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

EP Europace ◽  
2021 ◽  
EP Europace ◽  
2020 ◽  
Vol 22 (11) ◽  
pp. 1742-1758 ◽  
Author(s):  
Jens Cosedis Nielsen ◽  
Josef Kautzner ◽  
Ruben Casado-Arroyo ◽  
Haran Burri ◽  
Stefaan Callens ◽  
...  

Abstract 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.


2019 ◽  
Vol 35 (1) ◽  
pp. 3-17 ◽  
Author(s):  
Regis J O'Keefe ◽  
Rocky S Tuan ◽  
Nancy E Lane ◽  
Hani A Awad ◽  
Frank Barry ◽  
...  

2015 ◽  
Vol 16 (5) ◽  
pp. 3-13 ◽  
Author(s):  
Beth A. Harkness ◽  
Jerry D. Allison ◽  
Jessica B. Clements ◽  
Charles W. Coffey ◽  
Frederic H. Fahey ◽  
...  

2007 ◽  
Vol 120 (6) ◽  
pp. 1373-1377 ◽  
Author(s):  
Linda Cox ◽  
Thomas A.E. Platts-Mills ◽  
Ira Finegold ◽  
Lawrence B. Schwartz ◽  
F. Estelle R. Simons ◽  
...  

2013 ◽  
Vol 60 (8) ◽  
pp. 1253-1260 ◽  
Author(s):  
Daniel A. Weiser ◽  
Sue C. Kaste ◽  
Marilyn J. Siegel ◽  
Peter C. Adamson

Policy Papers ◽  
2013 ◽  
Vol 2013 (8) ◽  
Author(s):  

This paper reviews the macroeconomic characteristics and performance of small states and discusses ways in which the Fund’s engagement with these countries could be better tailored to meet their needs. The Fund previously examined small states issues in 2000, informed by a Joint Task Force Report of the Commonwealth Secretariat (CS) and World Bank. Small states continue to face many of the same challenges they did then, and the 2000 Small States Report remains the foundation for much of the work in this area, both inside and outside the Fund. However, the relative macroeconomic performance of small states has deteriorated since the late 1990s, and a fresh look is warranted.


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