A new Italian regulation governing health data registries and surveillance programs aims at facilitating the use of such tools for purposes of monitoring health of the population, as well as healthcare spending. A comprehensive legal instrument regulating the various categories of registries and programs was much needed. In fact, the adoption of such a regulation was envisaged by national legislation since 2012 (Section 10 of law decree 179/2012), but no implementing measures has yet been adopted. A draft of regulation has now been released by the Italian government and submitted to the State-Regions conference prior to formal entry into force. The draft has already been reviewed by the Italian Data Protection Authority.
The new regulation aims at standardizing registries and programs adopted over the years, by setting forth: (i) the entities and professionals who may access the information contained in the registries, (ii) the categories of data that are available, and (iii) the measures to be adopted to ensure the security of data in line with data protection legislation.
The goals pursued by the regulation include a better monitoring of diseases at national level and relating treatment, survival rates, mortality index, as well as the increase or decrease over time of a certain disease. The data stored in the registries should also facilitate the carrying out of epidemiological studies in specific territories and/or for specific subsets of the population. Such broad purposes would allow the data to be used in connection with scientific studies, but also for the treatment and prevention of particular diseases.
The data protection provisions enshrined in the regulation are particularly stringent, and provide that all data must be processed by individuals specifically appointed by the data controller and subject to secrecy obligations. Furthermore, the data shall be encoded in a way that does not allow the de-anonymization of the data. Only in case of adverse events and relating field actions, data may be used to contact the interested subject upon prior authorization of the national registry holder. Data breaches will also need to be reported to the Data Protection Authority.
In conclusion, the new regulation provides welcome clarity in a field where regulations have been sporadic and at times incoherent. Moreover, the new regulation seeks to govern at the same time the different legal aspects connected with registries, from healthcare monitoring to data protection. There is little doubt that the hope of the government is to optimize such instruments to better control healthcare spending and conduct a more effective assessment of therapies and products on the market.