Departmental draft of the Digital Health Applications Ordinance

Category: product liability, product safety, compliance Industry: healthcare Author: Year:
Miriam Schuh

The Digital Care Act establishes a claim for those with statutory health insurance to qualified digital health applications whose effectiveness, safety, quality and positive effect on care have been demonstrated. At the same time, such applications will have to comply with applicable data protection and security requirements and must be included in a directory of digital health applications following completion of a new procedure to be implemented by the Federal Institute for Drugs and Medical Devices (BfArM) in order to verify that the applications in question are eligible for coverage.

The stated goal of the law's drafters (the Federal Ministry of Health) is to establish requirements and procedures to ensure that only safe and high-quality applications are used in medical care. They also intended to provide manufacturers with clarity and advance notice about the requirements for inclusion in the digital applications directory.

Accordingly, the Digital Health Applications Ordinance (PDF) defines requirements with respect to

  • the procedure for inclusion in the digital health applications directory;
  • consultations with manufacturers of digital health applications;
  • providing notice of material changes; and
  • fees accruing in connection with the administrative procedure.

To this end, the departmental draft of the Ordinance defines requirements, in broad strokes, – with respect to effectiveness, safety, quality, data protection and security which manufacturers of digital health applications should keep in mind starting in the product development process. A medical device's effectiveness and safety is generally considered to be demonstrated by a CE marking.

Positive effects on care  

The application for inclusion in the digital health applications directory must also cite demonstrated positive effects on patient care. For the purposes of the Digital Health Applications Ordinance, positive effects on care may either be a medical benefit or procedural and structural improvements of relevance for patient care. A medical benefit is defined as a relevant therapeutic effect on the patient such as improvement of the patient's medical condition, shortening the duration of an illness, extending survival or improving quality of life.

Relevant procedural and structural improvements in patient care relate to medical actions to provide patients with support and processes for interactions between patients and medical care providers in connection with the identification, monitoring, treatment or mitigation of illnesses or the identification, treatment, mitigation or compensation of injuries or disabilities. 

Documentation through studies  

Positive effects on patient care claimed by manufacturers must be documented in a comparative study demonstrating that superior results can be achieved through intervention relative to cases where the digital health application is not used. BfArM will then evaluate whether positive effects on patient care have been demonstrated to a sufficient extent based on the documents presented. This evaluation will take into account the expected positive and negative effects based on the available findings, with due regard for the individual circumstances of the indication, the risks associated with the digital health application and whether or not patient care alternatives are available.

Data protection and security requirements

Manufacturers of digital health applications are required to implement statutory requirements with respect to data protection and data security consistent with the latest technological standards and with due regard for the nature of the processed data and the associated levels of protection, so as to ensure the necessary protection. Personal data may only be processed based on the consent of the insured person and only for certain purposes, which are listed in the Digital Health Applications Ordinance.


The departmental draft of the Digital Health Applications Ordinance advances efforts to digitize health care. It also emphasizes that apps must have positive effects on patient care in order to be eligible for coverage. To this end, it is necessary to clearly distinguish between wellness or lifestyle apps, which are not eligible for coverage, and health apps which qualify as medical devices.  Positive effects on patient care must be demonstrated through appropriate studies. The draft Ordinance does not specify precise assessment criteria for the documentation and depth of these studies. However, it is clear that ensuring standard coverage of digital health applications will require manufacturers to incur additional administrative and monetary expense in order to compile the application documents to enable BfArM to verify that the applications in question meet the requirements for coverage and in order to conduct the studies necessary to demonstrate positive effects on care.

[February 2020]