First "app on prescription" already in August? The Digital Health Applications Ordinance (Digitale- Gesundheitsanwendungen-Verordnung, DiGAV) has entered into force and the BfArM’s guidance to the fast-track procedure has been published

• The DiGA must be a medical device of risk class I or IIa. It is therefore assumed that the product meets the relevant requirements under the German Act on Medical Devices (Medizinproduktegesetz) (from 2021 the requirements under the EU Medical Device Regulation, MDR).
• The main function of the DiGA must be based on digital technologies and must not serve merely to supplement or control other medical devices. A combined use with diagnostic instruments is possible.
• It is necessary to meet the requirements of, inter alia, data protection and interoperability (Annexes 1 and 2 of the DiGAV).
• The application for inclusion in the directory of reimbursable digital health applications according to Section 139e SGB V can be directed at
  • immediate listing (prerequisite for this is proof of improvements in the delivery of care by at least one retrospective comparative study) or
• preliminary listing (prerequisite is the submission of a systematic data analysis and an evaluation concept).

In order to prove improvements in the delivery of care, a manufacturer must present the results of at least one comparative retrospective study showing that the application of DiGA is better than non-application. The study has to be implemented in Germany or provide proof of transferability to the German system. The study shall be published.

Manufacturers must demonstrate at least one improvement in the delivery of care, which can be either in the field of medical benefit or into the field of the patient-relevant structural and procedural improvements.
Examples of a medical benefit: Improvement of the state of health, shortening the duration of the illness, prolonging survival, improving the quality of life.

Examples of patient-relevant structural and procedural improvements: Coordination of treatment processes, alignment with guidelines, adherence, facilitating access to care, patient safety, health literacy, patient sovereignty, coping with disease-specific burdens.

In case of the combined use of diagnostic instruments, such as the measurement and interpretation of vital data, a survey of users on physical or mental conditions, an assessment of pain sensation, etc., additional studies on test quality have to be submitted.

If proof of improvements in the delivery of care cannot yet be provided when the application is submitted, an application for preliminary listing maybe filed. In addition to the results of a systematic data evaluation, the application must include a conclusive concept for evaluating the proof of improvements in the delivery of care within 12 months of inclusion in the directory (trial period). The trial period may be extended once by 12 months on request, provided that it can be conclusively demonstrated, at least 3 months before the end of the trial period, for what reasons it has not been possible to provide proof so far and how it can be provided in future.

The DiGAV specifies the following costs of the administrative procedures for an application and further examinations by the BfArM, among others:

• EUR 3,000 to EUR 9,900 for the decision on permanent listing the directory of digital health applications and for the decision on preliminary listing in the directory of digital health applications for trials
• EUR 1,500 to EUR 6,600 for decisions on permanent listing in the directory after the end of the trial period
• EUR 1,500 to 4,900 for decisions on the extension of the trial period
• EUR 1,500 to EUR 4,900 for the examination and evaluation of substantial changes to a DiGA

The framework agreement between manufacturers' associations (such as the SVDGV) and the National Association of Statutory Health Insurance Funds on the criteria for negotiating prices for apps is still pending. Initially, the prices set by the manufacturer will apply in the first year, both for permanent and preliminary listings. However, these must be based on the pricing standards in the framework agreement mentioned above and any group-related maximum prices envisaged there, which in turn can be influenced by the available proof of improvements in the delivery of care.

The basis for the price negotiations after the first 12 months is formed by proven improvements in the delivery of care, self-payer prices to be indicated, prices in other European countries and the content requirements of the framework agreement. Performance-related price components should also be agreed. A joint arbitration board is to settle disputes on remuneration issues.

The incentives underlying the listing in the DiGA directory, but also the growing interest in digital healthcare applications as a result of the corona pandemic, offer considerable opportunities for providers of digital products. Although the procedure for inclusion in the DiGA directory is complex and represents a hurdle, the requirements can be met when following a well-considered approach. A good first orientation is offered by the guidance of the BfArM [in German only].

It should be noted that the fast-track procedure offers an unprecedented opportunity to quickly introduce innovative digital products in mainstream healthcare in this form - with access to more than 70 million insured persons. In order to promote digitisation in the health sector, however, digital health applications should not be limited to medical devices of risk class I and IIa, in the medium term

As a result of the decision to postpone the validity of the Medical Devices Regulation by one year, developers have another year to have their health applications certified under "old" law.

Manufacturers should carefully consider the indication or scope of application for which the application for listing in the directory is to be submitted. They should be aware that if an application for listing in the directory is rejected due to lack of proof of improvements in the delivery of care, they have to wait at least one year before a new application can be submitted - and this only in the case of new proof of improvements in the delivery of care. In addition, significant subsequent changes are subject to notification and may result in deletion from the directory.