Legal aspects of telemedicine in cardiology in Germany

Abstract

Since 2016, quarterly telemedical remote monitoring of patients with an implanted defibrillator or cardiac resynchronization therapy (CRT) system is part of the Einheitlichen Bewertungsmaßstab (EBM, physician's fee schedule) and is the first telemedical service to be reimbursed in German cardiology. Many publications like the TIM-HF2 or the InTime trial have shown asignificant benefit for different endpoints in patients with advanced heart failure. Therefore, the German Society of Cardiology (DGK) has published different recommendations that emphasize an obvious indication of telemedical care with daily control of implantable cardioverter-defibrillator (ICD) information, parameters like blood pressure and weight, and telemedical counselling of patients with heart failure with reduced ejection fraction. This recommendation is also part of the guidelines of the European Society of Cardiology (ESC) published in 2021. It has alevel IIb for patients with heart failure. In December 2020 the "Gemeinsame Bundesausschuss" (G-BA) decided to accept telemonitoring as adiagnostic tool and treatment option for patients with heart failure. This service of physicians became part of the EBM and ever since may be offered to patients. This development is accompanied with many questions regarding aphysician's accountability, protection of data privacy, and also regarding the structures given by the G‑BA and the "Kassenärztlichen Vereinigungen" (KV). Thus, this paper tries to give an overview of these topics. It will also provide acritical discussion of these structures and their legal foundation because there are many constraints that need to be taken into consideration as acardiologist. These constraints may ultimately hinder the expansion of this service to patients in Germany.