Reference : Sistemi Medici e Conformità Legale
Scientific journals : Article
Law, criminology & political science : European & international law
Systems Biomedicine
Sistemi Medici e Conformità Legale
[en] Medical Systems and Legal Compliance
Bartolini, Cesare [University of Luxembourg > Interdisciplinary Centre for Security, Reliability and Trust (SNT) > >]
Lenzini, Gabriele mailto [University of Luxembourg > Interdisciplinary Centre for Security, Reliability and Trust (SNT) > >]
Rivista Italiana di Medicina Legale: Dottrina, Casistica, Ricerca Sperimentale, Giurisprudenza e Legislazione
Dott. A. Giuffre Editore
[en] legal compliance ; medical devices ; GDPR
[en] The present document addresses the topic of legal compliance of medical systems, that is, hardware and software devices medically used on people for clinical tests, diagnosis, study, and similar purposes, mainly with respect to EU law. The work briefly overviews the applicable laws and regulations and discusses the relevance on medical systems of concepts that General Data Protection Regulation (GDPR) covers in a wider scope, such as data protection and transparency. The document looks into the practical meaning of legal compliance in a medical system and in the software that defines its behavior. Granted that any lawfulness decision is a prerogative of the judicial authority, the document concludes by suggesting currently-available means, such as official conformity checks, standards, but also conformity guidelines during development, to build a reasonably compliant medical system, or to check for its conformity.
Interdisciplinary Centre for Security, Reliability and Trust (SnT) > Applied Security and Information Assurance Group (APSIA)
Fonds National de la Recherche - FnR
Data Protection Compliance (DAPRECO)
Professionals ; General public
FnR ; FNR11333956 > Gabriele Lenzini > DAPRECO > DAta Protection REgulation COmpliance > 01/02/2017 > 30/06/2019 > 2016

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