28 August

HEALTHCARE

Sunshine Act: consultation of the draft decree and the technical regulations on the electronic Public Register is open

28/08/2023

The Italian Ministry of Health promoted a public consultation (from 17 August to 17 September 2023) with the aim of collecting comments on the draft decree and technical regulations indicated by art. 5 Law 62/2022 (so-called Sunshine Act), with regard to the electronic public register (called "Sanità Trasparente").

In particular, the Ministry specifies that the two documents were prepared by an interinstitutional working Group and that:

- the draft decree governs the type of data collected, the transmission and publication of the same, the reports of conduct in violation of the law, as well as the times for publication and storage of data;

- the technical regulations defines the subjects required to transmit data to the Ministry of Health, as well as the authentication and authorization processes of the same, the data to be transmitted, the procedures for consulting the electronic public register, as well as the infrastructural characteristics of the same.

Consultation of the decree and the related technical  regulations allows anyone to provide their own contribution on the proposed topics. The Ministry invites, in particular, to take part in the public consultation the subjects directly involved by the legislation, namely:

  • manufacturing companies operating in the human and veterinary health sector;
  • subjects operating in the health sector;
  • health organizations

From the link https://partecipa.gov.it/processes/sanitatrasparente it is possible to download the questionnaire for the consultation (to complete it, it is necessary to register with your SPID account). As indicated by the Ministry, the data collected will be treated anonymously and the results of the consultation will be made public on 8 October 2023.