Security tags – summary of care – receive

System Under Test Instruction

1. Summary records in accordance with the test steps below, based on the health IT setting(s), are provided by the ASTP Standards Implementation & Testing Environment (SITE): C-CDA Validator under the “Receiver” system.
2. The health IT developer identifies the policies associated with the handling of the DS4P documents.

Receive

3. Using the Health IT Module, a user receives summary record document(s) formatted in accordance with the standard specified at § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, that is tagged as restricted and subject to restrictions on re-disclosure, according to the standard adopted at § 170.205(o)(1) HL7^® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1, which includes the following:
   • Privacy Segmented Document Template;
   • Clinical Document Architecture (CDA) Mandatory Document Provenance;
   • CDA Mandatory Document Assigned Author Template;
   • If a document contains information protected by specific privacy policies, the CDA Privacy Markings Section and Privacy Marking Entry(ies);
   • Privacy Segmented Section Template(s); Privacy Annotation Template; and
   • Protected Problem Template.
4. The received Consolidated- Clinical Document Architecture (C- CDA) tagged as restricted document received in step 3, includes the following data elements:
   • The originating document Individual Author or Organization; and
   • Confidentiality Code constrained in accordance with the standard specified in § 170.205(o)(1) HL7^® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1.
5. Using the Health IT Module, a user receives a summary record document(s) formatted in accordance with the standard specified at § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, without any restrictions.

All Steps (Approved SVAP Version)

• Complete steps above using SITE: C-CDA Validator for USCDI v4 and;
• Use HL7® CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes Edition 3.0 - US Realm, May 2024 for § 170.205(a)(4), (a)(5) or (a)(6).

Test Lab Instruction

1. The tester creates a human-readable version for each of the documents received in steps 3-5, of the System Under Test to be used for verification.
2. The tester verifies the health IT developer has provided identification of the policies associated with the handling of the DS4P documents.

Receive

3. The tester verifies a Health IT Module can receive a summary record document formatted in accordance with the standard specified at § 170.205(a)(4) that is document-level section-level and entry-level tagged as restricted and contains restrictions on re-disclosure according to the standard adopted at § 170.205(o)(1) for each health IT setting being certified, using visual inspection of the following:
   • Privacy Segmented Document Template;
   • CDA Mandatory Document Provenance;
   • CDA Mandatory Document Assigned Author Template;
   • If a document contains information protected by specific privacy policies, the CDA Privacy Markings Section and Privacy Marking Entry(ies);
   • Privacy Segmented Section Template(s);Privacy Annotation Template; and
   • Protected Problem Template.
4. The tester verifies the document received includes the following data elements:
   • The originating document Individual Author or Organization; and
   • Confidentiality Code constrained in accordance with the standard specified in § 170.205(o)(1) HL7^® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1.
5. The tester verifies a Health IT Module can receive a summary record document formatted in accordance with the standard specified at § 170.205(a)(4) that is not document-level tagged as restricted for each health IT setting being certified, using visual inspection.

1. The health IT developer attests that privacy markings are preserved by the Health IT Module to ensure fidelity to the tagging based on consent and with respect to sharing and re-disclosure restrictions.

1. The tester verifies the health IT developer attests that the Health IT Module preserves privacy markings to ensure fidelity to the tagged based on consent and with respect to sharing and re-disclosure restrictions.