What was published
IHE Radiology has published Manifest-based Access to DICOM Objects. It reached Trial Implementation on 16 March 2026, and the current text is revision 1.2, dated 20 August 2026, active on the publications site from 3 September. The FHIR implementation guide beside it is version 1.0.0, marked trial-use, built on R4.
It did not arrive the usual way. The profile was drafted inside EURIDICE, a joint effort of HL7 Europe and IHE-Europe, at the request of the Xt-EHR joint action, which had been asked to turn the European Health Data Space into technical specifications. The supplement says so in its own scope: the need for this profile was identified as part of the sharing of imaging studies and related reports as required under the EHDS Regulation.
That is worth holding onto. MADO is a European regulatory artefact that happens to be a good general-purpose profile, rather than a general-purpose profile Europe later adopted.
The seam it cuts
A clinical imaging report is a statement about a patient, made by a named person, at a moment in time. It is signed, it is registered, and it does not change: when the finding changes, a new version is issued and the old one is kept. A retrieve address is the opposite kind of fact. It changes whenever an archive is migrated, a hostname is re-pointed, a data centre is consolidated or a vendor is replaced.
Put both in the same signed payload and every infrastructure change becomes a document event. The bytes that were signed have changed, so the signature over them no longer verifies, and the document has to be re-issued and re-registered. The number of documents affected is the number of studies in the archive.
MADO makes the manifest a document in its own right. The report says what was found. The manifest says what exists and where it can be fetched from. They are linked, versioned independently, and the one that changes when infrastructure changes is the one that was cheap to change.
There is a second consequence, and it shows up in a support queue rather than in an architecture review. When the content of a shared study is updated to add or remove instances, the Content Creator shall publish a new manifest and deprecate the previous one. A manifest is a claim about a moment, and saying so is what stops a consumer treating a two-year-old inventory as current.
RUN AN EVENT
Nothing has happened yet. The study is stored where it was acquired.
XDS-I.b · ONE DOCUMENT
Report text + retrieve endpoint, in one signed document
STORAGE · On-premise archive
SIGNATURE VERIFIES
Everything works. This is the state the architecture was designed in, and the state it is never left in.
MADO · TWO DOCUMENTS
Report text, signed, no endpoint inside it
Manifest holds the WADO-RS base URL for each series
STORAGE · On-premise archive
SIGNATURE VERIFIES
Two documents, one reference between them. The report has never needed to know where the pixels live.
The images move to a cloud archive. Every retrieve address for the study changes.
XDS-I.b · ONE DOCUMENT
Retrieve endpoint rewritten inside the signed document
STORAGE · Cloud archive
SIGNATURE DOES NOT VERIFY
The bytes that were signed have changed, so the signature over them no longer matches. The document has to be re-issued and re-registered for every affected study, and the count of affected studies is the count of studies in the archive.
MADO · TWO DOCUMENTS
Report untouched. Not opened, not re-signed, not re-registered
New manifest published with the new WADO-RS base URL
STORAGE · Cloud archive
SIGNATURE VERIFIES
The Content Creator publishes a manifest for the updated study and deprecates the previous one. That is the whole migration story for the document layer.
The radiologist adds an addendum. The images and their addresses have not changed at all.
XDS-I.b · ONE DOCUMENT
Report text and endpoint re-issued together as one document
STORAGE · On-premise archive
RE-SIGNED AND RE-REGISTERED
The clinical change and the technical pointer are the same object, so amending the finding means republishing the image references with it.
MADO · TWO DOCUMENTS
New report version, signed and registered
Unchanged. Nothing about the study inventory moved
STORAGE · On-premise archive
SIGNATURE VERIFIES
A clinical amendment costs a clinical document. The technical inventory is not touched, because nothing technical happened.
A clinician in another department opens the study from the EHR.
XDS-I.b · ONE DOCUMENT
Endpoint resolved out of the signed document
STORAGE · On-premise archive
SIGNATURE VERIFIES
Retrieval runs over WADO-RS, and an XDS-I.b responder is obliged to support all four message pairs, whether or not the deployment uses them.
