Healthcare interoperability header background

Healthcare interoperability

HL7 v2, HL7 FHIR R4, IHE, ISiK and MIO. What actually moves between the hospital system, the practice system, the lab and the ePA.

FHIR R4base of ISiK and MIO
1 July 2025ISiK stage 3 mandatory
TBDdate for stage 5
Noone profile for every system

Why interoperability decides whether a project works

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Healthcare interoperability means the receiving system understands the data clinically. A PDF that only a person can read is not an exchange. The hospital system, the practice system, the lab, radiology and PACS stay separate systems. The interface translates admission, order, result and document. If the shared structure is missing, the workflow stops even when each application runs on its own.

In Germany the profiles are not a free choice. HL7 v2 still carries messages between hospital systems. HL7 FHIR R4 carries ISiK and the KBV medical information objects. The specifications are published by HL7 Germany. What is mandatory in hospital is on the gematik ISiK page. The MIO catalog is kept by the KBV.

Where the exchange breaks

Four breaks explain most standstills. They are not defects of the individual application.

IDdoes not match

Patient identity

The case number, the insurance number and the subsystem id are not the same identifier. Without a map the lab creates a second patient. PIX and PDQ help only when both sides know the same domain.

v2beside R4

Two formats

HL7 v2 and HL7 FHIR R4 do not replace each other. A lab order often travels as a v2 message. The ISiK interface in the hospital speaks FHIR. Middleware has to keep both, not drop one of them.

Codelocal

Terminology

An in-house lab code is silent for the neighbouring system. LOINC, SNOMED CT and ICD-10-GM are the terminologies the specifications name. Which one is mandatory is stated in that profile, not in a general list.

PDFinstead of an object

A document without structure

A finding as a PDF stays readable and is not computable. For defined ePA content the object is a MIO, a FHIR bundle. The file alone does not meet that rule.

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The interface, not a new hospital system

The interface, not a new hospital system

We build the interface and the middleware between systems that already exist. The hospital system stays with hospital software. Imaging sits with PACS, the lab with laboratory software.

The interface, not a new hospital system

The interface, not a new hospital system

We build the interface and the middleware between systems that already exist. The hospital system stays with hospital software. Imaging sits with PACS, the lab with laboratory software.

Profile and test

Profile and test

We map to the profile the other side requires: the German base profile, ISiK or a MIO. Acceptance runs against the vendor test system. gematik’s ISiK confirmation is a separate procedure, not a side effect of the mapping.

Running the interface

Running the interface

Messages that are not acknowledged stay visible in a queue. A silent loss is the most common operational failure. The standards are introduced on healthcare IT consulting.

Hospital, practice, record, FHIR

Hospital, practice, record, FHIR

The record integrations are listed under EHR integrations and in the integration overview. FHIR interfaces are on FHIR API integration. The telematics connection is a separate page. The existing service page remains at interoperability solutions.

Interfaces to the hospital system, the practice system and the lab

The path of one order. Each line is a hop. None of them covers the others.

Step 01

Register the patient in the hospital system

The hospital information system assigns the case and the stay. Lab, radiology and the record have to recognise that identity. A second local number without a map creates duplicates.

FormatHL7 v2 ADT

Step 01

Register the patient in the hospital system

The hospital information system assigns the case and the stay. Lab, radiology and the record have to recognise that identity. A second local number without a map creates duplicates.

FormatHL7 v2 ADT

Step 02

Order to the lab

The order from the hospital system to the LIS carries the test and the specimen. HL7 v2 is the usual path for this in German hospitals. A FHIR order replaces that message only when both sides have agreed it.

FormatHL7 v2 ORM or OML

Step 03

Result back

The lab returns the result to the ordering system. Values need a terminology the receiver knows. LOINC is the usual path for lab observations when the profile requires it.

FormatHL7 v2 ORU

Step 04

Image and report

RIS and PACS exchange the order and the image. The image format is not the report message. Both channels are tested separately.

FormatOrder plus image

Step 05

ISiK inside the hospital

Subsystems in the hospital read and write patient and movement data over the FHIR interface of the ISiK modules. That is exchange inside the hospital. It is not access to the telematics infrastructure.

