Germany’s healthcare system has established a robust framework for integrating and reimbursing artificial intelligence (AI) technologies, particularly through the Digital Healthcare Act (DVG). This system ensures AI tools can be prescribed and reimbursed if they meet strict regulatory, clinical and economic criteria. Below is a detailed breakdown of the process, highlighting the scientific rigour, application specifics and the key authorities involved.
The Digital Healthcare Act (DVG) enables certified digital health applications (DiGA), including AI-driven technologies, to be prescribed by physicians and reimbursed under Germany’s statutory health insurance (SHI). This system focuses on solutions that directly benefit patients, enhance clinical processes, or improve healthcare efficiency. Key objectives of the system include:
– Simplifying the market access process for innovative digital solutions.
– Ensuring patient access to cutting-edge technologies and,
– Providing a pathway for reimbursement by statutory health insurance providers.
To achieve reimbursement for an AI application in Germany, developers must navigate a multi-tiered process that involves certification, evaluation and collaboration with various authorities.
Step 1: Certification as a Medical Device
AI tools must first obtain certification under the Medical Device Regulation (MDR), which governs safety and performance in the European Union.
– Authority Involved: Independent Notified Bodies (e.g., TÜV SÜD, DEKRA Certification GmbH).
– Focus Areas: Clinical safety, Risk management and Performance validation in medical environments.
Step 2: Application Submission to BfArM
Once certified, the developer applies to the Federal Institute for Drugs and Medical Devices (BfArM), the primary agency responsible for evaluating digital health applications for inclusion in the DiGA Directory.
Requirements for Application:
– Clinical Evidence:
– Randomised Controlled Trials (RCTs) or real-world evidence showing medical benefits.
– Proof of improved clinical outcomes or enhanced care processes.
– Economic Analysis:
– Evidence of cost-effectiveness compared to conventional approaches.
– Potential savings for healthcare providers and payers.
– Data Protection and Security:
– Adherence to GDPR and national regulations for patient data security.
– Secure handling of sensitive healthcare data.
– Interoperability:
– Compatibility with existing healthcare IT systems (e.g., electronic health records).
Step 3: Real-World Data Collection and G-BA Review
During the provisional period, the developer must collect real-world evidence (RWE) in clinical settings to support the initial claims of efficacy and cost-effectiveness.
Step 4: Pricing Negotiation
If the G-BA grants final approval, the developer enters pricing negotiations with Germany’s statutory health insurance providers. The outcome determines the reimbursement rate for the AI tool.
Key Managing Authorities include:
The Federal Institute for Drugs and Medical Devices (BfArM): Oversees evaluation of AI tools for provisional approval.
The Federal Joint Committee (G-BA): Conducts long-term evaluations and final approvals for AI reimbursement.
The Statutory Health Insurance Funds (GKV-Spitzenverband): Collaborates with developers to negotiate reimbursement rates.
Applying for Reimbursement in Germany: A Step-by-Step Guide
1. Obtain MDR Certification:
– Work with a Notified Body to certify your AI tool as a medical device.
2. Prepare Application for BfArM:
– Submit clinical evidence, economic analysis, and technical documentation.
3. Engage with Healthcare Providers:
– Collaborate with hospitals and clinicians during the real-world evidence phase.
4. Monitor G-BA Evaluation:
– Ensure ongoing communication with G-BA during the final review process.
5. Negotiate Pricing with SHI:
– Partner with statutory insurers to set reimbursement rates.