidelines for the Evolutionary Path of Medical Systems for Telemonitoring.” This initiative is part of AGENAS’s responsibilities outlined in Law No. 25, dated March 28, 2022. The document seeks to establish comprehensive standards and protocols for the development and integration of medical telemonitoring systems across Italy’s healthcare infrastructure. The guidelines will address the need for systems to be interoperable with existing telemedicine frameworks and ensure they meet high standards of security and functionality.

By setting clear expectations and requirements, AGENAS aims to facilitate a smoother integration of these technologies into the national healthcare system. The public consultation is intended to engage a wide range of stakeholders, including medical professionals, technology experts, and the general public, to gather diverse perspectives and insights. This collaborative approach is designed to harness collective expertise in refining and enhancing the framework for telemonitoring systems. Through this process, AGENAS is committed to enhancing patient care and optimizing health service delivery throughout the country.

Guidelines for Medical Systems Integration with Italy’s Regional Telemonitoring Infrastructure

The forthcoming document aims to set forth specific requirements for Medical Systems to ensure they are interoperable with the Italian Regional Telemedicine Infrastructure as outlined by the Ministerial Decree of September 21, 2022. The guidelines will delineate the necessary levels of certification and security that these systems must meet. Furthermore, the document will offer a comprehensive framework detailing the characteristics, requirements, recommendations, and standards essential for shaping the developmental trajectory of Medical Systems within telemonitoring.

The primary audience for these guidelines includes manufacturers and distributors of medical devices, as well as Italian health authorities and regional/public authorities. This targeted approach aims to streamline the integration and enhancement of telemonitoring services across Italy’s healthcare landscape.


AGENAS Seeks Broad Input to Refine Italy’s Telemonitoring Guidelines

The consultation seeks to engage a wide array of stakeholders to refine and enhance the quality of the guidelines. Participants will include individual citizens, patients, caregivers, associations, health decision-makers, managers of health services, healthcare professionals, and other socio-health professionals who have expertise in medical devices and health information systems. Their contributions are expected to bring invaluable insights and additional knowledge, aiding in the improvement of the document.

The public consultation represents a critical step toward ensuring that the telemonitoring systems developed are not only technically proficient but also aligned with the needs and expectations of end-users. By soliciting feedback from a broad spectrum of stakeholders, AGENAS aims to foster a more inclusive and well-rounded development process for medical telemonitoring systems in Italy.


Resource: Agenzia Nazionale per i Servizi Sanitari Regionali, May 08, 2024

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