DiPAs are designed to support the everyday lives of people in need of care and their environment through web and smartphone apps. For example, a digital care application could help to minimize the risk of falls for people in need of care or improve communication between relatives and carers.<\/p>\n
The Regulation on the Assessment of the Reimbursability of Digital Care Applications (DiPAV<\/a>) provides information on how the DiPA application process works and what requirements DiPA must meet in order to be included in the directory of digital care applications.<\/p>\n In this article<\/strong>, we explain the difference between DiPA and DiGA, discuss the most important aspects of DiPAV, and ultimately provide a guide<\/strong> to the DiPA procedure. This guide outlines the process your application must go through in order to be included in the BfArM directory.<\/p>\n Important<\/strong>: In this article, we describe the current legal regulations governing DiPA<\/strong>. However, in November 2025, the BEEP<\/strong> Act (Act on the Expansion of Powers and Debureaucratization in Care<\/strong>) was passed by the German Bundestag, which in its current version provides for relevant changes with regard to DiPA.<\/p><\/blockquote>\n The BEEP Act was supposed to come into force on January 1, 2026, but was referred to the Mediation Committee by the Federal Council due to last-minute amendments relating to hospital financing. If it comes into force unchanged, it would contain important improvements for DiPA:<\/p>\n Note: As the BEEP Act has not yet come into force and changes to its content are still possible, we will update this article as soon as new information becomes available. Below, we provide information about the current legal regulations governing DiPA.<\/em><\/p>\n To better understand the digital care application, it helps to differentiate its use and content from the DiGA.<\/span><\/p>\n DiGA are apps that support sick people in the treatment, diagnosis, compensation or alleviation of illnesses, injuries and disabilities. Their use was recognized on December 19, 2019 with the <\/span> DVG<\/span><\/a> legally established. Since then, DiGA can be reimbursed by health insurance companies as part of medical and psychotherapeutic treatment. DiPA is a similar concept, but is primarily aimed at people in need of care. It was incorporated in mid-2021 through the Digital Care and Nursing Modernization Act (DVPMG) into the <\/span> eleventh German Social Code (SGB)<\/span><\/a>.<\/span><\/p>\n Distinction between DiGA and DiPA <\/strong><\/p>\n As the distinction between DiGA and DiPA is not entirely obvious at first glance, we would like to highlight the most important differences in the following chapters.<\/span><\/p>\n The first major difference between DiGA and DiPA can be found in their place in the legal text. DiGA are defined in SGB V \u2013 Statutory Health Insurance<\/a>, DiPA in SGB XI \u2013 Social Care Insurance<\/a>. A DiGA is therefore reimbursed by the health insurance fund, whereas the costs of a DiPA are covered by the social care insurance fund.<\/p>\n A DiGA is prescribed by doctors and psychotherapists and is explicitly intended to support people with specific indications in terms of relief, therapy, and diagnosis. Similar to medication, the prerequisite for reimbursement of a DiGA by health insurance is a prescription from a doctor or psychotherapist. Direct approval from the health insurance company is also possible. A digital care application, on the other hand, can only be applied for by those in need of care from their long-term care insurance provider.<\/p>\n End user application for a DiPA – Procedure<\/strong><\/p>\n The provision of a DiPA is approved by the long-term care insurance fund upon application by the person in need of care. The initial approval must be limited in time and may not exceed six months. Within this period, the long-term care insurance fund checks whether the digital care application has actually been used and whether the purpose of the DiPA is being achieved in the specific care situation.<\/p>\n If this review shows that both requirements are met, a permanent permit shall be issued. A new application is not required for this.<\/p>\n The permanent approval means that the nursing care insurance fund will grant the monthly reimbursement of up to \u20ac50 on a permanent basis, as long as the legal eligibility requirements are met.<\/p>\n 40a Digital care applications SGB XI:\u201c(1) People in need of care are entitled to care with applications that are essentially based on digital technologies\u201d<\/p><\/blockquote>\n 33a Digital health applications SGB V: \u201c(1) Insured persons are entitled to care with low-risk class medical devices whose main function is essentially based on digital technologies […].\u201d<\/p><\/blockquote>\n These are the introductory words of both paragraphs in the legal text, which immediately make it clear that there is a big difference in terms of the requirements for the digital care application.<\/span><\/p>\n While DiGA are explicitly defined as class I or IIa medical devices, DiPA only refer to \u201capplications\u201d. A DiPA may or may not be a medical device. This means that many of the regulatory requirements with which DiGA manufacturers struggle are (at first glance) not relevant for many DiPAs. <\/span><\/p>\n However, the BfArM also places similar requirements on DiPA that are not medical devices. For example, manufacturers must have a quality management system in place and meet requirements for the safety and functionality of the app. In the current <\/span> DiPA guidelines<\/a> (as of October 11, 2023) therefore reference numerous ISO\/IEC standards for medical devices and refer to the Medical Device Regulation (MDR) in many places. As a result, the requirements for DiPA do not differ significantly in most cases, as they are based on the requirements for medical devices according to MDR.<\/p>\n If it is a medical device, it must belong to a low risk class (I or IIa).<\/p>\n If your application is to be certified as a medical device, you can find further information here.