On December 19, 2019, the Digital Supply Act (DVG) made it possible for doctors to be able to prescribe digital health applications (DiGA) to patients in a standardized way for the first time. Now a counterpart has also been created for nursing care: digital care apps (DiPA).
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 apps could help to minimize the risk of falls for people in need of care or improve communication between relatives and carers.
The Ordinance on the Examination of the Reimbursability of Digital Care Apps (DiPAV) now provides information on how the DiPA application procedure works and what requirements are placed on DiPA in order to be included in the list of digital care apps.
DiPA is particularly interesting for companies from a monetary perspective because – unlike DiGA – it generates permanent income. While DiGA is only prescribed and paid for a certain period of time, the costs for DiPA can be reimbursed indefinitely. This means that people in need of care can only apply for a DiPA once, but can use it indefinitely.
In this article we explain the difference between the DiPA and DiGA, cover the most important contents of the DiPAV and finally created a guide for the DiPA procedure, which shows which process your application must go through in order to be included in the BfArM directory.
Differentiation from DiGA
To better understand the digital care apps, it helps to differentiate its use and content from the DiGA.
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 DVG 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 eleventh German Social Code (SGB).
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.
In this article you will find out whether your app is a DiGA.
Health insurance vs. social long-term care insurance
The first major difference between DiGA and DiPA is their place in the legal text. DiGAs are listed in SGB V – Statutory Health Insurance, DiPAs in SGB XI – Social Long-Term Care Insurance. A DiGA is therefore reimbursed by the health insurance fund, whereas the costs of a DiPA are covered by the social long-term care insurance fund.
A DiGA is prescribed by doctors and psychotherapists and is explicitly intended to support people with certain indications in terms of relief, therapy and diagnostics. The prerequisite for getting a DiGA reimbursed by health insurance is – similar to medication – a prescription from a doctor or psychotherapist. Direct approval from the health insurance company is also possible. However, those in need of care can only apply for a digital care app from their care insurance provider. There is no provision for DiPAs to be prescribed. The care insurance fund will review the application and then decide whether the costs for the software will be covered.
A DiPA does not have to be a medical device
40a Digital care applications SGB XI:“(1) People in need of care are entitled to care with applications that are essentially based on digital technologies”
33a Digital health applications SGB V: “(1) Insured persons are entitled to care with low-risk class medical devices whose main function is essentially based on digital technologies […].”
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.
While DiGA are explicitly defined as class I or IIa medical devices, DiPA only refer to “applications”. 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.
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 DiPA Guide (Status 11/04/2022) therefore references numerous ISO/IEC standards for medical devices and refers 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 risk class I products.
If it is a medical device, it must – like a DiGA – belong to a low risk class (I or IIa).
If your application is to be certified as a medical device, you can find more information here.
Price cap
While the price limit for DiGA is based on the other applications in the same category, there is a fixed upper price limit for digital care apps. This means that a maximum of €50 per month can be reimbursed for a DiPA ( §40b SGB XI). This has been the subject of controversial debate in specialist circles, but the law is clear. In principle, a DiPA can also be more expensive, but additional costs must then be borne by the consumer of the DiPA.
Can a DiPA also be a DiGA?
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.
Guidelines for the DiPAV
We have the contents of the DiPAV summarized in the form of a guideline, which clearly explains the application as well as the requirements and their proof. Particularly important is the Proof of the nursing benefit, which is also explained.
DiPA requirements
The requirements are listed in the legal text at an abstract level. Central assistance is provided by the Annex documents 1 and 2 of the DiPAV, as well as Annex 1 to the DiGAV as these contain checklists that manufacturers can use to check the individual requirements for their product. The following requirements apply to DiPAs:
- Safety functionality (see DiPAV Annex 1): A distinction is made between medical devices and non-medical devices. Medical devices fulfill the requirements for safety and functionality through the CE conformity marking. Non-medical devices must fulfill the requirements according to Annex 1 of the DiPAV, which are very similar to the medical device requirements for risk class I, however. This requires, for example, the establishment of a quality management system for medical devices (e.g. in accordance with ISO 13485), as well as a risk management system.)
- Data protection and data security: In addition to the GDPR and the general state of the art in data security, the requirements specified by the BSI and the data protection test criteria defined by the BfArM for DiGA and DiPA must be fulfilled. In addition, all requirements from Annex 1 to the DiGAV must also be met for DiPA. However, as some of these points are not transferable 1:1, the BfArM’s DiPA guidelines provide further information on how to deal with these.
- Quality requirements: (see DiPAV Annex 2)
- Interoperability: Similar provisions apply here as for DiGA. An interoperable export of data must be offered in both machine-readable and human-readable/printable form. The DiPA must also allow medical devices used by users to be connected if data from them is required.
- Robustness
- Consumer protection
- Age-appropriate usability, user-friendliness and accessibility
- Support for people in need of care and users
- Quality of care-related content
- Safety of those in need of care (patient safety)
- Nursing benefits
What is a nursing benefit?
