Transparent Healthcare Register Technically Ready, Awaiting Further Dialogue

Italy’s long-awaited Transparent Healthcare electronic register Sanita Trasparente introduced under Law No. 62 of 2022, has reached an important technical milestone. According to the Ministry of Health, the regulatory and technical groundwork for the register is now complete and the official launch of the system now awaits additional consultation with sector stakeholders, with the stated aim of ensuring operational effectiveness and minimizing future disputes.

The register, often referred to as part of Italy’s Sunshine Act framework, is designed to increase visibility into financial and in-kind relationships within the healthcare sector. Once operational, it will track a wide range of economic interactions, including sponsorships, conference-related expenses, and other transfers of value involving healthcare companies and professionals.

Technical preparation completed

Responding to a parliamentary inquiry, Undersecretary of the Interior Emanuele Prisco, speaking on behalf of the Ministry of Health, confirmed that the implementing decree establishing the register, along with its technical specifications, is ready from a regulatory standpoint.

The Ministry outlined a multi-stage preparation process that included:

• A public consultation held in summer 2023, involving pharmaceutical companies, healthcare professionals, and representative associations
• Mandatory reviews by the Italian Data Protection Authority, the National Anti-Corruption Authority (ANAC), and the Agency for Digital Italy (AGID)
• The resolution of several interpretative issues, including the scope of indirect benefits and the tax treatment of donations

According to the Ministry, feedback from the supervisory authorities was fully incorporated into the final technical framework.

What’s next?

Though this marks a significant milestone, the register is not yet operational. The Ministry attributes this phase to a decision to conduct a final round of discussions with industry operators. This additional step is intended to identify and resolve potential technical or procedural issues before the system goes live.

The stated concern is that launching the register without sufficient alignment could lead to appeals, disputes, or operational inefficiencies that might undermine its purpose. The Ministry emphasized that the objective is to ensure the register is functional, usable, and resilient once implemented, rather than introducing avoidable administrative burdens.

Ongoing expectations

While some members of Parliament have reiterated the importance of timely implementation, the Ministry has maintained that the law’s objectives remain a priority and that the current phase is focused on ensuring long-term effectiveness rather than prolonging the process unnecessarily.

For now, no official launch date has been announced. The register remains a central pillar of Italy’s healthcare transparency framework, and its eventual rollout is expected to have a significant impact on how transfers of value are disclosed and monitored across the sector.

As discussions continue, stakeholders across the life sciences and healthcare ecosystem in Italy are watching closely to understand how the final implementation will translate regulatory intent into practical reporting obligations.

Gain Clarity and Control Before Reporting Pressure Begins

If you are responsible for managing a transparency program, or protecting your organization from the risks of incorrect or incomplete Sunshine reporting, this is your opportunity to prepare properly.

Our upcoming Italian Sunshine Reporting Intensive Training for Compliance Officers is the first end-to-end technical training delivering operational guidance, real case studies, and practical tools to help you assess readiness, fix gaps, and approach reporting with confidence.

Request your spot for the session and move from uncertainty to operational control, before Transparent Healthcare becomes a daily reality.