Q&A: REGULATION AND REIMBURSEMENT OF DIGITAL THERAPEUTICS (DTX) / Germany

To enable a consistent comparison of the legal frameworks surrounding digital therapeutics (DTx) across different jurisdictions, we have developed this Q&A template. It serves as the basis for a blog series on the BLE website that explores how various countries regulate, clas- sify, and reimburse digital health applications. By answering the following questions, you con- tribute to an international understanding of how DTx are integrated into national healthcare systems. We appreciate your time and expertise in supporting this cross-border digital health initiative.

A. Contributor Information 

Name: Dominik Roter

 Law Firm / Organization:  Dierks+Company    

 City / Country:  Berlin, Germany                                                             

 Email:  dominik.roter@dierks.company

B. Introduction – Status and Definition of DTx

1. Does your country have any uniform or established regulations for digital therapeutics (DTx) which provides for a legal definition of DTx? If not, are there any soft law instruments, guidance documents, or working definitions used by authorities or HTA bodies?

Germany has no single legal definition of 'legal therapeutics". However, the DiGA framework, introduced by the Digital Healthcare Act (DVG, 2019) and codified in §33a and 139e SGB V, effectively serves this role. DiGA are CE-marketed medical devices used by patients for therpeutic or diagnostic purposes. Initially limited to low-risk devices (Class I / IIa), eligibility now extends to certain Class IIb products under the 2023 Digital Act. BfArM provides guidance through its DiGA Guide.

C. Legal Classification of DTx in your Country

2. Under which legal framework do DTx fall in your country (e.g., medical devices, pharmaceuticals, others)?

DTx in Germany are regulated as medical devices under the EU Medical Device Regulation (MDR). They fall under this framework if they serve a medical purpose like diagnosis or treatment. Pharmaceuticals law does not apply unless the digital product contains a pharmacological component. [Sources: MDR Art. 2; MPDG] 

3. What criteria determine whether a DTx is classified as a medical device or as a well-ness/lifestyle/other product?

Classification depends on the intended medical purpose. Software that supports diagnosis or treatment is regulated under MDR as a medical device. Apps without medical claims, such as fitness trackers or general wellness tools, are not medical devices. [Sources: MDR Annex VIII, Rule 11; BfArM FAQ] 

4. What are the regulatory requirements for market access (e.g., conformity assessment, CE marking, national registration)?

DTx must obtain CE marking under the EU MDR, based on conformity assessment of safety and performance. Class I devices may self-certify; Class IIa and higher require Notified Body involvement. Registration in EUDAMED or national systems is required. There is no national registration requiered for marcet access.  

5. Are there specific cybersecurity, interoperability, or data protection requirements that apply to DTx?

Yes. DiGAV and BfArM require encryption, authentication, ISO 27001-based ISMS, and BSI-compliant penetration testing. GDPR applies fully. Interoperability with standards like HL7/FHIR and connection to ePA is mandatory.  

6. Is there a specific regulatory pathway or fast-track available for digital health products or DTx (e.g., expedited review, sandbox programs)?

Yes, the DiGA Fast-Track per §139e SGB V enables BfArM to evaluate qualifying CE-marked apps within 3 months. This pathway is exclusive to low-risk, patient-facing medical devices.

7. How is the legal distinction between DTx and other digital health applications handled (if any) in your jurisdiction?

The distinction is functional: apps with a medical purpose for patient use and CE marking can become DiGA. Wellness or provider-only tools are excluded. No legal definition for 'DTx' exists. 

D. Reimbursement According to your Jurisdiction

8. Is there a legal basis for the reimbursement of DTx in your healthcare system?

Yes. §33a SGB V guarantees reimbursement of BfArM-listed DiGA via statutory health insurance. §139e governs listing procedures. In addition, DTx that are not eligible for DiGA status may be reimbursed under §135 SGB V (for outpatient care) or §137c SGB V (for inpatient care) as new methods. These require assessment by the Federal Joint Committee (G-BA). The DiGA pathway is faster and manufacturer-driven, while the method route is initiated by providers and involves HTA via G-BA. 

9. Under what conditions can DTx be eligible for reimbursement (e.g., prescription require- ment, evidence of efficacy, medical benefit)?

DTx must be CE-marked, low-or higher risk medical devices with demonstrated patient benefit. Evidence of clinical or process-related improvement is required. Prescription by a physician or approval by the insurer is mandatory. Outside the DiGA route, DTx may be covered as treatment methods under §135 SGB V (ambulatory) or §137c SGB V (inpatient), requiring G-BA evaluation. 

10. How is reimbursement of DTx practically  carried out – through catalogs, individual agreements, or direct claims to insurers?

Reimbursement is based on the DiGA directory. Once prescribed, patients receive an access code from their insurer. Manufacturers are reimbursed directly. Prices are negotiated with GKV-Spitzenverband after 12 months. Other DTx may be reimbursed under §135 (outpatient) or §137c SGB V (inpatient) if G-BA approves the method. In practice, if a DTx is integrated into an accepted treatment method, it can be reimbursed within outpatient or inpatient care as part of the covered service, even if it is not listed as a DiGA.  

11. What role do health technology assessment (HTA) bodies or evidence evaluation procedures play in this process?

BfArM performs the DiGA benefit assessment using HTA. For other DTx, G-BA and IQWiG assess benefits under §135 (outpatient) and §137c (inpatient) before coverage. The HTA role is thus more formal and intensive outside the DiGA pathway. 

12. What limitations or uncertainties currently exist regarding the reimbursement of DTx in your country (e.g., missing lists, lack of contracts, definitional issues)?

Limitations include reliance on provisional DiGA listings, restricted access for high-risk DTx, and lack of cost-effectiveness assessment. Reimbursement via §§135/137c SGB V is slower, G-BA-driven depending on proven benefit. 

13. Is temporary or conditional reimbursement (e.g., while real-world evidence is collected) possible in your jurisdiction?

Yes. DiGA may be listed provisionally for up to 24 months while generating evidence. Separately, DTx assessed under §137c SGB V can receive conditional hospital coverage if G-BA identifies potential benefit. Ambulatory trials under §137e SGB V are also covered. 

E. Practical barriers

14. Have manufacturers of DTx in your country faced specific practical barriers (e.g., delays in evaluations, inconsistent insurer decisions, lack of digital infrastructure)?

Barriers include MDR certification delays, physician hesitancy, slow e-prescription rollout, and pricing pressures. Integration into care and digital infrastructure also remain challenges. We regard the main barrier in the proof of benefit. 

F. Perspectives – Future Outlook

15. Are there any ongoing initiatives or legislative efforts in your country to further develop or reform the legal and reimbursement framework for DTx?

No. But we expect legislative initiatives soon due to the financial problems of the statutory health insurance. 

16. Do these efforts include stakeholder consultations or pilot programs that manufacturers can engage with?

There is a formalised consultation procedure on government draft legislation. Pilots can be co-financed by means of tests in accordance with § 137e SGB V at the manufacturer's request. In Germany, manufacturers often try to obtain reimbursement through individual contracts with health insurance companies.