Is BloodPressureDB a DiGA?

When the Federal Ministry of Health released a press statement on July 10, 2019 (https://www.bundesgesundheitsministerium.de/presse/pressemitteilungen/2019/3-quartal/dvg-kabinett.html), the goal was named that diaries for people with diabetes or apps for people with high blood pressure could be prescribed by a doctor: 

Excerpt from the BMG press release from July 10, 2019, underlining by us

But in practice, that idea fell apart completely. For starters, simple diary apps are not medical devices in the first place. That would require a bit morebut thats not necessarily a problem. The idea that doctors would receive properly documented and processed data via a DiGA, which they can then use to treat the patient, is actually sensible.

However, the Federal Institute for Drugs and Medical Devices (BfArM) then made it clear that a DiGA is only allowed to be directed at the patient. If the purpose is to collect data for the doctor, then its no longer a DiGA. That means the major benefit that such apps can offer turned into a problem. Such features should not be the purpose of the application.

Nevertheless, patients who use an app demonstrably have a faster and better-controlled blood pressure. There are already studies with various apps for this. And we can also prove it easily with existing data. But in most cases, its not really the app that lowers blood pressureits ultimately the doctor who prescribes medication. And that makes it hard to prove the apps benefit without a doctor. More on that later.

Because were not done yet. The legislator deliberately introduced the so-called patient-relevant structure and process improvements as evidence checkpoints. In other words: an app that helps the patient deal with their illness can be approved as a DiGA.

But even here, disappointment came quickly. For the proof, of course, a study is required. For the relevant endpoints of such a study, there are unfortunately hardly any validated measurement instruments that the responsible federal authority for pharmaceuticals and medical devices (BfArM) accepts. These measurement instruments are usually questionnaires. They have to be validated for Germany. That means taking an English questionnaire and simply translating it isnt enoughit has to be tested in its own study. In the meantime, the BfArM has also allowed translations under certain conditions in a webinar, but in a subsequent consultation conversation they mentioned slightly different requirements again. However, none of the statements is binding. In summary, it is possiblebut with an unclear outcome as to whether a study would ultimately be accepted, or whether all the effort would be in vain.

But thats not enough either. We were told very clearly: the patient-relevant structure and process improvements are nicebut a blood pressure app must of course prove that it lowers blood pressure. And were back to the problem that this blood pressure reduction has to happen without the doctor.

So what you do in practice is run a randomized study: one group gets the app, the other does not. Blinding, as is common otherwise, isnt possible unfortunately, because the patient will notice whether they are using an app or not. The BfArM also likes to point out in its presentations that there is a particularly high placebo effect with blood pressure. Ultimately, you can only deal with this by running a study with a very, very large number of patients. You also have to make sure that the effect isnt simply due to the doctor having better data. Otherwise, the effect would be with the doctornot with the appand then approval as a DiGA would not be possible. The costs for this quickly end up in the high six- to seven-figure range.

And then there are ongoing costs for new requirements around data protection and -security (ISO 27001, BSI TR-03161, data protection certificate, ...), requirements for interoperability with unclear specifications, further requirements every few months, and the costs for a study. Whether that would actually lead to approval is anyones guess. If the BfArM doesnt want it, it will always find some small thing that doesnt fit. Unfortunately, legal certainty isnt there.

And in its weighing of usability versus data security, the Federal Office for Information Security (BSI) regrettably gives the user no real competence. Screenshots are banned, and many other gotchas are currently set to ruin the fun especially for older users. 

A DiGA should also only be usable on the latest smartphonesbecause with older ones, the fingerprint sensor might not meet the highest security requirements.

Dominik Burziwoda, founder of the DiGA manufacturer Perfood, criticizes the poor user-friendliness of his own app due to strict requirements:
If the phone doesnt have a screen lock with password protection, the app logs out automatically after 2 minutes of inactivity. That means you have to enter your email address and password again and again. (Source).

We hope your blood pressure monitor measures quickly. Although the second measurement after 12 minutes is probably something most people will prefer to skip. Because even then, you need new authenticationthis is specialist jargon for signing in. Ideally with 2 factors every time. Two-factor authentication is mandatory, even if only a small fraction of the affected users actually know what that means.

