Da Vinci Clinical Data Exchange (CDex)
2.1.0 - STU 2.1 United States of America flag

Da Vinci Clinical Data Exchange (CDex), published by HL7 International / Payer/Provider Information Exchange Work Group. This guide is not an authorized publication; it is the continuous build for version 2.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/davinci-ecdx/ and changes regularly. See the Directory of published versions

Requirements: CDex Signer Requirements

Official URL: http://hl7.org/fhir/us/davinci-cdex/Requirements/cdex-signer Version: 2.1.0
Standards status: Trial-use Maturity Level: 2 Computable Name: CDexSignerRequirements
Other Identifiers: OID:2.16.840.1.113883.4.642.40.21.36.4

Copyright/Legal: Used by permission of HL7 International all rights reserved Creative Commons License

This Requirements resource lists all the CDex Signer requirements defined in the narrative sections of this IG.

Language: en

CONF-026SHALL

* When using a FHIR Questionnaire to request data, the [DTR Standard Questionnaire] Profile is used to profile the Questionnaire. Both [CDex Task Attachment Request Profile] and the [DTR Standard Questionnaire] profile have the overlapping capability to indicate that a signature is required. Signers SHALL meet both the Task and Questionnaire signature expectations. The Task's signature input parameter represents the need for a verification signature for the QuestionnaireResponse. The [DTR Standard Questionnaire] profile supports many reasons for signatures, including verification signatures.

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CONF-027SHALL
  1. SHALL use the [CDex Digital Signature Profile] with the [CDex Signature Bundle Profile] for digitally signed Bundles and with the [CDex SDC QuestionnaireResponse Profile] for digitally signed QuestionnaireResponse. This Signature DataType profile enforces the various elements of digital signatures documented in this section.

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CONF-028SHALL
  1. Implementers SHALL follow the following FHIR R6 JSON Signature rules

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CONF-029SHALL
  • The JWS mime type application/jose SHALL be indicated in the Signature.sigFormat element.

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CONF-030SHALL
  • CDEX is pre-adopting the changes to FHIR R6 json canonicalization guidance and SHALL use the IETF JSON Canonicalization Scheme (JCS) (see [RFC 8785]) to generate the canonical form of the resource. JCS is a well-documented standardized canonicalization algorithm with multiple open-source implementations across several programming languages.

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CONF-031SHALL
  • This canonicalization method is identified by the URI application/fhir+json;canonicalization=http://hl7.org/fhir/canonicalization/json#document and SHALL be indicated in the Signature.targetFormat element.

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CONF-033SHALL
  • identifying This canonicalization method by the URI application/fhir+json;canonicalization=http://hl7.org/fhir/canonicalization/json+xml#document and SHALL indicate it in the Signature.targetFormat element.

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CONF-034SHALL
  • Bundle.id, and Bundle.meta SHALL be removed before canonicalization. In other words, everything in a Bundle is signed except for these elements.

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CONF-035SHALL
  • For signatures representing the entire QuestionnaireResponse, QuestionnaireResponse.id, and QuestionnaireResponse.meta elements SHALL be removed before canonicalization. In other words, everything in a QuestionnaireResponse is signed except for these elements.

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CONF-036SHALL
  • For signatures representing an item in the QuestionnaireResponse, the QuestionnaireResponse.item.id SHALL be removed before canonicalization. In other words, everything in the QuestionnaireResponse.item is signed except for these elements.

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CONF-037SHALL
  • The signature SHALL include a "srCms" signer commitments" header element for the Purpose(s) of the Signature (see JAdES-B-T, page 17). The Purpose can be the action being attested to, or the role associated with the signature. The value shall come from ASTM E1762-95(2013).

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CONF-038SHALL
  • The "srCms" header SHALL contain an "id": "urn:oid:1.2.840.10065.1.12.1.5" (Verification Signature)

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CONF-039SHALL
  • The Signature.type.code elements SHALL contain the same values as the "srCms" header ids.

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CONF-040SHALL
  1. SHALL include an "alg" parameter for the JSON Web Algorithms (JWA) (see [RFC 7518]). "alg": "RS256" is preferred.

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CONF-042SHALL
  1. SHALL have "x5c" (X.509 certificate chain) equal to an array of one or more base64-encoded (not base64url-encoded) DER representations of the public certificate or certificate chain (see [RFC 7517]).

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CONF-043SHALL
  1. SHALL include a "sigT" header parameter with a timestamp of the signature.

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CONF-044SHALL
  1. SHALL include a "srCms" signer commitments as defined above.

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CONF-046SHALL
  1. SHALL support JWS compact serialization format for single signatures

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CONF-048SHALL
  1. The certificate SHALL include a Subject Alternative Name (SAN) which

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CONF-049SHALL

include a Subject Alternative Name (SAN) which SHALL match the Signature.who.identifier

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CONF-045SHOULD
  1. SHOULD use the hashing algorithm SHA256. The signature validation policy will apply to the signature and determine the acceptability

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CONF-047SHOULD
  1. SHOULD support [JWS JSON Serialization] format to represent multiple signatures with identical parameter values except "x5c".

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CONF-050SHOULD
  • The certificate Issuer SHOULD be a trusted CA for the Consumer

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CONF-051SHOULD
  • The certificate KeyUsage SHOULD include 'DigitalSignature'

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CONF-052SHOULD
  • The certificate Validity Dates SHOULD be appropriate/long enough as determined by the business partners

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CONF-032MAY

Implementers that support both XML and JSON wire formats MAY support cross format signatures by:

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