The stack exists and none of it is finished
The first wave of imaging AI arrived as products rather than as participants. Each one came with a viewer, a routing arrangement and its own idea of how a finding should reach a radiologist, which is how a reading room ends up with four screens and one patient. The standards that fix this now exist, and they cover the whole path: asking for the work, encoding the result, displaying it, recording what the reader did with it, putting the number in the chart, and watching the model afterwards.
What does not exist is a finished stack. Not one IHE profile on that path has reached final text: five are trial implementation, and the sixth is still out for public comment. profiles.ihe.net says so with dates against each one.
| Profile | What it covers | Status |
|---|---|---|
| AIW-I | Requesting and managing inference over the DICOM worklist | Trial implementation, August 2020 |
| AIR | Encoding, storing, retrieving and displaying the result | Trial implementation, revised August 2025 |
| AIRA | Recording the assessment of an individual result | Trial implementation, June 2025 |
| IRA | Reporting applications inside the reading environment | Trial implementation, October 2023 |
| IDR | Packaging verified measurements into discrete report fields | Public comment, March 2026 |
| MADO | Manifest-based access to the studies themselves | Trial implementation, revised September 2026 |
Trial implementation is not a quality warning. It means the text is stable enough to build against and IHE is still collecting what implementers hit, which is exactly the state a profile should be in while products are being written to it. It does mean two conformant systems can still differ in the corners, and it means an answer of "supports AIR" in a procurement response is the beginning of the conversation rather than the end of it. Ask which actor, which transactions, which optional elements, and when it was last taken to a Connectathon. Public comment is a stage below that, so a conformance claim against IDR today is a claim about a draft.
What follows walks the path in the order a study actually moves through it, and then the two layers that decide whether any of it survives contact with an operating budget.
Six handoffs
An imaging AI deployment is not one integration. It is six, and they fail differently: the early ones fail loudly, as a study that never arrives or a task nobody claims, and the late ones fail quietly, as a finding no clinician can act on or a model nobody is measuring.
SCANNER TO CHART · SIX HANDOFFS
Open a handoff for the standards that govern it and the payload that crosses it. Every tag, template and resource name is the real one; the payloads are shortened to the elements under discussion and none of them is a complete instance.
Reaching the priors without moving the pixels
A comparison model is worth little without the prior study, and fetching every prior in full is how an imaging AI rollout takes the archive network down with it. MADO publishes a manifest instead: a FHIR document listing what exists, series by series, with the retrieve endpoint attached. The router reads the inventory, decides what it wants, and asks for that.
- GOVERNED BY
- IHE MADO, PIX/PDQ, ATNA
- ON THE WIRE
- WADO-RS Retrieve [RAD-107]
Identity comes first. PIX or PDQ reconciles the patient identifier across enterprise boundaries before anything is retrieved. A model that quietly compares two patients is worse than no model.
ATNA is not paperwork. An automated consumer reading imaging is an audit event and a node that has to authenticate before it gets one. The audit record is also the only evidence available later that the training set was assembled from studies the organisation was allowed to use.
{
"resourceType": "Bundle",
"type": "document",
"entry": [
{ "resource": { "resourceType": "Composition",
"type": { "coding": [{ "system": "http://loinc.org",
"code": "18748-4" }] } } },
{ "resource": {
"resourceType": "ImagingStudy",
"status": "available",
"identifier": [{ "system": "urn:dicom:uid",
"value": "urn:oid:1.2.840.10008.5.1.4.1.1.2" }],
"numberOfSeries": 4,
"series": [{ "uid": "1.3.6.1.4.1.5962.99.1.2280943358",
"modality": { "code": "CT" },
"numberOfInstances": 318 }],
"endpoint": [{ "reference": "Endpoint/wado" }] } }
]
}[{
"0020000D": { "vr": "UI", "Value": ["1.2.840.10008.5.1.4.1.1.2"] },
"00080060": { "vr": "CS", "Value": ["CT"] },
"00201206": { "vr": "IS", "Value": [4] },
"00201208": { "vr": "IS", "Value": [1272] }
}]
# StudyInstanceUID, Modality, NumberOfStudyRelatedSeries,
# NumberOfStudyRelatedInstances. The counts are the reason to read
# the manifest first: 1272 instances is not a prefetch decision to
# take blind.The worklist is the integration point
AIW-I names three actors, Task Requester, Task Manager and Task Performer, and carries them over the DICOM RESTful worklist service. A router posts a work item, an inference service claims it and moves it through the state machine. The proprietary alternative is an endpoint per vendor and a routing table maintained by hand.
