- \n
- 1. Prescribing apps<\/a><\/li>\n
- 2. Accelerated market launch<\/a><\/li>\n
- 3. Criteria for inclusion in the directory of digital health applications<\/a><\/li>\n
- 4. Conclusion<\/a><\/li>\n<\/ul>\n
1. Prescribing apps<\/h2>\n
Basically, we are not talking about apps, but about health applications in general. These are medical devices that use digital technologies to support the detection, monitoring, treatment, compensation, or alleviation of diseases, injuries, or disabilities. These include, for example, apps that help diabetes patients document their blood sugar levels or apps that remind their patients to take their medication.<\/p>\n
Patients will be able to obtain such applications in the future through a prescription from their treating physician or with the approval of their health insurance company. The app manufacturer will receive appropriate financial compensation for this.<\/p>\n
To do so, however, the app manufacturer must first submit its app to the BfArM (Federal Institute for Drugs and Medical Devices)<\/a> for review. If the BfArM approves, the app will be covered by statutory health insurance for a provisional period of one year. Once a positive effect on care has been demonstrated, the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) will negotiate with the manufacturer to determine the amount of reimbursement by the health insurance funds. Prior to permanent inclusion, the prices set by the manufacturer apply.<\/p>\n
2. Accelerated market launch<\/h2>\n
Another important point is the accelerated market launch: The BfArM decides on the application within three months of receiving the complete application documents. If the BfArM accepts the application\/app, it is added to the DiGA directory (d<\/strong>igital h<\/strong>ealth a<\/strong>pplications).<\/p>\n
Once the app has been permanently approved, negotiations with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) begin to determine the reimbursement amount. Here, too, there is a clear timeline: if no agreement is reached within six months of the start of negotiations, the arbitration board will determine the reimbursement amounts within three months.<\/p>\n
If the health application meets all criteria, the way is clear for a rapid market launch. This makes it easier for startups in particular to enter the already difficult healthcare market.<\/p>\n
3. Criteria for inclusion in the directory of digital health applications<\/h2>\n
Akzeptiert das BfArM die Anwendung\/App, wird sie in das DiGA-Verzeichnis (Di<\/strong>gitale G<\/strong>esundheits-A<\/strong>nwendungen) aufgenommen. F\u00fcr die Aufnahme muss die Anwendung laut Aussage des BfArM u.a. folgende Kriterien erf\u00fcllen. Alle Details zum Verfahren inkl. der genauen Kriterien zur Aufnahme in das DiGA-Verzeichnis werden in einer erg\u00e4nzenden Rechtsverordnung behandelt. Diese Rechtsverordnung nennt sich DiGAV (Digitale-Gesundheitsanwendungen-Verordnung). Wir haben zur DiGAV hier einen umfangreichen Leitfaden geschrieben<\/a>. Hier ist schon mal ein grober \u00dcberblick:<\/p>\n
#1: The application must be a low-risk medical device (Class I or IIa) and have successfully completed a conformity assessment procedure in accordance with MDR (Medical Device Regulation) or MDD (Medical Device Directive).<\/p>\n
This criterion is very clear and compliance is specifically regulated by the MDR and 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 using our MDR guide<\/a>.<\/p>\n
#2: Positive effects on care must be demonstrated through application.<\/strong><\/p>\n
The DiGA must demonstrate positive effects on healthcare. If the manufacturer is initially unable to demonstrate any positive effects on healthcare, 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 12 additional months. More information on this can be found in our guide to the DiGAV.<\/a><\/p>\n
#3: The application is tested for security, functionality, and quality.<\/strong><\/p>\n
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 health applications than the Medical Devices Act\/Medical Devices Regulation.<\/p>\n
#4: The application must ensure data security and data protection.<\/strong><\/p>\n
A fundamental distinction is made between data security and data protection. Data security refers to technical safeguards for protecting data (against viruses, manipulation, hackers, etc.). Data protection describes how personal data can be processed in order to protect it from misuse (regulated by law).<\/p>\n
![\"Graphic:](\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2019\/01\/Requirements-for-data-security-and-data-protection-at-DiGA-e1768298371262.webp\")
