How to DiGA & DiPA?

The path to reimbursable digital health and care applications

The German Digital Healthcare Act (DVG), the Digital Modernization of Care and Nursing Act (DVPMG), and the Digital Act (DigiG) enable faster integration of Digital Health (DiGA) and Care (DiPA) Applications into the German healthcare system. But how does an app get listed as prescribable, and how can this complex process be made as lean and agile as possible for start-ups and other companies? This course offers a practical introduction to the requirements and outlines the steps needed for your app to be listed in the DiGA or DiPA directory.

Course Content

6 Course Modules

Self-paced digital modules with a final Q&A session led by industry experts.

DiGA and DiPA – Formal Requirements
This module outlines the legal framework, defines what constitutes a DiGA and a DiPA, and explains the role of BfArM in the Fast-Track process.

The DiGA & DiPA Fast-Track Process
Detailed overview of the application process with BfArM, including the submission portals and directories for DiGA and DiPA.

Basic and Technical Requirements
Explanation of key legal and technical requirements from the DiGAV and DiPAV regulations. Covers aspects like data protection, data security, and interoperability.

Demonstrating Positive Healthcare Effects and Care Benefits
Insights into how to demonstrate positive healthcare effects for DiGA or care-related benefits for DiPA. Includes types of effects, evaluation concepts, and clinical study requirements.

DiGA and DiPA Pricing
Explains pricing components: manufacturer price, actual price, reimbursement amount, thresholds. Covers DiGA negotiation processes and DiPA pricing models.

Prescription and Billing
Outlines how DiGAs and DiPAs reach patients and provides an overview of the billing process with statutory health insurers. Also covers reimbursement for healthcare providers.