<\/a><\/p>\n While the price limit for DiGA is based on other applications in the same category, a fixed price cap is planned for digital care applications. This means that a maximum of \u20ac50 per month can be reimbursed for a DiPA ( <\/span>\u00a740b SGB XI<\/span><\/a>). Although this has been the subject of heated debate among experts, the law is clear. In principle, a DiPA can also be more expensive, but any additional costs must then be borne by the consumer of the DiPA. <\/span><\/p>\n In principle, an application can be both a DiPA and a DiGA. The current status for manufacturers is that both applications can be submitted for one and the same app. However, deviations in the requirements must be noted. If a listing in both directories is achieved, the consumer’s service provider must check individually which health insurance fund will reimburse the application. <\/span><\/p>\n We have the contents of the <\/span>DiPAV<\/span><\/a> summarized in the form of a guideline, which clearly explains the application as well as the requirements and their proof. Particularly important is the <\/span>Proof of the nursing benefits<\/b>, which is also explained.<\/p>\n The requirements are listed in the legal text at an abstract level. Central assistance is provided by the <\/span>Appendices 1<\/a> and 2<\/a> of the DiPAV, as well as Appendix 1 of the DiGAV<\/a>, as these contain checklists that manufacturers can use to check the individual requirements for their product.<\/p>\n The following requirements apply to DiPAs:<\/span><\/p>\n The nursing benefit of a DiPA exists if the use of the application prevents an <\/span>impairment of independence <\/b>or<\/span> abilities<\/b> of the person in need of care is counteracted. This also includes the progression of a person’s need for care. <\/span><\/p>\n In addition, there must be a nursing benefit in at least one of the following areas:<\/span><\/p>\n \u2192 In addition to these areas, the care benefit can also be given in the area of household management. <\/span><\/p>\n It is important to note that DiPA users do not necessarily have to be the person in need of care themselves. Even if <\/span>If caregivers are supported in providing assistance in one of the above-mentioned areas through the application, there is a nursing benefit.<\/p>\n In order to demonstrate the nursing benefits, manufacturers must submit comparative studies. These may also be retrospective comparative studies, including retrospective studies with intra-individual comparisons.<\/p>\n Alternatively, prospective studies, and specifically randomized controlled trials, are recommended due to their high informative value. The studies should be conducted in Germany. If this is not possible, transferability to the German healthcare context must be demonstrated.<\/p>\n Unfortunately, the only publicly known application for listing in the DiPA directory 2024 was rejected precisely because of the study. According to Lindera’s press release<\/a>, the BfArM criticized, among other things, that the study submitted was unable to prove the effects of the app in isolation from existing care services.<\/p>\n The application for inclusion in the DiPA directory is submitted by the manufacturer to the <\/span>Federal Institute for Drugs and Medical Devices <\/b>(<\/span>BfArM<\/span><\/a>).<\/span><\/p>\n 14 days after receipt of the complete application documents, the BfArM confirms receipt of the documents to the applicant or requests missing documents. The manufacturer has up to three months to complete missing documents. If no complete application documents have been submitted by the end of this period, the application will be rejected. <\/span><\/p>\n Once all documents are complete, the BfArM normally has 3 months to review the application and come to a decision regarding inclusion in the DiPA directory. <\/span><\/p>\n It is important to note that digital care applications can only be listed permanently. There is no trial phase. In plain language, this means that all necessary documents – including proof of the nursing benefits – must already be available at the time of application. The application includes: <\/span><\/p>\n The manufacturer must also provide the following information in the application <\/b>(according to \u00a72 DiPAV):<\/b><\/a><\/p>\n The BfArM advises manufacturers both before and after inclusion in the DiPA directory. The topics covered in the consultations are largely determined by you as the manufacturer. It is possible to clarify general questions of understanding regarding the DiPA requirements or to discuss product-specific documents.<\/p>\n For manufacturers whose DiPA is already listed, however, questions relating to the modification of the product can be dealt with.<\/p>\n The consulting fee ranges from \u20ac250 to \u20ac5,000 (admittedly a very wide range).<\/p>\n After a positive decision by the BfArM, your DiPA will be included in the directory. Congratulations – at this point you have completed a large part of the work and can celebrate with your team. However, you are not quite there yet: within three months of the listing, the remuneration amount for the DiPA will be negotiated with the National Association of Nursing Funds. In addition, technical and contractual framework conditions for the provision of the DiPA must be regulated in accordance with Section 40a (4) SGB VI. <\/span><\/p>\n The price for the DiPA is negotiated<\/span> during the first three months<\/b> negotiated between the manufacturer and the nursing care insurance fund after inclusion in the BfArM directory. If these two parties cannot reach an agreement, the arbitration tribunal determines the price of the DiPA. Details on the arbitration procedure can be found in section 8 (\u00a7 30 \u2013 \u00a7 32) of the <\/span> DiPAV<\/span><\/a>.<\/span><\/p>\n In addition to the DiPA procedure, there are also several other ways in which software manufacturers can obtain reimbursement under the German healthcare system. These include, among others:<\/p>\nTable of Contents<\/h2>\n
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1. Latest Updates: DiPA in the Act on the Expansion of Powers and Debureaucratization in Care (BEEP)<\/h2>\n
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2. Distinction between DiPA and DiGA<\/h2>\n
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<\/p>\n2.1 Health insurance vs. social care insurance<\/h3>\n
2.2 A DiPA does not have to be a medical device<\/h3>\n
2.3 Price cap<\/h3>\n
2.4 Can a DiPA also be a DiGA?<\/h3>\n
3. Guidelines for DiPAV<\/h2>\n
3.1 Requirements for DiPA<\/h3>\n
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What is a nursing benefit?<\/h4>\n
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Admissible studies to prove the nursing benefit<\/h4>\n
3.2 Application<\/h3>\n
Application procedure<\/h4>\n
Content of the application<\/h4>\n
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3.3 Consultation from the BfArM<\/h3>\n
3.4 My DiPA is listed! What now?<\/h3>\n
3.5 Arbitration proceedings<\/h3>\n
4. Further ways to achieve reimbursement by health insurance companies<\/h2>\n