FormatHL7 FHIR R4

Step 06

The practice system writes to the ePA

The practice system places defined content into the electronic patient record as a MIO. The bundle follows the KBV specification. A PDF in the same place is a different object.

FormatMIO

Step 07

Middleware maps

Middleware translates identity, code and message. It does not keep its own patient register as the source. The source stays the leading system, hospital or practice.

FormatMapping

Step 08

Test against the other side

Each interface is run against the vendor test system, including errors and retries. For ISiK the gematik confirmation procedure is added. A passed test of one message does not cover the others.

FormatAcceptance per channel

One channel that works says nothing about the next.Name the channels

Standards: HL7 v2, FHIR and IHE profiles

The standard, what it describes, and whether it is mandatory in Germany. ISiK table as read on the gematik site on 6 October 2026.

Standard
What it describesContent
Mandatory in Germany
HL7 v2
Messages for admission, order and result between hospital, lab and radiology
Widely used, no single nationwide duty for every message
HL7 FHIR R4
Resources and a REST interface, the base of the German profiles
Mandatory where ISiK or a MIO requires it
IHE XDS
Document registry and repository between organisations
Used in some networks, not the general duty
IHE PIX and PDQ
Patient identity and a demographics query
Useful with several ids, not required everywhere
ISiK
gematik FHIR modules for hospital systems, section 373 SGB V
Stage 3 since 1 July 2025 for the named modules, stage 5 still without a date
MIO
Defined FHIR content of the ePA, such as the vaccination record and maternity record
Binding for those contents, catalog of the KBV
LOINC, SNOMED CT, ICD-10-GM
Terminologies for lab, clinical terms and billing
ICD-10-GM in billing, the others where the profile names them
German base profiles
HL7 Germany profiles that ISiK and MIO build on
The target profile in Germany, not a profile from another market
  • No ranking, only the standard
  • Mandatory only where statute or the specification says so
  • Another profile does not satisfy the requirement
Which profile applies is decided by the other system and the specification.Match the profile

Timeline of a connection

The ranges are planning corridors for a known counterpart with a test system. They are not a quote and not a promised date. The ISiK confirmation runs at gematik and is not included here.

Corridor, not a promise

One channel

Weeks

one known v2 profile

  • ADT, order or result, one direction
  • The vendor test system is required
  • Not a few days
  • Character set and version are part of it
  • No fixed price in this table
Name the channel

Several systems

Per channel

hospital, lab, radiology, practice

  • Each hop is counted on its own
  • The lab does not replace imaging
  • Practice and hospital are two sources
  • Identity is agreed once and tested per system
  • Middleware maps, it does not invent a profile
Count the systems

ISiK

Separate procedure

gematik confirmation

  • Stage 3 since 1 July 2025
  • Stage 5 published, date still open
  • Fee under the telematics fee regulation
  • SNOMED CT licence for the implementation
  • Not inside the weeks of the message channel
Check the module

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ISiK and MIO: what is binding in Germany

Two duties are often mixed. ISiK applies to information systems in the hospital. MIOs apply to defined content of the electronic patient record. The source is the gematik portal, table as read on 6 October 2026.

ISiK stage 3

ISiK stage 3

Base, document exchange, medication, appointment planning, and vital signs with body measurements have been mandatory since 1 July 2025. gematik ends that duty by a formal withdrawal. The table does not yet give that date.

Stage 5 has no date yet

Stage 5 has no date yet

Stage 5 was published on 1 July 2025. The latest date for mandatory implementation is not set. A vendor with a valid stage 3 confirmation receives an extension once that date exists and does not confirm again.

What has been withdrawn

What has been withdrawn

Stage 4 and the stage 2 modules were withdrawn on 1 July 2025. Stage 3 security is not set as normative in the table. An old certificate does not replace the current duty.

KBV MIOs

KBV MIOs

Medical information objects set syntax and semantics for ePA content, as FHIR R4 XML. The vaccination record, the maternity record and the child examination record are examples. The current catalog is at the KBV, not in this text.