<\/a>Requirements for data security and data protection at DiGA<\/strong><\/p>\nThe Medical Devices Act and the GDPR already set out requirements for data security and data protection. The BfArM also uses a questionnaire to ask for specific details, as can be seen in the DiGAV<\/a>. From 2022 at the latest, certification in accordance with the ISO 27000 series will even be required. From 2023, all DiGA (including those already listed) must have a data security certificate from the BSI and a data protection certificate. Find out more in this article<\/a>: Data security and data protection certificates for DiGA<\/a><\/p>\n
In addition to the criteria mentioned above, there are several other conditions that we will not explain in detail here. You can find a complete list of all criteria in our article on the topic \u201cIs your app a DiGA?\u201d<\/a><\/p>\n
If the application meets all criteria and is accepted by the BfArM, statutory health insurance companies will reimburse the costs of the application for one year. During this period, the manufacturer must demonstrate whether its app improves patient care. At the end of the year, an evaluation is carried out to determine whether the application will remain in the DiGA directory or not. In principle, the BfArM also advises companies on inclusion in the DiGA directory (subject to a fee).<\/p>\n
4. Conclusion<\/h2>\n
The Digital Care Act is an important step toward enabling continuous innovation in the healthcare sector in Germany in the future. The specific provisions are a long-overdue step toward advancing the digitization of the healthcare system.
\nThis will not only facilitate the market launch of health apps, but also accelerate it. This will enable more companies to bring innovative digital products to market.<\/p>\nOf course, not every health app is useful. It is therefore important to question the benefits of each health application. Health insurance companies should not be expected to pay for applications that offer no added value for patient treatment.<\/p>\n","protected":false},"excerpt":{"rendered":"
The Digital Care Act for \u201cbetter care through digitization and innovation\u201d came into force on December 19, 2019. The aim of the Digital Care Act (DVG) is to enable patients to have health applications prescribed by their doctor, make telemedicine more accessible, and promote digital innovation. The DVG also initiated the introduction of electronic patient […]<\/p>\n","protected":false},"author":1,"featured_media":23402,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"","_et_pb_old_content":"The Digital Care Act for \u201cbetter care through digitalization and innovation\u201d came into force on December 19, 2019. The aim of the so-called \u201cDigital Care Act\u201d (DVG)<\/strong>: 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 \u201cdoctors may prescribe apps\u201d 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.\r\n
Prescribing apps<\/h2>\r\nBasically, 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)<\/a> 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.\r\n
Accelerated market launch<\/h2>\r\nAnother 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 (Di<\/strong>gital H<\/strong>ealth A<\/strong>pplications). 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.\r\n
Criteria for inclusion in the list of digital health applications<\/h2>\r\nIf the BfArM accepts the application\/app, it will be included in the DiGA directory (Di<\/strong>gital H<\/strong>ealth A<\/strong>pplications). 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<\/a>. 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 <\/strong>(Medical Device Regulation) or MDD (Medical Device Directive).<\/strong> 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<\/a>. If you already know that it is a medical device, you can find its risk class in our MDR guide<\/a>. #2: Positive health care effects must be demonstrated by the application.<\/strong> 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<\/a>. #3: The application is tested for safety, functionality and quality<\/strong> 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<\/strong> 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).
![\"\"](\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/07\/Blogartikel-Grafiken-600-\u00d7-400-px-1875-x-1250-px-1224-x-740-px-980-x-551-px-980-x-579-px-937-x-731-px-913-x-1024-px-907-x-1024-px-980-x-510-px.png\")
<\/a> 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<\/a>. 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<\/a>: Data security and data protection certificates for DiGA<\/a> 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 \u201cIs your app a DiGA?\u201d<\/a>. 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).\r\nConclusion<\/h2>\r\nThe 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<\/a>) or send us an email (kontakt@quickbirdmedical.com<\/a>). <\/strong>","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-15360","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-unkategorisiert"],"acf":[],"yoast_head":"\n
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- 2. Accelerated market launch<\/a><\/li>\n