On April 21, 2020, the “Regulation on the Requirements and the Process for the Examination of the Eligibility of Digital Health Applications for Reimbursement by the State Health Schemes” (Digitale Gesundheitsanwendungen-Verordnung – „DiGAV“) came into force in Germany. It is accompanied by an extensive Guidance (Leitfaden) issued by the Medicines and Medical Devices Agency “BfArM”.
The German Federal government wants to promote and support the digitalization of the health system, which has stalled for many years. It adopted important measures in this respect over the last couple of months. A major step was the Digital Healthcare Act (Digitale Versorgung-Gesetz) of December 2019. The act, for instance, enables state health schemes to cooperate with providers in the development of digital health applications and to invest in digital applications.
The act also provides for the reimbursement of low risk digital health applications (sections 33a and 139e of the Social Code, Book V (“SGB V”). The related process is now implemented in the DiGAV. The DiGAV administrative process is designed as a “fast track” process to encourage companies that are less familiar with standard reimbursement procedures to develop digital health applications. It provides for registration of a digital health application with the BfArM, which then qualifies it for reimbursement by the state health schemes. Prices will be regulated under a framework agreement which is currently being negotiated between the associations of insurers and providers; services required by healthcare professionals required for using the application may also be reimbursable.
A separate bill, which is still in draft stage, regulates the establishment of the infrastructure for electronic patient files. Interoperability issues are high on the agenda because of the fragmented nature of the current IT landscape in the health sector.
Scope of the DiGAV
The DiGAV applies to all applications the main functionality of which is based on digital technologies. It is thus not limited to mobile apps.
Broadly, the application must be classified as a low-risk medical device (Class I or IIa) under the Medical Devices Regulation (EU) 2017/745 or Directive 93/42/EEC and be legally on the market (cf. sec. 33a(2) SGB V).
The digital application may include hardware, but not every-day or lifestyle objects such as digital scales or a yoga mat used to do exercises recommended by the application.
The scope of the DiGAV is limited to applications that are used by patients or jointly by a patient and a physician, dentist, or psychotherapist.
Digital applications intended only for the prevention of diseases in healthy people are excluded (section 2.1 of the BfArM Guidance).
The Fast Track Procedure
The DiGAV procedure is separate from the existing procedures, such as the one for new treatment methods, but is not available when an existing procedure has resulted in a refusal.
The provider of the application must apply for registration in a new public registry, which will be kept by BfArM.
The BfArM intends to make available a web portal for the processing of applications, starting this month. The application forms will also be available in English, but the supporting documents must be in German, at least to the extent that they will be published in the registry. The BfArM must approve or reject a complete application within three months.
The digital health application provider must include proof of the following (sec. 139e SGB V):
- safety and functional reliability;
- data protection requirements and data security according to the state of the art (Stand der Technik); and
- positive healthcare effects (positive Versorgungseffekte); if these these cannot be substantiated yet, the provider can ask for the application to be registered for evaluation (Erprobung).
As a rule, the safety and functional reliability are deemed to be confirmed by the CE-mark, but BfArM is entitled to conduct additional tests in exceptional cases (sec. 3 DiGAV).
We discuss the data protection and data security requirements in our Inside Privacy blog here.
Quality requirements (sec. 5 DiGAV)
The digital health applications must
- conform to accepted medical standards;
- meet certain interoperability requirements;
- include measures aimed at ensuring patient safety;
- be robust against incidents and user errors;
- meet consumer law requirements, e.g., consumer information obligations;
- not contain advertising;
- be easy to use and include a free support function (also for the health care professional involved in the use);
- meet certain accessibility requirements.
Types of “positive healthcare effects”
Positive healthcare effects can consist of a medical benefit (medizinischer Nutzen), which is defined as a “patient-relevant effect” that can relate, e.g., to the improvement of the patient’s health status, a shortening of the duration of an illness, an extension of the survival time, or an improvement of the patient’s quality of life.
The positive healthcare effects can also consist in a “patient-relevant improvement of healthcare structures and processes” (patientenrelevante Struktur- und Verfahrensverbesserung in der Versorgung). This can, for instance, relate to:
- coordination of treatment processes,
- alignment of the treatment with guidelines and accepted standards (for treatment or patient behaviour),
- adherence to therapeutic measures by the patient,
- improved accessibility of healthcare,
- patient safety,
- health-related knowledge of the patient,
- patient autonomy,
- assisting the patient in performing his or her daily routine, despite illness-related difficulties,
- reducing and managing difficulties and hardships in connection with an illness or a therapy.
Proof upfront or evaluation
Proof of positive healthcare effects (sec. 10 and 11 DiGAV) requires a quantitative comparative study, which can be a retrospective intra-individual comparison, demonstrating the benefit of using the digital health application (compared to not using it). The methodology can be that of clinical research or of other scientific areas, in particular, healthcare research (Versorgungsforschung) and social research (Sozialforschung). If the digital health application includes a diagnostic instrument, the provider must also submit a study proving the sensitivity and specificity of the digital health application with respect to the targeted patient group (sec. 12 DiGAV).
If the study has not been conducted in Germany, the provider must also prove that its results are applicable in the context of the German healthcare system. The study must be registered in a public study registry that is (1) a primary registry or (2) a partner registry or (3) a data provider under the WHO International Clinical Trials Registry Platform.
If the provider of the digital health application is not yet able to prove positive healthcare effects at the time he files the application for registration with BfArM, he can ask for the application to be registered for evaluation (Erprobung). Registration for evaluation requires a statement by the digital health app provider describing the expected positive healthcare effects based on “plausible grounds” (plausible Begründung) and a scientific evaluation concept from an institution that is independent of the developer of the digital health application, which must include at least a systematic data analysis of the use of the digital health application (sec. 139e par. 4 SGB V, sec. 14 DiGAV). BfArM approves the design of the study or studies to be submitted as proof and sets a deadline for filing them. The evaluation timeframe is usually twelve months, and that period can be prolonged by another twelve months.
The exact scope of the documents published in the registry must be agreed with the BfArM. The DiGAV provides that “information on” the positive effects must be published, but also that the provider must identify in his application the information for which legal requirements concerning the protection of industrial and commercial secrets, of personal data or of intellectual property prevent publication (sec. 2(2) DiGAV).
It can be expected that the detailed rules and especially the BfArM guidelines will be regularly adapted based on the experience obtained with the system.