Countdown to Sanità Trasparente: What U.S. Compliance Teams Must Know
Author
Sabrina Morgan is the Head of Global Compliance & Customer Delivery at Vector Health. She oversees global transparency reporting and international disclosure requirements along with the Italian Sunshine Act strategy. She also leads the global client delivery team dedicated to data integrity, compliance solutions, and regulatory alignment for pharmaceutical and MedTech organizations.
Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance
Cerchi supporto per la compliance al Sunshine Act?
Hai domande pratiche?
Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.
What counts as a “transfer of value” in Washington may be reported differently in Rome, and a single miscoded payment can echo across public databases in two countries. Each dataset tells a story about your organization’s ethics and controls, and once it’s public, that story can’t be rewritten.
For compliance officers in the U.S.-based companies operating in Italy, the year’s end brings a new kind of deadline pressure. The Sanità Trasparente portal, Italy’s long-awaited transparency register, is rumoured to go live soon, triggering the enforcement of the Italian Sunshine Act. For organizations already managing the demands of Open Payments in the U.S., this isn’t just another reporting obligation; it’s a second, parallel system with similar intent but different rules, thresholds, and recipient definitions.
With the clock running down toward Italy’s first reporting cycle, the question isn’t whether you’re compliant on paper, it’s whether your systems, people, and data are ready to perform under real scrutiny.
Current Status and Timeline
Although Italy’s Sunshine Act (Law No. 62/2022) has been in force since mid-2022, its practical implementation depends on the launch of the Sanità Trasparente portal, the central register managed by the Ministry of Health. The Ministry has circulated draft decrees and a technical discipline for consultation and stakeholders report the implementation phase is active; final ministerial decrees and full production testing remain pending The portal is rumoured to go live by the end of 2025, which means companies will likely submit their first disclosures in mid-2026 for transfers made during the second half of 2025. But this timing is conditional on the date the register is published and the final decree setting submission windows
While the legislative framework and reporting thresholds are now clear, several procedural aspects are still being refined, particularly around file format, data validation rules, and whether automated API submission will be supported. These details will be outlined in a final ministerial decree following the testing phase. For companies already subject to Open Payments, this timeline provides a narrow but valuable window to align existing systems and perform readiness checks before the first reporting cycle formally begins.
Challenges and Pitfalls
The most immediate challenge for US-based companies operating in Italy is data granularity. The Italian regime defines recipients more broadly than the U.S. system, extending beyond individual physicians to ‘subjects who operate in the health sector’ and ‘healthcare organizations’ (including patient associations, scientific societies, hospitals, universities and research institutes), so the recipient universe is wider than typical Open Payments lists. Missing or inconsistent identifiers can easily trigger validation errors once submissions are uploaded to the portal.
Another pitfall lies in taxonomy mismatches between Open Payments and the Italian classification logic. Categories such as “research,” “consulting,” or “grants” may not map one-to-one, which risks misclassification and public confusion. Companies should document every crosswalk rule and maintain auditable logic explaining category decisions.
Cross-border transactions add further complexity. Payments routed through Italian affiliates or distributors still fall under disclosure requirements if the benefit reaches a covered recipient. Clear internal ownership of reporting responsibility is essential to avoid duplication or omission.
Finally, privacy and reputational risks should not be underestimated. The Sanità Trasparente register will be publicly accessible for at least five years, meaning even minor inaccuracies become durable public records. Aligning with GDPR principles, data minimization, secure storage, and clear legal basis for processing, reduces both regulatory exposure and stakeholder disputes. Conducting internal audits and dry-run submissions ahead of go-live will help identify weak points early and protect relationships once transparency data becomes public.
The Executive Perspective: Strategic Considerations
Technology Investment Reality Check Most companies won’t need entirely new systems. The infrastructure supporting Open Payments, with CRM integration, payment tracking, and recipient management, applies directly to Sanità Trasparente. The differentiators are data model flexibility, multi-jurisdictional reporting capabilities, and automated compliance checking.
Operational Impact Assessment Transparency reporting shouldn’t slow business development, but it does require discipline. Front-loading the compliance work, capturing correct categorization and recipient details when agreements are signed rather than scrambling during reporting periods, actually streamlines operations over time.