MADO · TWO DOCUMENTS
Report read from the EHR as text
Study-level web viewer endpoint, if the manifest carries one; the series-level WADO-RS endpoint if not
STORAGE · On-premise archive
SIGNATURE VERIFIES
The web viewer endpoint is optional and the per-series WADO-RS endpoint is not, so a consumer always has a way through even when the convenient one is absent.
Three actors, one transaction
The profile is unusually small. A Content Creator produces the manifest, deciding which part of the local study to publish and guaranteeing that everything it references is available when it publishes. An Imaging Document Consumer parses a manifest, picks what it wants and issues the retrieve. An Imaging Document Source answers it, and may return only what was published even when the request names a whole study.
There is deliberately no Content Consumer actor. The supplement says why: the Imaging Document Consumer is the consuming partner of the Content Creator, which keeps the profile small and matches what XDS-I.b already did.
The single transaction is WADO-RS Retrieve, [RAD-107], required in the Requester role on the consumer and the Responder role on the source. Everything else the profile does, it does through the shape of the content rather than through new messages on the wire.
| Actor | Content or transaction | Optionality |
|---|---|---|
| Content Creator | DICOM KOS-based manifest | Required, and it must be able to produce the FHIR form too |
| Content Creator | FHIR-based manifest | Required, configurable to emit either |
| Imaging Document Consumer | WADO-RS Retrieve [RAD-107], Requester | Required |
| Imaging Document Consumer | KOS-based or FHIR-based manifest, as consumer | Optional, but at least one shall be supported |
| Imaging Document Source | WADO-RS Retrieve [RAD-107], Responder | Required |
| Both | Rendered Instances Option | Optional |
Read the first two rows together. A producer has to be able to do both encodings; a consumer only has to do one. The cost of the dual-format world sits on the side that publishes, which is the side that can afford it, and a consumer product can implement the format its ecosystem actually uses without failing conformance.
What the manifest carries
An XDS-I.b manifest is close to a bare list of identifiers: study, series and SOP instance UIDs, and a retrieve location. It answers which objects exist and little else, so a consumer that wants to know which of nine series is worth pulling finds out by pulling them.
The MADO manifest extends that definition with modalities, anatomic regions, accession and placer order numbers, procedure codes, series number, description and date-time, instance and frame counts, and the Key Image Note title code that flags the significant images. The stated purpose is retrieval economics: identify the series and instances of interest, and retrieve those instead of the whole study.
Put that in units. A multi-phase CT is routinely several gigabytes across a dozen series. A manifest that lets a consumer identify the two series it needs turns a multi-gigabyte transfer into a few hundred megabytes. Across a regional network that is not a performance optimisation. It is the difference between a workflow people use and one they abandon.
PICK A DIMENSION
Six places where the two profiles decide something different. No scores: every line is a statement from the supplement, with the section it came from.
How much can a consumer learn before it retrieves anything?
XDS-I.b
The XDS-I.b manifest is a Key Object Selection document listing the study, series and SOP instance UIDs, and not a great deal around them. A consumer that wants to know which series is the axial reconstruction generally finds out by retrieving it.
MADO
The MADO manifest extends that definition with modalities, anatomic regions, accession and placer order numbers, procedure codes, series number, description and date-time, instance and frame counts, and the Key Image Note title code flagging key images. The stated purpose is to identify the series and instances of interest and retrieve those instead of the whole study.
SOURCE · RAD TF-1: X.4.1.1
What format does the manifest arrive in?
XDS-I.b
DICOM KOS, and only DICOM KOS.
MADO
Two: a DICOM KOS-based format and an HL7 FHIR-based format, plus a specified bi-directional mapping between them, so an engine holding one can produce the other. The Content Creator shall be capable of producing both and configurable to emit either. It may publish both at once, and is not required to.
SOURCE · RAD TF-1: X.1.1.1, TF-3: 6.X.5
What has to be in place underneath?
