Remote monitoring of cardiac implanted electronic devices: Legal requirements and ethical principles - ESC Regulatory Affairs Committee/EHRA joint task force report

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F20%3A00080549" target="_blank" >RIV/00023001:_____/20:00080549 - isvavai.cz</a>

Result on the web

<a href="https://academic.oup.com/europace/article/22/11/1742/5877304" target="_blank" >https://academic.oup.com/europace/article/22/11/1742/5877304</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/europace/euaa168" target="_blank" >10.1093/europace/euaa168</a>

Result language

angličtina

Original language name

Remote monitoring of cardiac implanted electronic devices: Legal requirements and ethical principles - ESC Regulatory Affairs Committee/EHRA joint task force report

Original language description

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&apos;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. © The Author(s) 2020.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2020

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Europace

ISSN

1099-5129

e-ISSN

—

Volume of the periodical

22

Issue of the periodical within the volume

11

Country of publishing house

GB - UNITED KINGDOM

Number of pages

17

Pages from-to

1742-1758

UT code for WoS article

000593357300025

EID of the result in the Scopus database

2-s2.0-85096152808