Risk Mitigation Priority The highest-impact risk isn’t regulatory penalties; it’s relationship damage from inaccurate disclosures. A physician who discovers their consulting relationship was miscategorized as a research payment faces uncomfortable conversations with colleagues and institutions. Prevention requires investment in data quality from the start.
Practical Implementation: Your Roadmap
Phase 1: Expand Your Universe Start with your existing Open Payments stakeholder list, then systematically add Italian-specific recipient categories. Map every administrative decision-maker, patient association, professional society, and CME provider in your current relationship portfolio.
Phase 2: Harmonize Your Taxonomies Create cross-reference tables linking your US payment categories to Italian disclosure types. This enables consistent classification while meeting each system’s specific requirements. Document the logic. You’ll need it when stakeholders ask why the same activity appears differently in each database.
Phase 3: Automate the Heavy Lifting Code thresholds and aggregation rules directly into your systems. Manual calculations introduce errors, and errors become public records. Build validation checks at data entry points, not just at reporting time.
Phase 4: Build Your Communication Strategy Develop standard notification templates for recipient verification. Create FAQ documents addressing common questions about disclosure rationales. Prepare talking points for inevitable media or stakeholder inquiries about payment patterns.
Conclusion
The transition from preparation to execution is closer than it appears. Once the Sanità Trasparente portal goes live, compliance teams will move from theory to performance, and the spotlight will be on data accuracy, system readiness, and governance discipline. For U.S.-based companies operating in Italy, this is the moment to stress-test your reporting framework, validate your taxonomy mapping, and close any operational gaps before the first upload window opens.
To help you get there, we’re hosting a full-day on-site workshop “Practical Training on Italian Sunshine Act Reporting” on 18th November in Milan, Italy. This is a hands-on, operational training program where you’ll test your systems, processes, and XML reporting capabilities against the Ministry of Health’s evolving requirements. Together, we’ll transform global best practices into concrete strategies for Italy, helping you strengthen governance, reduce reporting risks, and lead your organization with confidence.
What counts as a “transfer of value” in Washington may be reported differently in Rome, and a single miscoded payment can echo across public databases in two countries. Each dataset tells a story about your organization’s ethics and controls, and once it’s public, that story can’t be rewritten.
For compliance officers in the U.S.-based companies operating in Italy, the year’s end brings a new kind of deadline pressure. The Sanità Trasparente portal, Italy’s long-awaited transparency register, is rumoured to go live soon, triggering the enforcement of the Italian Sunshine Act. For organizations already managing the demands of Open Payments in the U.S., this isn’t just another reporting obligation; it’s a second, parallel system with similar intent but different rules, thresholds, and recipient definitions.
With the clock running down toward Italy’s first reporting cycle, the question isn’t whether you’re compliant on paper, it’s whether your systems, people, and data are ready to perform under real scrutiny.
Current Status and Timeline
Although Italy’s Sunshine Act (Law No. 62/2022) has been in force since mid-2022, its practical implementation depends on the launch of the Sanità Trasparente portal, the central register managed by the Ministry of Health. The Ministry has circulated draft decrees and a technical discipline for consultation and stakeholders report the implementation phase is active; final ministerial decrees and full production testing remain pending The portal is rumoured to go live by the end of 2025, which means companies will likely submit their first disclosures in mid-2026 for transfers made during the second half of 2025. But this timing is conditional on the date the register is published and the final decree setting submission windows
While the legislative framework and reporting thresholds are now clear, several procedural aspects are still being refined, particularly around file format, data validation rules, and whether automated API submission will be supported. These details will be outlined in a final ministerial decree following the testing phase. For companies already subject to Open Payments, this timeline provides a narrow but valuable window to align existing systems and perform readiness checks before the first reporting cycle formally begins.
Challenges and Pitfalls
The most immediate challenge for US-based companies operating in Italy is data granularity. The Italian regime defines recipients more broadly than the U.S. system, extending beyond individual physicians to ‘subjects who operate in the health sector’ and ‘healthcare organizations’ (including patient associations, scientific societies, hospitals, universities and research institutes), so the recipient universe is wider than typical Open Payments lists. Missing or inconsistent identifiers can easily trigger validation errors once submissions are uploaded to the portal.
