In the German healthcare system, everything currently revolves around the term DiGA. What DiGA means, how DiGA is defined and why DiGA will continue to play an important role in the future are explained on the following page.
Product Owner, IT Expert, eHealth Specialist & Managing Director at Bornholdt Lee GmbH
Over 20 years of IT project experience and conception of numerous digital health applications
DiGA expert informs!
Digital health applications
DiGA is the abbreviation for digital health application. A DiGA is a digital medical device that must meet certain guidelines of the German Federal Institute for Drugs and Medicine (BfArM). If all guidelines are met in the DiGA development and the DiGA is included in the DiGA directory, the DiGA can be prescribed by physicians*. DiGA is also often called "app on prescription".
DiGA Consulting
As [bornholdt lee] we offer comprehensive DiGA consulting for all technical areas in the context of the technical implementation of a DiGA.
From DiGA conception, to DiGA development, to DiGA certification. [bornholdt lee] is your digital partner for the technical challenges of a DiGA. Since a DiGA is a complex product, DiGA consulting is a very important undertaking here. In advance, a DiGA consultation can define and evaluate certain challenges, technical requirements, and more.
Schedule your free initial DiGA consultation now to talk about the technical aspects of your DiGA. Our DiGA experts are based in Hamburg, but can of course advise you digitally throughout Germany!
What distinguishes [bornholdt lee] in the DiGA project
We know the challenges involved in launching a medical product such as a DiGA or in setting up a company: Preparation of a business plan, clarification of financing, review and implementation of required regulations and requirements of various ordinances and legal bases, certifications and audits, compliance with data protection guidelines and IT security, ... for the experts of [bornholdt lee] no new topics!
We have already successfully supported numerous digital health start-ups and assisted in the successful introduction of medical devices into the DiGA directory. Therefore, we are not only able to support every step towards DiGA with expertise and experience, but also actively contribute to its success with know-how! And if we can't, we have a network of (legal) experts and consultants to fall back on.
Whether at our headquarters in Hamburg or digitally throughout Germany. [bornholdt lee] is your DIGA partner !
AGILE AND FLEXIBLE
We are not a large corporation and can respond specifically to the needs of our customers: In DiGA development we act agile, flexible, transparent and price-conscious!
TRUSTFUL AND HONEST
Open and direct communication is important to us: we talk about difficult situations as well as solutions. We know the limits of IT, but also the opportunities in innovations.
IN PARTNERSHIP
We are partners for our customers and feel responsible for our customers and our customers' products from the idea to the operation.
DiGA Development Process
The DiGA development process is a complex process that needs to be thought through from A-Z. Due to the guidelines of the German Federal Office for Drugs and Medicine (BfArM), there is no room for maneuver in DiGA development. [bornholdt lee] has already accompanied and implemented a DiGA project from the idea to the inclusion in the DiGA directory and is continuously working on further DiGA developments. According to our expertise, the DiGA development process can be divided into 6 phases. You can find out more about this on our DiGA development section.
DiGA certification is a comprehensive and complex process. The legal basis for DiGA certification is the Digital Delivery Act (DVG), which went into effect on Dec. 19, 2019. An important term here is: DIGAV. DIGAV is the abbreviation for Digital Health Applications Ordinance. This defines the requirements that a DiGA must meet in order to be certified and included in the DiGA Directory. For inclusion in the DiGA directory, a distinction is made between permanent and provisional DiGA approval. This distinction is based on the requirements of the DIGAV or on the proof of the positive supply effect. Attention: A permanent DiGA approval is only possible with a proving study!
Due to the strict regulations, there is little room for maneuver in DIGA certification. From the idea to the DiGA conception, the DiGA development, up to the DiGA certification, every step has to be compliant with the rules. It is important here, apart from the positive precautionary effect, to consider the technical refinements. Data protection and security also play a very important role in a DiGA. [bornholdt lee] already has experience in successfully accompanying the certification process. We are experts in all technical aspects of a DiGA and look forward to supporting you in your DiGA certification.
