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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. 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.
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 pwilson@ncpdp.org on 2021-09-29

NCPDP Comments

NCPDP supports ONC’s recommendations.

Submitted by michael.e.prevoznik on 2021-09-30

Comments for 2021 Reference Edition publication of the ONC (ISA)

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

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Comment

NCPDP Comments

Comments for 2021 Reference Edition publication of the ONC (ISA)