- GOVERNED BY
- IHE AIW-I, DICOM UPS-RS, DICOM Supplement 224
- ON THE WIRE
- POST /workitems, then claim and change state
The state machine is the contract. SCHEDULED, IN PROGRESS, COMPLETED or CANCELED, with a transaction UID held by whoever claimed the item. Two services cannot both own one study, and a service that dies holding a claim is visible as a work item stuck in progress rather than as a result that never arrived.
Eligibility is a coding problem. A model trained on non-contrast head CT has to be handed non-contrast head CT, and that decision is made on the procedure code. A department whose procedure names are local has a terminology mapping to do before it has an AI deployment to do.
Supplement 224 describes the service itself. Applications made of Components, each exposing an entrypoint, registered with a Platform through a manifest that states what the component consumes and produces. It is packaging and registration, which is what a routing table was standing in for.
(0074,1000) ProcedureStepState = IN PROGRESS
(0008,1195) TransactionUID = 1.2.276.0.7230010.3.1.4.1
(0074,1204) ProcedureStepLabel = AI lung nodule detection
(0040,4005) ScheduledProcedureStepStartDateTime = 20260917T103000
(0040,4025) ScheduledStationNameCodeSequence
>(0008,0100) CodeValue = AI-NODULE-01
(0040,4021) InputInformationSequence # the study to read
>(0020,000D) StudyInstanceUID = 1.2.840.10008.5.1.4.1.1.2{
"application": "nodule-detect",
"version": "3.2.0",
"components": [
{
"name": "detect",
"entrypoint": "/jobs",
"scope": { "modality": ["CT"], "bodyPart": ["CHEST"] },
"produces": ["SR", "SEG"]
}
]
}
# The elements Supplement 224 defines are applications, components,
# entrypoints and scope. The field names here are not a quotation
# from the supplement.One finding, three encodings
This is the only handoff in the six where the same object genuinely exists in three forms at once, and it is where most of the integration cost sits. The measurement is authored as a DICOM Structured Report on template TID 1500, which is the encoding the archive and the viewer understand. Supplement 219 is the same report as JSON, for the engineers who write the model. The FHIR Observation is the same number again, for the chart.
- GOVERNED BY
- DICOM TID 1500, DICOM Supplement 219, HL7 FHIR
- ON THE WIRE
- STOW-RS store, then map outward
SCOORD3D is what makes the number a finding. A volume with no spatial reference is a row in a spreadsheet. The coordinate ties it to the frame it was measured on, which is what a reader needs to disagree with it.
Supplement 219 is a bridge, not a second truth. It supports a full-fidelity round trip: business names make the JSON readable, and a conformant binary SR can be regenerated from it. Treat it as a separate record and the two drift, which is a bug nobody sees until an audit compares them.
Units are UCUM on both sides. DICOM and FHIR agree here, and it is one of the few places in this stack where a mapping is a copy rather than a decision.
(0040,A730) ContentSequence
>(0040,A040) ValueType = CONTAINER
>(0040,A043) ConceptNameCodeSequence
>>(0008,0100) CodeValue = 126000
>>(0008,0102) CodingSchemeDesignator = DCM
>>(0008,0104) CodeMeaning = Imaging Measurement Report
>(0040,A730) ContentSequence # TID 1411 measurement group
>>(0040,A040) ValueType = NUM
>>(0040,A043) ConceptNameCodeSequence
>>>(0008,0100) CodeValue = 118565006
>>>(0008,0102) CodingSchemeDesignator = SCT
>>>(0008,0104) CodeMeaning = Volume
>>(0040,A300) MeasuredValueSequence
>>>(0040,A30A) NumericValue = 142.5
>>>(0040,08EA) MeasurementUnitsCodeSequence
>>>>(0008,0100) CodeValue = mm3
>>>>(0008,0102) CodingSchemeDesignator = UCUM
>>(0040,A730) ContentSequence
>>>(0040,A040) ValueType = SCOORD3D
>>>(0070,0022) GraphicData = 12.4\-45.1\102.8{
"ImagingMeasurementReport": {
"ProcedureReported": "CT of chest",
"ImagingMeasurements": [
{
"TrackingIdentifier": "nodule-1",
"Finding": "Pulmonary nodule",
"Volume": { "value": 142.5, "units": "mm3" },
"ReferencedSOPInstanceUID": "1.2.840...1272",
"GraphicData": [12.4, -45.1, 102.8]
}
]
}
}
# The keys are business names bound to coded tuples in a separate
# definition file, which is how the JSON stays readable without
# losing the codes underneath it.{
"resourceType": "Observation",
"status": "final",
"code": { "coding": [{ "system": "http://radlex.org/RID",
"code": "RID50149" }],
"text": "Pulmonary nodule volume" },
"valueQuantity": { "value": 142.5, "unit": "mm3",
"system": "http://unitsofmeasure.org",
"code": "mm3" },
"derivedFrom": [{ "reference": "ImagingSelection/nodule-1" }],
"device": { "reference": "Device/nodule-detect-3.2.0" }
}What the radiologist did with it
AIR is the profile that makes a result displayable: it sets what an image display has to do with an AI-authored SR, segmentation or parametric map so the same finding looks the same on the next workstation. AIRA is the profile for the sentence after that one. It records the outcome of assessing an individual AI result, accepted, corrected or rejected, by a human reader or by another process, as an interoperable object rather than as a click that vanished.