XDS-I.b
XDS.b. The profile and the registry it rides on are one decision.
MADO
None in particular. The manifest can be published to MHD, MHDS, XDS.b, XDS-I.b or a proprietary document sharing scheme, and the profile maps its own search parameters onto MHD and XDS.b metadata so that one query means the same thing on either.
SOURCE · RAD TF-1: X.4.1.1 and X.6, TF-3: Appendix A
What does a responder actually have to implement?
XDS-I.b
A responder in XDS-I.b shall support all four WADO-RS message pairs: Get Instances, Get Metadata, Get Bulkdata and Get Rendered Instances.
MADO
A responder in MADO shall support the Get Instances pair for Study, Series and Instance resources, and may support the Frame Pixel Data resource. Get Rendered Instances is required only of an actor claiming the Rendered Instances Option. MADO does not require metadata or bulk data retrieval at all.
SOURCE · RAD TF-2: 4.107.4.1.1 and 4.107.4.1.4
What happens when the images are in another community?
XDS-I.b
Cross-community imaging retrieval is a separate profile and a separate conversation, and the address rewriting between gateways is where deployments have historically diverged.
MADO
The profile is grouped with XC-WADO, and an appendix works the URL rewriting through four figures covering both the Retrieve Location UID case and the Retrieve URL case, with worked hostnames on both sides of the gateway.
SOURCE · RAD TF-1: X.6.5, TF-2: Appendix XA
Can an XDS-I.b estate adopt this incrementally?
XDS-I.b
An existing XDS-I.b deployment keeps working. Inside one, a MADO Content Creator must emit the KOS-based format, which is backward compatible with the XDS-I.b manifest, and the Imaging Document Source in that community is configured to match.
MADO
Existing XDS-I.b KOS manifests may be consumed by MADO Imaging Document Consumers. The supplement says so, then says the price in the same sentence: the enhanced features introduced by the MADO manifest will not be available. Old manifests keep working. They do not become richer.
SOURCE · RAD TF-1: X.6.4
Two encodings, and the mapping between them
MADO defines the same manifest in two formats and specifies the transformation in both directions.
The DICOM KOS-based format encodes it as a Key Object Selection document in the PS3.10 file format. It is what an existing imaging estate can produce today, and it is backward compatible with the XDS-I.b manifest. In an XDS-I.b deployment it is not a choice: the format the Content Creator uses must be the KOS-based one, which constrains the Imaging Document Source in that community to match.
The FHIR-based format encodes it as a Bundle of type document. That is the format that fits a network already speaking MHD, and the one a browser client can read without a DICOM library.
Neither is a migration path away from the other. They are two views of one object, which is the pragmatic answer to a two-decade transition: a hospital does not have to pick the year it becomes FHIR-native.
PICK AN ELEMENT
What it is in the DICOM KOS manifest, what it becomes in the FHIR manifest, the rule that governs the crossing, and where Europe differs.
DICOM KOS
(0020,000D) UI
The identifier of the imaging study, and the value every later retrieve is built from.
HL7 FHIR
ImagingStudy.identifier:study-instance-uid
A mandatory 1..1 slice profiled as MadoStudyInstanceUidIdentifier, with identifier.system fixed to urn:dicom:uid.
WHY THE RULE IS THERE
The slice is not optional. A manifest without a study UID cannot be resolved to anything, which is why the cardinality is 1..1 rather than a should.
IN EUROPE
The HL7 Europe R5 draft adds invariant im-imagingstudy-01, requiring the identifier value to begin ihe:urn:oid:. No such prefix appears anywhere in the IHE R4 profile or the supplement. An engine translating between the two guides has to know which one it is writing for.
FHIR fragment
{
"system": "urn:dicom:uid",
"value": "1.2.840.113619.2.55.3.2831183778"
}DICOM KOS
(0008,0050) SH
The order number the RIS minted when the procedure was requested.
HL7 FHIR
ImagingStudy.identifier:accession-number
Profiled as MadoAccessionNumberIdentifier, with MadoReferencedAccessionNumberIdentifier for the order reference alongside it.
