Luca Bolognini is the President of the the Italian Institute for Privacy and Data Valorisation (IIP) and Co-chair of the Privacy Symposium. See the full speaker profile here.
What kind of privacy reform has just been approved in Italy? And why is it relevant for scientific research in the biomedical sector?
The Italian Parliament has just voted and approved an important amendment to Section 110 of the Italian Privacy Code. Previously, this section required that for studies, such as retrospective observational studies, which are very relevant in the healthcare and biomedical sectors, a prior consultation and authorization would be required from the Italian Data Protection Authority in case the consent of data subjects had not been collected by controllers promoting the studies.
But the amendment changed the rule. The rule was effectively blocking relevant studies in Italy. Italian research and researchers were hindered in their work, particularly when interacting and cooperating with researchers from other countries in Europe. The amendment removed the requirement for prior consultation and authorization and instead, the Italian Data Protection Authority will now simply issue general rules of conduct to clarify the measures and safeguards that researchers in such fields need to observe.
This is a small amendment, but it represents a significant reform for privacy and scientific research in Italy. We can certainly celebrate it.
How did you manage to imagine, discuss, and finally draft the amendment proposal? What kind of role did the Privacy Symposium have in the process?
Over the past two years, I chaired a roundtable of stakeholders involved in research initiatives in the healthcare sectors in Italy. This roundtable was promoted within the initiative of Garante per la Protezione dei Dati Personali, which is the Italian Data Protection Authority, the so-called “State of Privacy” initiative. As chair, I promoted this initiative at meetings, roundtables and at the Privacy Symposium.
We had the opportunity, during the Privacy Symposium, to meet and discuss these roundtable issues, collecting proposals from stakeholders, authorities, researchers, and institutions involved in the research field. This dialogue and work at various meetings and at the Privacy Symposium allowed us to imagine the reform and intervention.
We discussed and collected ideas, gathered proposals, and then, Diego Fulco, an Italian jurist, and I worked to concretely draft the amendment. We also prepared an explanation of this potential reform, which we presented as the Italian Institute for Privacy to stakeholders, the government, and legislators. The explanation was convincing not just because of our hard work, but because it was fruit of dialogue and collaboration promoted by the State of Privacy Initiative and thanks to the opportunity to come together at the Privacy Symposium.
Was it difficult to explain the proposal to the legislator, obtaining the amendment to be presented and approved by the Italian Parliament?
When you build consensus and work by listening to stakeholders and the best experts in the field— in this case, experts in data protection as well as scientific research—the likelihood of success is very high.
The potential to convincingly explain it to institutions and legislators, including deputies, senators, and government officials, is certainly more probable and credible. Having worked effectively beforehand and having promoted such dialogue, it was ultimately very easy to explain the reform to politicians, the government, and the legislature. The consensus was very high.