Another pitfall lies in taxonomy mismatches between Open Payments and the Italian classification logic. Categories such as “research,” “consulting,” or “grants” may not map one-to-one, which risks misclassification and public confusion. Companies should document every crosswalk rule and maintain auditable logic explaining category decisions.
Cross-border transactions add further complexity. Payments routed through Italian affiliates or distributors still fall under disclosure requirements if the benefit reaches a covered recipient. Clear internal ownership of reporting responsibility is essential to avoid duplication or omission.
Finally, privacy and reputational risks should not be underestimated. The Sanità Trasparente register will be publicly accessible for at least five years, meaning even minor inaccuracies become durable public records. Aligning with GDPR principles, data minimization, secure storage, and clear legal basis for processing, reduces both regulatory exposure and stakeholder disputes. Conducting internal audits and dry-run submissions ahead of go-live will help identify weak points early and protect relationships once transparency data becomes public.
The Executive Perspective: Strategic Considerations
Technology Investment Reality Check Most companies won’t need entirely new systems. The infrastructure supporting Open Payments, with CRM integration, payment tracking, and recipient management, applies directly to Sanità Trasparente. The differentiators are data model flexibility, multi-jurisdictional reporting capabilities, and automated compliance checking.
Operational Impact Assessment Transparency reporting shouldn’t slow business development, but it does require discipline. Front-loading the compliance work, capturing correct categorization and recipient details when agreements are signed rather than scrambling during reporting periods, actually streamlines operations over time.
Risk Mitigation Priority The highest-impact risk isn’t regulatory penalties; it’s relationship damage from inaccurate disclosures. A physician who discovers their consulting relationship was miscategorized as a research payment faces uncomfortable conversations with colleagues and institutions. Prevention requires investment in data quality from the start.
Practical Implementation: Your Roadmap
Phase 1: Expand Your Universe Start with your existing Open Payments stakeholder list, then systematically add Italian-specific recipient categories. Map every administrative decision-maker, patient association, professional society, and CME provider in your current relationship portfolio.
Phase 2: Harmonize Your Taxonomies Create cross-reference tables linking your US payment categories to Italian disclosure types. This enables consistent classification while meeting each system’s specific requirements. Document the logic. You’ll need it when stakeholders ask why the same activity appears differently in each database.
Phase 3: Automate the Heavy Lifting Code thresholds and aggregation rules directly into your systems. Manual calculations introduce errors, and errors become public records. Build validation checks at data entry points, not just at reporting time.
Phase 4: Build Your Communication Strategy Develop standard notification templates for recipient verification. Create FAQ documents addressing common questions about disclosure rationales. Prepare talking points for inevitable media or stakeholder inquiries about payment patterns.
Conclusion
The transition from preparation to execution is closer than it appears. Once the Sanità Trasparente portal goes live, compliance teams will move from theory to performance, and the spotlight will be on data accuracy, system readiness, and governance discipline. For U.S.-based companies operating in Italy, this is the moment to stress-test your reporting framework, validate your taxonomy mapping, and close any operational gaps before the first upload window opens.
To help you get there, we’re hosting a full-day on-site workshop “Practical Training on Italian Sunshine Act Reporting” on 18th November in Milan, Italy. This is a hands-on, operational training program where you’ll test your systems, processes, and XML reporting capabilities against the Ministry of Health’s evolving requirements. Together, we’ll transform global best practices into concrete strategies for Italy, helping you strengthen governance, reduce reporting risks, and lead your organization with confidence.
Author
Sabrina Morgan is the Head of Global Compliance & Customer Delivery at Vector Health. She oversees global transparency reporting and international disclosure requirements along with the Italian Sunshine Act strategy. She also leads the global client delivery team dedicated to data integrity, compliance solutions, and regulatory alignment for pharmaceutical and MedTech organizations.
Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance
Cerchi supporto per la compliance al Sunshine Act?
Hai domande pratiche?
Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.