The Digital-Supply-Act (Digitale-Versorgung-Gesetz, 'DVG'), which aims to further promote digitization in the German health care system, entered into force on 19 December 2019 and regulates, inter alia, the prescription of Digital Health Apps by HCPs (including the cost bearing by statutory health insurance). Patients insured with statutory health funds are eligible for reimbursement of Digital Health Apps. As of this August, prescription for Digital Health Apps will be available, according to statements made by the Federal Ministry of Health at an event of the Health Innovation Hub on 16th July 2020. If an HCP issues a prescription for a specific Digital Health App, the patient will receive a prescription code from its statutory health insurance provider. The patient will then enter the code into the Digital Health App when downloading from the manufacturer's website or an app store. This code will then be transmitted back to the statutory health insurance provider to verify the code. After verification, the Digital Health App will be activated and can be used by the patient. Costs for the Digital Health App will be borne by the statutory health insurance provider. This prescription option will likely be an incentive for patients to expand the use of Digital Health Apps.
Digital Health Apps are understood as CE-marked medical devices of lower risk classes (I, IIa) that are intended to support the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities. CE-marking and classification are based on the Medical Devices Directive 93/42/EEC and (as of its date of application) on the Medical Devices Regulation (EU) 2017/745 which provide for a number of regulatory requirements for obtaining the CE mark.
Patients who have statutory health insurance are entitled to be provided (and paid for by their statutory health insurance provider) with a Digital Health App if the Digital Health App is listed by the Federal Institute for Drugs and Medical Devices ('BfArM') in the directory for Digital Health Applications (officially published in the Federal Gazette) and either an HCP or psychotherapist prescribes it or the health insurance provider has approved it.
To be included in this directory, the Digital Health App manufacturer must submit an application and confirm that the Digital Health App fulfils the requirements laid out in the supplementary Digital Health Applications Ordinance (Digitale Gesundheitsanwendungen-Verordnung, 'DiGAV') by the Federal Ministry of Health, which entered into force on 21 April 2020. The requirements concern in particular aspects on safety and functionality, data protection, data security and quality, and positive healthcare effects. Safety and functionality may be proven by the CE conformity marking¹ under medical device law, but the BfArM may conduct additional examinations of the Digital Health App.
Annexes 1 and 2 to the DiGAV specify the requirements for data protection, data security and quality in form of two questionnaires. The manufacturers of Digital Health Apps must complete the questionnaire set out in annex 1 of the DiGAV and attach it to the application. Annex 2 of the DiGAV must either be completed and attached to the application or, alternatively, the manufacturer must attach a self- declaration as to what degree and why the Digital Health App deviates from the requirements set out in annex 2. The BfArM has to decide on the application within three months of receipt of the completed application. The BfArM also published a guidance document (Leitfaden, only available in German), which includes a summary of the requirements and describes the application and decision-making process.
The application to the BfArM will incur costs (approximately 3.000 to 10.000 EUR). The BfArM is also offering to advise manufacturers on the application process for a fee. To help manufacturers of Digital Health Apps prepare to apply to the BfArM using the electronic application portal (currently not yet available in English), please find below convenience translations of the questionnaires in annex 1 and 2 of the DiGAV.
Click here to access Annex.
1. The CE mark displays conformity with applicable medical device law. Depending on risk classification, the manufacturer may carry out conformity assessment underlying the CE mark with or without involvement of a Notified Body, i.e. an accredited technical auditing organization.