DiGA FAQ
The big DiGA FAQ around the topic DiGA. Whether for patients, doctors or companies in the healthcare sector. Our DiGA experts answer all DiGA relevant questions in our DiGA FAQ!
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What is a DiGA?
DiGA is the abbreviation for "Digital Health Application." A DiGA is a digital application such as an app, web application or program that serves medical purposes. These applications are tested and certified by the Federal Institute for Drugs and Medical Devices (BfArM) before they are included in the DiGA directory. Only then can an app also call itself DiGA.
What is the meaning of DiGA abbreviation?
The term "DiGA" is short for "Digital Health Application".
What is the definition of DiGA?
A "digital health application", or DiGA for short, is defined by the German Federal Institute for Drugs and Medical Devices (BfArM) as a type of medical product. A DiGA is therefore an app, software or other digital technology. A DiGA always has the goal of supporting or facilitating the diagnosis, therapy or follow-up care of diseases. An important concept here is the "positive care effect."
DiGAs must be approved by the BfArM in an elaborate procedure by demonstrating scientific evidence of their efficacy and safety. Once a DiGA is included in the DiGA directory, it can be prescribed by physicians or similar and used by patients."
What is the Digital Provision Act (DVO)?
The Digital Healthcare Act (DVG) is a law in Germany that came into effect in December 2019. The goal of the law is to drive digitization in healthcare and make it easier for patients* to access digital health applications.
The DVG includes several measures. These include the introduction of electronic patient records (ePA). In addition, the promotion of telemedicine and the expansion of telemedicine services.
Another important aspect of the DVG is the creation of a legal framework for digital health applications (DiGA). This is intended to improve the quality and safety of digital health applications (DiGA) and provide patients* with a better choice of high-quality digital health applications.
The Digital Care Act can thus be seen as the cornerstone of digital health applications (DiGA).
Overall, the Digital Health Care Act is intended to help improve healthcare in Germany and give patients more options and control over their health data.
Who can prescribe DiGA?
A DiGA can be prescribed by doctors or psychotherapists. The DiGA is then noted on a prescription and can subsequently be paid for by the health insurance company, provided it is listed in the DiGA directory. An important term here is "DiGA prescription." For this reason, DiGA is also often referred to as "app on prescription".
What is a DiGA prescription?
A DiGA prescription is a prescription that can be issued by doctors or psychotherapists and contains a digital health application (DiGA). With this prescription, patients can submit the DiGA to their health insurers and apply for coverage. For this reason, DiGAs are often referred to as "apps on prescription".
Note: In the context of the prescription, the term DIGAV is very important, because in the context of a DiGA, there is not only the DiGA prescription as a prescription, but also the term DiGAV.
What does the DIGAV abbreviation stand for?
The DiGAV abbreviation stands for "Digital Health Applications Ordinance".
What is the Digital Health Applications Regulation?
DIGAV is the regulation that defines the process and requirements for reviewing the eligibility of digital health applications (DiGA) for reimbursement by German statutory health insurers.
DiGAV runs in the context of the "Digital Health Care Act".
How does DiGA work?
DiGAs can function in different ways. Some DiGAs aim to treat or diagnose diseases, for example by recording symptoms or monitoring the intake of medication. Other DiGAs help patients* prevent disease or improve quality of life by, for example, evaluating health data or offering personalized exercise programs. Here, too, a positive care effect is important.
What are the advantages of a DiGA?
The benefits of a DiGA are primarily that they can help patients manage their health more independently and in a more targeted way. DiGAs can, for example, help to record symptoms. In addition, they can help patients to take their medication correctly and reduce psychological stress. DiGAs can help improve the effectiveness and efficiency of medical treatments.
What are the risks of DiGA?
