The Italian scientific and medical research community is celebrating a significant victory with the recent decree known as “PNNR bis,” which brought about crucial changes to the Privacy Code regarding the use of health data in research projects.
Published in the Official Journal on 29 April 2024, the decree eliminated the requirement for prior consultation by the Privacy Guarantor to use health data in scientific research. This change, which came into effect on 1 May 2024, allows for the processing of personal data for scientific research purposes in the medical, biomedical, and epidemiological fields without the need for prior authorization, as long as the favorable opinion of the competent ethics committee is obtained and the necessary data protection guarantees are in place.
According to Pierfranco Conte, President of the Periplo Foundation, regional and national databases containing valuable health data can now be accessed for purposes such as clinical governance, research, and improving the quality of care without the obstacles posed by the previous regulations. The complex process of obtaining informed consent from patients, especially in cases where consent could not be obtained retroactively, has been addressed with this change.
The Italian Society of Leadership and Management in Medicine, along with several other medical organizations, played a crucial role in advocating for these changes to the privacy law. Mattia Altini, president of SIMM, emphasizes the importance of overcoming barriers to the secondary use of health data to improve healthcare networks and services for citizens.
While the recent decree marks a significant milestone for Italian research, Ruggero De Maria, president of the Alleanza Contro il Cancro, highlights the need to await further provisions from the Guarantor to fully realize the benefits of these changes. The hope is that the new regulations will pave the way for utilizing patient data to enhance disease prevention and treatment strategies, bringing Italian research closer to European standards.
Overall, the decree represents a positive step forward for the scientific and medical research community in Italy, signaling a shift towards greater accessibility and utilization of health data for the advancement of healthcare practices and patient outcomes.