Digital health applications (DiGA) in the German healthcare system

Increasing digitalization is changing all areas of life, and the healthcare sector is no exception. Natalie Michel examined this development in detail in her Bachelor's thesis, focusing on digital health applications (DiGA). Her research, which she completed at the end of 2023 in collaboration with 5-HT Chemistry & Health, earned her a Bachelor's degree in Digital Business Management at Worms University of Applied Sciences.

Angespornt durch die wachsende Bedeutung digitaler Gesundheitsanwendungen (DiGA) im deutschen Gesundheitssystem, beleuchtet Natalie Michel die zunehmende Notwendigkeit solcher Lösungen, die durch die Corona-Pandemie weiter verstärkt wurde. Ihre Arbeit bietet wertvolle Einblicke in die Herausforderungen und Chancen, die diese technologischen Innovationen mit sich bringen. Michel zeigt, wie Startups die regulatorischen und qualitativen Hürden meistern können, um erfolgreich digitale Gesundheitslösungen zu entwickeln und im Markt zu etablieren.

“In my bachelor's thesis, I am immersing myself in the world of digital health applications, which are playing an important role in the German healthcare system in times of increasing digitalization,” says Natalie Michel.

"The words of Prof. Karl Lauterbach, Federal Minister of Health, in an interview in March 2023, have strengthened my conviction that digitization in the healthcare system is not just an end in itself (see BMG, 2023). The consequences of the coronavirus pandemic in particular have increased the need for digital solutions. Electronic sick notes and apps for managing illness were quickly introduced and used in many companies, which illustrates the dynamics of the digital transformation in the healthcare sector (cf. Bozem & Nagl, 2021, p.2).

In 2018, the Bertelsmann Stiftung's Digital Health Index found that the introduction of digital solutions in the German healthcare sector was still lagging behind, but new models and applications have since seen the light of day (cf. Thiel et al., 2018). Digital therapy support in particular appears to be benefiting from this development. The German government is also keen to drive forward the digitalization of the healthcare system and is planning further legislation to simplify the everyday lives of patients and doctors through digital solutions. These developments are not only fascinating, but also offer enormous potential for improving patient care and access to modern treatment methods.

When I started looking into the topic of digital health applications (DiGA), I quickly realized that there is a world of potential and innovation behind this term. As I was able to work on precisely these topics, such as innovation management and the creation of a business model for start-ups, through various subjects in my Digital Business Management degree program, the decision was not difficult for me. As I was employed as an intern at 5-HT at the time I chose my topic and had already had the opportunity to talk to start-ups that wanted to become a digital health application, I was also able to benefit from the expertise of my colleagues and 5-HT's large network.

My motivation to delve deeper into this topic came mainly from the desire to support startups that want to take the step to become DiGA. But before I dove into the details, it was important to decode the term “DiGA” itself and understand what exactly is behind it. With this in mind, in this thesis I wanted to not only shed light on the technological aspects of DiGA, but also analyze its importance in healthcare and its potential impact on patient care."

The following illustration shows how the process of reimbursement by health insurance companies can take place.

_{The patient's path to DiGA prescription}

In summary, it is concluded that start-ups aiming for a digital health application must adapt their business models in line with the regulatory and quality standards of the German healthcare system. This requires close cooperation with healthcare professionals and a thorough examination of the legal regulations and requirements. Even though the processes are listed and described in detail in the DiGA guidelines, the preparation is time-consuming and the requirements should be explicitly completed in sequence.

_{DiGA Fasttrack procedure (from the BfArM website)}

For startups, the decision to set up a DiGA is a decision in favor of a certain business model. It would be advantageous for start-ups to approach the foundation with a well-developed business plan. This business plan should be drawn up in such a way that all the facts, from the concept, market and competition to marketing and finances, have already been thought through and processed in advance.

A possible DiGA business model is presented below, which is based on Alexander Osterwalder's business management tool, the Business Model Canvas.

_{Application of Osterwalder's Business Model Canvas to DiGA, which is used to analyze business models}

Sources:

Bozem, K. & Nagl, A. (2021). Digitale Geschäftsmodelle erfolgreich realisieren: Business Model Building mit Checklisten und Fallbeispielen. Springer Gabler.

BfArM. (2023a). Das Fast-Track-Verfahren für digitale Gesundheitsanwendungen (DiGA) nach § 139e SGB V – Ein Leitfaden für Hersteller, Leistungserbringer und Anwender. (Version 3.4 vom 11.10.2023). DiGA-Leitfaden. Berlin.

BMG. (2023a, 03. März). Lauterbach: Elektr. Patientenakte ab Ende 2024 für alle verbindlich. Bundesministerium für Gesundheit. https://www.bundesgesundheitsministerium.de/presse/interviews/interview/fas- 030324-elektronische-patientenakte abgerufen am 26.11.2023

BMG. (2020). Ärzte sollen Apps verschreiben können. Bundesministerium für Gesundheit. https://www.bundesgesundheitsministerium.de/digitale-versorgung-gesetz. abgerufen am 01.12.2023

Osterwalder, A. & Pigneur, Y. (2011). Business Model Generation: Ein Handbuch für Visionäre, Spielveränderer und Herausforderer. Frankfurt (u.a.): Campus Verlag.