As with any medical treatment or application, there are risks associated with a DiGA. These risks include privacy concerns, safety issues, and malfunction of the application. Therefore, it is important that a DiGA must undergo extensive certification by the BfArM and be monitored by experts. In this way, potential risks can be minimized. [bornholdt lee] can help you to minimize these errors and risks in the DiGA development process, as [bornholdt lee] has already accompanied a DiGA through the certification process of the BfArM and is currently working on further great DiGA projects.
How safe are DiGAs?
Yes, DiGAs are safe because they undergo extensive clinical trials before approval and are regularly monitored. Data protection and data security requirements are also included in the approval.
How does DiGA deal with data protection and the GDPR?
Eine DiGA muss den Anforderungen der DSGVO entsprechen, da sie personenbezogene Daten verarbeitet. Die Anforderungen an Datenschutz und Datensicherheit sind in der DiGA-Verordnung genau festgelegt und werden regelmäßig überprüft.
How does DiGA certification work?
DiGA certification is carried out by the Federal Institute for Drugs and Medical Devices (BfArM). The process consists of several steps in which the efficacy, safety and quality of the DiGA are tested. If a DiGA successfully passes the certification, it is included in the official DiGA directory of the BfArM and can be prescribed by physicians*. Only then can a medical app truly be called a DiGA. Find out more about DiGA certification in a free DiGA consultation with one of our experts in Hamburg. Arrange a free DiGA consultation now.
What is the fast track procedure?
The fast-track procedure is a procedure to be able to include a DiGA in the DiGA directory more quickly. The fast track procedure specifies a processing time of three months for the DiGA application. In these three months, the Federal Institute for Drugs and Medical Devices (BfArM) must review the DiGA application for inclusion in the DiGA directory.
The fast-track procedure is intended to make the DiGA certification process and inclusion in the DiGA directory faster.
What is the BfArM?
BfArM is short for Federal Institute for Drugs and Medical Devices. BfArM is the German higher federal authority for the approval and supervision of medicinal products and medical devices. Among other things, the BfArM is responsible for the approval of DiGAs. In addition, it is also responsible for the CE certification of digital medical devices.
The BfArM maintains the DiGA directory.
What is the DiGA directory?
The DiGA directory is a publicly accessible directory that lists all DiGAs that are approved in Germany. This DiGA directory is managed and maintained by the Federal Institute for Drugs and Medical Devices (BfArM).
What are the future opportunities for DiGAs?
DiGAs have great potential to improve and optimize healthcare. In addition, DiGAs can help personalize patient care and improve patient self-management. Therefore, DiGAs are expected to play an increasingly important role in healthcare in the future. Especially in rural areas, DiGAs can fill certain bottlenecks and gaps in care.
What is the difference between a digital medical device and a DiGA?
A digital medical device is a broader term than DiGA. This term includes all types of medical devices that are digital. Digital medical devices include monitoring devices, diagnostic tools, or medical apps.
A DiGA, on the other hand, is a special type of digital medical device that is included on the DiGA list after certification by the BfArM and can thus be prescribed by physicians*. The most similar to a DiGA is a digital health app as it can be CE certified, for example. Both are part of "Digital Health" or "eHealth". More about eHealth can be found here: eHealth
What is eHealth? How is eHealth defined?
eHealth is short for "electronic health." eHealth refers to the application of information and communication technologies (ICT) in healthcare. eHealth is designed to improve the quality and efficiency of healthcare. eHealth includes a variety of applications such as electronic health records, health apps, telemedicine, and e-learning tools. Of course, DiGA as well as DiPA.
What is the volume of the German digital health market?
The German digital health market is growing rapidly. The German digital health market is expected to grow to a volume of around EUR 4.4 billion by 2025.
Why should I have a DiGA developed?
f you are a healthcare company or have an innovative idea for a digital health application, developing a DiGA can be an opportunity. A chance to establish your product on the German healthcare market and benefit from the advantages of certification as a medical product.
