What can the “prescription app” do? DGIM working group presents expert consensus

03.02.2022 17:54

For just over a year it has been possible to prescribe digital health applications (DiGA) with a prescription. The prerequisite for this is that they are approved as medical devices with a CE certificate and have already proven a medical benefit or an improvement in patient care or are likely to do so within a year. In this case you will receive provisional approval. But what about the actual benefits in practice? How can the new applications be integrated into medical diagnostics and therapy? What legal aspects are there and what can internal medicine in particular expect from DiGA? The “Digital Health Applications” working group of the German Society for Internal Medicine (DGIM) has obtained an initial overview and published it in the specialist journal “Der Internist”, the official organ of the DGIM.

Applications in the medical field whose main function is based on digital technology and which are primarily used by patients are referred to as DiGA. “These are usually smartphone or computer apps, but web applications or other programs can also function as DiGA,” explains Professor Dr. medical Martin Möckel, medical director of emergency medicine/central emergency rooms and the chest pain units at the Mitte campus and at the Virchow Clinic of the Berlin Charité. He is chairman of the working group Digital Health Applications/AI in Guidelines of the German Society for Internal Medicine, which is responsible for the contribution to internal medicine. DiGA differs from conventional health apps in that it has CE certification and the fact that its provider must prove the medical benefit or a so-called “patient-relevant structural and procedural improvement in care”. “The costs are also a factor, because these have to be borne primarily by the statutory and private health insurance companies and the manufacturers themselves are not allowed to place any advertising,” says Möckel.

By mid-December - the time at which Möckel and his colleagues wrote the overview article - 24 DiGAs were listed on the website of the Federal Institute for Drugs and Medical Devices (BfArM). “Obvious areas of application include tracking functions that automatically record movement or pulse or allow nutrition, weight or specific complaints to be noted in diary form,” explains the Berlin expert.

“Some DiGA also create doctor’s reports from this data, which can provide valuable information for individual treatment,” says Möckel. Other apps specifically support patients in their everyday lives with detailed instructions on exercise or advice for a healthy lifestyle. Of the 24 DiGAs listed by mid-December 2021, however, there was only one that specifically addressed an internal disease - obesity - and another related to rheumatic diseases. “The manufacturers clearly have some catching up to do here,” says Möckel.

Lack of testing options for doctors, open questions about areas of application

This also applies to the testing options for doctors that have not yet been provided. “The BfArM list contains information about the indications for which the respective app was developed. However, in order to decide whether it is suitable for a particular patient, the doctor must be able to test the app himself,” says Möckel. For this purpose, and in order to be able to explain the app to the patient on the screen, it would make sense to have test access that is as unlimited as possible. In addition, the previous applications primarily appeal to practicing physicians; they are not intended for inpatient use. “However, they could also be of interest to clinicians as part of discharge management,” says Möckel. However, there is still no experience with prescription practice here.

Regardless of the setting, the use of DiGA should under no circumstances lead to the relationship of trust between doctor and patient being disturbed. “DiGA can certainly enrich the spectrum of medical devices in the future. “But it is also clear that they only support the treatment and medication provided by the treating doctor, which means that their use must remain under the doctor’s control,” emphasizes Professor Dr. medical Markus M. Lerch, Medical Director and Chairman of the Board of the LMU Clinic Munich and President of the DGIM.

The AG DiGA paper can be found: https://www.springermedizin.de/praktische-anwendung-digitaler-gesundheitsanwendungen-diga-in-de/20040790?fulltextView=true