At the beginning of the DGIM talk, Dr. Mirja Mittermaier (Berlin Institute of Health Research and member of the DGIM working group on Digital Health Applications/AI in Guidelines) explained the significance of Digital Health Applications, or DiGAs for short. Since the Digital Healthcare Act came into force in Germany on December 19, 2019, DiGAs can be prescribed by physicians or psychotherapists at the expense of statutory health insurance. In the first year (2020), around 50,000 DiGAs were prescribed, and approximately 801 of these were activated, for which the health insurance funds paid around 13 million euros in benefits. According to Mittermaier, 901 DiGAs were prescribed, while the health insurance funds approved 101 DiGAs (without a prescription). DiGAs are low-risk medical devices whose main function is based primarily on digital technologies ("app on prescription"). If the product is successfully listed by the BfArM, the health insurance funds will cover the costs (§§ 33a, 139e SGB V).
In contrast, telemonitoring is not a digital health application (DiGA), but rather a medical examination and treatment method recognized under Section 135 Paragraph 1 of the German Social Code, Book V (SGB V) within the framework of contracted medical care ("telemedicine on referral") (1). The Joint Federal Committee had already adopted the necessary resolution on December 15, 2020, the so-called "Methods Guideline" (2). The Extended Assessment Committee established the basis for the remuneration of telemonitoring services provided by contracted physicians with its resolution of December 15, 2021 (3).
According to Section 1 of the Methods Guideline, telemonitoring for heart failure is a data-driven, timely management approach implemented through collaboration between a primary care physician (PCP) and a telemedicine center (TMC). The PCP determines the indication and refers the patient to the TMC. According to Section 2 of the Methods Guideline, the following conditions must be cumulatively met in the patient: Heart failure according to NYHA class II or III with an ejection fraction < 401 Tp3 T, the patient has an implanted cardiac device (ICD, CRT-P, CRT-D), or has been hospitalized for cardiac decompensation within the past year.
According to Section 3 of the Methods Guideline, the TMZ is responsible for conducting telemonitoring and for documentation. Furthermore, the TMZ is specifically responsible for ensuring the proper functioning of the patient's technical infrastructure and maintaining the data transmission connection.
The implementation and billing of telemonitoring at the expense of statutory health insurance requires approval from the relevant Association of Statutory Health Insurance Physicians. According to Section 2 of the Quality Assurance Agreement for Telemonitoring in Heart Failure (4) – abbreviated QS-V TmHi – the physician is to be granted approval if three conditions are met:
1. Admission to the statutory health insurance system;
2. Authorization to use the specialist medical title
Designation „Internal Medicine and Cardiology“ or „Internal Medicine with a focus on Cardiology“ and Ge-
Approval in accordance with the quality assurance agreement for rhythm implant monitoring;
3. Fulfillment of the technical requirements according to § 5 QS-V TmHi

Accordingly, the following should be used by the TMZ: Cardiac implantable devices (ICD, CRT-P, CRT-D) or external (measuring) devices to record body weight, electrical heart activity, blood pressure and to transmit information collected by the patient himself for the subjective assessment of his general health status.
This very precise, albeit technically complex-seeming, specification is based on the IQWiG Rapid Report N19-01 „Data-driven, timely management in collaboration with a medical telemedicine center for advanced heart failure“ (5). In particular, the results of the TIM-HF2 study, a randomized controlled trial by Prof. Köhler on telemonitoring in chronic heart failure, were unequivocal, as Charité writes on the study website (5): Following the publication of initial results from the TIM-HF study (6), the TIM-HF2 study (7) demonstrated that patients receiving telemedicine care significantly improved their quality of life and even experienced lower mortality rates in high-risk patients. Furthermore, in non-depressed patients with adequate cardiac function who had been hospitalized for decompensation within the previous two years, mortality from cardiovascular diseases was halved compared to the control group. The results of the TIM-HF2 study thus created the conditions for the G-BA decision.
