Digital Nursing Applications (DiPA) in Germany (BfArM)

Legal Framework and Purpose

Digital Nursing Applications (DiPA) were introduced through the Nursing Strengthening Act (Pflegeunterstützungs- und -entlastungsgesetz) and the DiPA Ordinance (DiPAV), extending the successful DiGA model to the long-term care sector. DiPA are CE-marked (MDR Class I) or non-medical digital applications that support insured persons in long-term care insurance with care-relevant needs (e.g., mobility, self-care, cognitive stimulation, social participation). The goal is to improve care quality, relieve caregivers, and promote independent living. Digital Nursing Applications - BfArM

Eligibility and Requirements

To qualify for inclusion in the DiPA directory:

• Positive care effect must be demonstrated (structural/procedural improvement or relief for care recipients/caregivers).
• Compliance with data protection (GDPR), IT security (BSI TR-03161), and interoperability standards.
• User-friendly design, accessibility, and positive benefit-risk profile.
• For medical DiPA: MDR CE marking (low risk); non-medical DiPA follow similar quality criteria.

Assessment and Inclusion Process

Application and Provisional Inclusion

• Manufacturer submits application to BfArM with product description, intended use, evidence plan, and preliminary data.
• BfArM checks formal requirements and basic eligibility within approx. 3 months.
• Provisional inclusion granted for 12 months allows prescription by care professionals and reimbursement while final evidence is collected.

Final Benefit Assessment

• During provisional phase, manufacturer provides comparative evidence (e.g., studies, real-world data) proving positive care effect.
• BfArM evaluates submitted dossier against predefined criteria (care benefit, quality, security).
• Positive decision leads to permanent directory inclusion and ongoing reimbursement; negative results in removal.

Prescription, Reimbursement, and Access

• Care professionals (e.g., nurses, physicians in long-term care) prescribe DiPA using directory codes.
• Long-term care insurance funds reimburse at manufacturer-set price (initial cap, later negotiated).
• Users access DiPA via app stores or platforms after prescription and approval.

BfArM Responsibilities and Transparency

• Maintains the public DiPA directory listing approved applications, evidence summaries, and assessment decisions.
• Publishes guidance, application forms, checklists, and FAQs to support manufacturers.
• Collaborates with G-BA and long-term care insurance bodies on evaluation standards.

This pathway integrates digital innovations into long-term care, ensuring evidence-based, secure, and reimbursable support for care-dependent individuals and their caregivers in Germany. Digital Nursing Applications - BfArM