In Germany, doctors are prescribing state-approved healthcare apps to help contextualize illness and disorders, as well as educate users on health issues.
Apps are quickly becoming the superior way to access information and educate ourselves on important topics.
However, accurate information doesn’t necessarily proliferate across mainstream apps, making it difficult to understand what of it is true.
This particularly applies to our health - there’s so much conflicting information out there that it can be hard to distinguish myths from facts.
Germany is one step ahead and is using DiGAs (digital apps) to help patients learn more about their conditions, manage symptoms, and seek guidance.
We at Cybernews have broken down what DiGA is, who’s behind it, and what apps are readily being prescribed to patients.
What is DiGA?
DiGA is a regulatory framework implemented by the Federal Institute for Drugs and Medical Devices (BfArM) in Germany.
“Digitale Gesundheitsanwendungen” aka DiGA translates to “Digital Health Applications.”
These digital health applications supported by BfArM claim to “open up a wide range of possibilities both regarding the diagnosis and treatment of diseases as well as supporting a self-determined, healthy lifestyle,” the federal institute said.
However, not just any old app can become BfArM-certified.
There are a few hoops manufacturers and developers need to jump through before getting on the list.
What makes an app DiGA-certified?
Apps that make their way onto the list have certain properties that are not found in mainstream health and wellness apps.
Key features of DiGA include:
- Class I or IIa, meaning that they fall in the low-risk category of apps and devices.
- Must be digital, i.e., an app as opposed to a piece of hardware.
- An app whose main function is to help with medical issues and not primarily collect data or control a device.
- The app must treat or improve the condition through the app alone – for example, providing counselling or educational information about the condition.
- The app must be used directly by patients or with their healthcare provider. The app can’t be used by physicians to treat the patient as the person must use the app themselves.
- DiGA apps must comply with data protection and information security under the GDPR and ISO.
Why aren’t all health apps DiGA-approved?
Alongside these criteria, apps must undergo rigorous testing to ensure they’re good enough to prescribe to patients.
Therefore, health and wellness apps with a business-to-consumer (B2C) model may not fit as the company wants to sell its products to customers.
The B2C model doesn’t align with DiGA’s structure, as these companies often rely on customers paying for a monthly subscription. Doctors prescribe DiGA, which is covered by statutory health insurance in Germany (GVK).
Therefore, apps with this model wouldn’t be a viable solution for doctors, the state, or users.
What apps are approved by BfArM?
There are roughly 55 apps that are approved by the Federal Institute for Drugs and Medical Devices in Germany.
These range from apps like “edupression.com,” which is used to treat mild to moderate depressive episodes and recurrent depressive disorder, to the “Endo app,” designed for those suffering from endometriosis.
Interestingly, a few non-smoking apps feature on the list, which helps those dependent on tobacco and nicotine.
I’ve actually tried one of the approved apps called “Smoke Free – Quit smoking,” which, spoiler alert, didn’t help me quit smoking.
My experience with BfArM-approved apps
While I wasn’t prescribed the app, I used the free function briefly, which records how long you have been “smoke free.”
Features of the app include health improvement and how much money you have saved by quitting smoking.
The paid version or “PRO version” claims to “greatly increase your chances of quitting” for the one-time charge of roughly $10.
According to the DiGA directory, the app is prescribed for 90 days, and follow-up prescriptions are provided as needed.
The manufacturer's price of the service is around $440, which is covered by the state's health insurance.
If I’ve used this app for free, then why can’t any old app be accepted? Cybernews has used the example of the popular health app with over 100 million users worldwide, Flo, to dive deeper into state-approved DiGAs.
Flo: Why isn’t it BfArM-approved?
Let’s take the example of Flo, the period tracking app, as one of the apps that is not BfArM-certified.
As said before, Flo is an example of a B2C model, which means that it wouldn’t be covered under Germany’s health insurance.
The app lacks a CE certification needed for DiGA apps. Flo also lacks clinical evidence, which is essential for DiGA under BfArM.
Furthermore, the German federal ministry of health states that these apps must have “sufficient evidence” and “must be shown to have a positive effect on the user’s healthcare.”
“In other words, the DiGA must have a medical benefit or must enable important structural and procedural improvements for patients.”
Flo claims to have over 20 scientists “working to advance female health” and over 22 million research participants.
While this does meet the criteria, as private clinical trials are valid, the tests must meet specific scientific requirements, and the findings must be presented to the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband).
Flo has had its fair share of controversies surrounding its data handling and protection.
The Federal Trade Commission (FTC) launched a complaint against Flo in 2021. The complaint said that developers of the period and fertility tracking app shared users' health information with third parties without their knowledge.
“The company shared the health information of users with outside data analytics providers after promising that such information would be kept private,” the FTC said.
Under the criteria, apps must comply with GDPR and ISO policies, meaning that users’ data should be protected.
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