Over the past twenty-five years, ICT has greatly expanded the scope of data production, collection, storage, and sharing. The growth rate of electronic data in healthcare is above average. This is happening by virtue of four major phenomena: the digitisation of imaging; the digitisation of medical records and health files; the explosion of the Internet of Things; as well as the spread of mHealth applications, biobanks and the development of sequencing techniques. This huge amount of diverse data, produced from heterogeneous sources, being collected and updated for reasons largely unrelated to clinical and epidemiological research, risks to become an impediment when one wishes to translate them into new scientific discoveries. In addition to epistemological and technical issues, the most recalcitrant critical issues are ethical and legal. Secondary use of data, consent as a legal basis and control by supervisory authorities may affect the possibilities to exploit health data for research.
This discussion will involve health and data protection experts and analyse the European and Italian legislative framework applicable to clinical trial and personalised medicine, and showing that many are the open questions that not even the recently proposed European Health Data Space may solve.
Chair: Federica Casarosa
Elisabetta Biasin – KU Leuven
Mariavittoria Catanzariti – EUI
Francesca Gennari – SSSA
Reply by the Author
Paola Aurucci – UNIBO