Become a DiGA/DTx in Germany: Consulting Offer

In order for a Digital HealthCare Application (DiGA) or Digital Care Application (DiPA) to become reimbursable under German health insurance, it must meet a defined set of requirements related to IT security, data protection, and data integrity.

B’IMPRESS is offering a free 60-minute expert session to help DiGA/DiPA developers and manufacturers:

  • Understand the core requirements of the Digital Care Applications Regulation (DiPAV)
  • Clarify what’s needed for successful application submission to the BfArM DiPA directory
  • Identify current gaps in IT security or data protection compliance
  • Plan technical steps such as penetration testing and ISMS implementation

Process / Steps of the Consulting Offer:

  1. Introduction to DiPA & DiPAV – What qualifies a digital care application for reimbursement?
  2. Regulatory Roadmap – Review of security, privacy, and quality requirements
  3. Initial Assessment – Discussion of your current application readiness
  4. Service Overview – Explanation of B’IMPRESS support offerings (penetration tests, ISO audits, data protection checks)
  5. Next Steps – Guidance on preparing for BfArM submission

What You’ll Get

  • Personalized consultation with B’IMPRESS DiPA experts
  • Clarity on DiPAV regulatory requirements and timelines
  • An overview of needed documentation and technical validations
  • Introduction to possible tests
    • o Penetration testing
    • o Data protection maturity assessments
    • o ISO/IEC 27001 & IT-Grundschutz audits

Secure your place in the DiPA directory and get reimbursable — start with a free 60-minute briefing with B’IMPRESS compliance experts.

Deal Requirements

  • Manufacturers of digital care applications seeking DiPA listing
  • Health tech startups developing reimbursable digital services
  • IT security or compliance teams preparing for DiPA submissions

Next Steps if Accepted

Our team will contact you shortly to schedule your deal session.
Contact us here for your request. Contacts

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