Diagnostics as a Service in Germany: how blood test results interact with ePA
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
Your customer expects a blood test result to appear in their national health record. In a Diagnostics as a Service arrangement one supplier runs the kit, the blood draw, the laboratory and the result screen, while your brand is the only name the customer sees. That arrangement covers everything up to the result. It says nothing about who puts the finished result into the record. That is the first thing a buyer will ask you.
The record in question is the "elektronische Patientenakte", which is German for electronic health record, shortened everywhere to ePA. Almost every German with statutory health insurance now has one. The short answer to the buyer's question is that a laboratory has no route of its own into that record today, according to the KBV. The doctor who ordered the test puts the result there, and for now it goes in as a PDF. A better format is on its way, with its dates already published. The rest of this article sets out the route as it works today, the format that replaces the PDF, and what to ask a supplier about both.
What is the ePA, and who gets it?
The ePA is Germany's national health record. The health insurance fund holds it on behalf of the person, who controls it. Everyone with statutory insurance got one automatically, unless they said no.1
Two things about the record matter if you sell blood tests. The first is that it belongs to the person rather than to any clinician or laboratory. The second follows from the first. Access to the record follows from treating that person, which is why the published guidance points at the ordering doctor rather than at the laboratory.
Who is allowed to put a blood test result in the ePA?
In practice, the doctor who ordered the test. Paragraph 347 of the social code, book five, tells providers taking part in statutory outpatient care to put results reports, blood test results, scan results and electronic doctor's letters into the record. A laboratory is not among the providers with a route of its own, so the KBV says a laboratory cannot upload today.1
The KBV, which is the national association of statutory-insurance doctors, names one exception to that. A person can open their record app and give the laboratory access themselves.
The KBV describes that exception as what is possible now rather than as a rule on who is permitted.1 So read the routes below as the routes that exist today, not as a closed legal list.
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 this means for a Diagnostics as a Service product
Those routes leave you three options. The doctor who ordered the test uploads the result, your customer gives the laboratory access from their own record app, or the result never reaches the record at all. Make that choice before you design the result screen, because the choice decides what the screen has to tell your customer.
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
A PDF is a picture of a result rather than the result itself. A person can read it and a computer can store it, and beyond those two things the file does nothing. None of the numbers in it can be charted, compared with last year's test, or checked against a normal range unless somebody retypes them by hand.
When will lab results stop being PDFs?
When the replacement format is in use. That format is already written, and its switch-on dates are published.
The replacement is called the "MIO Laborbefund". MIO is short for "Medizinisches Informationsobjekt", a standard way of writing down one kind of medical information. Laborbefund is the German word for a lab result. The format uses HL7 FHIR, the international standard for sending health data. A coding page in the same specification gives the 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 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 mio42, the KBV company that builds these formats, published a draft. On 15 September 2026 gematik, the national agency for Germany's health IT, opened that draft for comments. The build instructions for the software makers are due at the end of 2026.3
What a Diagnostics as a Service supplier can promise before then
Not much, because the plan after the build instructions is also published. gematik's own plan of 27 May 2026 lists this work as ePA 27, the lab process. As we read the bars on that chart, the format is finished at the end of 2026, the software is built and switched on during 2027, and general use follows in 2028.4
gematik publishes that roadmap as a plan and not as a commitment. So no supplier can send the German format today, because the build instructions do not exist yet. A supplier who promises it sooner is describing a plan we could not find published.
What happens when the European rules start?
The same format arrives a second time, under European law. The European version comes from the European Health Data Space regulation and applies from 26 March 2031.45
The German format was already adjusted to match the European one, so the two are better treated as one subject than as two.3
That timetable also settles what a supplier can claim about Europe. A supplier claiming to be ready for the European Health Data Space today is claiming to be ready for a laboratory specification that is still being written. The useful claim is a narrower one. Which codes does the supplier send now, and can its output be mapped to the German format when the build instructions come out? Our piece on what the European Health Data Space changes has the wider timetable.
Does a clinician ever have to upload a result you sold?
No, as we read the four conditions on that duty, though the duty itself is real. Doctors have had to fill the record since 1 October 2025. A practice that cannot show electronic evidence of having done so faces a one percent cut to its pay.2
The duty is narrower than it sounds, because the KBV sets out four conditions and says the duty applies only when all four 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.
On the KBV's wording, 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.
Now put your own product beside those four conditions. As we read them, a blood test sold by a wellness brand, a health app or an online clinic fails the first two, because no practice ran the test as part of a treatment of its own. No regulator has published a statement either way on that case. So plan on the step into the record being one you design and build yourself, and treat your regional association of statutory-insurance doctors as the body that settles it for a given practice.
What should you ask a supplier about the ePA?
Everything above comes down to four questions, and each one has an answer you can check.
1. Which codes do you send with each test result, and are they LOINC codes with UCUM units? LOINC is the international list of test codes. UCUM is the standard list of units, which is what stops one unit being read as another. 2. When the German build instructions come out, who at your company does that work, and by when? A name and a month are answers you can hold someone to, unlike an intention. 3. Which of the two routes into the record does your product support today, the doctor who ordered the test or your customer, and if neither, what happens to the result? The answer tells you how much of that step you are building yourself. 4. What does your interface send back today? Show us the list of fields, rather than a description of that list.
A supplier who answers all four has read the same documents you have. A supplier who cannot answer them has not.
Where Aniva is on this
Aniva runs the order, the kit, the collection on a network of its own, the accredited laboratory work and the result your customer reads, as one service on one contract and under your brand. That service ends at the result screen. Which of the two routes into the record your product uses, if it uses either, is a decision that stays with you.
The format question is the same for every supplier. No supplier can send the German format today, for the reason given above, and readiness for the European Health Data Space would be a claim about something still being written. What you can compare today is the codes a supplier already sends and whether there is a named plan for the format work.
Bring those four questions with you when you book a demo.
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.
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