Digital Health Applications (DiGA): Six facts for medical manufacturers

With the Digital Health Care Act (DVG), the Digital Health Application (DiGA) has been included as a new category of services in the catalog of standard services provided by the public health insurance system (SHI). Patients with public health insurance are now guaranteed the provision of a DiGA.

This opens up a wide range of opportunities for manufacturers and creates a number of challenges. Even the publication of the DiGA guide by the Federal Institute for Pharmaceuticals and Medical Devices (BfArM) could not eliminate all uncertainties.

What manufacturers should know about the legal requirements of the law and the conditions for inclusion in the DiGA directory? We have summed it up.

Legal framework

The legislature relied on three different types of standards to structure the legal framework for DiGA. At the highest level, there is the parliamentary law, the Digital Health Care Act (DVG), which defines the regulatory framework, the essential key points and criteria. A second elaboration of the DVG framework is provided by a legal ordinance of the Federal Ministry of Health (BMG), the so-called Digital Health Applications Ordinance (DiGAV).

According to Section 139 e (9) of the German Social Health Code (SGB V), the DiGAV is intended to regulate relevant detailed questions regarding the material requirements of DiGA, the inclusion procedure in the directory for digital health applications pursuant to Section 139 e of the German Social Health Code (SGB V) (“DiGA directory”), and the arbitration procedure regarding the payment amount.

The third type of standard is an administrative regulation of the BfArM, the so-called DiGA Guideline, which was published at the end of April 2020.

DiGA register

The register of refundable DiGA can be found on the website of the BfArM. Manufacturers must essentially follow the following steps in accordance with Section 139 e (2) of the German Social Code, Book V (SGB V) to achieve inclusion in the DiGA Directory:

Electronic application to the BfArM
Fulfillment of the requirements for safety, functional capability and quality of the DiGA
Proof of the requirements for data protection as well as data security
Proof of positive supply effects

Electronic request to the BfArM

The electronic application can be directed to a provisional as well as to a final inclusion in the DiGA register. A final inclusion in the DiGA list will probably be determined by a comparative study already completed by the manufacturer to prove the positive health care effects. According to Section 1 (2) of the DiGAV, manufacturers of the medical device as defined by the applicable medical device regulations are eligible to apply.

Compliance with the requirements for safety, functional performance and quality

According to § 2 para. 1 DiGAV, verification of compliance with the requirements for safety, functional capability and quality of the DiGA is deemed to be provided by the CE conformity marking.

Data protection and data security requirements

Manufacturers provide the data protection and data security requirements by a self-declaration. The content of the self-declaration is determined by appendix 1 of the DiGAV. Therefore, the BfArM does not conduct its own assessment of the manufacturer’s conformity with data protection law. Thus, the manufacturer ultimately bears the risk of a false assessment.

Demonstration of positive health care effects

Finally, the manufacturer must provide documentation of positive effects on healthcare. A definition of positive health care effects can be found in Section 8 (1) of the DiGAV, according to which these effects are reflected either in a medical benefit or in patient-relevant structural and procedural improvements in health care. Both medical benefits and structural and procedural improvements in care are further defined in Section 8 (2) and (3) DiGAV.

Finally, in the application for registration, the manufacturer must specifically name the positive effect on healthcare, which has been proven by a comparative study or is still to be proven in the context of a provisional registration in the DiGA directory, as well as the patient group concerned (or the indications according to ICD-10-GM).

Preview

The proof of positive health care effects is likely to prove to be the biggest barrier in practice. In addition to the manufacturers access to billing and research data for a retrospective study, there is still a lack of a general data strategy in the health care system, which would be important for such proof. In the event of a rejection of inclusion in the DiGA directory, the only option left to manufacturers is to appeal the rejection decision.

Digital Health Applications (DiGA): Six facts for medical manufacturers

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