Health data, the Privacy Code to protect scientific research

The value of clinical data does not end with patient care, but can be further exploited by research. "Health data are a collective asset that allows medicine to evolve towards more and more predictive and personalised models," explained Alessandro Venturi, president of the Fondazione Irccs Policlinico san Matteo, during the meeting 'The value of health data for research in the Irccs: the application of article 110 bis and the experience of san Matteo' yesterday morning.

The proof is a study carried out by the San Matteo that - argues Salvatore Corallo, oncologist and professor at the University of Pavia - analysed the causes of unequal access to treatment and technology for biliary tract cancer patients. The research is also made possible by the special dispensation granted by the 'Privacy Code' to the Irccs. Article 110 bis, paragraph 4, in fact provides that the Institutes of hospitalisation and care of a scientific nature may process personal data collected for clinical purposes also for research, without the need to obtain consent again. San Matteo has also availed itself - explains Dr Alessandra Ferrari, clinical trial office coordinator - of Article 14 of the Gdpr, thanks to which it was sufficient to publish the privacy policy on the Institute's website for acknowledgement.

According to Fausto Massimino, Legal governance & compliance One Roche Head, 'Article 110-bis represents one of the important steps towards a more modern and sustainable approach to the use of health data forscientific purposes, overcoming a exclusively consent-centric view and at the same time maintaining high protection guarantees for patients'. However, a Faq published by the Privacy Guarantor on 6 June 2024 risks complicating the picture: the pronouncement envisages the possibility of extending Article 110-bis to 'any type of medical, biomedical, epidemiological, prospective and retrospective research' carried out by bodies that do not enjoy the recognition of an IRCCS, provided that it is promoted by an IRCCS. It is a prospect, concludes lawyer Agostino Migone De Amicis of the Lca law firm, that risks limiting research: 'We have important research centres that are not Irccs, so from this point of view that prerogative may become an obstacle'.