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Portrait of Ana Nordberg. Photo.

Ana Nordberg

Senior lecturer

Portrait of Ana Nordberg. Photo.

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

Author

  • Ana Nordberg
  • Déborah Eskenazy
  • Petra Müllerová

Summary, in English

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.

Department/s

  • Department of Law
  • Health Law
  • Human Rights Law
  • LU Profile Area: Human rights

Publishing year

2025

Language

English

Pages

308-333

Publication/Series

European Journal of Health Law

Volume

32

Issue

3

Document type

Journal article

Publisher

Martinus Nijhoff Publishers

Topic

  • Law

Keywords

  • Connected Objects
  • Health and Health-related Data
  • European Health Data Space
  • Medical Devices
  • Artificial Intelligence
  • Medicinsk rätt
  • Artificiell intelligens

Status

Published

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

Research group

  • Health Law
  • Human Rights Law

ISBN/ISSN/Other

  • ISSN: 0929-0273