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Remote monitoring of cardiac implanted electronic devices: legal requirements and ethical principles - ESC Regulatory Affairs Committee/EHRA joint task force report
JC. Nielsen, J. Kautzner, R. Casado-Arroyo, H. Burri, S. Callens, MR. Cowie, K. Dickstein, I. Drossart, G. Geneste, Z. Erkin, F. Hyafil, A. Kraus, V. Kutyifa, E. Marin, C. Schulze, D. Slotwiner, K. Stein, S. Zanero, H. Heidbuchel, AG. Fraser
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, práce podpořená grantem
NLK
Free Medical Journals
od 1999 do Před 1 rokem
PubMed Central
od 2008
Open Access Digital Library
od 1999-01-01
Medline Complete (EBSCOhost)
od 1999-01-01
Oxford Journals Open Access Collection
od 1999-01-01
PubMed
32725140
DOI
10.1093/europace/euaa168
Knihovny.cz E-zdroje
- MeSH
- elektronika MeSH
- kardiologie * MeSH
- lidé MeSH
- monitorování fyziologických funkcí MeSH
- poradní výbory MeSH
- zabezpečení počítačových systémů MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
The European Union (EU) General Data Protection Regulation (GDPR) imposes legal responsibilities concerning the collection and processing of personal information from individuals who live in the EU. It has particular implications for the remote monitoring of cardiac implantable electronic devices (CIEDs). This report from a joint Task Force of the European Heart Rhythm Association and the Regulatory Affairs Committee of the European Society of Cardiology (ESC) recommends a common legal interpretation of the GDPR. Manufacturers and hospitals should be designated as joint controllers of the data collected by remote monitoring (depending upon the system architecture) and they should have a mutual contract in place that defines their respective roles; a generic template is proposed. Alternatively, they may be two independent controllers. Self-employed cardiologists also are data controllers. Third-party providers of monitoring platforms may act as data processors. Manufacturers should always collect and process the minimum amount of identifiable data necessary, and wherever feasible have access only to pseudonymized data. Cybersecurity vulnerabilities have been reported concerning the security of transmission of data between a patient's device and the transceiver, so manufacturers should use secure communication protocols. Patients need to be informed how their remotely monitored data will be handled and used, and their informed consent should be sought before their device is implanted. Review of consent forms in current use revealed great variability in length and content, and sometimes very technical language; therefore, a standard information sheet and generic consent form are proposed. Cardiologists who care for patients with CIEDs that are remotely monitored should be aware of these issues.
BIOTRONIK SE and Co KG Berlin Germany
Boston Scientific Arden Hills MN USA
Cardiac Pacing Unit Cardiology Service University Hospital of Geneva Geneva Switzerland
Centre for Biomedical Ethics and Law KU Leuven Leuven Belgium
Cyber Security Group Delft University of Technology Delft The Netherlands
Department of Cardiology Erasme University Hospital Université Libre de Bruxelles Brussels Belgium
Department of Cardiology UniversityHospital Antwerp University of Antwerp Antwerp Belgium
Department of Cardiovascular Sciences Katholieke Universiteit Leuven Leuven Belgium
Dipartimento di Elettronica Informazione e Bioingegneria Politecnico di Milano Milan Italy
ESC Patient Forum member Brussels Belgium
Imperial College London and National Heart and Lung Institute Dovehouse Street London SW3 6LY UK
School of Computer Science University of Birmingham Birmingham UK
School of Medicine Cardiff University Cardiff UK
University of Bergen Stavanger University Hospital Stavanger Norway
University of Rochester Medical Center Clinical Cardiovascular Research Center Rochester NY USA
Citace poskytuje Crossref.org
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