As of April 19, 2021 The Digital Care Act for “better care through digitalization and innovation” came into force on December 19, 2019. The aim of the so-called “Digital Care Act” (DVG): Patients will be allowed to have healthcare applications prescribed by their doctor, telemedicine will become more accessible and digital innovations will be promoted more strongly. The introduction of the electronic patient file (on the telematics infrastructure) in January 2021 was also initiated by the DVG. In this article, we explain what is meant by “doctors may prescribe apps” and specifically how app manufacturers can have their app prescribed. The DVG not only makes the financing of apps easier, but should also significantly speed up the negotiation process with health insurance companies.
Prescribing apps
Basically, we are not talking about apps, but about health applications in general. We are talking about medical devices that use digital technologies to support the detection, monitoring, treatment, compensation or alleviation of illnesses, injuries or disabilities. This includes, for example, apps that help diabetes patients to document their blood sugar levels or apps that remind patients to take their medication. In future, patients will be able to obtain such applications with a prescription from their doctor or with the approval of their health insurance provider. The app manufacturer will be compensated accordingly. However, the app manufacturer must first submit their app to the BfArM (Federal Institute for Drugs and Medical Devices) and have it checked. If the BfArM gives its approval, the app is provisionally paid for by the statutory health insurance for one year. As soon as a positive effect on care has been proven, the GKV-Spitzenverband will negotiate the amount of reimbursement by the health insurance funds together with the manufacturer. Prior to permanent inclusion, the prices set by the manufacturer apply.
Accelerated market launch
Another important point is the accelerated market launch: the BfArM decides on the application within 3 months of receiving the complete application documents. If the BfArM accepts the application/app, it will be included in the DiGA directory (Digital Health Applications). After permanent inclusion, the negotiation phase on the reimbursement amount for the app begins with the GKV-Spitzenverband. Here, too, there is a clear timetable: If no agreement is reached within six months of the start of negotiations, the arbitration board will determine the reimbursement amounts within 3 months. If the healthcare application meets all the criteria, this paves the way for a rapid market launch. This makes it easier for start-ups in particular to enter the healthcare market, which is difficult anyway.
Criteria for inclusion in the list of digital health applications
If the BfArM accepts the application/app, it will be included in the DiGA directory (Digital Health Applications). According to the BfArM, the application must meet the following criteria for inclusion. All details of the procedure, including the exact criteria for inclusion in the DiGA directory, are dealt with in a supplementary legal ordinance. This ordinance is called DiGAV (Digital Health Applications Ordinance). We have written a comprehensive guide to the DiGAV here. Here is a rough overview: #1: The application must be a medical device of a low risk class (Class I or IIa) and have successfully completed a conformity assessment procedure in accordance with the MDR (Medical Device Regulation) or MDD (Medical Device Directive). This criterion is very clear and fulfillment is specifically regulated by the MDR or MDD. We explain how you can decide whether your application is a medical device in a separate article. If you already know that it is a medical device, you can find its risk class in our MDR guide. #2: Positive health care effects must be demonstrated by the application. The DiGA must demonstrate positive care effects. If the manufacturer is not yet able to demonstrate positive care effects at the beginning, it can still apply for the digital health application to be included in the DiGA directory for testing. With sufficient justification, this period can be extended by up to a further 12 months. More information on this can be found in our guide to the DiGAV. #3: The application is tested for safety, functionality and quality Since the application must be a medical device, this criterion will naturally be met. There is currently no better proof of safety, functionality and quality for healthcare applications than the Medical Devices Act/Medical Devices Ordinance. #4: The application must guarantee data security and data protection A fundamental distinction is made between data security and data protection. Data security is about technical protective measures to protect data (from viruses, manipulation, hackers, etc.). Data protection describes how personal data can be further processed in order to be protected against misuse (regulated by law). 
The Medical Devices Act and the GDPR already stipulate requirements for data security and data protection. The BfArM also uses a questionnaire to request specific requirements, as can be seen in the DiGAV. From 2022 at the latest, certification in accordance with the ISO 27000 series will even be required. From 2023, all DiGAs (including those already listed) must have a data security certificate from the BSI and a data protection certificate. Find out more in this article: Data security and data protection certificates for DiGA In addition to the criteria mentioned, there are a few other conditions that we will not explain in detail here. You can find a complete list of all the criteria in our article on “Is your app a DiGA?”. If the application fulfills all criteria and is accepted by the BfArM, statutory health insurance companies will reimburse the costs of the application for one year. During this time, the manufacturer must prove whether their app improves patient care. At the end of the year, it is then evaluated whether the application remains in the DiGA directory or not. In principle, the BfArM also advises companies on inclusion in the DiGA directory (subject to a fee).
Conclusion
The Digital Healthcare Act is an important step towards enabling continuous innovation in the healthcare sector in Germany in the future. The specific provisions are a long overdue step towards advancing the digitalization of the healthcare system. The market launch of health apps will not only be facilitated, but also accelerated. This will enable more companies to launch innovative, digital products on the market. Of course, not every health app is useful. It is therefore important that the benefits of every health app are scrutinized. Insurance companies must not pay for applications that offer no added value for patient treatment. Any further questions? Please feel free to call us (+49 (0) 89 54998380) or send us an email (kontakt@quickbirdmedical.com).
