No 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.

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Medical liability cases are becoming common practice in Belgium. There are several reasons for the increasing amount of liability cases. First of all, more people than ever are involved in providing health care. The chance that something goes wrong is therefore increasing. Moreover, medicine needs technology but technology may also lead to failures which explains partly the increase in claims. Another important reason why physicians and hospitals are sued more than before, has to do with the role of the sickness funds. These organisations, which pay for the medical expenses, are entitled to bring an action against a physician who, in their opinion, made a mistake. The sickness funds are also partly responsible for their expenses and they are, more than before, inclined to bring actions against physicians in order to have their expenses reimbursed. Finally, the patient is becoming more proactive and will contact the physician, the hospital, the sickness fund and/or a lawyer if he is of the opinion that something went wrong during the treatment. If one looks at the published case law on medical civil liability it becomes clear that the position of the patient is improving. We will explain this on the basis of four selected cases. These cases deal with specific topics of medical civil liability, i.e. the issue of informed consent and information errors (what information has to be given to the patient, who has to give the information, are there any exceptions to the information obligation, etc.), the causation (what about the causal connection between an error and the damage or the loss due to damage), the burden of proof (on whom does the burden of proof fall, on the patient or on the physician e.g. in case of informed consent issues, what about methods of easing the burden of proof) and the extent of compensation (what types of compensation exist). These issues are analysed by summarising, analysing and evaluating four interesting cases. These cases are put in perspective, while the trends in the development of medical civil liability are described.

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