On March 6, 2020, the Italian Data Protection Authority (“Garante”) reported on new measures designed to protect the health data of patients in the context of Government procurement efforts (calls for tender) to acquire medical equipment and devices. The new measures are the result of a collaboration between the Garante and Consip, a company wholly owned by the Ministry of Economy that supports public administration in the area of procurement.

According to the Garante, calls for tender for medical equipment and devices must include clauses prohibiting suppliers who perform remote maintenance services from directly accessing patient “master data” in diagnostic images. The tender must also designate the awarded supplier as a data processor of patient health data processed in the context of the maintenance services. Finally, tenders must contain specific language on the appropriate modalities for suppliers to obtain anonymized diagnostic images.

According to the Garante, Consip will initiate discussions with the sector on how to implement features in their equipment that respect principles of privacy by design and default in the context of remote assistance and maintenance services.

This follows from a decision issued by the Garante in September 2019, in which it found that a healthcare institution unlawfully disclosed CT images to a company supplying medical equipment for diagnostic purposes. The Garante determined that there was no adequate legal basis for the disclosure of this health data of the patients affected. The Garante also found that the company used the data for purposes other than those for which it was permitted as a data processor (e.g., in support of its tender applications).