Tests that result in visual images requiring interpretation by a credentialed professional.

Data Element
Imaging Reference
Description
The technical details of the retrieval access path to indicate network services that can be used to access DICOM studies, series, or instances content and metadata (e.g., a DICOMweb server endpoint providing QIDO-RS, WADO-RS, or WADO-URI).
Submitted By: Brian Bialecki / American College of Radiology
Data Element Information
Data Element Description The technical details of the retrieval access path to indicate network services that can be used to access DICOM studies, series, or instances content and metadata (e.g., a DICOMweb server endpoint providing QIDO-RS, WADO-RS, or WADO-URI).
Rationale for Separate Consideration This Data Element is related to Diagnostic Imaging Report. “DICOM Image Files” is recommended as a high priority data element for USCDI v3 by the U.S. Core Data for Interoperability Task Force 2021. See additional information in Data Element Description
Use Case Description(s)
Use Case Description The typical case involves a radiology procedure being ordered, scheduled and performed for a registered patient. The administrative steps involve a patient being registered, a Diagnostic Imaging Order being placed for the registered patient, a unique Accession Number assigned, and the order being scheduled as a Requested Procedure. The procedure is then performed, with DICOM Images produced and archived in the PACS or VNA, and with status messages communicated to the EHR, VNA and other interested systems.
Upon receipt of completion and availability status messages, images are interpreted by a physician (e.g., a radiologist) who dictates a Diagnostic Imaging Report. The system responsible for generating the report generates DICOM Image References in the CDA that may be used by the ordering physician or patient to access the DICOM Images in the PACS or VNA.
This use case covers both inpatient and outpatient procedures. The patient may be new or known to the current healthcare facility.
Estimate the breadth of applicability of the use case(s) for this data element Diagnostic Imaging scheduled workflow is universal and well-adopted. More than 4,000 hospitals and 1 million providers are or are likely to be capturing, accessing, and exchanging Diagnostic Imaging orders and reports. Standardizing these terms in USCDI v4 would further improve health information exchange between hospitals, providers, and patients across all communities.
According to the ISO 21860:2020 product adoption and site deployment IHE Scheduled Workflow is “Moderate”.
This usage is consistent with USCDI Level 2 descriptor, “elements pertain to most or all patients, providers, or requestors.”
Link to use case project page https://www.ihe.net/uploadedFiles/Documents/Radiology/IHE_RAD_TF_Vol1.pdf
Use Case Description Additional links to support use case.
See 34.4.2.1 IHE Scheduled Workflow Simple Use Case https://www.ihe.net/uploadedFiles/Documents/Radiology/IHE_RAD_TF_Vol1.pdf
HL7 Standard for CDA Imaging Integration http://www.hl7.org/implement/standards/product_brief.cfm?product_id=13
FHIR ImagingStudy https://www.hl7.org/fhir/imagingstudy.html
DICOMWeb https://www.dicomstandard.org/dicomweb/
US Core Data Interoperability Task Force 2021 https://www.healthit.gov/hitac/events/us-core-data-interoperability-task-force-2021-27
Estimate the breadth of applicability of the use case(s) for this data element Diagnostic Imaging scheduled workflow is universal and well-adopted. More than 4,000 hospitals and 1 million providers are or are likely to be capturing, accessing, and exchanging Diagnostic Imaging orders and reports. Standardizing these terms in USCDI v4 would further improve health information exchange between hospitals, providers, and patients across all communities.
According to the ISO 21860:2020 product adoption and site deployment IHE Scheduled Workflow is “Moderate”.
This usage is consistent with USCDI Level 2 descriptor, “elements pertain to most or all patients, providers, or requestors.”
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Reducing the cost of care
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) LOINC/RSNA Radiology Playbook includes Diagnostic Imaging Procedure Codes and Descriptions.
HL7 Standard for CDA® Release 2: Imaging Integration; Basic Imaging Reports in CDA and DICOM Release 1 references LOINC® Document Type Codes, SNOMED CT® Quantity Measurement Type Codes, as well as DICOM Code Systems.
FHIR ImagingStudy references SNOMED CT Body Structures
https://loinc.org/oids/1.3.6.1.4.1.12009.10.2.5.1/
Additional Specifications Interactive Multimedia Report (IMR) Profile https://profiles.ihe.net/RAD/IMR/index.html
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts ISO 21860:2020
https://www.iso.org/standard/72004.html
Extent of exchange 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts Starting in 2009, under a contract funded by the National Institute of Biomedical Imaging and Bioengineering, RSNA oversaw the creation of the Image Share Network, which enabled participating radiology sites to share imaging records with patients via secure online accounts. To promote adoption of the standards used in the Image Share Network, RSNA partnered with the Sequoia Project, an independent nonprofit dedicated to promoting health information exchange, to develop the RSNA Image Share Validation Testing Program.
Many vendors have created private networks to share this data including PowerShare https://www.nuance.com/healthcare/diagnostics-solutions/radiology-network/powershare-medical-image-sharing.html
https://www.rsna.org/practice-tools/data-tools-and-standards/image-share-validation-program
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) HL7 FHIR is licensed under Creative Commons "No Rights Reserved". SNOMED is licensed. However, it is a current requirement of the USCDI. DICOM is copyrighted by National Electrical Manufacturers Association, IHE Scheduled Workflow is copyrighted by IHE International. Both organizations extend an irrevocable, worldwide, perpetual, royalty-free, nontransferable, nonexclusive, non-sublicensable license for the use of their respective standards and associated publications.
Privacy and Security Concerns Security is addressed within the DICOM Standard Parts 15 and 18. IHE profiles also include security considerations.
Estimate of Overall Burden We believe these data elements represent important additions over previous USCDI version, posing low-to-modest technical effort for EHR developers based on the maturity level of the standards referenced above.
These data elements require minimal effort to develop an implementation guide. The underlying standards are mature and IHE profiles include use cases and transactions needed to develop implementation guides for certified APIs.
These data elements also pose minimal burdern to the development of health IT modules as demonstrated by the testing of the FHIR ImagingStudy resourse in FHIR connectathon events.
Since these data elements have already been universally adopted, they create no implementation burden on providers and health systems.
Other Implementation Challenges None
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 2 - Use cases apply to most care settings or specialties.
Evaluation Comment Rationale for Level 2:

