Digital Health Applications (DiGA) and Digital Care Applications (DiPA) in Germany (BfArM)

Legal Basis and Introduction

Germany introduced the Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) in 2019, amended by the Digital Healthcare Act 2 (GDNG) and related ordinances, creating a specific fast-track pathway for reimbursable digital health solutions. Digital Health Applications (DiGA) and Digital Care Applications (DiPA) are low-risk medical devices or digital care products that support diagnosis, therapy, alleviation, or compensation of diseases/injuries or care needs via digital means (primarily apps). Digital Health Applications - BfArM

Scope and Eligibility Criteria

• DiGA: Software-based medical devices (apps) intended to treat, alleviate, or compensate diseases/injuries, with CE marking under MDR (Class I or higher), positive benefit-risk profile, data protection/security compliance, interoperability, and proven positive care effect.
• DiPA: Digital care applications supporting care needs (e.g., elderly care, rehabilitation), with similar requirements but focused on care rather than medical treatment.
• Both must demonstrate medical benefit, structural/ procedural quality, and data security (BSI TR-03161 compliance).

Fast-Track Assessment Process

Provisional Inclusion

• Manufacturer applies to BfArM for provisional inclusion in the DiGA/DiPA directory.
• BfArM checks formal requirements (CE mark, risk classification, data protection) within 3 months.
• If positive, provisional inclusion for 12 months allows prescription and reimbursement while evidence is gathered.

Final Benefit Assessment

• During provisional period, manufacturer conducts comparative study or uses existing evidence to prove positive care effect.
• BfArM evaluates submitted evidence (clinical studies, real-world data) against predefined endpoints.
• Positive assessment leads to permanent inclusion and continued reimbursement; negative leads to removal.

Prescription and Reimbursement

• Physicians prescribe DiGA/DiPA via code in the directory.
• Statutory health insurance reimburses at manufacturer-set price (capped for first year, then negotiated).
• Patients access via app stores after prescription.

BfArM Role and Transparency

• Maintains public DiGA/DiPA directory with details on applications, evidence summaries, and assessment outcomes.
• Provides guidance documents, application forms, checklists, and FAQs for manufacturers.
• Coordinates with G-BA (Federal Joint Committee) on benefit evaluation criteria.

This innovative framework accelerates patient access to evidence-based digital health solutions while ensuring quality, safety, and cost-effectiveness in the German healthcare system. Digital Health Applications - BfArM