Source: https://www.healthit.gov/test-method/data-segmentation-privacy-send
Timestamp: 2019-04-26 10:33:23+00:00

Document:
Added supplied test data and respective steps.
Removed step 6 under TLV to remove redundancy.
The General Header constraint bullet from TLV step 5 was removed.
Updated TLV step 3 and 4 from ‘Health IT developer-supplied data’ to ‘ONC-supplied data’.
Enable a user to create a summary record formatted in accordance with the standard adopted in §170.205(a)(4) that is document-level tagged as restricted and subject to restrictions on re-disclosure according to the standard adopted in §170.205(o)(1).
Using the ETT: Message Validators – C-CDA R2.1 Validator, the health IT developer downloads the ONC-supplied data instructions through the sender download selections of the “170.315_b7_DS4P Amb” or “170.315_b7_DS4P_Inp” criteria and one of the DS4P instruction documents and executes the download.
Using the ONC-supplied DS4P instruction document downloaded in step 1, a user enters the information as appropriate into the Health IT Module including the DS4P tags and notices.
Privacy and Security Markings Section with Re-disclosure notice.
A summary record document must be submitted for each health IT setting being certified.
Using the ETT: Message Validators – C-CDA R2.1 Validator, the tester uploads the submitted summary record(s) with restrictions (xml file) from step 4 of the SUT, through the sender upload selection of the “Data Segmentation for Privacy –send – Ambulatory” or ” “Data Segmentation for Privacy –send – Inpatient” criteria and executes the upload of the submitted file(s) to the ETT: Message Validators.
The tester uses the Validation Report(s) created by the ETT: Message Validators in step 1 to verify the Health IT Module passes without error in order to confirm that the document is conformant to each of the standards adopted in § 170.205(a)(4).
If the summary record(s) submitted includes unstructured text data elements, the tester uses the ONC-supplied data instructions and the Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text.
Using the ETT: Message Validators Message Content Report, the tester verifies that the summary record(s) submitted is accurate and without omission using the ONC-supplied data instructions.
Privacy and Security: This certification criterion was adopted at § 170.315(b)(7). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(b) “paragraph (b)” criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
Technical outcome – The health IT can create a summary record (formatted to Consolidated CDA (C-CDA) Release 2.1) that is tagged at the document-level as restricted and subject to re-disclosure restrictions using the HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1.

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