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Health and Health-Related Connected Objects : Regulatory Intersections, Grey Zones and Blind Spots

Nordberg, Ana LU orcid ; Eskenazy, Déborah LU and Müllerová, Petra LU (2025) In European Journal of Health Law 32(3). p.308-333
Abstract

The present paper explores legal issues concerning connected objects used for health or health-related purposes and their corresponding usage of health and health-related data. It focuses on a patient/healthcare-user-centred perspective and researches the EU legal framework for health data and health-related data. Arguing that the legal framework, as recently complemented with the European Health Data Space (EHDS) Act, is plagued by complex intersections, between this recently enacted legislation and various other legal instruments, e.g. Medical Device Regulation (MDR), General Data Protection Regulation (GDPR), Data Act, Data Governance Act, Artificial Intelligence Act, etc. Furthermore, the legal framework applicable to health and... (More)

The present paper explores legal issues concerning connected objects used for health or health-related purposes and their corresponding usage of health and health-related data. It focuses on a patient/healthcare-user-centred perspective and researches the EU legal framework for health data and health-related data. Arguing that the legal framework, as recently complemented with the European Health Data Space (EHDS) Act, is plagued by complex intersections, between this recently enacted legislation and various other legal instruments, e.g. Medical Device Regulation (MDR), General Data Protection Regulation (GDPR), Data Act, Data Governance Act, Artificial Intelligence Act, etc. Furthermore, the legal framework applicable to health and health-related connected objects also contains several grey zones (i.e. areas of legal uncertainty concerning interpretation and applicability of existing norms), and unintended blind spots (i.e. areas potentially left untouched by the existing frameworks). The paper focuses on data quality, acceptability of connected objects, availability and accessibility of data, as well as the overarching topic of privacy and data protection. Concluding that, examined in conjunction, existing regulatory safeguards and certification mechanisms do not offer sufficient protection and simultaneously result in an excessively complex, cumbersome and opaque regulatory framework that has underestimated the specific needs of users in the health and health-related sectors.

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Please use this url to cite or link to this publication:
author
; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Connected Objects, Health and Health-related Data, European Health Data Space, Medical Devices, Artificial Intelligence, Medicinsk rätt, Artificiell intelligens
in
European Journal of Health Law
volume
32
issue
3
pages
26 pages
publisher
Martinus Nijhoff Publishers
external identifiers
  • pmid:40541389
  • scopus:105009947384
ISSN
0929-0273
DOI
10.1163/15718093-bja10149
project
The European University Alliance for Global Health – Transformation through Joint Research and Innovation Action (EUGLOHRIA)
AI and Automated systems and the Right to Health - Revisiting law accounting for the exploitation of users’ preferences and values (AICARE)
Using humanities to address technological progress in the field of connected objects related to health
language
English
LU publication?
yes
id
a236482a-079b-44f6-bd14-7fd1aa099ad3
date added to LUP
2024-12-15 12:01:24
date last changed
2025-10-27 14:48:37
@article{a236482a-079b-44f6-bd14-7fd1aa099ad3,
  abstract     = {{<p>The present paper explores legal issues concerning connected objects used for health or health-related purposes and their corresponding usage of health and health-related data. It focuses on a patient/healthcare-user-centred perspective and researches the EU legal framework for health data and health-related data. Arguing that the legal framework, as recently complemented with the European Health Data Space (EHDS) Act, is plagued by complex intersections, between this recently enacted legislation and various other legal instruments, e.g. Medical Device Regulation (MDR), General Data Protection Regulation (GDPR), Data Act, Data Governance Act, Artificial Intelligence Act, etc. Furthermore, the legal framework applicable to health and health-related connected objects also contains several grey zones (i.e. areas of legal uncertainty concerning interpretation and applicability of existing norms), and unintended blind spots (i.e. areas potentially left untouched by the existing frameworks). The paper focuses on data quality, acceptability of connected objects, availability and accessibility of data, as well as the overarching topic of privacy and data protection. Concluding that, examined in conjunction, existing regulatory safeguards and certification mechanisms do not offer sufficient protection and simultaneously result in an excessively complex, cumbersome and opaque regulatory framework that has underestimated the specific needs of users in the health and health-related sectors.</p>}},
  author       = {{Nordberg, Ana and Eskenazy, Déborah and Müllerová, Petra}},
  issn         = {{0929-0273}},
  keywords     = {{Connected Objects; Health and Health-related Data; European Health Data Space; Medical Devices; Artificial Intelligence; Medicinsk rätt; Artificiell intelligens}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{308--333}},
  publisher    = {{Martinus Nijhoff Publishers}},
  series       = {{European Journal of Health Law}},
  title        = {{Health and Health-Related Connected Objects : Regulatory Intersections, Grey Zones and Blind Spots}},
  url          = {{https://lup.lub.lu.se/search/files/226237303/ejhl-article-p308_3.pdf}},
  doi          = {{10.1163/15718093-bja10149}},
  volume       = {{32}},
  year         = {{2025}},
}