Da Vinci Clinical Data Exchange (CDex)
2.0.0 - STU2 United States of America flag

This page is part of the Da Vinci Clinical Documentation Exchange (v2.0.0: STU2) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Change Log

Page standards status: Informative

Version = 2.0.0

This STU2 version of The Da Vinci Clinical Data Exchange (CDex) Implementation Guide is the third published version of this guide and is the result of the 2022 September HL7 balloting process. The resulting resolution of the community comments and edits to this guide has been agreed to and voted on by the members of the sponsoring HL7 International Patient Care and Payer/Provider Information Exchange Work Groups.

What’s new in Version 2.0.0 of CDex:

  1. New Requesting Attachments Using Questionnaires functionality. In prior versions, CDex supported requested attachments using the request model of LOINC attachment codes, and the provider typically submitted CCDA or PDF documents in response. In this version, CDex aligns with DTR functionality and provide the ability to request attachment using Questionnaire, CQL, and QuestionnaireResponse as supported by DTR when there is no transition into/out of X12 transactions in the interactions. In addition, this approach will enable specific requests for missing data and avoid unnecessary document formats, yet still provide the ability for signature attestation if required.
  2. New Task-Based transactions functionality for Using Questionnaire as Task Input. In prior versions, CDex Task Based Approach supported requests using the request model of FHIR RESTful query syntax, codes, and free-text. As a result, the provider typically returned references to FHIR Bundles. Similar to the Attachments updates, this added functionality leverages DTR and enables specific requests for missing data, avoiding unnecessary use of Bundles.
  3. Improved navigation:
    • Menu Bar drop-downs for all the pages to allow faster navigation to a specific topic
    • Re-organization of FHIR Artifacts by transaction type. This version has several FHIR artifacts and dozens of examples grouped by Attachments, Task-Based Approach, and Signatures.
  4. Conforming to CDex Attachments and Conforming to CDex Task Based Approach, including interactions for each role and the conformance resource and terminology that makes them unique.
  5. After receiving many comments on CDex POU support, the CDex Purpose of Use Value Set now includes a hierarchy to the base “Treatment”, “Payment”, or “Health Care Operations” (TPO) concepts.
  6. More examples, including examples of failed signature verifications, signed QuestionnaireResponse, and requesting Attachments for prior authorization using Questionnaire.

Changes:

These changes are the result of over 60 trackers listed below. They include the 2022 September HL7 balloting process and non-ballot issues.

September 2022 ballot and non-ballot comments and links to the updated content are below:

Status: Summary (Jira Issue) Link to Change

  1. Applied: Correct $submit-attachment input parameter Typo. (FHIR-37956) and (FHIR-38175) See Changes Here
  2. Applied: Correct claim flow diagram typo (FHIR-38060) See Changes Here
  3. Applied: Added missing service line item extension to CDex Task Attachment Request Profile (FHIR-38070) See Changes Here
  4. Applied: Document POU ValueSet Hierarchy to TPO (FHIR-38142) See Changes Here
  5. Applied: DS4P should be evaluated before required (FHIR-38144) See Changes Here
  6. Applied: Correct capitalization (FHIR-38145) See Changes Here
  7. Applied: Change 277 to: “277 Request for Additional Information (RFAI)” (FHIR-38152) See Changes Here
  8. Applied: Update sentence (FHIR-38153) See Changes Here
  9. Applied: Correct Typo (FHIR-38154) See Changes Here
  10. Applied: Modify sentence (FHIR-38155) See Changes Here
  11. Applied: Change X12n 277 message to X12n 277 RFAI transaction. (FHIR-38156) See Changes Here
  12. Applied: Update Data Elements table (FHIR-38172) See Changes Here and Here
  13. Applied: Update Data Elements table (FHIR-38174) See Changes Here
  14. Applied:Change X12n 275 message to X12n 275 transaction (FHIR-38177) See Changes Here
  15. Applied:Change all documents to submitted documents (FHIR-38178) See Changes Here
  16. Applied: Remove HIPAA compliance language (FHIR-38179) See Changes Here
  17. Applied: Change Claim to claim or prior authorization (FHIR-38184) See Changes Here
  18. Applied: Normalize term “prior authorization” (FHIR-38186) See Changes Here
  19. Applied: Update Grammar (FHIR-38187) See Changes Here
  20. Applied: Clarify that signature support is not required (FHIR-38188) See Changes Here and Here
  21. Applied: Clarify in operation that either an OrganizationId or ProviderId is required. Allow for both Ids to be sent in request.(FHIR-38189) See Changes:[
  22. Applied: Change Task service date input parameter to min = 0 and required only for claims (FHIR-38191) See Changes Here and Here
  23. Applied: Clarify conformance expectations (FHIR-38192) See Changes Here and Here
  24. Applied: Clarify patient account number (FHIR-38194) See Changes Here
  25. Applied: Task Infrastructure Elements (FHIR-38195) See Changes Here
  26. Applied: Separate solicited and unsolicited attachments workflows (FHIR-38210) See Changes Here
  27. Applied: Make LOINC code display and text consistent (FHIR-38233) See Changes Here
  28. Applied: Fix Typo in example (FHIR-38236)w See Changes Here
  29. Applied: Clarify Attachment Scope (FHIR-38240) See Changes Here
  30. Applied: Expand Attachments and Task based approach to support Questionnaires and DTR (FHIR-38241) See Changes:
  31. Applied: Clarify when human involvement needed (FHIR-38242) See Changes Here
  32. Applied: Add link to PAS Guidance on pended results (FHIR-38244) See Changes Here
  33. Applied: Add POU for Attachment Request as optional input parameter (FHIR-38245) See Changes Here and Here
  34. Applied: Correct operation name (FHIR-38253) See Changes Here
  35. Applied: Change only accepts to only accept(FHIR-38255) See Changes Here
  36. Applied: Clarify use of cdex-temp code system (FHIR-38259) See Changes Here and Here
  37. Applied: Clarify use of data tagging (FHIR-38286) See Changes Here
  38. Applied: Updated X12 element mappings and X12 required citations (FHIR-38287) See Changes Here and Changes Here
  39. Applied: Clarify how to find patient FHIR ID (FHIR-38318) See Changes Here
  40. Applied: Clarify X12 Compatibility (FHIR-38326) See Changes Here
  41. Applied: Add Qualifier to Signed Document Bundle (FHIR-38327) See Changes Here
  42. Applied: Remove words transaction layer (FHIR-38328) See Changes Here
  43. Applied: Word change analogs to fields (FHIR-38330) See Changes Here
  44. Applied: Correct rendering of CCDA (FHIR-38367) See Changes Here
  45. Applied: removed ‘*’ from button bar (FHIR-38368) See Changes Here
  46. Applied: Change follows to adheres to (FHIR-38576) See Changes Here
  47. Applied: Revise section ‘what Do Payers Do with Clinical Information?’ (FHIR-38578) See Changes Here
  48. Applied: Clarify when CDex is used instead of other guides (FHIR-38585) See Changes Here
  49. Applied: Remove the HIE paragraph (FHIR-38588) See Changes Here
  50. Applied: Create failed signature example transaction (FHIR-38596) See Changes Here
  51. Applied: Clarify benefits of POU element (FHIR-38598) See Changes Here
  52. Applied: change SHOULD to SHALL (FHIR-38599) See Changes Here
  53. Applied: Correct Preconditions and Assumptions (FHIR-38600) See Changes Here
  54. Applied: Correct Preconditions and Assumptions (FHIR-38601) See Changes Here
  55. Applied: Update polling frequency guidance(FHIR-38602) See Changes Here
  56. Applied: Remove trading partner agreement statement (FHIR-38603) See Changes Here
  57. Applied: Clarify association comment and assign FMM levels to guide (FHIR-38605) See Changes Here
  58. Applied: Clarify Profile relationship to X12 (FHIR-38612) See Changes Here
  59. Applied: Change $submit-attachment’s Attachment input parameter to min=1. (FHIR-38632) See Changes Here
  60. Applied: Change Tracking-id.system to Must Support; and $submit-attachment TrackingId to type Identifier. (FHIR-39337) See Changes Here and Here
  61. Applied: Update NPI codesystem (FHIR-39626) See Changes Here

Version = 2.0.0-ballot

Changes:

Da Vinci CDEX 2022 September Ballot. This ballot is restricted to the Draft content in the STU 1.1.0 version of CDex. The draft content includes 1) requesting and sending attachments and 2) communicating the purpose of use in Task Based Queries.

Version = 1.1.0

This STU1.1 version of The Da Vinci Clinical Data Exchange (CDex) Implementation Guide is the second published version of this guide and is the result of the 2022 May HL7 balloting process. The resulting resolution of the community comments and edits to the guide has been agreed to and voted on by the members of the sponsoring HL7 International Patient Care and Payer/Provider Information Exchange Work Groups.

