For services that serve prevention and health promotion in accordance with Section 20 SGB V, certification as a DiGA is generally ruled out – after all, this must always be based on specific existing indications. Instead, however, there is another regulatory framework that also opens up these possibilities for prevention services. This article is intended to provide you with an overview of the requirements and opportunities as well as the specific process of creating digital prevention services.
This article deals with the certification of digital prevention and health services in accordance with the GKV-Spitzenverband’s prevention guidelines. Since 2020, purely digital offers without personal course instruction can also be certified by the Central Prevention Testing Center (ZPP) and reimbursed by the statutory health insurance funds, whereby the content is conveyed by media and content, e.g. by means of an app, instead of by a “real” course instructor.
Overview
- Basis and Background
- What are digital prevention and health promotion services according to Chapter 7?
- Differentiation from DiGA (special chapter)
- The four fields of action of prevention and health promotion
- Guidelines for the certification of digital prevention and health promotion services
- Benefits and cost-effectiveness of a digital prevention application
- Conclusion
Basis and Background
The regulatory basis for the work of the Central Prevention Testing Center – which is jointly supported by numerous health insurance funds – is the “Prevention Guidelines” of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), which in turn was mandated by the legislator in §20 SGB V. The historical and systematic background to this legal standard, which was introduced in 1988, was the realization that the health and social system at the time placed too much emphasis on purely curative measures, neglecting those of (primary) prevention.
In order to take advantage of the opportunities offered by the latter and thus provide more benefits for patients and reduce the burden on the healthcare system, Section 20 SGB V was introduced. It stipulates that health insurance companies must reimburse course participants for at least the majority of the costs of attending a course after the course has been completed and a certificate of attendance has been submitted, provided that the course complies with the aforementioned GKV guidelines and has been certified by the ZPP.
In 1989, those involved were more likely to have course offerings from fitness studios and other course providers in mind – the fact that (interactive) prevention work would one day also be carried out via the screen was probably not on the minds of politicians or health insurance fund officials in the year of reunification. As awareness of the importance and opportunities of digitalization in the healthcare sector grew, so did the need to create a framework for digital prevention services – which happened in 2020, one year after the introduction of the DiGA. A seventh chapter was added to the “Prevention Guidelines”, which deals exclusively with digital prevention and health promotion services.
What are digital prevention and health promotion services according to Chapter 7?
The key definitional difference to conventional offerings lies in the extent of human interaction. While a “real” trainer or instructor is actively involved in a traditional course, this task can be taken over by digital technologies – this is a definitional parallel to DiGA. Digital offerings also allow you to respond more closely to the individual needs of your users (e.g. through individual configuration or learning algorithms). In addition, users can act far more autonomously and self-determined, as the offer usually does not have to be used within fixed time windows.
A basic distinction is made between the following sub-groups of digital prevention and health promotion services:
Internet Interventions
Roughly speaking, internet interventions include all “classically structured” offers that can be accessed via a web browser. These include, for example, static online courses consisting of videos and other media content that can be accessed on-demand. Conceptually, these offers are similar to regular health courses and consist of a certain number of units that are completed weekly, for example.
Mobile Applications
This includes genuine “apps” that are installed and optimized as such on the (mobile) end device – i.e. primarily smartphones and tablets. These offerings represent the greatest innovation in the field of prevention and health promotion, as they enable features that go beyond the classic course structure. In principle, an app can map all the functions of a classic internet intervention – but supplement them with app-specific elements such as push notifications for short exercise sessions or connectivity with wearables and much more, thus enabling a more dynamic and individualized course sequence. Mobile applications can therefore be implemented in a more versatile way than pure internet interventions, but are also more complex to develop. Mobile applications are characterized by their relatively short use at a high frequency.
Hybrid Training Concepts
Hybrid applications combine the internet interventions described above with mobile applications. A hybrid offer could, for example, be an online relaxation course in which knowledge is imparted in weekly units and in the meantime a mobile app is used to carry out short daily exercise units.
Differentiation from DiGA (special chapter)
Digital health applications (DiGA) are characterized, among other things, by the fact that they are not purely preventive offers. They must address a clear medical indication. Apps certified by the ZPP and other digital prevention and health promotion services, on the other hand, can also be aimed at completely healthy people. The presence of an illness, for example, is not a criterion for use.
In addition, DiGAs are necessarily medical devices in risk class I or IIa according to the MDR. Although prevention products can also be approved as medical devices (see illustration), this is not a prerequisite for certification. In general, it can be said that the demands placed on DiGA are much higher overall. Find out more about this in our article on the subject.