WHY THE RULE IS THERE
This is the join back to the order, and it is what lets a report and a manifest be recognised as being about the same procedure without either one pointing at the other.
IN EUROPE
Carried through unchanged. Accession numbers are assigning-authority scoped, so a cross-border consumer reads the namespace before it reads the value.
FHIR fragment
{
"type": { "coding": [{ "code": "ACSN" }] },
"system": "urn:oid:1.2.3.4.5",
"value": "A-2026-0099413"
}DICOM KOS
(0010,0020) LO
Patient ID, with the issuer carried separately in (0010,0021).
HL7 FHIR
ImagingStudy.subject → Patient
A mandatory 1..1 subject reference resolving to the Patient entry in the same document Bundle.
WHY THE RULE IS THERE
The Bundle is a FHIR document, so the patient travels inside it rather than being resolved from a server the consumer may not be able to reach.
IN EUROPE
This is where the European work concentrates: the EU extensions align the patient with the European core patient model so a name arriving from one member state parses in another. That guide is a continuous build and not an authorised publication.
FHIR fragment
{
"subject": { "reference": "Patient/pat-1" }
}DICOM KOS
(0008,2218) Anatomic Region Sequence
In the KOS manifest it is carried as the coded Target Region content item, (123014, DCM), from the high-level anatomic regions value set.
HL7 FHIR
ImagingStudy.extension:anatomical-region
A CodeableConcept extension, 0..* with a preferred binding.
WHY THE RULE IS THERE
Preferred, not required. A consumer filtering studies by body region cannot assume the code is there, and a producer that omits it is still conformant.
IN EUROPE
The reason this matters more in Europe than anywhere else is translation: a coded region is what lets a Spanish system render a French study as head and neck without reading French. The published European drafts have not yet tightened it — the R5 draft is 0..1 with an example binding, which is looser than the IHE base, not tighter.
FHIR fragment
{
"url": ".../StructureDefinition/anatomical-region",
"valueCodeableConcept": {
"coding": [{
"system": "http://snomed.info/sct",
"code": "774007",
"display": "Structure of head and/or neck"
}]
}
}DICOM KOS
(0008,0061) Modalities in Study
Series-level acquisition modality, coded from DCID 29. Non-acquisition modalities from DCID 32 may also appear.
HL7 FHIR
ImagingStudy.series.modality
Mandatory 1..1 on every series, alongside series.uid and the instance count.
WHY THE RULE IS THERE
Modality is on the series, not the study, because a study routinely holds more than one and a consumer choosing what to pull needs the distinction.
IN EUROPE
Unchanged. Modality is one of the few places in imaging where the terminology has been settled for decades.
FHIR fragment
{
"uid": "1.2.840.113619.2.55.3.2831183778.1",
"modality": {
"system": "http://dicom.nema.org/resources/ontology/DCM",
"code": "CT"
},
"numberOfInstances": 412
}DICOM KOS
(0008,1190) Retrieve URL
The WADO base URI, or a Retrieve Location UID that a lookup service resolves into one. Both methods have to be implemented.
HL7 FHIR
ImagingStudy.series.endpoint:wado and .endpoint:webviewer
For each series the manifest SHALL contain a WADO endpoint. At study level it MAY contain a web viewer endpoint.
WHY THE RULE IS THERE
The mandatory one is the machine path and the optional one is the human path. A consumer can always retrieve; it cannot always launch a viewer, and a product that assumes otherwise will meet a manifest that has no viewer endpoint in it.
IN EUROPE
Across a border the base URI is rewritten by the initiating and responding gateways under XC-WADO. The supplement works that rewriting through four figures rather than leaving it to the deployment, which is where XDS-I.b estates diverged.
