Digital health applications (DiGA)

The Digital Healthcare Act (DVG) introduced the "app on prescription" for patients in 2019 (Sections 33a and 139e of the Fifth Book of the German) Social Code Book).

Are you a manufacturer of a digital health application ("medical app") and would you like to find your way into the SHI reimbursement scheme in order to distribute a "medical app on prescription"?

What is it all about?

The objective of the Digital Healthcare Act (DVG) of 2019 is 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 positive healthcare effect (pVE) must be provided. A positive healthcare 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 alleviation of disease, injury or disability

What is a positive healthcare effect (pVE)?

The BfArM distinguishes between medical benefit and patient-relevant structural and procedural improvements:

1. medical benefit (mN):

• Improvement of the state of health
• Shortening the duration of the disease
• Prolongation of survival
• Improvement in quality of life

2. patient-relevant improvements of structure and processes (pSVV):

• Coordination of treatment processes
• Alignment of treatment with guidelines and recognised standards
• Adherence
• Facilitating access to care
• Health literacy
• Patient sovereignty
• Reduction of therapy-related expenses and burdens for patients and their relatives

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

What scientific evidence must be provided for a positive healthcare effect (pVE)?

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

The DiGA guideline sets out clearly defined requirements for the clinical study:

• Specification of at least one pVE(medical benefit (mN) or patient-relevant improvement of structure and processes (pSVV).
• Quantitative comparative study showing that the use of DiGA is better than non-use (= non-treatment, alternative treatment without DiGA, comparable DiGA)
• The selection of the comparison or control group must be oriented towards the reality of care in Germany
• Specification of the patient group and thus clear definition of the indications (according to ICD-10)
• Registration of the study in a public study register (e.g. WHO-ICTRP or DRKS)
• Complete publication of the results (e.g. peer-reviewed journal or website)

What regulatory requirements are placed on your DiGA?

We will be happy to consult you on the specific requirements that the Digital Health Applications Ordinance (DiGAV) places on manufacturers. We offer you support and guidance for the scientific consultations with the BfArM (according to §23 DiGAV) and carry out a systematic risk analysis together with you to identify possible obstacles in the evaluation process.

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

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

Benefit from our many years of experience in the design and implementation of clinical studies and contact us for an initial consultation.