- GOVERNED BY
- IHE AIR, IHE AIRA
- ON THE WIRE
- An assessment object beside the result it assesses
An unassessed finding is not a report. The assessment is what keeps an unverified machine output out of the signed document, and what tells a later reader which findings a person actually stood behind.
This is the only ground truth the department produces for free. Every correction is a labelled example generated by the workflow itself. Discard it and the monitoring in handoff 06 has nothing local to compare against, and the retraining question has no local evidence at all.
Both profiles are trial implementation. AIR was last revised in August 2025 and AIRA was published in June 2025. Neither is final text, so two conformant products can still differ in the corners, and a procurement that reads "supports AIR" is the start of the conversation rather than the end of it.
(0040,A491) CompletionFlag = COMPLETE
(0040,A493) VerificationFlag = VERIFIED
(0040,A073) VerifyingObserverSequence
>(0040,A027) VerifyingOrganization = Radiology
>(0040,A030) VerificationDateTime = 20260917T112412
(0018,1020) SoftwareVersions = nodule-detect 3.2.0
(0040,A730) ContentSequence # the corrected value
>(0040,A300) MeasuredValueSequence
>>(0040,A30A) NumericValue = 130.0
# The original 142.5 is not overwritten. A correction that erases
# what the model said destroys the only comparison worth having.The EHR wants a number, and a way back to the image
A measurement that stays in the archive is available to radiology and to nobody else. As a FHIR Observation it sits in the chart beside the labs, it can be trended, and a referring clinician can act on it without opening a viewer. The link back to the pixels is the part that breaks.
- GOVERNED BY
- HL7 FHIR, SMART on FHIR
- ON THE WIRE
- POST /Observation
Check the FHIR version before promising the tether. ImagingSelection is new in R5. It is the resource an Observation points at to say which frames the number came from, and on an R4 endpoint it does not exist. US Core still profiles R4, which is what a hospital integration is most likely to hand you.
SMART launches the viewer, it does not move the data. The OAuth2 launch gives an embedded application the patient context and a token. It is how a reader gets from the chart to the images; it is not a substitute for the Observation being in the chart.
Someone owns the terminology. The code on the Observation decides whether the value is findable later. RadLex is registered as a code system in HL7 Terminology and the LOINC-RSNA Playbook names the procedures, so both ends can be coded. Neither happens by default.
{
"resourceType": "ImagingSelection",
"id": "nodule-1",
"status": "available",
"studyUid": "1.2.840.10008.5.1.4.1.1.2",
"derivedFrom": [{ "reference": "ImagingStudy/chest-ct-0917" }],
"instance": [{ "uid": "1.2.840...1272",
"imageRegion3D": [{ "regionType": "point",
"coordinate": [12.4, -45.1, 102.8] }] }]
}{
"resourceType": "Observation",
"status": "final",
"derivedFrom": [{ "reference": "ImagingStudy/chest-ct-0917" }],
"note": [{ "text": "Series 1.3.6...358, instance 1.2.840...1272" }]
}
# R4 has no ImagingSelection, so the reference degrades to the
# study and the frame-level location ends up in text nothing can
# query. Plan the DICOM side of the link accordingly, or write the
# coordinates somewhere a machine can still read them.Concordance, computed by somebody else
Assess-AI is a registry inside the National Radiology Data Registry. A participating site submits de-identified AI output, report text and DICOM study metadata; the registry derives a surrogate label from the report text with a prompting pipeline over a commercial model held under a managed service, compares it with what the algorithm said, and returns concordance on a dashboard. It currently covers a named set of use cases, intracranial haemorrhage and pulmonary embolism among them, rather than any model a site happens to run.