Not the same procedure

Not the same procedure

An ISiK confirmation is not a MIO implementation and not a connection to the telematics infrastructure. Each of the three duties has its own specification and its own acceptance.

ePA and the telematics infrastructure

01

Access is not content

Access is not content

The telematics infrastructure is the access. The ePA is the record. ISiK is exchange inside the hospital. Three layers, three specifications. Access is described on the telematics page.

02

What goes into the record

What goes into the record

Defined clinical content goes in as a MIO. Documents that are only displayed stay documents. The primary system must write the current MIO version and be able to read older versions.

03

Hospital and practice stay the source

Hospital and practice stay the source

The record is not the leading hospital system and not the practice system. It receives what the specification provides. It does not become a second patient record beside them.

04

Apps at the record

Apps at the record

An application that exchanges data with the ePA uses the specified interface. It does not invent its own bundle. Whether it is also a DiGA is decided by the BfArM, not by the interface.

05

The page for access

The page for access

Connectors, cards and telematics deadlines are on connection to the telematics infrastructure. This page does not repeat them.

06

No promise that every write succeeds

No promise that every write succeeds

We do not promise that every record entry arrives. An insured person’s objection, a missing permission and a module that is not released rightly stop the write.

Typical pitfalls in integration projects

The same eight mistakes return in hospital, lab and record projects. They are a checklist here, not a charge against one product.

two patient numbers

Two patient numbers

Case number and insurance number are not mapped. The subsystem creates a second patient. The result is then attached to the wrong identity.

version and character set

Version and character set

One side sends HL7 v2.3, the other expects 2.5. Or UTF-8 meets another character set. The message arrives and cannot be read.

z-segments

Z-segments

Vendor-specific segments carry the actual information. The other side ignores them. The log still shows a successful send.

the wrong fhir profile

The wrong FHIR profile

A profile from another market, such as US Core, hits an ISiK interface. The resource is valid FHIR and still not the required German profile.

a local code instead of a terminology

A local code instead of a terminology

The lab value carries an internal key. LOINC, SNOMED CT or ICD-10-GM is missing although the profile requires it. The receiver cannot place the value.

pdf instead of a mio

PDF instead of a MIO

A readable document is stored where a MIO bundle is expected. Display works. Further processing does not.

no acknowledgement

No acknowledgement

The send is not acknowledged, and nobody sees the queue. The result is treated as delivered and never arrived.

a test without the procedure

A test without the procedure

A successful test against an in-house mock does not replace the vendor test system or gematik’s ISiK confirmation.

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Which profiles count in Germany

The target is the profiles published by HL7 Germany, gematik and the KBV: German base profiles, ISiK and MIO on HL7 FHIR R4. IHE profiles XDS, PIX and PDQ remain relevant in individual networks beside them. A profile from another market is not a substitute. The ISiK status is kept by gematik, the MIO catalog by the KBV.

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Questions on interoperability

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What does interoperability in healthcare mean?

Healthcare interoperability means systems exchange data so the receiving system understands it clinically. A file that only a person can read is not enough. In Germany, HL7 v2, HL7 FHIR R4, ISiK and the KBV MIOs set the structure. The hospital system, the practice system, the lab and the ePA stay separate systems. The interface translates between them.
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What is ISiK?

ISiK is gematik’s standard for data exchange between information systems in the hospital. The legal basis is section 373 of the Social Code, Book V, and the format is HL7 FHIR R4. Since 1 July 2025 several stage 3 modules are mandatory, including base, document exchange, medication, appointments and vital signs. Stage 5 has been published since 1 July 2025. A mandatory date for it has not been set.
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How do HL7 and FHIR differ?

HL7 v2 is a message format. A hospital information system sends admissions, orders and results with it, often to the lab and radiology. HL7 FHIR R4 describes resources and a REST interface. ISiK and the KBV MIOs are built on FHIR R4, not on v2. v2 does not disappear because of that. Both formats run side by side in the same organisation.
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How long does a hospital-system connection take?

A single HL7 v2 interface with a known profile and a test system often takes several weeks, not a few days. ISiK is a separate gematik confirmation and sits outside those weeks. If lab, radiology and the ePA are added, each interface is counted on its own. We do not promise a fixed date. The vendor profile sets the frame.