Digital Healthcare Applications
DiGA Consulting
DiGA – More Than Medical Apps.
With the introduction of DiGA (Digital Health Applications), Germany is taking on a leading position in digital healthcare. This new category of apps represents a major opportunity to improve digital patient treatment in the statutory health systems. Digital Oxygen is the one-stop-shop for your DiGA: From assessing your digital product concept to navigating you through the submission process. ⬢
DiGA Sales
Once the DiGA has been approved is listed in the BfArM directory for the first time, the DiGA manufacturers need to tackle the next big task: Ramping up sales, for which medical offices play a crucial role. This presents new challenges to all parties involved. Medical offices show increased needs for information and are often still skeptical about app-based treatment methods. This is what DiGA manufacturers are aware of. But having its own field service to convince the practices is obviously expensive. Our calculations show that it is only worthwhile when at least 3 DiGAs are discussed with a specialist target group or general physicians. Other sales concepts seem more attractive to create awareness for DiGAs.
We are happy to advise you on this.
Some of Our
DiGA Services
DiGA-Fast-Track Guidance
Despite detailed guidance from the Federal Institute for Drugs and Medical Devices, the DiGA fast-track approval process awaits with many unsolved questions.
Getting the application on the way is complex and time-consuming, often more so than expected. We guide our clients through the pitfalls and tackle administrative hurdles together – supported by our strong network of medical and regulatory experts.
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DiGA Specification Analysis
The first wave of DiGAs are on their way to the patients and many more will follow.
We check whether our clients’ app concepts and applications meet all requirements from usability to data privacy and interoperability for a smooth (preliminary) approval process. Our services also include support for the Protection Need Analysis (Schutzbedarfsanalyse) and providing contacts to privacy officers from out network if necessary.
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Relaunch of Existing Products
There are many fantastic health applications and services out there.
Unfortunately, they are often built without DiGA approval in mind. Even established and successful products need a revamp to comply with DiGA regulation. Together with our clients, we build the concept, define the roadmap, and translate DiGA requirements into user stories.
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Economic Benefit And Pricing
For long-term success, a DiGA needs to achieve an adequate reimbursement price.
To be willing to reimburse it, health insurers need to be convinced that the DiGA does not just help the patient “somehow”, but that there are clear benefits that insurers themselves can profit from. We model the insurers’ cost savings and help our clients identify economic arguments through the DiGA, making sure that our clients are optimally prepared for all upcoming negotiations.
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DiGA Go-To-Market Advice
Physicians have little time per patient and many topics to discuss – counselling their patients on available DiGAs is not necessarily one of them.
In consequence, patients are left with an overwhelming number of digital offerings. We help our clients to stand out from the crowd – with viable go-to-market strategies to excite patients as well as healthcare professionals.
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Digital Oxygen is a member of SVDGV
(The German Association for Digital Healthcare).
Whitepaper:
DiGA In A Nutshell.
This DiGA whitepaper maps your way to a commercially successful DiGA (Digital Health Application / Digitale Gesundheitsanwendung). We have summarized the challenges and success factors from the listing in the DiGA directory to the go-to-market and distribution, to pricing negotiations with health insurers.
Don’t worry, it’s free.
Some Of
Our Projects
DiGA Specification Analysis
In this project, we supported our client with the implementation of all DiGA requirements as defined for example in the DiGA guide and the annexes of the DiGA ordinance. For this purpose, we analyzed the requirements regarding the existing app concept and derived concrete recommendations for action. In addition, our customer received support in carrying out the protection need analysis (Schutzbedarfsanalyse) and on additional questions raised by the developer team.
What have we learned? DiGAs are not just regular health apps – the requirements in areas such as data protection and data security are multi-layered and complex. Thus, the project plan should always include enough room for implementation.
DiGA-Fast-Track Guidance
The fast-track procedure of the BfArM represents an innovative path in the field of MedTech admission. Together with a customer, we have taken this new path and organized the exchange with the BfArM as part of a project. The project work included coordinating open questions concerning the DiGA application procedure directly with BfArM employees. In addition, we took over the preparation of the kick-off meeting – from filing the application to preparing the DiGA presentation.
What have we learned? There is always some room for interpretation on how to apply the DiGA requirements to a certain app concept. Therefore, it is key to ask the BfArM the right questions when preparing the DiGA application.
Economic Benefit and Pricing
In preparation for the market entry and price negotiations with the statutory health insurers’ head organization GKV, we validated the economic arguments for a DiGA. In a first step, the stakeholders were analyzed in regard of their influence on the prescription and reimbursement of DiGA. Results were visualized in interactive stakeholder maps. In addition, an interview study with healthcare professionals was conducted to identify the economic benefits for practices and derive recommendations for the go-to-market. Finally, we developed a health economic model to calculate potential cost savings for health insurers.
What have we learned? Some key players in the German healthcare market are still critical of DiGA. Therefore, a successful market entry requires good and sound arguments, which are not always immediately obvious.
Alexander Voigt
Healthcare Expert
