Trattamento dei dati sanitari e ricerca medica: profili informatico-giuridici e istituzionali nel contesto europeo

This essay aims to examine the highly sensitive issue of the processing of health data for medical research
purposes by addressing, on the one hand, the legal-informatic profiles and, on the other, the institutional dynamics within
the European context. Taking into account the applicable legal framework – particularly, though not exclusively,
Regulation (EU) 2016/679 (GDPR) – the contribution offers a critical discussion of existing data governance mechanisms.
Against this backdrop, it argues that current EU policy and legislative trajectories amount to a normative ‘dataism’: a
data-centric reductionism that prioritises computability and reusability at the expense of the effective protection of human
dignity and personality, thereby eclipsing the person in favour of the ‘data subject’. Special attention is devoted to clinical
trials and observational studies, within a domain marked by an inherent tension between the advancement of scientific
research and the protection of fundamental rights, notably the right to data protection and the right to health. Accordingly,
the article: (i) outlines the factual and legal framework governing the processing of health data for medical, biomedical,
and epidemiological research, adopting an interdisciplinary perspective; (ii) critically discusses the relevant theoretical
implications, including the drift towards normative ‘dataism’ and its implications for the person/data subject divide; (iii)
presents a case study concerning the return of clinical trial data to patients (the IMI 2 FACILITATE project); and (iv)
delineates, as its principal object, theoretical and practical developments aimed at achieving a concrete equilibrium
between the person and the data subject, restoring primacy to the person and to human dignity over the individual
conceived as a ‘complex of data’.