Digital Innovations on the Way to Reimbursement by Health Care Service Providers

The Digital Healthcare Act (Digitale-Versogungs-Gesetz, DVG) introduced the “app on prescription” for medical device software (MDSW) for patients (§§ 33a and 139e Fünftes Buch Sozialgesetzbuch).

We support you in developing scientific concepts to prove the positive healthcare effect for the inclusion of your DiGA in the directory of the Federal    Institute    for    Drugs    and    Medical    Devices (Bundesinstitut  für  Arzneimittel  und  Medizinprodukte, BfArM).

Digital Health Applications (DiGA)

Are you a manufacturer of a digital health application ("medical app" medical device software (MDSW)) and would like to find your way into the statutory health insurance (Gesetzliche Krankenversicherung, GKV) reimbursement system and thus develop a "medical app on prescription"? We are happy to support you in developing scientific strategic approaches in a goal-oriented manner and implementing them in accordance with the requirements of the BfArM.

What is at stake?

The Digital Healthcare Act (DVG) of 2019 aims to provide manufacturers of digital health solutions with a significantly accelerated process for the reimbursement of their innovative digital medical devices in a "fast-track procedure". The criteria according to BfArM evaluates new digital health solutions in this process are described in detail and are interpreted according to strictly scientific criteria. In addition to comprehensive proof of technical safety, functional suitability, data protection and data security, as well as the quality of medical content of the digital healthcare application, proof of a so-called positive health care effect (German: positiver Versorgungseffekt, 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 medical apps are listed in the "Directory for Digital Health Applications" in accordance with §139e SGB V.

What is 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 by digital technologies
• Assists in the detection, monitoring, treatment or alleviation of disease, injury or disability

What is a positive healthcare effect (positiver Versorgungseffekt, pVE)?

The BfArM distinguishes products with:

1.  Medical benefit (medizinisches Nutzen, mN)

e.g.

• Improvement of the state of health
• Shortening of the duration of the disease
• Extension of survival
• Improvement in the health-related quality of life

2. Patient-relevant improvement of structure and processes (Patientenrelevante Struktur- und Verfahrensverbesserung, pSVV)

e.g.

• Coordination of treatment processes
• Alignment of treatment with guidlines and recognized standards
• Adherence
• Facilitating access to healthcare
• Patient safety
• Health literacy
• Patient autonomy
• Coping with illness-related difficulties in everyday life
• Reducing therapy-related expenses and strains 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 digital healthcare application.

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

Basically, a clinical trial must be conducted to prove that a digital healthcare application is better than not using it.

The digital health application guideline sets clearly defined requirements for the clinical study:

• Indication of at least one positive healthcare effect (either a medical benefit or patient-relevant improvement of structure and processes in healthcare)
• Quantitative, comparative study showing that use of digital health application is better than non-use (= non-treatment, alternative treatment without DiGA, comparable DiGA)
• The selection of the comparison or control group must be based on the German health care reality
• Specification 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 the results (e.g. peer-reviewed journal or website)

Benefit from our many years of experience in designing and conducting clinical trials!

What are the regulatory requirements for your DiGA?

We are happy to advise you on what specific requirements the Digital Health Applications Ordinance (German, Digitale-Gesundheitsanwendungen-Verordnung, DiGAV), imposes on manufacturers. We offer you support and guidance for the consultation meetings with the BfArM (according to §23 DiGAV) and conduct a systematic risk analysis together with you to identify potential obstacles in the evaluation process.

Your digital solution needs scientific proof? Contact us.

info_at_mediac.de

Phone: +49 30 521 044 80