The Garante, Italy’s Data Protection Authority (IDPA), has released three decisions related to research and a register of welfare positions.
The Purpose of Medical Research Does Not Eliminate the Legal Requirements of Data Processing
Each legal entity dealing with medical and epidemiological research cannot use personal data collected by public healthcare facilities of dialysis without having first informed patients and having obtained their consent. In absence of express consent, they, should use only anonymous data. The IDPA prohibits the use of patients personal information to a nephrologists medical association who runs an important Italian registry of people affected by chronic renal insufficiency.
From the evidence collected by the Garante, as a result of an inspection, it was found that the responsible for the regional and provincial registries of dialysis and transplantation, managed by public agencies, sent to this association some clinical data, though in a disaggregated way. The data were first collected by the association in its own register, in order to perform statistical and epidemiological analysis, and then transferred to a similar European private registry.
The IDPA, in stressing the importance of scientific research, prohibited the association of nephrology from processing patients’ personal data without their informed consent.
Garante Give Green Light to New Register of Welfare Positions
The IDPA gave its green light to a draft of decree setting up the general register of welfare positions. The positive opinion follows a set of informal meetings by means of which the Garante provided some suggestions and observations.
The purpose of the decree is to define a global overview of the social care sector in order to manage, organize, track the expenses, evaluate the effectiveness of interventions and process statistics and studies. In order to acquire these goals, local governments and any other entity that provides these services shall provide the register with the information required by the decree and INPS, the national institute for social care, shall make available the information to the Ministry of Employment, the Ministry of Economy and Finance, to the regions, autonomous provinces and municipalities.
The database will collect, store and manage the personal and family data of beneficiaries, information on suppliers institutions and services rendered. Special sections will be dedicated to not self-sufficient individuals and children in conditions of poverty. The identification data will be available only to the local authorities, with specific regard to the benefits they provide, and INPS, the Guardia di Finanza and to the Revenue Agency, in order to carry out checks on the beneficiaries.
Authorization to the Processing of Health and Genetic Data for Purposes of Scientific Research Without Information and consent
The Garante authorized the Hospital of Bologna, S. Orsola Malpighi to process health and genetic data of about 200 patients, even without the consent of all the patients involved.
The study aims at monitoring the clinical outcomes of patients affected by liver cirrhosis and subjected to liver transplantation in the period between January 1, 2005 and December 31, 2010. It also includes data and specimens of patients who died in the period after transplantation.
The hospital will be able to process only the data and specimens referring to the patients that, during their life, have not denied their consent to their use for research purposes. In the cases of patients who are still alive, the hospital must inform and obtain their consent. The authorization will give only access to the data that is strictly necessary and relevant for the execution of the study.
Rocco Panetta is an Italian lawyer and partner of Panetta & Associati Studio Legale in Rome. He is the former head of legal at the Italian Data Protection Authority and a past member of the IAPP Europe Advisory Board.