Who may put a blood test result into the German health record
A lab cannot put a blood test result into the German health record. The doctor who ordered the test does it, and today it goes in as a PDF. The format that replaces the PDF has published dates, and the commenting round opened on 15 September 2026. Here is the route, the four conditions, and what to ask a supplier.
Written by
Robert Jakobson
Published on
September 22, 2026
Diagnostics as a Service means one company does the whole blood test for you: the kit, the blood draw, the lab, and the screen where the result appears. You sell the test under your own name. If you sell it in Germany, a buyer will ask you one question you may not have an answer for. Where does the result go afterwards?
Every German who pays into the statutory health insurance now has a national health record. It is called the elektronische Patientenakte, the ePA for short. It is the place their doctors can see what has been done to them. Your customer will expect their blood test to be in there.
The short version is that the lab cannot put the result in the ePA. The doctor who ordered the test does that, and today it goes in as a PDF. A better format is coming, the dates for it are published, and almost nobody selling blood tests in Germany can tell you what they are.
The lab tests the blood and sends the result to the doctor who ordered the test, and the doctor uploads it to the ePA as a PDF. A lab cannot upload it itself unless the person gives the lab access through their record app. Source: KBV questions and answers on the ePA, read 21 September 2026.
What is the ePA, and who gets it?
The ePA is Germany's national health record. The health insurance fund holds it, and the person it belongs to controls it. Everyone with statutory insurance got one automatically, unless they said no.
Two things about it matter if you sell blood tests. The record belongs to the person, not to any doctor or lab. And getting into it depends on treating that person, which is why the next part looks the way it does.
Who is allowed to put a blood test result in the ePA?
The doctor who ordered the test. German law, paragraph 347 of the social code, book five, tells doctors to put results reports, blood test results, scan results and referral letters into the record.
A lab has no way in of its own. The KBV, the national body that sets the rules doctors follow, says a lab cannot load a result directly. The one exception is when the person opens their record app and gives the lab access.1
What this means for a Diagnostics as a Service product
You have three options and no fourth: the doctor who ordered the test uploads the result, your customer uploads it from the app, or it never gets there at all.
Pick one of the three, because a product that has not picked one is not finished.
When does a doctor have to upload a Diagnostics as a Service result?
A doctor has to upload a result only when all four of these are true.1
The practice ran the test itself.
The result is from the treatment happening now.
The practice has the result as a file.
The person has not said no to it.
Miss any one of the four and the duty is off.
A doctor has to upload a result only when the practice ran the test itself, it is from the treatment happening now, the practice has it as a file, and the person has not said no. Source: paragraph 347 of the German social code, book five, as the KBV explains it.
Doctors have had to fill the record since 1 October 2025. A practice that cannot show it has done so loses one percent of its pay.2
Now put your own product against those four conditions. A blood test sold by a wellness brand, a health app or an online clinic fails the first two, because no practice ran it during their own treatment. So German law will not put your result in the ePA for you. You have to build that step.
What does a result look like inside the ePA today?
It looks like a PDF, because that is what it is. The KBV says results go through the ePA as PDF/A, which is the version of PDF made for long-term storage.3
Germany has no single agreed way to send lab data between systems, so the digital links that do work are arranged one lab and one practice at a time.
A person can read a PDF and a computer can store it, and that is the end of what it can do. Nothing in it can be charted, compared with last year's test, or checked against a normal range unless somebody retypes the numbers by hand.
When will lab results stop being PDFs?
The replacement is called the MIO Laborbefund. MIO stands for Medizinisches Informationsobjekt, which is a standard way of writing down one kind of medical information. It uses HL7 FHIR, the international standard for sending health data, and LOINC codes, which make sure the same test means the same thing in two different systems.3
The format was written in summer 2024, matched to the European version in autumn 2025 and published as a draft in July 2026. gematik opened it for comments on 15 September 2026, software makers get the build instructions at the end of 2026, and the European version applies from 26 March 2031. Sources: KBV MIO Laborbefund 1.0.0, status September 2026, and the gematik OneRoadmap of 27 May 2026.
The dates are published, and they are worth reading closely. The format was first written in summer 2024 and updated in summer 2025. In autumn 2025 it was matched to the European version of the same thing. In July 2026 a draft was published by mio42, which is the KBV company that builds these formats.
Then on 15 September 2026 gematik, the national agency for Germany's health IT, opened it for comments. The build instructions go out to the software makers at the end of 2026.3
What a Diagnostics as a Service supplier can promise before then
There is not much any supplier can promise before then. gematik's own plan of 27 May 2026 lists this work as ePA 27, the lab process. It shows the format published at the end of 2026, the software built and switched on during 2027, and everyone using it during 2028.4
So nobody in Europe sends the German format today, because it does not exist yet. Any supplier who tells you otherwise has not read the plan.
What happens when the European rules start?
The European version of this format comes from the European Health Data Space regulation, and it has a date on it, 26 March 2031.45
Germany matched its own version to the European one during 2026, so the two are one subject rather than two.3
So a supplier claiming to be ready for the European Health Data Space today is claiming to be ready for something still being written. The useful claim is narrower than that. Which codes does the supplier send now, and can their output be mapped to the German format when the instructions come out? Our piece on what the European Health Data Space changes has the wider timetable.
What should you ask a Diagnostics as a Service supplier?
Ask these four questions, because each one has an answer you can check.
Which codes do you send with each test result, and are they LOINC codes with UCUM units? UCUM is the standard list of units, and it is what stops one unit being read as another.
When the German build instructions come out, who at your company does that work, and by when?
In our product, who uploads the result to the ePA, the doctor or our customer?
What does your interface send back today? Show us the list of fields, not a description of it.
A supplier who answers all four has read the same documents you have. A supplier who answers with a logo has not.
Where Aniva is on this
Aniva runs the whole chain, from the order to the kit to the accredited laboratory and back to the result your customer reads. We do not send the German format, because it does not exist yet and neither does anyone else. What you can compare today is the codes a supplier already sends and whether they have a named plan for the format.
If you are building a product that gives blood test results to people in Germany, book a demo and bring those four questions. We will answer them on the call.
This article describes how the German health record works for companies that sell blood testing. It is general information and not legal advice, and your own arrangement is a question for your own adviser.
Add blood testing to your business
Aniva provides the labs, the test kits, the shipping, the software and the data protection paperwork. You offer blood tests under your own brand. Tell us which tests you need and we will show you how it works.
