Start of Scientific Activities: November 2023 Duration: 2023-2024 Lead Institution: UOC HTA AGENAS Scientific Coordinator at Agenas: dr. Marco Marchetti Scientific Coordinator at Farmindustria: dr. Roberto Triola

 

AGENAS has initiated a collaborative activities with Farmindustria aimed at developing research, training, evaluation, study, and analysis projects related to digital transformation in healthcare, including telemedicine.

As part of this collaboration, a project has been launched with the following objectives:

• development of an HTA evaluation framework and a specific regulatory and reimbursement framework to Digital Therapeutics (DTx), in order to allow patients access to those therapies that prove effective.
• definition of criteria for the utilization of health data resulting from the application of artificial intelligence systems (guidelines, outcome measurement, and modalities for data access by all stakeholders in the healthcare chain, both public and private, compliant with existing privacy regulations).

This initiative is aligned with the European Commission's proposal to establish the European Health Data Space (EHDS) in order to:

• enable users greater digital access to personal electronic health data, ensuring greater control over such data at national and cross-border levels, and promoting a single market for medical devices and AI systems;
• provide a coherent, reliable, and efficient system for the continuous and real-time collection of real-world data (RWD), as well as the processing of information useful for research (RWE), therapy optimization, and innovation;
• establish regulations to facilitate the secondary use of data.

To carry out the project activities, the parties have established a working group composed of experts (selected from scientific societies and/or academia) and patient associations, whose participation is voluntary.

Members are engaged in studying a technology assessment model for AI and DTx systems based on a list of technical and organizational requirements that also allow the use and access to RW health data.

The overall responsibility for the research project, as well as the supervision and coordination of all activities, will be shared between AGENAS and Farmindustria, as promoters of the initiative. No spending commitment is expected from the parties.