Building & Listing a Reimbursable Health App (DiGa) - U Talk #32

TL;DR

Learn the practical steps and challenges involved in building a Diga (medical app) for reimbursement in Germany, including clinical studies and regulatory criteria.

Transcript

foreign kind of New Concept since approximately two and a half years in Germany on how to get your software or your medical app into reimbursement so how to actually Finance what you built for patients and I'm going to talk about some practical implications especially so I'm going to talk about how to build such a Diga in a very brief way but mostl... Read More

Key Insights

• 😀 The Diga Fast Track provides a standardized and transparent process for accessing insurance reimbursements for medical apps in Germany.
• 😷 Building a Diga involves fulfilling medical device criteria and additional Diga-specific criteria, such as interoperability and positive healthcare effects.
• 🌱 Conducting a clinical study for a Diga is time-consuming, cost-intensive, and should be carefully planned.
• 👂 While being listed in the Diga directory is an achievement, distribution, marketing, and sales remain challenging and expensive.
• 😷 Considerations for building a successful Diga include focusing on proven concepts, getting expert medical device consultants, and carefully planning clinical studies.
• 🏃 The preliminary listing option should be considered, but caution should be exercised as meeting the full study requirements within one year can be challenging.

Questions & Answers

Q: What is a Diga and how does it differ from previous reimbursement processes?

A Diga is a medical app that meets specific criteria for reimbursement by insurances. Unlike before, where developers had to negotiate contracts individually, Digas have a standardized and transparent process for access to all insurances.

Q: How long does it take to conduct a clinical study for a Diga?

The timeline for a clinical study varies but typically includes three months for ethical approval, additional time for patient recruitment, the duration of the study itself (based on prescription time), and evaluation time. Overall, it could take one to two years.

Q: How much does it cost to build a Diga and conduct a clinical study?

Building a Diga and conducting a clinical study can cost six figures, particularly when outsourcing to clinical research organizations. Costs should be carefully evaluated for each indication or Diga to ensure profitability.

Q: What are the limitations or challenges of the Diga system?

The Diga regulatory authority is strict in evaluating Digas, and statistics for prescriptions are currently low, making profitability uncertain. Additionally, distribution, marketing, and sales pose significant challenges and costs. Changes to an approved Diga are also costly and time-consuming.

Summary & Key Takeaways

• A Diga is a medical app that fulfills certain criteria to be reimbursed by insurances in Germany, providing direct access to all major insurance providers.

• Before the Diga Fast Track, developers had to negotiate contracts with individual insurances, making the process less standardized and transparent.

• Building a Diga involves fulfilling medical device criteria, conducting costly clinical studies, and addressing challenges in distribution, marketing, and sales.