When is the processing of data from medical implants lawful? The legal grounds for processing health-related personal data from ICT implantable medical devices for treatment purposes under EU data protection law

Sarita Lindstad and Kaspar Rosager Ludvigsen

Medical Law Review, 2023, vol. 31, issue 3, 317-339

Abstract: Medicine is one of the biggest use cases for emerging information technologies. Data processing brings huge advantages but forces lawmakers and practitioners to balance between privacy, autonomy, accessibility, and functionality. ICT-connected Implantable Medical Devices plant themselves firmly between traditional medical equipment and software that processes health-related personal data, and these implants face many data management challenges. It is essential that healthcare providers and others can identify and understand the legal grounds they rely on to process data. The European Union is currently updating its framework, and the special provisions in the GDPR, the current ePrivacy Directive, and the coming ePrivacy Regulation all provide enhanced thresholds for processing data. This article provides an overview and explanation of the applicability of the rules and the legal grounds for processing data. We find that only a cumulative application of the GDPR and the ePrivacy rules ensure adequate protection of this data and present the legal grounds for processing in these cases. We discuss the challenges in obtaining and maintaining valid consent and necessity as a legal ground for processing and offer use case-specific discussions of the role of consent long-term and the lack of an adequate ‘vital interest’ exception in the ePrivacy rules.

Keywords: E-privacy; GDPR; healthcare; ICTIMD; privacy; processing (search for similar items in EconPapers)
Date: 2023
References: Add references at CitEc
Citations:

Downloads: (external link)
http://hdl.handle.net/10.1093/medlaw/fwac038 (application/pdf)
Access to full text is restricted to subscribers.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:oup:medlaw:v:31:y:2023:i:3:p:317-339.

Access Statistics for this article

Medical Law Review is currently edited by Professor Sara Fovargue and Professor Jose Miola

More articles in Medical Law Review from Oxford University Press
Bibliographic data for series maintained by Oxford University Press ().