- GOVERNED BY
- ACR Assess-AI, ISO/IEC 42001
- ON THE WIRE
- Submission through ACR Connect, comparison held centrally
The label is a surrogate, and surrogates are noisy. The comparison is against what the report said, not against what was there. Extraction error and model error arrive inside the same number, and error in the reference makes a real difference harder to detect rather than easier.
A registry is a comparison, not a cause. Concordance falling tells a site that something moved. Which scanner, which population, which software version is a question for the local lineage record, and no registry holds that.
This is the loop a change control plan runs on. A predetermined change control plan needs an observable trigger. A monitored metric is the only kind of trigger a regulator can check, which makes this handoff the one that turns a plan into a control loop.
ai_output : positive, score 0.86, nodule-detect 3.2.0
report_text : de-identified, free text
study_metadata : modality CT, manufacturer, model, kVp, slice
surrogate_label : positive # extracted from the report
concordant : true
# The fields are the ones the registry describes submitting and
# computing. The record shape is drawn here for legibility; ACR
# publishes no wire format for it.One finding, three encodings, and a version to check
The measurement a model produces gets written down three times. It is authored as a DICOM Structured Report on template TID 1500, because that is what the archive stores and the viewer understands. Supplement 219 is the same report as JSON, with business names bound to the coded tuples in a separate definition file so the payload reads as field names while the codes stay underneath it. The FHIR Observation is the same number again, for the chart.
Three encodings of one fact is a synchronisation problem, and the supplement is careful about it: the JSON supports a full-fidelity round trip, so a conformant binary SR can be regenerated from it. Treat the JSON as a second record that is merely similar and the two drift, which is the kind of defect nobody notices until an audit reads both.
The version trap is at the chart end. A measurement in the record is worth more when a clinician can get from the number back to the frames it came from, and in FHIR that link is ImagingSelection: the resource an Observation points at through derivedFrom to say which study, series, instances or image region produced the value. It is new in R5. It does not exist in R4, US Core still profiles R4, and R4 is what a hospital integration is most likely to hand you. On that endpoint the reference degrades to the study, the frame-level location ends up in a text note nothing can query, and the tether that was promised in the design review is not there.
This is worth finding out in week one rather than in acceptance testing. It is also the cheapest question on the list: ask for the capability statement and read the version off it.
The only ground truth a department produces for free
Every reading session generates labelled examples. A radiologist accepts a finding, corrects a volume, or rejects a detection outright, and each of those is a judgement about a specific model output on a specific study. In most deployments it is a click that goes nowhere.
AIRA is the profile that makes it data. It defines the recording and transfer of the outcome of assessing an individual AI result, by a human reader or by another process, as an object in its own right, defined across the range of DICOM objects a result might be. AIR is what gets the result in front of the reader in the first place, and sets the baseline an image display has to meet so the same finding looks the same on the next workstation.
Two things follow from capturing assessments, and both are worth the integration on their own. An unverified machine output can be kept out of the signed report, because the verification state is recorded rather than assumed. And the department acquires a local evaluation set that matches its own scanners, its own protocols and its own patients, which is the only evidence available when a vendor claims a new version is better.
Keep the original. A correction that overwrites the model output destroys the comparison. Store both values and which reader made the change, and the pair becomes the input to everything in the next section.
What a registry can and cannot see
The ACR runs Assess-AI inside the National Radiology Data Registry. A participating site submits de-identified algorithm output, report text and DICOM study metadata through ACR Connect. The registry derives a surrogate label from the report text using a prompting pipeline over commercial models held under a managed service, compares it with what the algorithm said, computes concordance centrally, and returns it on a dashboard. It covers a named set of use cases, intracranial haemorrhage and pulmonary embolism among them, rather than whatever a site happens to be running.
Two limits come with that design, and neither is a criticism of the registry. The reference is what the report said rather than what was there, so extraction error and model error arrive inside the same number. And a registry tells a site that something moved, not what moved it: which scanner, which software version, which population is a question for the local lineage record.
