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 The Act on Expanding Authority and Reducing Bureaucracy in Long-Term Care (BEEP Act)<\/strong>, which took effect on January 1, 2026, revised key provisions regarding DiPA. In particular, a one-year pilot period was introduced, the monthly reimbursement limit was raised, and the focus was expanded to include providing relief for caregivers.<\/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 The Act on Expanding Powers and Reducing Bureaucracy in Long-Term Care (BEEP Act)<\/strong> was passed by the Bundestag on November 6, 2025, subsequently referred by the Bundesrat to the Mediation Committee, and agreed upon in the mediation process on December 17, 2025. Following approval by the Bundestag and the Bundesrat (December 19, 2025), it entered into force on January 1, 2026. For DiPA, the Act contains the following significant changes<\/strong>, which have been in effect since then:<\/p>\n Note: We will update this article on an ongoing basis as soon as the BfArM updates its DiPA guidelines to reflect the new legal situation or publishes further details (e.g., regarding evaluation concepts or negotiation frameworks).<\/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 specifically designed to help people with certain medical conditions with pain relief, treatment, and diagnosis. To have a DiGA reimbursed by health insurance, a prescription from a doctor or psychotherapist is required, similar to the process for medications. Direct approval from the health insurance provider is also possible. A digital care application, on the other hand, can only be requested by those in need of care from their long-term care insurance provider<\/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<\/strong>. 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 An indefinite authorization means that the long-term care insurance fund will provide a monthly reimbursement of up to 70 EUR<\/strong> (of which up to 40 EUR is for the DiPA and up to 30 EUR for supplementary support services; see Section 2.3) on a permanent basis, as long as the statutory eligibility requirements are met.<\/p>\n \u00a7 40a Digital care applications SGB XI:<\/b><\/p>\n \u201c(1) People in need of care are entitled to care with applications<\/b> that are essentially based on digital technologies\u201d<\/span><\/i><\/span><\/i><\/p><\/blockquote>\n \u00a7 33a Digital health applications SGB V: <\/b><\/p>\n \u201c(1) Insured persons are entitled to care with low-risk class medical devices whose main function is essentially based on digital technologies [\u2026].\u201d<\/i><\/span><\/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, IIa, or IIb medical devices, DiPA are simply referred to as \u201capplications.\u201d A DiPA may be a medical device, but it is not required to be one. As a result, many of the regulatory requirements that DiGA manufacturers must navigate are (at first glance) not relevant to many DiPA. <\/span><\/p>\n However, the BfArM imposes similar requirements on DiPA that are not medical devices. For example, manufacturers must have a quality management system in place and meet requirements regarding the app\u2019s safety and functionality. The BfArM\u2019s current DiPA guidelines<\/a><\/span> (Version 1.2, as of October 11, 2023; a version adapted to the BEEP legal framework is expected) therefore reference numerous ISO\/IEC standards for medical devices and frequently cite the Medical Device Regulation (MDR). Thus, in most cases, the requirements for DiPA do not differ significantly, as they are based on the requirements for medical devices under the MDR.<\/p>\n If it is a medical device, it must belong to a low risk class (I or IIa). Unlike DiGA, DiPA is currently still not eligible for Class IIb.<\/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 cap for digital health applications (DiGA) is based on other applications in the same category, a fixed price cap is set for digital care applications. This stipulates that, since the BEEP Act took effect on January 1, 2026, up to 40 EUR per month can be reimbursed for the digital care application (DiPA), plus an additional 30 EUR per month for supplementary support services. In total, this amounts to up to 70 EUR per month (Section 40b of SGB XI<\/a><\/span> in its current version; previously a uniform upper limit of 50 EUR). In principle, a DiPA may also be more expensive, but any additional costs must then be borne by the DiPA user.<\/p>\n Important from the manufacturer\u2019s perspective<\/strong>: The new \u20ac40 limit under Section 40b(1)(1) of SGB XI is an exclusive cap on the DiPA itself. Up to \u20ac30 under No. 2 is earmarked for outpatient care facilities (Section 39a of SGB XI) and cannot be redirected to the manufacturer. Furthermore, these are reimbursement caps set by the long-term care insurance fund, not the provider\u2019s price. The actual monthly reimbursement amount for your DiPA is negotiated individually with the Central Association of Long-Term Care Insurance Funds and may also be less than 40 EUR.<\/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 DiPA:<\/span><\/p>\n A DiPA is considered to provide a care benefit if its use helps counteract a decline in the independence<\/strong> or abilities of the person in need of care. This also includes the progression of a person\u2019s need for care. Furthermore, since January 1, 2026 (BEEP Act), a preventive effect<\/strong> \u2014 that is, the stabilization of existing independence before a deterioration occurs\u2014has also been explicitly recognized as a nursing benefit.<\/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 Under the BEEP Act, it is no longer mandatory<\/strong> to demonstrate a benefit to the care recipient<\/strong>. Alternatively, a DiPA may be included in the directory if it results in a measurable reduction in the burden on caregivers\u2014the legislature assumes that such a reduction indirectly has a positive effect on the care recipient. Manufacturers must submit an evaluation for this purpose; the methodological requirements are expected to be specified in an updated version of the BfArM DiPA guidelines.<\/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\u2014and particularly randomized controlled trials\u2014are recommended due to their high level of validity. The studies should be conducted in Germany. If this is not possible, their applicability to the German healthcare context must be demonstrated.<\/p>\n According to publicly available information, no DiPA had been permanently added to the registry by the time the BEEP Act took effect. Lindera\u2019s widely discussed application in 2024 was rejected by the BfArM. According to Lindera\u2019s press release<\/a>, the BfArM criticized, among other things, that the submitted study could not demonstrate the app\u2019s effects in isolation from existing care services. With the possibility of provisional inclusion as part of the trial year (see Section 3.2), the starting point for manufacturers could improve.<\/p>\nTable of Contents<\/h2>\n
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1. Changes Introduced by the BEEP Act (in effect since January 1, 2026)<\/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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Alternative since BEEP: Evidence of reduced burden on caregivers<\/h4>\n
Admissible studies to prove the nursing benefit<\/h4>\n
3.2 Application<\/h3>\n
Application procedure<\/h4>\n