What’s new in Version 1.1.0 of CDex:

  • This content is DRAFT and is open for review. An Attachments section documenting how to exchange attachments for claims or prior authorization.
    • A Solicited and Unsolicited Attachments page documents the differences and similarities between solicited and unsolicited attachments workflows and the CDex transactions that can be used for each.
    • A Sending Attachments page that documents a FHIR-based approach for sending attachments for claims or prior authorization directly to a Payer.
    • A [Requesting Attachments] page to document a FHIR-based approach for requesting attachments for claims or prior authorization from a Provider.
    • A Using CDex Attachments with DaVinci PAS page that illustrates where in the PAS workflow the Payer could use CDEX to request attachments and the Provider could use CDEX to submit attachments.
  • Signatures page sections for each transaction in CDex to provide specific guidance and rules to exchange signed data using FHIR and non-FHIR signatures.
  • A Change Log page to document the changes across the versions of CDex
  • More examples and example scenarios

Changes:

These changes are the result of almost 60 trackers listed below. They include the 2022 May HL7 balloting process, non-ballot issue, and Draft new content to meet anticipated Attachments legislation and rules.

May 2022 Ballot comments and links to the updated content are below::

Status: Summary (Jira Issue) Link to Change

  1. Applied: Typo (FHIR-36819)
  2. Applied: Typo (FHIR-36820)
  3. Applied: Typo (FHIR-36821)
  4. Applied: Add guidance when Signatures fail verification (FHIR-36842) See Changes:
  5. Applied: Add link to Example of Completed Task Request for Signed Data(FHIR-36844) See Changes Here
  6. Applied: Clarification on who is signing(FHIR-36845) See Changes:
  7. Applied: Clarify system level signatures (FHIR-36847) See Changes Here
  8. Applied: Add example FlowSheets for each Transaction (FHIR-36854) See Changes Here
  9. Applied: Typo (FHIR-36917)
  10. Applied Update Figure (FHIR-36918) See Changes Here
  11. Applied Clarify purpose for additional information (FHIR-36919) See Changes Here
  12. Applied: Typo (FHIR-36921)
  13. Applied: Typo (FHIR-36922)
  14. Applied Clarify Figure 4 and associated text in 2.6.2 (FHIR-36985) See Changes:
  15. Applied: Add non-document based attachment scenario (FHIR-36995) See Changes Here
  16. Applied: Clarify association of data (FHIR-36996) See Changes Here
  17. Applied: Document using CDex Attachments with DaVinci PAS (FHIR-36997) See Changes Here
  18. Applied: Replace EHR with Source HIT (FHIR-36999) See Changes Here
  19. Applied: Remove “preferred” approach from direct query (FHIR-37166) See Changes Here
  20. Applied: Clarify H&P in diagram is object or behavior (FHIR-37225) See Changes Here
  21. Applied: Clarify roles in attachments diagram(FHIR-37226) See Changes Here
  22. Applied: Typo (FHIR-37227)
  23. Applied: Typo (FHIR-37229)
  24. Applied: Typo (FHIR-37233)
  25. Applied: Clarify Figure 7 step 4 text to match the description (FHIR-37234) See Changes Here
  26. Applied: Typo (FHIR-37235)
  27. Applied: Rewrite introduction to Signature (FHIR-37243) See Changes Here
  28. Applied: Add best practice guidance for signatures (FHIR-37246) See Changes Here
  29. Applied: Remove “preferred” (FHIR-37248)
  30. Applied: Use term Data Consumer consistently and Define how terms used in guide(FHIR-37250) See Changes Here
  31. Applied: Re-write Signature sections(FHIR-37251) See Changes:
  32. Applied: Rewrite introduction to Signature (FHIR-37253) See Changes Here
  33. Applied: Update Polling Guidance (FHIR-37260) See Changes Here
Non-Ballot Issues and links to the updated content are below::

