Recent regulatory interventions of both a European and a national matrix on the regulation of health data have highlighted the importance of defining a comprehensive and uniform regulation for a common space that is able to ensure the improvement of health services offered to European citizens, promote research, develop digital innovation in the medical field, and foster clinical trials.

In the framework that the EU Member States are outlining, companies operating in the healthcare and life-science sector will have to develop a health data governance model that presides over the correct application of regulatory developments and allows for the adoption of adequate security measures, also considering the now long-awaited transposition in Italy of Directive (EU) 2022/2555, which extends the scope of cyber risk governance safeguards to a broader audience of operators in the pharmaceutical and medical sector.

Recent changes to health data regulations both in Italy and the EU have highlighted the need for a single, shared system of regulations to improve health services for European citizens, promote research, develop digital innovation and foster clinical trials.

In the framework that EU member states are outlining, companies operating in the healthcare and life sciences sector will be asked to develop a governance model for health data that ensures the proper application of new rules and includes adequate security measures. This is especially true considering the long-awaited transposition in Italy of Directive (EU) 2022/2555, which extends the scope of application of cybersecurity risk-management measures to a broader base of operators in the pharma and medical industries.

Our Healthcare & Life Sciences and Innovation & Digital Transformation focus teams break down the issues here.