Key result
Remote cardiac device monitoring resolves legal liability within established duty of care frameworks without new laws.
Cardiologists using telemetric remote monitoring can manage liability risks by following standard operating procedures and establishing clear patient agreements under existing legal frameworks.
Clinicians in Germany and Italy may adopt remote monitoring under existing duty-of-care rules; leaves open need for broader validation and harmonization.
Objectives Telemetric remote monitoring of cardiac pacemakers and implanted defibrillators constitutes significant medical-technical progress and an improvement of healthcare. However, for the car-diologist providing aftercare, this also incurs liability risks which he should be aware of and take into consideration. This article presents the reason for and limits of said liability and of the re-sponsibility of the acting cardiologist. The cardiologist is aware of his risks and is advised on how to avoid them. Methods The legal situation is examined from the perspective of continental European legal tradition, namely from the German and Italian perspectives. The authors examine both aspects in Penal Law as well as in Civil Law and show which agreements and patient information can minimize the liability risks for the cardiologist. Results The article clarifies whether alarms only need to be evaluated during consultation hours and what consequences arise if data transmission does not occur or the cardiologist is unable to re-ceive the data. Furthermore, the patient's cooperation duties for the individual products and the significance of a patient information talk with the doctor are elucidated. Conclusions Although the medical side, including patient satisfaction and economic aspects, is well backed-up internationally, expert legal literature has not yet adequately addressed the problem. However, no "telemetry law" is required, the legal issues can be solved within the established liability and re-sponsibility category and the terms of "breach of duty of care"/"imperizia". The following paper lines out the SOP, a doctor has to follow it to avoid liability and to ensure that patients have bene-fits from telemetric remote monitoring.
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Schneider et al. (2018) conducted a review in Patients with cardiac pacemakers and implanted defibrillators. Telemetric remote monitoring was evaluated. Telemetric remote monitoring of cardiac devices does not require new telemetry laws, as legal liability issues can be resolved within established duty of care frameworks in German and Italian law.
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