The nursing benefit of a DiPA exists if the use of the application prevents an impairment of independence or abilities of the person in need of care is counteracted. This also includes the progression of a person’s need for care.
In addition, there must be a nursing benefit in at least one of the following areas:
- Mobility
- cognitive and communicative skills
- Behavioral and psychological problems
- Self-catering
- Coping with and independently dealing with illness- or therapy-related demands and stresses
- Organization of everyday life and social contacts
→ In addition to these areas, the care benefit can also be given in the area of household management.
It is important to note that DiPA users do not necessarily have to be the person in need of care themselves. Even if caregivers are supported by the application in providing help in one of the areas mentioned above, there is a care benefit.
Admissible studies to prove the nursing benefit
Manufacturers must present comparative studies in order to prove the nursing benefit. These are usually retrospective comparative studies, including retrospective studies with interindividual comparisons.
Alternatively, prospective comparative studies are also permissible, particularly if no suitable data are available to enable a meaningful retrospective comparison and no sufficient interindividual comparability can be achieved. The studies should be conducted in Germany. If this is not possible, transferability to the German healthcare context must be demonstrated.
Application
Application procedure for digital care apps
The application for inclusion in the DiPA directory is submitted by the manufacturer to the Federal Institute for Drugs and Medical Devices (BfArM).
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.
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.
Content of the application
It is important to note that digital care apps 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:
- Electronic application via the BfArM application portal
- Documents proving the nursing benefit
- Documents to prove compliance with all requirements
- If applicable, further documents (e.g. instructions for use or, in the case of medical devices, conformity assessment according to MDR or MDD)
The manufacturer must also provide the following information in the application (according to §2 DiPAV):
- Manufacturer and identifying features of the DiPA
- The intended purpose
- Associated notified body (if applicable)
- Certificates issued by the notified body and the manufacturer’s declaration of conformity (if applicable)
- Instructions for use
- Purpose, mode of operation, content and use of the DiPA in a generally understandable form
- DiPA functions
- Institutions and organizations involved in the development of the DiPA (if applicable)
- Sources for the nursing-related content and procedures implemented in the DiPA, in particular nursing-medical guidelines and expert standards, textbooks and studies
- Evidence of a nursing benefit including supplementary support services provided by third parties (according to “Evidence of nursing benefit” and “Studies to demonstrate nursing benefit”) in a simple and generally understandable summary
- Group of people in need of care for whom a nursing benefit has been proven
- Care benefits that have been demonstrated for the specified group of care recipients and users
- Study/studies by the manufacturer to demonstrate the nursing benefits including supplementary support services by third parties
- The fulfillment of the requirements and specifications for a DiPA including the respective questionnaires
- Intended user roles
- Quality-assured use of DiPA in the home environment, including exclusion criteria for use
- The type, content, scope and duration of the third-party support services required for the use of DiPA, if applicable
- Data processing locations
- Manufacturer’s compatibility commitments regarding supported platforms and devices as well as required accessories and other product components (if applicable)
- Standards and profiles used as well as human-readable export formats to create semantic, syntactic and technical interoperability
- Sum insured under the liability insurance taken out by the manufacturer for personal injury
Advice from the BfArM
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.
For manufacturers whose DiPA is already listed, however, questions relating to the modification of the product can be dealt with.
The consultancy fee is between 250 and 5,000 euros.
My DiPA is listed! What now?
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.
Arbitration
The price for the DiPA is negotiated during the first three months after inclusion in the BfArM list between the manufacturer and the long-term care insurance fund. If these two parties fail to reach an agreement, the arbitration tribunal determines the price of the DiPA. Details on the arbitration procedure can be found in Section 8 (§30 – §32) of the DiPAV.
Conclusion
It is not easy to meet all the requirements for DiPA. In particular, the submission of the study/studies as proof of efficacy at the time of the initial application is a challenge for manufacturers. There is a fast-track procedure for the approval of DiGA, which enables manufacturers to prove the benefit of an application in a study within one year. However, such a procedure is not intended for DiPA.
However, after a long period of uncertainty, the course has finally been set for submitting an application to the BfArM as a DiPA. We are curious to see when the first apps will be listed in the directory.
Further information on DiPA and DiGA
- Ordinance on the examination of the reimbursability of digital care apps in accordance with the Eleventh Book of the German Social Code (Digital Care Applications Ordinance – DiPAV)
- DiPAV Annex 1
- DiPAV Annex 2
- Guide: Is your app a medical device?
- Phrasing of the intended purpose for (software) medical devices
This guide is revised regularly to ensure that it is up to date.
QuickBird Medical develops medical apps for companies and research institutions on a contract basis. If you are planning a medical app, DiGA or DiPA and need support with the development, please get in touch with us and we will discuss the project without obligation.
Any further questions? Please feel free to call us (+49 (0) 89 54998380) or e-mail us (kontakt@quickbirdmedical.com).
We look forward to hearing from you!