DiGA are prescribed by physicians and reimbursed by health insurance companies.
This allows you to reach a larger number of patients. You can also benefit from the increasing demand for digital health applications. Another interesting area here can also be subsidies or investments.
How do I prescribe a DiGA?
A DiGA is prescribed by a doctor or physiotherapist. They must see a medical indication for the use in a patient.
If you are a doctor or physiotherapist and wish to prescribe a DiGA, you must search for the DiGA in the DiGA directory of the BfArM and issue the prescription according to the specifications of the DiGA prescription.
The patient* can then install and use the application on a smartphone or tablet. The costs for the "app on prescription" are covered by the health insurance.
How can I get a DiGA prescribed?
DiGAs can be prescribed by doctors and physiotherapists. If they see a medical need for the application in a patient. For this purpose, the application must be listed in the DiGA directory of the Federal Institute for Drugs and Medical Devices (BfArM). In addition, a prescription must be available in accordance with the requirements of the DiGA regulation. The patient can then install and use the DiGA on a smartphone or tablet. The costs are covered by the health insurance.
Can a DiGA be billed to a health insurance company?
Yes, DiGAs can be paid for by statutory health insurers. Of course, this DiGA must be listed in the DiGA directory of the BfArM. In addition, have received a positive evaluation by the "Gemeinsamer Bundesausschuss" (G-BA). The DiGA prescription must be issued by a physician, physiotherapist or similar. They must confirm the medical necessity for the patient. Reimbursement is usually made directly between the health insurance company and the DiGA provider.
What devices are DiGAs available for?
DiGAs can be used on various devices and platforms, including smartphones, tablets, PCs, and smartwatches. However, it depends on the publisher which devices and platforms are supported. Common here are, of course, iPhones and iPads from Apple with iOS and iPadOS, but also Android smartphones and tablets.
Where can I download a DiGA?
Basically, DiGAs can be downloaded from the Apple Appstore or the Google Play Store.
How much does DiGA development cost?
The cost of developing a DiGA can vary widely and depends on several factors. For example, the complexity of the application, the features required, and quality assurance. However, it is known that the development of a DiGA can be very cost-intensive, as it requires extensive regulatory review by the BfArM. Through the expertise of [bornholdt lee] we can save you a lot of money, as we have already successfully developed a DiGA that is listed in the DiGA directory. More about DiGA development can be found here: DiGA Development
Why should I have my DiGA developed by Bornholdt Lee GmbH in Hamburg?
Bornholdt Lee GmbH is a Hamburg-based company specializing in the development of eHealth applications such as CE certified medical apps and digital health applications (DiGA).
[bornholdt lee] shines with many years of experience in the field of app development and implementation of digital solutions. [bornholdt lee] offers comprehensive support in the development of eHealth solutions. From conception to certification and market launch. In addition, [bornholdt lee] works very closely with physicians and other experts to ensure that the DiGA meets the highest quality standards.
Bornholdt Lee GmbH is one of the few companies that have successfully managed to guide a DiGA through the complex certification process of the BfArM up to its inclusion in the DiGA directory. Benefit from the expertise of the DiGA experts at Bornholdt Lee GmbH.
Click here for a free consultation on the technical implementation of eHealth applications.
DiGA consultation
We are happy to support you in problem solving, idea generation, implementation of digital health applications and/or the application for DiGA certification.
Bornholdt Lee GmbH specializes in the design and development of digital sustainable solutions, smart products and innovative platforms that simplify and improve lives and thereby enhance quality of life.
The focus of digital solutions are mobile apps (iOS / Android; native and hybrid), web and backend services, web applications as well as voice control, augmented reality and IoT products.
Product Owner, IT Expert, eHealth Specialist, Mentor in the eHealth Network Hamburg & Managing Director at Bornholdt Lee GmbH
Over 20 years of IT project experience and conception of numerous digital health applications
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