Please dont misunderstand us: high standards for the security of your dataespecially in light of the many problems in this area overallwe find it highly desirable. In practice, though, the situation today already looks like this: those who become victims of data theft dont follow the existing requirements. That usually isnt done intentionally. Mistakes happen. Adding more requirements instead of demanding compliance with what already exists isnt helpful. Introducing yet more new requirements all the time steals time from the actual work and, in our view, leads to more problems rather than fewer.

The BfArM is also creative when it comes to coming up with new nonsense. For example, after the prescription period ends, a DiGA has to delete all data. That means: if the patient doesnt immediately get a follow-up prescription, all stored data is simply gone. The patient can export the data and import it again later. That is data protection as the federal office imagines it.

Push notifications are also not always allowed with DiGAs. They would go through Apples and Googles servers. Providers from the U.S. are repeatedly excluded from data processing. There are always agreements with the U.S. that allow data processing, but these are then banned again via legal action. This game has been going on for several years now. In principle, its also a good ideabut if you dont want any data at Apple and Google, there just isnt much left in the world of smartphones. In practice, data protection experts argue about whether push notifications are outright forbidden, or whether theyre not allowed to contain health data. Of course, just the DiGA itself already gives away that it has something to do with health. If I use a blood pressure app on a Google Android smartphone, Google knows that. But if, within the app, a push message is displayed via Googles servers, is that suddenly a problem?

How quickly your own data can be lost:

If you use a DiGA, you often spend weeks carefully collecting health data, diaries, exercises, measurements, or progress information. But these data dont simply belong permanently to your personal user account. When the prescription expires, the purpose of data storage ends in principle as well. Only if, beforehand, a separate consent was given for a short transition period may the account and data be kept for a limited timeand even then, during that time they are essentially locked. If a follow-up prescription with a new enablement code doesnt come in on time, the account and data can be deleted or blocked. This is particularly problematic because a follow-up prescription is by no means automatically available: patients have to get another medically justified prescription or apply to their health insurance, after which the insurer checks it and only then issues the enablement code. So if you dont get an appointment in time, rely on a printed document, or chase the code afterward, you may find that the painstakingly collected data are gone faster than youd expect.

The BloodPressureDB app came out of day-to-day practice, where our founder built it according to his own requirements to keep his blood pressure as well under control as possible. Thanks to the interest of other users and their donations, a real company was able to grow from this. Since the app can also be used free of charge and fairly unrestricted, its naturally not a particularly profitable companyhowever, its still enough to pay the staff and genuinely help around 200,000 high blood pressure patients a year.

Even if DiGA approval were to succeed, the prescriptions would still have to cover the costs again. If a diary app is held to the same standards as a cancer medication, that drives the price unnecessarily up into absurd heights. Suddenly wed be talking about a DiGA that costs 250300 euros for 3 monthswhere previously 50 euros for a year were enough. That health insurers would protest is completely clear. And yet the insolvencies among DiGA providers show that the costs would even have to be higher.

Update from 3 Jan 2024: The first DiGA for high blood pressure actually costs 593.81 per 90 days. Thats 2,408.23 per yearthe app is therefore more than 48 times as expensive as BloodPressureDB.

Update from 25 Jun 2025: The price has since been reduced to 289.17 euros. 
Update from 19 Nov 2025: The application was removed from the directory on 1 Oct and is therefore no longer available as a DiGA. The manufacturer states: Since the launch on the market in December 2023, several thousand patients have used actensio and provided positive feedback. At the same time, the requirements for evidence, technology, and regulation are associated with high costs. Against this background, it isnt possible for us to operate actensio profitably in the long term as a manufacturer..

Update from 20 Jan 2026: Since 19 January 2026, there is a new DiGA for high blood pressure. Oviva Direkt Bluthochdruck costs 599 euros per quarter, i.e. 2396 euros per year. 

So we have affordable applications that many patients use voluntarily, at their own expense, and with plenty of proof that they provide benefitsthen once the health system grinds them through its machinery, the result is DiGAs that cost more than ten to twenty times up to fifty times as much, and come with some preset limitations in terms of function and usability.

That isnt good for blood pressure. With that in mind, regardless of the enormous effort weve already put into this project, we wont pursue inclusion as a DiGA any further for now.

Related articles:

• Medical benefits of BloodPressureDB
• What is a DiGA?
• What is the ePA (electronic patient record)?
• Telemedicine
• Blood Pressure App with Bluetooth