"State of the Art" Report

The aim of this Report is to define the legal and regulatory data protection framework to be taken into account to ensure the lawful and most efficient implementation of My Health My Data project (hereinafter “MHMD” or the “Project”).1 The complexity and the uniqueness of the processes and data flows underpinning the Project make indeed necessary to carry out an in-depth assessment as to which legal requirements must be complied with to prevent, or at least reduce, any risk for data subjects’ rights and fundamental freedoms and to ensure high security standard and reliability. But not only. MHMD idea itself was conceived to become a new point of reference for the EU digital market and to set new benchmarks and rules for data security in the healthcare and medical sector. For this reason, each stage of the Project will be the object of a specific privacy impact assessment, as required by the applicable legislation, so to address all the key vulnerabilities of data-driven services through ground-breaking solutions for anonymization, encryption and secure data sharing, by so validating the new technologies upon which MHMD is based before relevant implementation. The needed evaluations will be conducted step-by-step, starting from the pivotal milestones provided for by the laws and regulations in force to date and then moving to the peculiarities of the Project, so to raise the overall awareness regarding what is permitted and what is still likely to be regarded as a breach of fundamental rights both in the European Union and in the Member States.This corresponds to Deliverable 2.1 (D2.1) of the MyHealthMyData project