The four fields of action of prevention and health promotion
The regulatory framework specifies four fields of action within which offers can generally be certified and reimbursed:
Physical activity habits
Physical activity habits include, for example, measures that promote endurance, flexibility and strength, shorten periods of inactivity (e.g. sitting) or increase the amount of time spent moving. Fall prevention programs also fall into this category. In general, this includes all offers aimed at increasing physical and/or sporting activity.
Nutrition
Products in this category aim to achieve a varied and balanced – i.e. healthy – diet and encourage mindful eating. It is also about promoting the consumption of healthy foods and reducing the consumption of unhealthy foods.
Stress and resource management
Courses in this area aim to change the general experience of stress and teach techniques for relaxation and dealing with stress. This can be achieved, for example, through mindfulness exercises or strengthening self-esteem and self-efficacy. Offers to improve the quality of sleep also fall into this category.
Use of addictive substances
In the field of addictive substance use, the focus is on offers to reduce tobacco and alcohol consumption. Here, for example, the frequency or quantity of consumption can be addressed.
Guidelines for the certification of digital prevention and health promotion services
Even if the requirements for a DiGA in terms of certification are higher, the legislator attaches importance to standardized quality assurance for digital applications for prevention and health promotion. In the following, we explain which requirements you need to meet and how the certification process works. You can find more information on this in chapter seven of the prevention guidelines.
Criteria for certification by the Central Prevention Testing Center
Health Benefits
The health benefit is basically the reason for your product’s existence. It is derived from the field of activity in which your product is to be used. Once your field of activity has been defined, it is important to work out the extent to which your product can provide added value here. You must then prove this added value by means of a study (more on this below). You can find out which endpoints are permitted in the document Criteria for the certification of digital prevention and health promotion services in accordance with the 2020 Prevention Guidelines, Chapter 7, as of December 2020.
Some examples of end points are:
- Increasing strength and endurance (field of action: physical activity habits)
- Reduction in sugar consumption (field of action: nutrition)
- Strengthening self-esteem (field of action: stress and resource management)
- Reducing the weekly amount drunk (field of action: substance use)
Requirements for the Study
The aim of the study is to demonstrate the effect of your offer over a certain period of time. One advantage: a comparison with a control group is not necessary (but of course not excluded), instead an intra-individual comparison is sufficient. For this purpose, the defined endpoints are measured at fixed points in time and compared with each other in order to evaluate the improvement brought about by your offer. The study must be registered in a public register and the results must be reported completely and transparently.
Availability of Individual Support
Even if your offer is a web application or a mobile app, personal support and availability are mandatory. This includes user support in particular, which provides assistance with technical, content-related and health-related issues. This can be a single person (e.g. yourself) or a larger team. It is obligatory to ensure that the persons involved are qualified (e.g. through an appropriate degree) and to provide documented instruction on the service.
Quality
Your offer must have a clearly defined target group and also point out possible contraindications. All content claims – both in the application itself and in its marketing – must be backed up by sources. For example:
- “Regular endurance training reduces your risk of a heart attack.”
- “Progressive muscle relaxation helps to reduce the experience of stress.”
- “Consuming social media before going to sleep reduces the quality of sleep.”
You are also responsible for ensuring that users understand how your service works. Please note that not only users of the service, but also any persons involved (e.g. coaches) must be instructed accordingly.
User-friendliness and Usability
The interface between humans and digital technology has long been a major topic. Entire fields of research deal with questions relating to the design of user interfaces. This also plays a central role in digital prevention services. The goals here are:
- High level of user engagement
- Positive user experience
This can be achieved, for example, through the use of gamification elements or a lot of interactive content. An important source for implementing user-friendliness is the ISO 9241 standard, which is explicitly referred to in the GKV guidelines. When implementing usability standards, user-friendliness and accessibility, we advise you to seek external support if this topic is new to you. It is advisable to consider this aspect as early as the planning phase of the project, and it may be necessary to carry out several user tests. We are happy to support you here with our experience gained in a large number of medical software projects.
