A Commentary on Decentralized Privacy-Preserving Proximity Tracing in the Context of the EU Legal Framework for Medical Devices

10 Pages Posted: 5 May 2020

See all articles by Erik Kamenjasevic

Erik Kamenjasevic

KU Leuven - Centre for IT & IP Law (CiTiP)

Elisabetta Biasin

KU Leuven - Centre for IT & IP Law (CiTiP)

Date Written: April 27, 2020

Abstract

So far, the debate on contact tracing technologies to fight COVID19 heavily focused on the ethical and legal aspects concerning privacy and data protection. This Commentary (working paper) analyses the applicability of the EU Medical Devices Directive to the software for decentralized privacy-preserving proximity tracing by following MEDDEV 2.1/6 guidelines’ five-step approach. It concludes that the software at stake might qualify as a medical device.

Keywords: Software as a medical device, COVID19, proximity tracing

Suggested Citation

Kamenjasevic, Erik and Biasin, Elisabetta, A Commentary on Decentralized Privacy-Preserving Proximity Tracing in the Context of the EU Legal Framework for Medical Devices (April 27, 2020). Available at SSRN: https://ssrn.com/abstract=3586418 or http://dx.doi.org/10.2139/ssrn.3586418

Erik Kamenjasevic (Contact Author)

KU Leuven - Centre for IT & IP Law (CiTiP) ( email )

Sint-Michielsstraat 6 box 3443
Leuven, 3000
Belgium

Elisabetta Biasin

KU Leuven - Centre for IT & IP Law (CiTiP) ( email )

Sint-Michielsstraat 6
Leuven, Vlaams-Brabant 3000
Belgium

HOME PAGE: http://https://www.law.kuleuven.be/citip/en/staff-members/staff/00121994

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