Is Tensana a DiGA?

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

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

But in practice, it all went completely wrong. For starters, simple diary apps are not medical devices in the first place. That requires a bit more, but that is not necessarily a bad thing. The idea that the doctor 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) suddenly 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 it is no longer a DiGA. That means the major benefit that such apps can offer has turned into a problem. Such features should not be the purpose of the application.

However, patients who use an app have been shown to achieve controlled blood pressure more quickly and effectively. Studies involving various apps have already demonstrated this. We, too, can easily prove it using existing data. However, in most cases, it is not the app that lowers blood pressure, but ultimately the doctor, by prescribing medication. This makes it difficult to prove the benefits of the app without a doctor. More on this later.

Because we're not quite done yet. The legislator deliberately introduced the so-called patient-relevant structural and procedural improvements as evidence criteria. In other words, an app that helps patients manage their illness can be approved as a DiGA.

But here, too, disillusionment quickly set in. This is because a study is, of course, required to provide evidence. Unfortunately, there are hardly any validated measurement instruments for the relevant endpoints of such a study that the responsible Federal Institute for Drugs and Medical Devices (BfArM) accepts. These measurement instruments are usually questionnaires. They must be validated for Germany. In other words, simply taking an English questionnaire and translating it is not enough; it must be evaluated in a separate study. The BfArM has since stated in a webinar that translation is also permitted under certain conditions, but then gave us slightly different requirements in a consultation. However, none of these statements is binding. In summary, it is possible, but it remains unclear whether a study would ultimately be accepted or whether all the effort would have been in vain.

However, that is not enough anyway. We were told very clearly that while the patient-relevant structural and process improvements are nice, a blood pressure app must of course prove that it lowers blood pressure. And that brings us back to the problem that this reduction in blood pressure has to occur without a doctor.

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

There are ongoing additional costs for new data protection and security requirements (ISO 27001, BSI TR-03161, data protection certificate, ...), interoperability requirements with unclear specifications, further requirements every few months, and the cost of a study. Whether that would actually lead to approval is anyone's guess. If the BfArM doesn't want it, it will always find some small detail that doesn't meet the requirements. Unfortunately, there is no legal certainty.

And in weighing usability against data security, the Federal Office for Information Security (BSI) regrettably assumes that users have no competence whatsoever. Screenshots are banned, and many other restrictions will spoil the experience, especially for older users. 

A DiGA, too, should of course be usable only on the latest smartphones, since the fingerprint sensor on older ones might not meet the highest security requirements.

Dominik Burziwoda, founder of the DiGA manufacturer Perfood, criticizes the poor user-friendliness of its own app due to the strict requirements:
"If the phone doesn't have a screen lock with password protection, the app automatically logs out after 2 minutes of inactivity. That means you have to enter your email and password again and again." (Source).

We hope your blood pressure monitor takes readings quickly. That said, most people would probably prefer to skip the second measurement after 1-2 minutes. After all, even then, you need to authenticate again-the technical term for logging in. Preferably with 2 factors every time. So-called two-factor authentication is mandatory, even though very few of the users affected actually know what it is.

Please don't misunderstand us: we consider high standards for the security of your data highly desirable, especially in view of the many problems in this area in general. In practice, however, those who fall victim to data theft are already failing to comply with existing requirements. But this is rarely intentional. Unfortunately, mistakes happen. Imposing additional requirements instead of insisting on compliance with the existing ones is not helpful. Continually introducing new requirements takes time away from the actual work and, in our opinion, 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 that if the patient does not 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 a federal office imagines it.

Push notifications are also not always permitted for DiGAs. After all, they would pass through Apple's and Google's servers. American providers are occasionally excluded from processing data. Time and again, an agreement with the U.S. permits data processing, only for it to be prohibited again following legal action. This has been going on for several years now. In principle, this is also a good idea, but for anyone who does not want Apple and Google to have their data, there is simply not much left in the world of smartphones. In practice, data protection experts disagree on whether push notifications are not permitted at all or are merely not allowed to contain health data. Of course, the DiGA itself already reveals that it has something to do with health. If I use a blood pressure app on a Google Android smartphone, Google knows about it. But if a push notification is then displayed in this app via Google's servers, is that suddenly a problem?

How quickly your own data can be lost:

If you use a DiGA, you often spend weeks painstakingly recording health data, diaries, exercises, measurements, or progress information. But these data do not simply remain permanently associated with your user account. When the prescription expires, the purpose of storing the data generally ends as well. Only if separate consent has been given beforehand for a short transition period may the account and data be retained for a limited time – and even then, they are essentially locked during this period. If a follow-up prescription with a new activation code is not obtained in time, the account and data may be deleted or blocked. This is particularly problematic because a follow-up prescription is by no means automatically available: patients must obtain another medically justified prescription or submit an application to their health insurer. The insurer then reviews it and only afterward issues the activation code. So if you cannot get an appointment in time, have to rely on a printout, or have to chase up the code, you may find that the painstakingly recorded data are gone sooner than expected.

The Tensana app grew out of our founder's daily practice, where he developed it to meet his own needs and help him keep as close an eye as possible on his blood pressure. Thanks to the interest and donations of other users, it evolved into a real company. Since the app can also be used relatively freely at no cost, it is of course not a particularly profitable company, but it still generates enough income to pay its employees and genuinely help around 200,000 patients with high blood pressure each year.

Even if DiGA approval were successful, prescriptions would still have to cover the costs. If a diary app is held to the same standards as a cancer medication, that drives the price up to absurd levels completely unnecessarily. Suddenly, we'd be talking about a DiGA that costs 250-300 euros for 3 months, whereas previously 50 euros for a year had been enough. It is completely understandable that health insurers are protesting. And yet the insolvencies among DiGA providers show that the costs would have to be even higher.

Update from 3 Jan 2024: The first DiGA for high blood pressure actually costs 593.81 euros per 90 days. That's a hefty 2408.23 euros per year, so the app is more than 48 times as expensive as Tensana.

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 isn't 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 evidence of their benefits. Once the health system puts them through its machinery, they emerge as DiGAs that cost more than ten to twenty times as much up to fifty times as much and come with certain prescribed limitations in functionality and usability.

That isn't good for blood pressure. With that in mind, regardless of the enormous effort we've already put into this project, we won't pursue inclusion as a DiGA any further for now.

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