Maturity - standards / technical specs: Level 2

Maturity - current use: Level 2

Maturity - current exchange: Level 2

Maturity - breadth of applicability: Level 2

Comment

Submitted by EmoryHealthcare on

Emory Healthcare Comments on Diagnostic Imaging Reference

EHC strongly supports the inclusion of Diagnostic Imaging Reference and data elements that support the exchange of diagnostic imaging tests and results. Weblinks for images are an important part of efficient patient-facing image sharing which allows patients to access their own radiology images, on-demand. 

Submitted by mbenitz on

Medicom Comments on Draft USCDI v7

The Diagnostic Imaging Reference element is the single most consequential addition in Draft USCDI v7 from the perspective of enterprise imaging interoperability. It is the first USCDI data element to explicitly establish that diagnostic imaging studies must be electronically accessible and referenceable across health IT systems, a foundational step toward eliminating the physical media and proprietary silo dependencies that continue to fragment clinical imaging workflows across the United States.

The current definition "the information that can be used to access a diagnostic imaging study" correctly captures the intent of the element. However, it is insufficiently specific to ensure consistent, interoperable implementation. The accompanying examples ("imaging study endpoint weblink, unique identifiers, and contextual information needed to retrieve a diagnostic imaging study") describe the types of components but do not define the required structure, format, or technical mechanism. Without greater specificity, implementation will vary widely across EHR vendors, PACS vendors, and imaging exchange platforms, resulting in a fragmented ecosystem in which a reference generated by one system cannot be reliably consumed by another.

