Digital Health Applications Ordinance – DiGAV of 21 April 2020

To contain the spread of the coronavirus, the use of applications (apps) that are used on smartphones or smart watches has been proposed frequently. It is not least this consideration that suggests that digitisation should also be promoted in the healthcare sector. To this end, the legislator has initiated the next steps towards digitisation of the healthcare system with the Digital Supply Act Digital Supply Act (Digitales-Versorgungs-Gesetz, "DVG") and the supplementary Digital Health Applications Ordinance Digital Health Applications Ordinance (Digitale Gesundheitsanwendungen-Verordnung, "DiGAV").

The DVG came into force on 19 December 2019. It has thus created the basis for the insured persons' entitlement to benefits from the provision of digital health applications. Among other things, the DVG has made amendments to the German Social Code Book V (Fünftes Buch Sozialgesetzbuch, "SGB V"). For instance, section 33a SGB V was newly included which defines digital health applications in legal terms. According to the amended section 33a (1) of SGB V, insured persons are entitled to be supplied with low-risk medical devices whose main function is essentially based on digital technologies and which are intended to support the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities among the insured persons or in the care provided by service providers. Medical devices of low risk class are those that are assigned to risk class I or IIa in accordance with the EU Medical Devices Regulation (EU) 2017/745. Digital health applications are thus to be considered as medical devices in the sense of section 33a SGB V. As a consequence, the regulations of medical device law must first be observed, in particular the implementation of a conformity evaluation procedure in accordance with the Medical Device Directive 93/42/EEC, which is still in force, and the EU Medical Device Regulation which will be in force as of 26 May 2021. For medical devices of risk class

I as defined by the EU Medical Devices Regulation, the conformity evaluation procedure can be carried out by the manufacturer himself.

The claim according to section 33a (1) SGB V only covers those digital health applications which have been included by the Federal Institute for Drugs and Medical Devices ("BfArM") in the directory for digital health applications according to the also newly included section 139e SGB V and which are used either according to the prescription of the attending physician or with the approval of the health insurance company. Section 139e (1) SGB V stipulates that the BfArM maintains a directory for reimbursable digital health applications according to section 33a SGB V. The respective directory is published in the Federal Gazette. Pursuant to section 139e (2) SGB V, the medical device in question is included in the directory upon electronic application by the manufacturer to the BfArM, which has to decide on the application within three months of receipt of the complete application pursuant to section 139e (3) SGB V.

The DiGAV also came into force on 21 April 2020. Among other things, the DiGAV sets out the requirements to be met by digital health applications for inclusion in the directory, particularly with regard to security, quality, data protection and data security (cf. sections 3 to 6 DiGAV) and determines the procedure for inclusion of the relevant medical device in the directory for digital health applications. According to this, the safety and functionality of the digital health application is proven in particular by the CE conformity marking in the sense of the medical device law (also see our contribution to Placing on the market of medical devices in the course of the corona crisis). The BfArM may carry out additional examinations for substantiated reasons, e.g. demand the submission of further documents, in particular the declarations and certificates necessary for the conformity evaluation procedure. Furthermore, BfArM may require the manufacturer to submit certificates confirming that the requirements pursuant to sections 4 to 6 DiGAV have been met, insofar as corresponding certificates are provided for on the basis of safety, quality or environmental standards or other recognised certificates are suitable as proof of the requirements. The certificates must not be older than twelve months. Pursuant to section 7 (2) DiGAV, the certificates must have been issued by an appropriately qualified and recognised certification body. A further prerequisite for inclusion in the directory is the provision of evidence of positive supply effects. According to section 8 (1) DiGAV, positive healthcare effects are either a medical benefit or structural and procedural improvements in healthcare relevant to patients. In accordance with section 10 DiGAV, the manufacturer must submit a comparative study as evidence.

Together with the DiGAV, Guidance document of the BfArM has also been published. The guidance document offers a summary of the regulations of DVG and DiGAV and illustrates with examples when a registrable digital health application in the sense of the legal regulations is at hand. Among other things, the guidance document addresses the fact that digital health applications serve to support the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities. Accordingly, primary preventive digital health applications cannot be listed in the directory according to section 139e SGB V, since primary prevention serves to prevent the development of diseases and not to detect or treat them. The guidance document also illustrates the basic application procedure and explains that the procedure is designed as a fast track. The BfArM has to assess the product within the three-month period according to section 139e (3) SGB V. If the requirements for safety, quality, data protection and data security are met and if there are positive supply effects, the BfArM must include the digital health application in the directory. In this context, evidence of safety and functional capability is generally deemed to have been provided upon successful completion of the conformity evaluation procedure. If only the positive effects of supply are not proven, provisional inclusion in the directory can be granted upon application which triggers a test phase of up to one year during which the necessary comparative study is to be carried out.

Dr Silke Dulle

Robert Schmid

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Dr Silke Dulle T   +49 30 26471-155 E
Robert Schmid T   +49 30 26471-262 E