Digital health applications (DiGA)

The Digital Healthcare Act (DVG) introduced the "app on prescription" for patients (Sections 33a and 139e of the Fifth Book of the German Social Code).

We support you in the development of scientific concepts to prove the positive supply effect for the inclusion of your DiGA in the list of the BfArM.

Are you a manufacturer of a digital health application ("medical app") and would like to find your way into the statutory health insurance reimbursement system in order to distribute a "medical app on prescription"? We will be happy to support you in developing scientific strategic approaches in a targeted manner and implementing them in accordance with the requirements of the BfArM.

What is it about?

The Digital Healthcare Act (DVG) of 2019 aims to enable manufacturers of digital healthcare solutions to significantly accelerate the reimbursement process for their innovative digital medical devices in a "fast-track procedure". The criteria according to which the Federal Institute for Drugs and Medical Devices (BfArM) evaluates new digital healthcare solutions are described in detail and are designed according to strict scientific criteria. In addition to comprehensive evidence of technical safety, functional suitability, data protection and data security as well as the quality of the medical content of the DiGA, proof of a so-called positive care effect (pVE) must be provided. A positive care effect must be explicitly proven on the basis of at least one clinical study of sufficient quality. If the criteria are met, the DiGAs are listed in the "Directory for Digital Health Applications" in accordance with §139e SGB V.

What is a DiGA?

According to the BfArM, a DiGA must have these characteristics:

• CE-marked medical device of low risk class (I or IIa)
• Main function is achieved through digital technologies
• Assists in the detection, monitoring, treatment, or mitigation of disease, injury, or disability

What is a positive supply effect (pVE)?

The BfArM distinguishes products with:

1. Medical benefit (mN)

E.g.

• Improvement of the state of health
• Shortening the duration of illness
• Prolongation of survival
• Improving the quality of life

2. Patient-relevant structural and procedural improvements (pSVV).

E.g.

• Coordination of the treatment processes
• Alignment of treatment with guidelines and recognized standards
• Adherence
• Facilitating access to care
• Health Literacy
• Patient Sovereignty
• Reduction of therapy-related expenses and burdens for patients and their relatives

In its evaluation, the BfArM only considers products that have a direct patient benefit. Products that only reduce the workload or have an economic benefit do not count as DiGA.

What scientific evidence must be provided to demonstrate a positive effect of care (pVE)?

In principle, a clinical study must be conducted to prove that DiGA is better than not using it.

The DiGA guideline sets clearly defined requirements for the clinical trial for this purpose:

• Specification of at least one pVE(medical benefit (mN) or patient-relevant structural and procedural improvements (pSVV))
• Quantitative, comparative study showing that DiGA use is better than no use (= no treatment, alternative treatment without DiGA, comparable DiGA).
• The selection of the comparison or control group must be based on the German health care reality
• Indication of the patient group and thus clear definition of the indications (according to ICD-10)
• Registration of the study in a public study registry (e.g. WHO-ICTRP or DRKS).
• Full publication of results (e.g. peer-reviewed journal or website).

Benefit from our many years of experience in the design and implementation of clinical studies!

What are the regulatory requirements for your DiGA?

We will be happy to advise you on the specific requirements that the Digital Health Applications Ordinance (DiGAV) places on manufacturers. We offer you support and guidance for consultations with the BfArM (in accordance with Section 23 DiGAV) and work with you to carry out a systematic risk analysis to identify potential obstacles in the assessment process.

The path to inclusion in the DiGA directory simply as an infographic:

‍