Digital health applications (DiGA) are digital or technical medical devices that serve to promote health, detect, monitor or treat diseases or disabilities. Certified DiGA can be included in a benefit catalog of the statutory health insurance (GKV) and be reimbursed by them. They are also subject to the MDR (or MDD) certification process as a medical device.
The Digital Health Care Act (DVG) and Digital Health Applications Regulation (DiGAV) provide the legal framework for inclusion in the benefits catalog. The Digital Supply and Care Modernisation Act (DVPMG) further supplemented these in June 2021.
What are Digital Health Applications (DiGA)?
On 19th December 2019, the “app on prescription” for patients was introduced into the healthcare system when the DVG came into force. Insured patients of the GKV are thus now entitled to a supply of DiGA.
Unlike normal health and lifestyle apps, DiGA are certified medical devices for which a health benefit has been proven. DiGA must therefore be developed in compliance with the law and, in the case of reimbursement by the SHI, must have successfully undergone a testing procedure by the Federal Institute for Drugs and Medical Devices (BfArM). The primary goal of a DiGA is the detection, monitoring, treatment or alleviation of disease. Accordingly, apps for primary prevention are not DiGAs and are not included in the directory.
The following table provides an overview of the most important differences between a DiGA and a “health app”.
Criteria Distinguishing DiGA and Health App
Requirements for a DiGA
DiGAs are generally medical devices with a low-risk class that are based on digital technologies. Primarily the following features characterise digital assistants in the patient’s hand:
The DVG and DiGAV define these characteristics in Germany. In order to facilitate identification for manufacturers, service providers as well as users of DiGA, the BfArM has drafted a guideline.
This guide articulates the requirements necessary for a DiGA to be included in the DiGA Directory. Here you will find a brief summary of the requirements for a DiGA according to the BfArM guidelines:
SUMMARY REQUIREMENT DiGA.
The detailed guideline of the BfArM can be found here:
GERMAN VERSION / ENGLISH VERSION
Admission to the DiGA Directory
DiGAs must meet the following requirements to be included in the DiGA directory of the BfArM in accordance with § 139e of the German Social Code, Book V, and must provide evidence of these requirements to the BfArM:
- Security and functionality
- Data protection and information security
- Quality, especially interoperability
Fast-track places DiGAs at the center of healthcare delivery and can be reimbursed accordingly by SHI. The procedure also defines a comprehensive requirements profile for DiGAs in healthcare for the first time. It thus combines requirements for user-friendliness and performance with data protection and information security. Another focus is on transparency: for manufacturers of DiGA, the path to reimbursability and inclusion in the DiGA directory should be easy to plan and implement through the formulation of clear specifications and interpretation aids. The corresponding guideline of the BfArM according to § 139e paragraph 8 sentence 1 SGB V supports the manufacturers by:
- Presents the individual steps and regulations of the application procedure clearly and in summary form.
- Creates transparency about the concrete requirements to be fulfilled and explains which proofs are to be provided.
- Explains how the normative requirements from DVG and DiGAV are interpreted.
- Shows the support possibilities of the BfArM
- Describes the DiGA directory and the information it contains on the listed DiGA.
The guide is thus a reliable basis for action for applicants and the BfArM. At the same time, it is also designed in such a way that all interested parties can form a comprehensive picture of the evaluation principles and consequently of the (quality) characteristics of a DiGA.
The guide focuses on the application/procedure for (possibly provisional) inclusion of a DiGA in the directory. In addition, it explains the necessary requirements for the quality of the DiGA as well as for the proof of the positive supply effect.
Reimbursement by the SHI: The Fast Track Procedure of the BfArM
The application for a provisional inclusion of a DiGA in the list represents the first, decisive step for the manufacturer towards reimbursement by the SHI. The review procedure for SHI reimbursement in the context of standard care is designed as a “fast track”: After receipt of the complete application by the manufacturer, the assessment period of the BfArM is a maximum of three months. The core of the procedure is, on the one hand, the examination of the manufacturer’s information on the basic requirements of the product. In addition, it is examined whether the specified, positive supply effect can be realised with the DiGA, or a process and structural improvement can be demonstrated.
If all requirements are met, the app is classified as reimbursable and included in the DiGA directory of the BfArM. If there is not yet sufficient evidence of a positive care effect of the DiGA, but the basic requirements are met, the app can also be provisionally included in the directory. The manufacturer must now conduct and submit the required studies within a trial period of up to one year (in exceptional cases up to two years).