Status: Summary (Jira Issue) Link to Change

  1. Applied: Recommendation for exchanging purpose of use. (FHIR-30824) See Changes:
  2. Applied Make Task.reasonReference.identifer 0…1 MS (FHIR-35151) See Changes:
  3. Applied: Create page for change log (FHIR-36727) See Changes Here
  4. Applied: Change re-associate to associate (FHIR-36733) See Changes Here
  5. Applied: Fix Typo(FHIR-36736) See Changes Here
  6. Applied: Clarify the relation between CDEX and HRex (FHIR-36741) See Changes Here
  7. Applied: Submit Attachment AttachTo text correction (FHIR-36756) See Changes Here
  8. Applied: Clarify that signature element should reference an Organization or Practitioner as signer (FHIR-36846) See Changes:
  9. Applied: Fix grammar(FHIR-36848) See Changes Here
  10. Applied: Fix formatting Error to separate several entries(FHIR-36853) See Changes Here
  11. Applied: Fix capitalization(FHIR-36896) See Changes Here
  12. Applied: Adds links to operation consistently (FHIR-36897) See Changes Here
  13. Applied: Rewrite digital signature functional requirements: (FHIR-36905) See Changes Here
  14. Applied: Add conformance Verbs to Submit Attachment operation page (FHIR-36906) See Changes Here
  15. Applied: Missing examples (FHIR-37245) See Changes Here
  16. Applied: Rewrite background on section on Payers(FHIR-37252) See Changes Here
  17. Applied: Clarify support for XML with signatures (FHIR-37264) See Changes:
  18. Applied: Add clarification on how to handle reads when signatures are needed (FHIR-37265) See Changes Here
  19. Applied: Update $submit-attachments diagram to show 200 w/ OperationOutcome (FHIR-37271) See Changes:
    • Here
    • [Here]sending-attachments.html#scenario-1b-ccda-document-attachments-submitted-prior-to-claim)
    • Here
  20. Applied: Add PayerId to $submit-attachments (FHIR-37331) See Changes Here
  21. Applied: Clarify that claim’s attachment submitter is same as claim submitter (FHIR-37332) See Changes:
  22. Applied: Add “Request Attachments” content as Draft (FHIR-37563) See Changes:
  23. Applied: Add CCDA example and Correct PDF example (FHIR-37655) See Changes Here
  24. Applied: Rewrite section on Discovery of FHIR IDs ([FHIR-37652] (https://jira.hl7.org/browse/FHIR-37652)) See Changes:
  25. Applied: Document how implementers locate the proper identifier (FHIR-37651) See Changes Here
  26. Applied: Clarify how to fetch data if can not perform a direct query. (FHIR-37649) See Changes Here

Version = 1.1.0-ballot

Changes:

Da Vinci CDEX 2022 May Ballot. This ballot is restricted to the Draft content in the STU 1.0 version of CDex. The draft content includes handling of Attachments and Digital Signatures.

Version = 1.0.0

Changes:

This STU1 version of Da Vinci Clinical Data Exchange (CDex) Implementation Guide is the first published version of this guide and is the result of the June 2019 and January 2021 HL7 balloting process. The resulting resolution of the community comments and edits to the guide has been agreed to and voted on by the members of the sponsoring HL7 International Patient Care Work Group.

January 2021 Ballot comments and links to the updated content are below::