A third limit is arithmetic, and it is the one that catches change control plans. A concordance rate computed on a month of studies is an estimate with an interval around it, and a fall smaller than that interval is not a signal. At three hundred monitored studies a month and a baseline of 94%, the 95% interval on one month is about 2.7 percentage points wide either side. A trigger written at two points fires on the calendar.
The detection horizon
ALPHA 0.05 · POWER 0.80- CASES NEEDED
- 555
- at 80% power
- TIME TO CALL IT
- 1.9 months
- at this volume
- ONE MONTH, 95% CI
- ± 2.7 pp
- Wilson, on one month
- FLOOR IN A YEAR
- 1.2 pp
- smallest detectable fall
A fall smaller than the interval is not a trigger. A dashboard that moves from 94.1% to 92.8% on a month of three hundred studies has moved less than its own uncertainty. Set the bound in a change control plan below the floor above and the plan commits to noticing something the monitoring cannot see.
Three things make the real horizon worse than this one. The reference label is extracted from a report rather than established, and error in a reference makes a true difference harder to detect. Checking every month is repeated testing, so some of the alarms are the calendar rather than the model. And a fall concentrated in one scanner or one subgroup is diluted in a pooled rate, which is the argument for stratifying before the volume gets spent.
Read the panel the other way round and it becomes a design constraint. Decide the fall that would matter clinically, read off the cases needed, divide by the volume the site can actually monitor, and that is the earliest the plan can honestly promise to notice. A predetermined change control plan needs an observable trigger, and a trigger set below the detection floor commits a manufacturer to seeing something the monitoring cannot show.
Stratifying makes it worse before it makes it better. A fall concentrated in one scanner model or one subgroup is diluted in a pooled rate, so the pooled rate is the wrong place to look, and every stratum divides the volume that was already the binding constraint. That is an argument for choosing the strata that matter in advance, not for pooling.
Who pays, and what is on the table this autumn
None of the above gets built twice, so the second question in every business case is where the money comes from. There are four routes and they are not alternatives so much as different settings.
| Route | Setting | Standing | What it turns on |
|---|---|---|---|
| CPT Category III | Outpatient professional | Temporary, tracking only | Priced by the local contractor, so payment varies by region and may be nothing at all |
| CPT Category I | Outpatient professional | Permanent, nationally priced | Published evidence and established use. CT-derived coronary FFR reached it as 75580 in the 2024 code set |
| CMS NTAP | Inpatient | Two to three years | The lesser of 65% of the technology cost or 65% of the amount by which the case exceeds the DRG payment |
| OPPS SaMS | Hospital outpatient facility | Proposed for CY 2027 | Status indicator O1 on 36 designated codes, with 21 of them moved into new technology APCs |
The fourth row is the live one. In the CY 2027 OPPS proposed rule, CMS renames the software codes Software as a Medical Service, designates 36 HCPCS codes as SaMS, creates status indicator O1 to mark them separately payable, and reassigns 21 of them from clinical APCs into new technology APCs at rates approximating what they are paid now. CMS-1850-P was published in the Federal Register on 7 July 2026 and comments closed on 31 August 2026, so the final rule is due in the next few weeks. A facility building a case for an algorithmic service this quarter is writing it against a payment category that does not exist yet.
No rate appears anywhere in this piece, and the omission is the point. A Category III code has no national rate to quote, because pricing is left to the contractor. SaMS is a proposal. A platform licence is whatever was negotiated. A calculator that multiplies an invented per-study figure by your volume returns a number that cannot survive a capital committee, and the number it returns is the one thing in the business case nobody will forget.
The catalog
Twenty-one entries: the profiles, the DICOM supplements, the FHIR resources, the vocabularies, and the governance and payment rules that sit over them. Search it or filter it by family. The five IHE profiles carry the state and date IHE publishes for them; nothing else carries a status, because there is no maturity score for a DICOM supplement that would not have been invented here.
TWENTY-ONE ENTRIES · PROFILES, SUPPLEMENTS, RESOURCES, RULES
21 OF 21 SHOWN
Requesting, managing and performing inference on acquired image data, with the work managed over the DICOM RESTful worklist service rather than over a vendor endpoint.
What it changes. A department can run several models from several suppliers against one worklist, and can see what is queued, what is running and what failed.
Implementation. Three actors: Task Requester, Task Manager, Task Performer. Transactions are UPS-RS, with DIMSE alternatives for the input retrieval.
