On December 31, 2020, the French National Authority for Health (HAS) published a methodological guide clarifying aspects related to the organizational impact of health technologies under the evaluation. As the organizational impact can be documented when submitting an evaluation file for a drug, medical device, or a procedure, the guide aims to define the types of organizational impact and to propose criteria to measure these effects.
The methodological guide consists of three parts: the context of the evaluation, macro-criteria (impact that directly affects the components of the care process, impact that affects the skills and capacities of the actors involved to implement the care process, general impact on the population), and the actors concerned for each criterion. For each macro-criterion, the indicators are described in order to make these criteria more objective and identify which data should be provided.
The methodological guide is of educational nature and is aimed at med-tech manufacturers or service providers who request the evaluation of health technologies, and it makes it possible to identify when the organizational impact is mentioned or claimed. However, it does not predict how the evaluation of the organizational impact of health technology will be taken into account within each HAS commission.
The full details in French can be found here.
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