In the DiGA directory of the BfArM, persons in the medical sector, psychotherapists, midwives and maternity nurses can see which application can be prescribed as an “app on prescription”. A suitable DiGA can now be prescribed by prescription and stating the pharmaceutical central number.
The patient submits the prescription or proof of indication directly to the SHI. The latter then checks the status of the insured and the eligibility for reimbursement. If reimbursement is approved, the GKV sends the person concerned an activation code with which the prescribed DIGA can be used free of charge for the specified period. Billing takes place directly between the manufacturer and the health insurer.
Evidence of Positive Healthcare Effects
The term positive health care effect (pVE) was introduced by the DVG and refers to either a medical benefit (mN) or patient-relevant structural and procedural improvements (pSVV) in care. When a manufacturer applies for inclusion in the DiGA Directory, they must demonstrate one or more pVEs for their DiGA. This can be around an mN as well as a pSVV.
Medical Benefit
The medical benefit is defined within the DiGAV, following the assessment of medicinal products, as patient-relevant effect(s), especially with regard to:
- Improvement of health status
- Shortening of disease duration
- Prolongation of survival
- Improvement of quality of life
If the manufacturer claims a mN for a DiGA, the manufacturer must show that patient-relevant endpoints, particularly morbidity, mortality, or quality of life, are positively affected.
Improvements in Structure and Process Relevant to Patients (pSVV)
DiGAs offer many opportunities to improve care – especially with regard to patient processes. For this reason, pSVVs have also been approved as a basis for reimbursement by the SHI. According to DiGAV § 8 paragraph 3, such pSVVs can be:
- pSVVs related to the detection, monitoring, treatment, mitigation or compensation of disease, injury or disability.
- pSVVs intended to support patient health care activities or to be integrated into processes between patients and health care providers.
- Specifically include the following areas:
- Coordination of treatment processes
- Alignment of treatment with guidelines and accepted standards
- Adherence
- Facilitating access to care
- Patient safety
- Health literacy
- Patient sovereignty
- Coping with disease-related difficulties in everyday life
- Reduction of therapy-related expenses and burdens for patients and their relatives.
Digital Healthcare Act (DVG)
The Act to Improve Healthcare Provision through Digitalisation and Innovation (Digital Healthcare Act – DVG) enables the simple use of apps on prescription and video consultations. At the same time, treatments are to access a secure data network in the healthcare system. The law came into force on 19th December 2019.
Digital Health Applications Ordinance (DiGAV)
The Digital Health Applications Ordinance (“Verordnung über das Verfahren und die Anforderungen an die Prüfung der Erstattungsfähigkeit von Digital Health-Anwendungen in der gesetzlichen Krankenversicherung”, DiGAV), which came into force at the end of April 2020, further developed the framework conditions for the inclusion of new digital products in the benefits catalog of the statutory health insurance system. Manufacturers can now apply to include their product in the list of reimbursable digital health applications via the BfARM application portal using a fast-track procedure.
The regulation specifies how the Digital Health Care Act (DVG) is to be implemented and what the key requirements for DiGA are:
- DiGA must be a medical device of risk class I or IIa (according to MDR or MDD, respectively)
- Requirements (especially for data protection and interoperability) must be met.
- Manufacturer must demonstrate positive supply aspects.
- The manufacturer must submit a successful application to the BfArM for inclusion in the “List of reimbursable digital health applications according to § 33a”.
The DiGAV now describes in more detail than the DVG how manufacturers can demonstrate that they or their products meet the legal requirements. It also regulates the costs, the process flow and the exact contents of the electronic directory.
Digital Supply and Care Modernisation Act (DVPMG)
With the Digital Care and Nursing Modernisation Act (DVPMG), the German Federal Ministry of Health aims to tie in with the DVG and the Patient Data Protection Act (PDSG). The DVPMG lays the foundation for a comprehensive connection of care to the telematics infrastructure, expands the functions of the ePA as well as the electronic prescription, expands remote treatment and introduces digital care applications at the expense of the SHI. Analogous to DiGA, digital applications (DiPA) are now also being introduced in the area of nursing care, which will be financed by the nursing care insurance in the future. The BfArM is also responsible for testing and certifying DiPA.
Do you need any further support?
Do you have further questions on the topic of digital health applications, or do you have a DiGA project that you need support in implementing? Please contact us at:
info@mic-mainz.de or +49 6131 17-9646.
We look forward to hearing from you!