IHE STATUS · Trial implementation, 6 August 2020
How AI results are encoded, stored, retrieved and displayed: structured reports, segmentations and parametric maps, and the baseline an image display has to meet to handle them.
What it changes. A finding renders the same way on the next workstation, which is the difference between one viewer per vendor and one reading list.
Implementation. Encoding on the archive side, presentation on the display side. AIW-I distributes its outputs through this profile.
IHE STATUS · Trial implementation, revised 8 August 2025
Recording and transferring the outcome of assessing an individual AI result. The assessing party may be a person or another process, and the assessment is its own object.
What it changes. Acceptance, correction and rejection become data. Without it the department generates ground truth all day and keeps none of it.
Implementation. Assessment objects are defined for a range of DICOM objects, so a mask and a measurement can both be assessed.
IHE STATUS · Trial implementation, 12 June 2025
A manifest listing what a study contains, published as a FHIR document or a DICOM key object selection, with the retrieve endpoint attached to each series.
What it changes. Retrospective dataset assembly and prior-study prefetch stop being a full-pixel transfer of everything that might be relevant.
Implementation. One transaction on the wire: WADO-RS Retrieve [RAD-107]. The rest of the profile is the shape of the content.
IHE STATUS · Trial implementation, revised 3 September 2026
Embedding a reporting application in the reading environment so results, including AI results, arrive inside the report the radiologist is writing.
What it changes. A finding that cannot reach the dictation is a finding the radiologist retypes, which is where measurements acquire transcription errors.
Implementation. The reporting context AIR-encoded results are distributed into.
IHE STATUS · Trial implementation, 4 October 2023
The structured report template for image-derived measurements: coded concepts, UCUM units, tracking identifiers, and spatial coordinates tying each value to the frames it came from.
What it changes. A measurement stops being a number in a PDF and becomes something a registry, a trial or a later model can read.
Implementation. SCOORD3D for spatial references, TID 1411 for the measurement group. It is the template Supplement 219 uses as its worked example.
A JSON encoding of any SR instance with full-fidelity round trip. Business names bound in a separate definition file let the JSON read as field names while the coded tuples stay underneath.
What it changes. The people writing the model can produce conformant SR without learning binary DICOM encoding first.
Implementation. A conformant binary SR can be regenerated from the JSON. Hold it as a second record and the two will drift.
How a processing service describes itself and is registered: applications built from components, each exposing an entrypoint, dispatched jobs by a platform according to a declared scope.
What it changes. Deployment stops being a hand-maintained routing table with one row per algorithm and one engineer who knows it.
Implementation. It covers description, registration and lifecycle. It does not specify failover or load balancing.
Unified Procedure Step over HTTP: create a work item, claim it with a transaction UID, move it through SCHEDULED, IN PROGRESS, COMPLETED or CANCELED, and subscribe to changes.
What it changes. Ownership of a task is explicit, so a dead inference service shows up as a work item stuck in progress rather than as a result that never came.
Implementation. Defined in PS3.18. It is the transport AIW-I builds its workflow on.
Voxel-level masks stored as first-class DICOM instances with their own series, frame of reference and coded segment labels, rather than as an overlay burned into a screenshot.
What it changes. A mask can be redisplayed, measured again, and compared against the next version of the model.
Implementation. Segment labels are coded, which is what makes a mask searchable later.
The resource an image-derived value lands on outside radiology: coded concept, quantity with UCUM units, the device that produced it, and a reference back to what it was derived from.
What it changes. A quantitative finding can be trended and acted on by clinicians who never open a viewer.
Implementation. The device reference is worth setting. An Observation that does not say which model version produced it cannot be reconciled after a retrain.
Identifies the specific study, series, instances or image region a measurement was taken from, so an Observation can point at the exact frames behind the number.
What it changes. The chart can offer a reader the image the value came from rather than the study it was somewhere inside.
Implementation. New in R5 and absent from R4. US Core profiles R4, so check the endpoint version before designing on it.
An OAuth2 profile for launching a third-party application inside the EHR or the reading environment with the patient context and a scoped token.
What it changes. A visualisation tool can be opened from the chart without a second sign-in and without a copy of the patient list.
Implementation. It is an authorisation and launch framework. It does not move imaging data.
RadLex is the radiology lexicon, now past 75,000 terms. The Playbook is the unified naming of radiology procedures, which is what a worklist filter has to match against.
What it changes. Model eligibility, worklist routing and later retrieval all depend on the procedure being named the same way twice.