Medicom strongly recommends that ASTP/ONC update the Diagnostic Imaging Reference definition and usage notes to specify the following:

  • FHIR ImagingStudy Resource as the Preferred Representation: The HL7 FHIR ImagingStudy resource (R4/R5) is the most complete structured representation of a Diagnostic Imaging Reference. It natively captures the DICOM Study Instance UID, series-level metadata, the DICOMweb WADO-RS endpoint for image retrieval, and contextual links to the ordering provider (ServiceRequest) and the resulting report (DiagnosticReport). ASTP/ONC should specify the FHIR ImagingStudy resource as the required representation for certified health IT systems implementing this element.
  • DICOM Study Instance UID as Required Identifier: The DICOM Study Instance UID is the globally unique, persistent identifier for every diagnostic imaging study and is universally captured by all PACS and VNA systems worldwide. Any compliant Diagnostic Imaging Reference must include this identifier. The accession number, while operationally important within a given facility's radiology information system (RIS) and PACS workflow, is facility-specific and not globally unique; it should be characterized as a complementary identifier within the reference.
  • DICOMweb WADO-RS Endpoint as the Required Retrieval Mechanism: The Diagnostic Imaging Reference must specify a machine-readable, standards-based retrieval mechanism. Medicom recommends requiring a DICOMweb WADO-RS (Web Access to DICOM Objects by RESTful Services) endpoint as the primary retrieval mechanism. DICOMweb is a DICOM standard (PS3.18) that enables web-based retrieval of imaging studies using standard HTTP APIs, making it compatible with modern EHR and application integration frameworks. It is implemented in production today by leading PACS vendors and imaging platforms and is the cornerstone of SMART Imaging Access and IHE SMART-on-FHIR workflows for imaging.
  • Sufficient Patient and Study Context: Beyond the technical identifiers, a compliant Diagnostic Imaging Reference should include sufficient contextual information to enable unambiguous study identification across organizational boundaries, such as patient identifier (MRN or national patient identifier); Study date; Imaging modality; and Imaging body region, where available. This context is critical for patient matching and for clinical disambiguation when multiple studies share similar characteristics.

Another important step is enhancing the FHIR ImagingStudy resource to include the transfer syntax necessary to enable DICOMweb. Together, these open the door for patients to directly access medical images from a preferred application or service while reducing the infrastructure and integration burden. This unlocking of patients’ medical images allows them to market-select any third-party viewing or analysis app.

Addressing the remaining barriers to patient imaging access will require continued progress toward standards-based interoperability between imaging systems, EHRs, and patient-facing applications. Ensuring that diagnostic imaging can be surfaced and exchanged through the same mechanisms used for other clinical data will be necessary for patients to fully access and manage their complete health record.

Medicom's operational experience across more than 2,500 institutions confirms that when these three technical components are present and standardized, seamless cross-institutional imaging retrieval is achievable today. When any one of them is absent or non-standardized, manual processes, proprietary integrations, and physical media reliance persist. The Diagnostic Imaging Reference element has an opportunity to be the regulatory lever that drives consistent adoption, but only if the definition provides the technical specificity needed for interoperable implementation.

Submitted by LisaRNelsonRI on

Generalize the Diagnostic Imaging Reference for greater utility

Diagnostic Imaging Reference

The information that can be used to access a diagnostic imaging study.

Examples include but are not limited to imaging study endpoint weblink, unique identifiers, and contextual information needed to retrieve a diagnostic imaging study.

Comment: Many different kinds of documents such as reports, plans, notes, letters, explanations etc. can be retrieved by virtue of an endpoint weblink, unique identifiers, and contextual information. The data element should be introduced generally so as to minimize the bloat of USCDI data elements.

Recommendation: Consider Creating a general data element in the context of the Healthcare Information Attributes data class called Document Reference define it as being the information that can be used to access a document or referenceable collection of information which can be retrieved as a meaningful assemblage of information about the patient or a patient’s encounter or delivered healthcare service(s). 

Examples include but are not limited to an endpoint weblink, unique identifiers, and contextual information needed to retrieve a document containing the information described in the Document Reference.

Submitted by david_rocha on

This data element is essential to elevate discoverability of imaging data.

CMS and the ONC should consider alignment with NEN 7541 for imaging retrieval across payers, providers, delegate entities, and PACS systems.

https://connect.nen.nl/Standard/Detail/3802320?compId=0&collectionId=0

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