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Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Federally required	Cost	Test Tool Availability
Implementation Specification	HL7® Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1—US Realm [HL7 Version 2.5.1: ORU_R01] Draft Standard for Trial Use, July 2012	Balloted Draft	Production	Yes	Free	Yes
Implementation Specification	NCPDP Specialized Standard, Implementation Guide, Version 2017071	Final	Production	Yes	$	No
Emerging Standard	HL7® Implementation Guide for C-CDA Release 2.1: Consolidated CDA for Clinical Notes and C-CDA on FHIR R4	Final	Production	No	$	No
Emerging Implementation Specification	HL7® Version 2.5.1 Implementation Guide: Lab Results Interface (LRI) Release 1, STU Release 3 - US Realm	Balloted Draft	Pilot	No	Free	No

Limitations, Dependencies, and Preconditions for Consideration	Applicable Security Patterns for Consideration
HL7® Version 2 Implementation Guide: Laboratory Value Set Companion Guide Release 1, STU Release 3 - US Realm, June 2018, provides cross-implementation guide value set definitions and harmonized requirements. The HL7® EHR-S Functional Requirements: S&I Framework Laboratory Results Messages, Release 1 - US Realm further clarifies sender/receiver responsibilities to achieve end-to-end interoperability for this interoperability need. See HL7 V2 projects in the Interoperability Proving Ground.	Secure Communication – create a secure channel for client-to- serve and server-to-server communication. Secure Message Router – securely route and enforce policy on inbound and outbound messages without interruption of delivery. Authentication Enforcer – centralized authentication processes. Authorization Enforcer – specifies access control policies. Credential Tokenizer – encapsulate credentials as a security token for reuse (e.g., – SAML, Kerberos). Assertion Builder – define processing logic for identity, authorization and attribute statements. User Role – identifies the role asserted by the individual initiating the transaction. Purpose of Use - Identifies the purpose for the transaction.

Limitations, Dependencies, and Preconditions for Consideration

Applicable Security Patterns for Consideration

HL7® Version 2 Implementation Guide: Laboratory Value Set Companion Guide Release 1, STU Release 3 - US Realm, June 2018, provides cross-implementation guide value set definitions and harmonized requirements.
The HL7® EHR-S Functional Requirements: S&I Framework Laboratory Results Messages, Release 1 - US Realm further clarifies sender/receiver responsibilities to achieve end-to-end interoperability for this interoperability need.
See HL7 V2 projects in the Interoperability Proving Ground.

Secure Communication – create a secure channel for client-to- serve and server-to-server communication.
Secure Message Router – securely route and enforce policy on inbound and outbound messages without interruption of delivery.
Authentication Enforcer – centralized authentication processes.
Authorization Enforcer – specifies access control policies.
Credential Tokenizer – encapsulate credentials as a security token for reuse (e.g., – SAML, Kerberos).
Assertion Builder – define processing logic for identity, authorization and attribute statements.
User Role – identifies the role asserted by the individual initiating the transaction.
Purpose of Use - Identifies the purpose for the transaction.

Comment

Submitted by michael.e.prevoznik on 2020-11-05

Comments for 2021 update of the ONC Interoperability Standards A

Quest Diagnostics, Incorporated collaborated with the American Clinical Laboratory Association (ACLA) to develop 2021 ISA comments (http://www.acla.com/). We support the comments submitted by ACLA. Thank you for the opportunity to provide comments.

Submitted by pwilson@ncpdp.org on 2020-11-07

NCPDP Comment

Modify the following:

Type-Change to: Implementation Specification Standard Implementation/Specification- HL7 Implementation Guide for C-CDA Release 2.1: Consolidated CDA for Clinical Notes and C-CDA on FHIR® R4

Modify the following:

Type-Implementation Specification Standard Implementation/Specification- NCPDP Specialized Standard, Implementation Guide, Version 2017071 Implementation Maturity- Production

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Comment

Comments for 2021 update of the ONC Interoperability Standards A

NCPDP Comment