Implementation. RadLex is registered as a code system in HL7 Terminology, so a FHIR resource can cite it by URI.
Cross-referencing patient identifiers between domains, querying demographics, and the authentication and audit requirements for any node handling patient data.
What it changes. An automated consumer reading across enterprise boundaries can be held to the same identity and audit rules as a person.
Implementation. Prerequisite infrastructure. It is also the only record that later shows which studies a training set was drawn from.
A registry in the National Radiology Data Registry. Sites submit de-identified AI output, report text and study metadata; surrogate labels are extracted from the reports by a prompting pipeline over commercial models under a managed service, and concordance is computed centrally.
What it changes. A site gets an outside comparison for a named set of use cases instead of an internal impression that the model is fine.
Implementation. Submission goes through ACR Connect. The reference is what the report said, not what was there.
The certifiable management system for AI, published December 2023. Plan-Do-Check-Act, an Annex A control set, and an AI system impact assessment that has to be repeated at planned intervals and whenever something significant changes.
What it changes. Oversight becomes auditable machinery with records and a schedule rather than a committee that met once.
Implementation. The impact assessment is Clause 8.4. The data controls, covering provenance and preparation, are in Annex A rather than in Clause 8.
An authorised description, filed before market, of exactly how a model may change afterwards without a new submission. The guidance was finalised on 4 December 2024 and covers AI-enabled device software functions generally.
What it changes. A model can be improved on a schedule the regulator has already agreed to, inside a stated envelope.
Implementation. Three parts: description of modifications, modification protocol, impact assessment. The vocabulary is training, tuning and testing.
Category III codes track an emerging service and are priced by the local contractor. Category I codes are permanent and nationally priced, and require published evidence and established use to obtain.
What it changes. The same service can be paid, paid variably, or not paid, depending on which code exists and who is adjudicating.
Implementation. CT-derived coronary FFR reached Category I as 75580 in the 2024 code set. That is the exception, not the pattern.
An add-on above the DRG payment for a qualifying new technology, paid at the lesser of 65% of the cost of the technology or 65% of the amount by which the cost of the stay exceeds the DRG payment.
What it changes. Part of the cost of an inpatient algorithm is recoverable, and only for as long as the technology counts as new.
Implementation. The newness period runs two to three years, after which the cost is treated as absorbed into the DRG.
In the CY 2027 OPPS proposed rule CMS would designate 36 HCPCS codes as Software as a Medical Service, create status indicator O1 to mark them separately payable, and move 21 of them into new technology APCs.
What it changes. Facility payment for algorithmic services would stop being an accident of which clinical APC a code happened to land in.
Implementation. Proposed, not final. CMS-1850-P published 7 July 2026; comments closed 31 August 2026.
What to build first
The order matters more than the choice of vendor, because two of these cannot be added afterwards.
- Identity and audit, before the first retrieval. PIX or PDQ and ATNA. An automated consumer reading across boundaries needs the same identity discipline as a person, and the audit trail is the only later evidence of which studies a dataset was drawn from.
- The worklist, before the second algorithm. One model can be integrated point to point. The second one is what turns a routing table into a maintenance problem, and AIW-I over UPS-RS is the answer that scales past it.
- The structured report as the record, not the export. Author on TID 1500 and derive the JSON and the Observation from it. Deriving the SR from a proprietary result later is the expensive direction.
- Assessment capture from day one. This is the retrofit that costs the most. A year of reading with no assessment capture is a year of ground truth that no longer exists, and no amount of later integration recovers it.
- The chart mapping, once the FHIR version is known. Design for what the endpoint actually is rather than for what the specification allows.
- Registry submission, and the monitoring plan it feeds. Decide the fall that matters and the volume available to see it before writing a trigger into anything a regulator will read.
The standards on this path are good. They were written by people who had watched the alternative, and taken together they describe a department where a finding travels from a scanner to a chart without anybody retyping it. None of that is the same thing as a stack a hospital can buy, and the six handoffs are where the difference lives.
If you want the whole of it, Imaging AI Standards: Everything Is Optional is the paper behind this piece. Twenty-six pages on the six layers and the document that governs each, the discovery supplement that was cancelled and what its absence costs, the fourteen exclusions in AIR and the two AIRA contradicts, the provenance chain DICOM has no attribute for, the three regulators and the one rule that actually binds, and twelve questions for a tender. It is free at /resources/imaging-ai-standards.