Last month, Germany introduced the Digital Health Service Act, which grants German patients access to reimbursable digital health applications. In order to establish the procedural formalities as well as material aspects of such health applications the German Federal Ministry of Health is working on an Ordinance concerning the procedure and the requirements for the assessment of reimbursability of digital health applications in the statutory health insurance.
Last month, Germany introduced the Digital Health Service Act, which grants German patients access to reimbursable digital health applications. (Digitale-Versorgungs-Gesetz – DVG; see also Dr. Jörg Schickert et. al. in: Hogan Lovells Newsflash of 15 November 2019, Digital health solutions to become reimbursable in Germany – milestone for patients and providers). In order to establish the procedural formalities as well as material aspects of such health applications the German Federal Ministry of Health is working on an Ordinance concerning the procedure and the requirements for the assessment of reimbursability of digital health applications in the statutory health insurance (Verordnung über das Verfahren und die Anforderungen der Prüfung der Erstattungsfähigkeit digitaler Gesundheitsanwendungen in der gesetzlichen Krankenversicherung – Digitale-Gesundheitsanwendungen-Verordnung – DiGAV ).
The ordinance aims explicitly at specifying expectations on functionality, safety, quality, and data privacy. Manufacturers of digital health applications that want their products to be reimbursable under the Digital Health Service Act must meet the criteria specified in the ordinance and apply for inclusion of the product in the register for digital health applications which is still to be established. Patients using digital health applications that are listed in the register for digital health applications will expect that the products meet these safety criteria.
Under the ordinance as currently drafted, manufacturers are, among other aspects, required to meet specified criteria on
- Safety and functionality. The manufacturer must provide proof of safety and functionality. These aspects are assessed in the conformity assessment of the product. The CE marking will usually be an indication that the product meets the criteria and the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) will generally not assess these aspects again for digital health applications. However, where the German Federal Institute for Drugs and Medical Devices has doubt about the evidence it may perform additional assessments or request additional evidence.
- Data privacy and data safety. The manufacturer must respect all applicable rules on data privacy and data safety. He must implement measures to safeguard the principles of data handling under the GDPR and to protect confidentiality, availability and integrity of data according to the state of the art.
- Robustness of the product. Product must be robust against malfunctions and misuse. As an example, the product must be robust in case of lack of power supply or internet access. Values used in the operation of the product should be subject to proof of plausibility.
- Consumer protection. This requirement concerns information of the patient on the product, instructions for use, its functionality, and the indication for use. The patient must also be informed upfront whether additional devices are required for use of the digital health application.
- Quality of medical content. The medical content must be up to date and in line with assured medical knowledge and recognized professional standards.
- Patient safety. Risks associated with the use of the digital health application must be as low as possible. While the conformity assessment generally safeguards the technical safety, this additional requirement aims at patient information on risks, sensitive conditions, and information on the necessity to consult with medical practitioners under certain circumstances.
The manufacturer's application to the German Federal Institute for Drugs and Medical Devices for inclusion of the product in the register for digital health applications must include declarations regarding these requirements.
Manufacturers wishing to participate in the reimbursement scheme must be aware of these requirements which may become law when the ordinance comes into effect. It is important to note that such clarification of safety expectations sets a standard and will be taken into account when assessing the safety of the device. Patients will rely on these safety expectations.
We will monitor the further development of the planned ordinance and are available to discuss any questions you may have.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.