Unpacking Performance Factors of Innovation Systems and Studying Germany's Attempt to Foster the Role of the Patient Through a Market Access Pathway for Digital Health Applications (DiGAs): Exploratory Mixed Methods Study.

Background: Health care innovation faces significant challenges, including system inertia and diverse stakeholders, making regulated market access pathways essential for facilitating the adoption of new technologies. The German Digital Healthcare Act, introduced in 2019, offers a model by enabling digital health applications (DiGAs) to be reimbursed by statutory health insurance, improving market access and patient empowerment. However, the factors influencing the success of these pathways in driving innovation remain unclear.

[Structural benefits on prescription? Exploring potentials and challenges of the pSVV concept in the approval process of digital health applications in Germany].

Background: With the introduction of the Digital Healthcare Act (DVG) at the end of 2019, digital health applications (DiGA) were included in the statutory health insurance in Germany. DiGA are digital medical products whose primary function is based on digital technologies. In the definition of the approval process, the term "therapeutic benefit", which is crucial to the evaluation of pharmaceuticals, was expanded to include the broader concept of "positive healthcare effect" ("pVE").

Digital Health Applications (DiGAs) on a Fast Track: Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024.

Background: This study aimed to analyze the rapidly evolving ecosystem of digital health applications (Digitale Gesundheitsanwendung; DiGAs) in Germany, spurred by the 2019 Digital Healthcare Act. With over 73 million people in Germany now having access to DiGAs, these prescribable digital health apps and web-based applications represent a substantial stride in health care modernization, supporting both patients and health care providers with digital solutions for disease management and care improvement.

Objective: Through a data-driven approach, this research aimed to unpack the complexities of DiGA market dynamics, economic factors, and clinical evidence, offering insights into their impact over the past years.