FHIR fragment
{
"endpoint": [{ "reference": "#wado-1" }],
"resource": {
"resourceType": "Endpoint",
"address": "https://example.org/dcm4chee-arc/aets/DCM4CHEE/rs"
}
}The document, opened
The FHIR encoding is a Bundle with type fixed to document. That is not cosmetic. A FHIR document is a closed, self-contained set: the first entry must be a Composition, everything it refers to travels inside it, and the whole thing can be signed as one object. It is a snapshot, which is what a manifest is.
The Composition is easy to read as ceremony around the real payload, and it is the opposite. Its narrative is what a system with no imaging integration at all still renders for a clinician: patient, date, modalities, regions. It is the difference between a manifest that degrades gracefully in a mixed estate and one that is inert outside the systems built for it.
MADO FHIR MANIFEST
Open a node for the constraint behind it.
A FHIR document rather than a collection or a searchset. The choice carries the consequences: the first entry must be a Composition, the set is a closed snapshot of the study inventory at the moment of publication, and it can be signed as one object. When the study changes, the Content Creator publishes a new manifest and deprecates the old one rather than editing this one.
The clinical header, and the reason a system that has never heard of MADO can still do something useful with the manifest. Composition.text carries generated narrative, so an EHR with no ImagingStudy support and no viewer integration still shows a clinician the patient, the date, the modalities and the regions. event.detail points at the ImagingStudy entry below, which is what binds the readable header to the structured inventory.
Mandatory: identifier:study-instance-uid at 1..1 with identifier.system fixed to urn:dicom:uid, status, subject, numberOfSeries and at least one series. The anatomical region extension sits here at 0..* with a preferred binding, which means a consumer filtering by body region has to handle its absence.
Each series carries its own Series Instance UID, its modality coded from DCID 29, and the number of instances in it. This is the level the retrieve decision is made at: a consumer reads the series list, picks the ones it wants, and asks for those rather than for the study.
For each series the manifest shall contain a WADO endpoint holding the base URI, for example https://example.org/dcm4chee-arc/aets/DCM4CHEE/rs. The consumer appends the study, series and instance UIDs from the manifest and issues WADO-RS Retrieve [RAD-107]. No out-of-band endpoint discovery, no directory lookup, no configuration file that has to agree with the registry.
An address that opens a zero-footprint viewer on the whole study. It is a convenience for a clinician who wants to look rather than to parse, and because it is optional a product cannot be built on the assumption that it is present. The mandatory WADO endpoint above is the path that is always there.
The subject travels inside the document rather than as a reference to a server the consumer may not be able to reach. This is also the element the European work is concentrated on, because a name that parses in one member state has to parse in the next.
Which device or organisation assembled this manifest. It matters more than it looks: the manifest is a claim about what a specific archive held at a specific moment, and a claim with no author cannot be followed up when it turns out to be wrong.
Accession number, placer order number and procedure codes, carried so the manifest can be joined back to the order that produced it. This is one of the additions over the XDS-I.b manifest, and it is what lets a consumer answer which order a study belongs to without opening the report.
Retrieval asks for less than you expect
MADO reuses an existing transaction rather than inventing one, and then asks less of it than the profiles beside it do. WADO-RS Retrieve defines four request and response pairs. A Requester shall support at least one; a Responder shall support all four, as defined in DICOM. Each profile then narrows that, and MADO narrows it hardest.
| Profile | Responder obligation |
|---|---|
| XDS-I.b | All four message pairs |
| Web-based Image Access | All four message pairs |
| Integrated Multimedia Reporting | All four message pairs |
| MADO | Get Instances, for Study, Series and Instance resources. Frame Pixel Data may be supported. Get Rendered Instances only under the claimed option |
| XC-WADO | Get Instances; Get Rendered Instances optionally |
The supplement is explicit that MADO does not require retrieval of Metadata, Pixel Data or Bulk Data resources at all. One message pair against three resource levels is the whole obligation. Anyone writing a tender should notice: demanding the full four specifies a different profile than the one they meant.
