The very recent «PNNR bis» decree, published in the Official Journal on 29 April 2024, has brought some important changes to the Privacy Code regarding medical scientific research. In particular, starting from 1 May 2024, one came into force new wording of article 110 That it no longer provides for prior consultation by the Guarantor in order to use health data in scientific research projects.
According to the new formulation, in the impossibility of obtaining the consent of the interested party, personal data may be processed for scientific research purposes in the medical, biomedical and epidemiological fields provided that the favorable opinion of the competent ethics committee is obtained and that the guarantees dictated by the Guarantor for the protection of personal data are observed (article 106 of the same Code).
Therefore, in short, the mandatory requirement of prior authorization to be requested from the Privacy Guarantor has been eliminated, replaced by mere compliance with the guarantees possibly indicated by the Guarantor in the ethical rules on the processing of data for research purposes.
First of all, what data are we talking about?
«The regional and national databases (Cancer Registries, administrative flows such as SDO – Hospital Discharge Cards, outpatient specialists, pharmaceuticals, hospice, prosthetic care, emergency room, home care and pathological anatomy flows) contain millions of health data of great clinical value and scientifically explains Pierfranco Conte, President of the Periplo Foundation -. To date access to this data with the purposes of clinical governance, research and improvement of the quality of care, was in fact prevented by the interpretation given by the Privacy Guarantor according to which the procedure must be similar to that of a typical clinical study: development of a research project, acquisition of informed consent from patients, approval by an Ethics Committee”.
Why is this information important?
“The value of this data is enormous: no formal clinical study will ever be able to answer fundamental questions such as, for example, the rare and late toxicities of treatments, the best therapeutic sequences, the risk-benefit ratio in patients not represented at all (or poorly represented) in clinical studies such as the elderly, patients with comorbidities (concomitant pathologies), with multiple medications… just to give some examples”.
What was the problem?
«The problem was the a priori acquisition of informed consent to the use of health data, because it effectively prevented any access to these databases as it was obviously impossible to acquire the consent of patients treated years ago – he clarifies Conte, Scientific Director IRCCS San Camillo of Venice and professor at the University of Padua -. A problem that also remained in the future, as it was very complex to process and acquire consent from all patients treated in hospitals during normal clinical practice.”
And now it’s fixed?
«Now, since the prior opinion of the Guarantor is no longer necessary, the problem of prior consent, without prejudice to the anonymization of the data, has been overcome. The problem of the so-called secondary use of data still remains to be overcome: that is, the use of these data for clinical research purposes. Because of this further measures will still be necessary to be defined in agreement with the Privacy Guarantor”.
A large part of the scientific community was mobilized to raise awareness and convince the legislator to approve the change to the privacy law. There Italian Society of Leadership and Management in Medicine (SIMM) had acted as spokesperson for a document of the document signed together with AIOM (Italian Association of Medical Oncology), ANMDO (National Association of Hospital Management Doctors), CIPOMO (Italian College of Chief Medical Officers of Hospital Medical Oncology), CITTADINANZATTIVA, FIASO (Italian Federation of Healthcare Companies and Hospital), Periplo Foundation, Periplo Association, ReS FOUNDATION, SIIAM (Italian Society for Artificial Intelligence in Medicine), SIBIOC (Italian Society of Clinical Biochemistry and Clinical Molecular Biology), signed on 20 February 2024 and presented to the Institutions.
«We can’t stop here – he comments Mattia Altinipresident of SIMM -: if not overcome barriers to secondary use of health data to build a continuous information flow from the hospital to the territory, it will not be possible to strengthen local assistance networks through Ministerial Decree 77/2022. This is the scenario on which we are working to propose, at institutional tables, a solution that benefits the health of citizens and the entire health service.”
Concludes Ruggero De Maria, president of Alliance Against Cancer: «This is certainly an improvement that could allow Italian research to get closer to European standards. However, we must wait for the new provision from the Guarantor indicated by the amendment. It will be crucial because it could set us back, making this change useless or, as we hope, allow us to work and be able to use patient data to improve the prevention and treatment of diseases.”