Data Protection & Data Security
First and foremost, it is trivially important to implement the requirements of the GDPR as well as the requirements of German data protection laws such as the BDSG, TMG, etc. It is advisable to consult with experts in this field, as data protection requirements not only have an impact on the content of your privacy policy, but also influence the selection of external providers involved in the operation of your software (e.g. hosting providers). Initial errors at this point can later lead to considerable additional expense due to the necessary “modification” of the software, or even generally jeopardize certification by the ZPP. It is crucial to develop an understanding of which data your app processes and which other parties (processors) are involved. Of course, in theory you can set up your own server on which your application runs and you store user data – however, with most software products it is impossible to completely dispense with external parties. Careful selection is therefore essential, as you are primarily responsible for the personal data of your users. Apart from data protection, data security (or information security) is also a key issue that should be given sufficient attention. For example, the GKV-SV requires the establishment of an information security management system (ISMS) in accordance with ISO 27001. While you do not currently have to provide proof of this, this will be mandatory from 2025 (as of February 2023). In addition, you must adhere to the BSI’s TR-03161 when developing the product. This is a “technical guideline” for the development of applications in the healthcare sector, which describes various aspects of data security. Data protection and information security are both very complex topics that harbor great potential for error. You should therefore consider this in advance and seek competent external advice. It is important to set the right focus and implement measures that are really effective. Feel free to contact us if you need support with this.
Further Legal Requirements
Identifying and implementing further legal requirements is a fundamental obligation for you as a provider. In addition to data protection regulations and the requirements of the Prevention Guideline, this could be the Medical Device Regulation (MDR), for example. This is the case if your product is a medical device; the MDR includes, among other things, the establishment of a quality management system. Our blog article on this topic will help you to determine whether your product is subject to the MDR.
Application and Certification
Once development is complete, the certification process begins. This is handled via the online portal of the Central Prevention Testing Center (ZPP). As soon as you have created an account, you enter your offer as a “course concept”. According to the ZPP, the assessment takes a maximum of 10 working days and is free of charge for you. Please note, however, that your offer and any persons involved (course instructors) will be checked separately. However, several review processes can be initiated at the same time. The certification process is free of charge for you as a provider and can also be restarted after a rejection. The reasons for a rejection should be communicated by the ZPP in order to enable you to clear them up. After successful certification, your course will be assigned an individual ID and included in the ZPP directory.
Benefits and Cost-effectiveness of a Digital Prevention Application
Digital Prevention Courses as a Passive Source of Revenue
For the user of a digital prevention application, the benefits are obvious – it enables measures that can be easily integrated into everyday life and improve quality of life in the long term. But digital applications also offer unique opportunities for course providers.
While the number of participants in “classic” course formats is subject to various limitations – time slots, regional catchment area, infrastructure, etc. – digital offerings are almost infinitely scalable. Administrative costs are also relativized as the number of users increases in digital applications – there is no longer any need for course instructors to worry about managing participant data, billing, confirmations of participation and much more. This makes offering digital courses a de facto passive source of revenue in the long term. The amount of reimbursement – which is paid directly to the user, who advances the costs – is decided and calculated by the health insurance companies on a case-by-case basis. By way of comparison, the average cost of a “conventional” course as determined by us is around €120.
Platform Utilization instead of Expensive In-House Development
However, before the fruits of the “digital prevention course” can be harvested, it must be created on a solid and requirements-compliant basis – a YouTube channel or a social media account is by no means enough. Your digital course software must meet all the requirements of the Central Prevention Testing Center and all other regulations in addition to simply reproducing content. Managing user accounts, tracking user progress, certifying successful participation on this basis and also being able to map payment processing securely and easily – only then can all the benefits of scaling through digital automation really be exploited. The development of such software is by no means a simple or even inexpensive undertaking. At the same time, there are essential recurring elements – e.g. content management, certificate and billing processing… – that every digital prevention offer inevitably contains. Therefore, the obvious approach was to create a platform that already contains all these elements as a kind of modular system, leaving you as a potential digital course provider with the task of developing content and entering it (without technical background knowledge). This idea gave rise to the digital prevention and health promotion platform (PdPG), which is being developed by the QuickBird Medical team, who are experienced in medical apps and development. It enables you to provide a wide range of content, define chapters and modules and automatically handle user, billing and certification management without any development effort on your part – all while meeting all regulatory requirements for the technical nature of a digital course. Even beyond the standard scope, PdPG can make almost anything possible for your course, from the integration of wearable data to provision as your own app for iOS and Android. Feel free to contact us for a customized demo of the PdPG: Contact us
Conclusion
By creating the framework for digital prevention and health promotion services, the legislator has closed an important gap that was left open by the conception of the DiGA as a purely curative application. The requirements for corresponding solutions have been appropriately toned down compared to the DiGA, but should by no means be underestimated. Nevertheless, in addition to the health benefits for the user, a digital course offering suitable for everyday use can also be a real benefit for course providers, as it can represent an almost passive and scalable source of revenue in the medium and long term. Since certain recurring functions and elements are included in every such offer on the software side, it makes sense to use a specialized platform such as PdPG. QuickBird Medical will be happy to support you on your way to your own digital prevention and health promotion offer.