Two details cost implementers real time. First, a consumer shall implement both ways of getting the base URI: the Retrieve URL carried in the manifest, and the Retrieve Location UID resolved through a lookup service that sits outside the profile. Second, a consumer requesting a series or study resource shall handle a larger or smaller number of instances than it expected. The manifest is a snapshot and the archive is live. Code that treats a count mismatch as an error will raise one against a correctly behaving system, in the first week.
What Europe adds, and what is still moving
The EHDS Regulation makes medical imaging studies and related imaging reports one of its priority categories, in Article 14. The dates are staged, and the staging is the part that gets misreported: the Regulation starts to apply on 26 March 2027, the first group of categories and the secondary use provisions land on 26 March 2029, and imaging, laboratory results and discharge reports follow on 26 March 2031.
Five years is not breathing room. It is roughly one procurement cycle plus one replacement cycle for a regional archive, so the estates that are ready in 2031 are the ones writing MADO into tenders in 2027. The systems being bought now are the systems that will be running then.
The European layer on top of the profile is less settled than the coverage suggests. The HL7 Europe EU extensions guide is a continuous build, version 0.2.1-build, carrying the standard warning that it changes regularly and is not an authorised publication. An earlier HL7 Europe R5 draft of the same profile says outright that it is not yet recommended for production use, and that it is being transferred to IHE Radiology.
Two specific divergences are worth knowing about, because they produce validator failures that look like implementation bugs. The IHE profile fixes identifier.system to urn:dicom:uid and carries the bare study UID as the value; the HL7 Europe R5 draft adds an invariant requiring that value to begin ihe:urn:oid:, a prefix that appears nowhere in the IHE text. And the anatomical region extension, which several summaries report as escalated in Europe to mandatory with a required binding, is 0..* preferred in the IHE base and 0..1 with an example binding in the R5 draft. That is looser, not tighter.
None of which is a reason to wait. It is a reason to build against the IHE supplement, pin revision numbers rather than guide names, and re-validate on every revision.
What to do about it now
The profile was tested at IHE-Europe Connectathon Week in Brussels from 23 to 27 March 2026, with the Xt-EHR Projectathon inside it from the 24th to the 26th, days after the Trial Implementation was published. The next European test week is 19 to 23 April 2027 in The Hague. That is the calendar an implementation plan hangs off.
Before then, five questions decide whether an estate is in a position to take part at all. None of them is a maturity score. Each is an obligation the supplement places on an actor.
FIVE OBLIGATIONS, CHECKED
Each one is a requirement the supplement places on an actor, with the section beside it. Nothing you answer leaves this page.
Requirements met
0 of 5
- Does the archive answer WADO-RS Retrieve over HTTP? Without this there is no Imaging Document Source. It is the one transaction the profile is built on, and nothing else in the list matters until it answers.
- Can the manifest producer emit both encodings? A Content Creator that can only produce one format does not conform, however good that one format is.
- What happens when the study changes? A manifest that is never re-issued becomes a list of instances that used to exist, and a consumer has no way to tell how stale it is.
- Does every series carry its own WADO endpoint? If the address lives in configuration then the manifest is not self-describing, and every consumer needs a deployment-specific setup step before it can retrieve anything.
- Is the manifest published into a sharing infrastructure? A manifest nobody can find is a file on a disk. Discovery is deliberately outside this profile, which means it is somebody in your organisation, and if it is nobody then the chain has no first link.
The short version for anyone deciding where to spend attention: the retrieve endpoint is the hard prerequisite, the dual-encoding capability is the conformance trap, and the manifest lifecycle is the thing nobody budgets for and everybody needs. Discovery is somebody else in your organisation, and if it is nobody, the chain has no first link.
Then read the supplement. It is free, sixty-six pages, and specific, and the difference between shall support all four message pairs and shall support Get Instances is the difference between two procurement documents.
If you want the whole profile in one place, MADO 101: The Manifest Becomes Its Own Document is the paper behind this piece. It works through the actors and their obligations, both encodings and the mapping between them, the FHIR document and the KOS document attribute by attribute, cross-community retrieval, the EHDS dates, and nine failure modes worth writing into a test plan. It is free at /resources/mado-101.