Status: Summary (Jira Issue) Link to Change

  1. Applied: CDex documents require signature, but do not explain how used (FHIR-26855) See Changes:
  2. Applied: Add reference to C-CDA on FHIR (FHIR-28158) See Change Here
  3. Applied: Provide another example of a use case not covered by another Da Vinci IG (FHIR-30146) See Change Here
  4. Applied: Fix link and expectations to CapabilityStatements (FHIR-30147) See Change Here
  5. Applied: Failed task or task without result? (FHIR-30148) See Changes:
  6. Applied: add item to list of benefits (FHIR-30440) See Change Here
  7. Applied: Update section on What Payers Do with Clinical Information (FHIR-30442) See Change Here
  8. Applied: Update text in sequence diagrams (FHIR-30445) See Change Here
  9. Applied: Update Scenarios to include to support claim submission - Attachments. (FHIR-30446) See Changes:
  10. Applied: Update definition of clinical data and added guidance on data provenance(FHIR-30489) See Changes:
  11. Applied: Referennce clinical safety section in HREX (FHIR-30490) See Change Here
  12. Applied: Delete use of word “complete” (FHIR-30494) See Change Here
  13. Applied: Explicitly reference the Da Vinci Guiding Principles in new Privacy and Security section. (FHIR-30498) See Change Here
  14. Applied: Update Figure 1 (FHIR-30500) See Change Here
  15. Applied: Typo. (FHIR-30812) See Change Here
  16. Applied: Remove word complete. (FHIR-30813) See Change Here
  17. Applied: Corrects and clarifies direct provider to provider scenario. (FHIR-30814) See Change Here
  18. Applied: Updates to Provider to Provider use case(FHIR-30815) See Changes:
  19. Applied: Please clarify whether any human involvement is required, and an example, as well as define the term fulfillment as it relates to attestation. (FHIR-30816) See Changes:
  20. Applied: Rephrase. (FHIR-30817) See Change Here
  21. Applied: Clarify how subscripition mitigates risks (FHIR-30819) See Change Here
  22. Applied: Add section on termination of access to request(FHIR-30820) See Change Here
  23. Applied: Update how a clients set of requests is terminated(FHIR-30821) See Change Here
  24. Applied: Formalize the current scenarios (FHIR-30826) See Change Here
  25. Applied: replace /Patient/$everything with /Group/$export in the bulk example (FHIR-30827) See Change Here
  26. Applied: Remove empty pages (FHIR-30828)
  27. Applied: Clarified formal authorization use case (FHIR-30829) See Changes:
  28. Applied: Data Consumer Server SHOULD support Claim. (FHIR-30830) See Change Here
  29. Applied: Modify CapabilityStatement Rest summary table (FHIR-30831) See Change Here
  30. Applied: Add hyperlinks. (FHIR-30834) See Change Here
  31. Applied: Add benefit of transition towards direct queries to Task benefits. (FHIR-30835) See Change Here
  32. Appied: Update section on Authoization requirements (FHIR-30836) See Change Here
  33. Applied: Typo (FHIR-30840) See Change Here
  34. Applied: Typo (FHIR-30841) See Change Here
  35. Applied: Typo (FHIR-30842) See Change Here
  36. Applied: Updated anticipated benefits of standard (FHIR-30843) See Change Here
  37. Applied: Typo (FHIR-30844) See Change Here
  38. Applied: Correct Grammar (FHIR-30845) See Change Here
  39. Applied: Correct Grammar (FHIR-30846) See Change Here
  40. Applied: Remove unsubstantiated claims. (FHIR-30847) See Change Here
  41. Applied: Remove HEDIS score claim. (FHIR-30849) See Change Here
  42. Applied: Relocate paragraph. (FHIR-30850) See Change Here
  43. Applied: Remove paragraph and refer to HREX security page. (FHIR-30851) See Change Here
  44. Applied: Typo (FHIR-30852) See Change Here
  45. Applied: Reword statement. (FHIR-30853) See Change Here
  46. Applied: Typo (FHIR-30854) See Change Here
  47. Applied: Typo (FHIR-30855) See Change Here
  48. Applied: Typo (FHIR-30856) See Change Here
  49. Applied: Typo (FHIR-30857) See Change Here
  50. Applied: Updated STU-note on when authorization needed? (FHIR-30863) See Change Here
  51. Applied: Remove “?” or correct the section name if it is in question (FHIR-30864) See Change Here
  52. Applied: Typo (FHIR-30865) See Change Here
  53. Applied: Updated Purpose of Use section for Direct Query. (FHIR-30867) See Change Here
  54. Applied: Updated Sensitivity and Confidentiality protection guidance. (FHIR-30868) See Change Here
  55. Applied: Updated Sensitivity and Confidentiality protection guidance. (FHIR-30869) See Change Here
  56. Applied: clarify when attribution is not present or non-repudiable (FHIR-30870) various changes
  57. Applied: Fix sequential numbering of figures (FHIR-30935) See Change Here
  58. Applied: correct last example bullet (FHIR-31050) See Change Here
  59. Applied: Remove reference to HREX CommunicationRequest plus Task transaction (FHIR-31516) See Change Here
  60. Applied: Clarify human involvement in Task transaction (FHIR-31886 See Change Here
  61. Applied: Create privacy and security page (FHIR-31885 See Change Here
  62. Applied: Clarify when HIEs are data sources (FHIR-31884)See Change Here
  63. Applied: Add supplemental security guidance on audit (FHIR-31888)See Change Here
  64. Applied: Add supplemental security guidance on scopes(FHIR-31887)See Change Here
  65. Applied: Clarify human involvement needed(FHIR-31886)See Change Here
  66. Applied: Provide guidance on finding organization and provider identifiers(FHIR-32841)See Change Here
  67. Applied: Update how to represent Purpose of Use and reason in Task Based Query (FHIR-31996)See Change Here
  68. Applied: Clarify the relationship between this guide and others(FHIR-32116)See Change Here
  69. Applied: Added guidance on matching patients(FHIR-32840)See Change Here
  70. Applied: Update to the USCDI link (FHIR-33265
  71. Applied: Add guidance how to provide some work queue tags(FHIR-31890 See Change Here
  72. Applied: Add push mechanism to support Attachments for Claims and Prior Auth(FHIR-33129 See Changes:
  73. Applied: Add figure to clarify relationship between cdex and hrex(FHIR-34559 See Change Here

Version = 0.2.0

Changes:

Based on the 2019-06-20 ballot feedback, this IG has been completely re-written for this ballot. The refactoring has been sufficiently large that it is not practical/useful to enumerate a list of changes between this ballot version (0.2.0) and the 2019-06-20 ballot version (0.1.0).

Version = 0.1.0

Changes:

June 2019 Ballot for Da Vinci CDex