Spethmann began his presentation by stating that telemonitoring is essentially indispensable in an aging society. The effects of the changing age pyramid are already clearly visible, particularly pronounced in the former East German states. In Brandenburg, Mecklenburg-Western Pomerania, and Thuringia, the proportion of 60- to 70-year-olds is currently 11 percent, and the figure is similar for those over 80. According to Spethmann, this is particularly significant because many cardiovascular diseases have a higher prevalence in old age. In contrast, the number of cardiologists available for outpatient care varies considerably across these three states: On average, one cardiologist in Brandenburg, Mecklenburg-Western Pomerania, and Thuringia cares for approximately 37,000 inhabitants, while in Saarland the figure is only 16,000. The national average is around 24,000. While these are only partial aspects, in combination with other factors they lead to an above-average hospitalization rate and an increased mortality rate for myocardial infarctions in the three eastern German states, according to the German Heart Report 2019.
Since heart failure is by far the most frequent single diagnosis for inpatients, action is needed. This is because, firstly, heart failure costs society around five billion euros per year, with the largest share attributable to inpatient treatment, but above all because – as Spethmann stated – „every hospitalization worsens the prognosis for our patients.“ Since the standard treatment of heart failure primarily takes place on an outpatient basis and patients only visit their general practitioner at certain intervals, closer monitoring, including a daily assessment of their condition, is essential – and this very idea, according to Spethmann, led to the development of telemonitoring.
While this has been possible for some time in the field of heart failure under integrated care contracts and has been implemented by various providers, it can now be used in standard care. Spethmann cautions that this is only possible if the necessary resources can be created as quickly as possible at existing and newly established transcardiac centers and scaled up to the required size, which, in his estimation, can only be achieved through the addition of decision support systems.
the use of artificial intelligence possible-
It will be quite possible. After all, the number of heart failure patients in Germany who would benefit from telemonitoring is around 200,000.
However, what's needed is not artificial intelligence, but rather a great deal of human intelligence, for physicians who are already ready and willing to apply for TMZ (Transmission of Medical Devices) accreditation with their respective regional associations of statutory health insurance physicians. For example, the Bavarian Association of Statutory Health Insurance Physicians requires applicants to submit declarations that would demand at least concentrated reading from an expert in medical device law. But it can be simpler, as the examples of the Berlin and Hamburg Associations of Statutory Health Insurance Physicians demonstrate. These associations only require confirmation from the cardiologist's service provider that the technical requirements of the QS-V TmHi (Quality Assurance Regulation for Transfusion Medicines) are met. This allows the cardiologist to dedicate their time to the patient – instead of studying medical device law texts.
Because medical device manufacturers have already caused confusion in the market, it must be clarified: Not every software used in connection with telemonitoring needs to have a CE marking as a medical device. This is stated by
Dr. Wolfgang Rehmann, one of the leading experts in medical device law in Germany, in his article on the requirements for the technical equipment for the implementation of telemonitoring in heart failure.
Unlike digital health applications (DiGA) and video consultations, telemonitoring requires asynchronous communication and a distribution of tasks between patients, the telemedicine center (TMZ), the patient information center (PBA), and service providers. Cloud services are ideally suited for this. The cloud offers significantly greater protection against hacker attacks, data loss, and system failures than operating a computer in the doctor's office. Seamless patient care demands constant availability and lightning-fast scaling, which only cloud services, with their enormous computing power, can provide (read more about this in this issue starting on page 34).
In any case, Köhler expressed his hope in the DGIM talk that the provider base of TMZ services would gradually develop and that "by summer there would be facilities that could offer corresponding services".
The first ones are already here: Dr. Ali Halboos, medical director of a nationwide TMZ (Transmission Technology Center), reports in this issue (p. 33) on the tasks that specialized service providers can take on for cardiologists and what TMZs should consider when selecting a provider. He notes that there are important differences between the services offered, especially regarding the user experience for patients. "Monitor Versorgungsforschung" (Monitor Healthcare Research) interviewed an entrepreneurial physician from Hamburg (pp. 28 ff.).
by: MVF editor-in-chief Peter Stegmaier