Applicability Statement for Secure Health Transport (Direct)

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

Website:	Go to site
Description:	The Applicability Statement for Secure Health Transport is intended to provide constrained conformance guidance on the interoperable use of a set of RFCs describing methods for achieving security, privacy, data integrity, authentication of sender and receiver, and confirmation of delivery consistent with the data transport needs for health information exchange. The document describes how to use SMTP, S/MIME, and X.509 certificates to securely transport health information over the Internet. Participants in exchange are identified using standard e-mail addresses associated with X.509 certificates.The data is packaged using standard MIME content types. Authentication and privacy are obtained by using Cryptographic Message Syntax (S/MIME), and confirmation delivery is accomplished using encrypted and signed Message Disposition Notification. Optionally, certificate discovery of endpoints is accomplished through the use of the DNS. Advice is given for specific processing for ensuring security and trust validation on behalf of the ultimate message originator or receiver.
Technology/Standard Usage Requirements:	Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v23.3
Decision Date:	03/29/2023 at 16:48:39 UTC
Aliases:	The Direct Standard
Introduced By:	TRM Request
Standards Body:	Direct Trust

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Industry Standard, obtained from the vendor (or from the release source).

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
1.2	08/01/2015
1.3	05/01/2021

Current Decision Matrix (02/23/2023)

Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

Release	Q1	Q2	Q3	Q4	Q1	Q2	Q3	Q4	Q1	Q2	Q3	Q4
<Past	CY2023				CY2024				CY2025				Future>
1.2	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved
1.3	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved
Note:	This standard is backwards compatible and recommended implementation of most current version. Please contact the VHA Office of Standards & Interoperability (Mailgroup: vhas&iresponseteam@va.gov) prior to implementation to obtain guidance and the VHA-endorsed version of this standard.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
Policy	Standards Version Advancement Process	ONC	The Standards Version Advancement Process (SVAP) permits health IT developers to voluntarily update health IT products certified under the ONC Health IT Certification Program (Certification Program) to newer versions of adopted standards as part of the “Real World Testing” Condition and Maintenance of Certification requirement (§ 170.405) of the 21st Century Cures Act. All the standards in this guidance are currently available for voluntary certification under the Certification Program. The approved SVAP versions for 2020 went into effect in the Certification Program beginning March 12, 2021. The 2022 approved SVAP versions were announced June 28, 2022 and went into effect on August 29, 2022. Once effective, any newer versions of approved standards replaced existing approved standards from previous years.
Vendor Provided*	ANSI/DS 2019-01-100-2021 - Applicability Statement for Secure Health Transport Version 1.3	Direct Trust	This document is intended as an applicability statement providing constrained conformance guidance on the interoperable use of a set of RFCs describing methods for achieving security, privacy, data integrity, authentication of sender and receiver, and confirmation of delivery consistent with the data transport needs for health information exchange. Unless explicitly stated otherwise within this document, RFCs noted in requirements apply in their entirety.
Policy	§ 170.202 Transport standards and other protocols	Code of Federal Regulations	(a)(2) Standard. ONC Applicability Statement for Secure Health Transport, Version 1.2 (incorporated by reference in § 170.299). <br><br> (b) Standard. ONC XDR and XDM for Direct Messaging Specification (incorporated by reference in § 170.299). <br><br> (c) Standard. ONC Transport and Security Specification (incorporated by reference in § 170.299). <br><br> (d) Standard. ONC Implementation Guide for Direct Edge Protocols (incorporated by reference in § 170.299). <br><br> (e) Delivery notification - <br><br> (1) Standard. ONC Implementation Guide for Delivery Notification in Direct (incorporated by reference in § 170.299).
Requirement	170.315(b)(1) - Transitions of care	ONC	This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule, 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
Requirement	170.315(h)(1) Direct Project	ONC	This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
Requirement	170.315(h)(2) Direct Project, Edge Protocol, and XDR/XDM	ONC	This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
Policy	Information Blocking (21st Century Cures Act)	ONC	Most clinical information is digitized, accessible, and shareable thanks to several technology and policy advances making interoperable, electronic health record systems widely available. In 2016, the 21st Century Cures Act (Cures Act) made sharing electronic health information the expected norm in health care by authorizing the Secretary of Health and Human Services (HHS) to identify `reasonable and necessary activities that do not constitute information blocking.` ONC``s 2020 Cures Act Final Rule established information blocking exceptions to implement the law.
*NOTE: Vendor provided information is subject to the accuracy of the manufacturer.

Standard Components

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Source	Name	Description
DirectProject.org	Implementation Guide for Delivery Notification in Direct	The Direct Project’s Applicability Statement for Secure Health Transport specifies that Security/Trust Agents (STAs) MUST issue a Message Disposition Notification (MDN, RFC3798) with a disposition of processed upon successful receipt, decryption, and trust validation of a Direct message. By sending this MDN, the receiving STA is taking custodianship of the message and is indicating that it will deliver the message to its destination. While the Applicability Statement indicates that additional MDNs may be sent to indicate further processing progress of the message, they are not required. The Applicability Statement also does not provide guidance in regards to the actions that should be taken by the sending STA in the event an MDN processed message is not received or if the receiving STA cannot deliver the message to its destination after sending the initial MDN processed message. Due to the lack of specifications and guidance in the Applicability Statement regarding deviations from normal message flow, STAs implementing only requirements denoted as MUST in Section 3 of the Applicability Statement cannot provide a high level of assurance that a message has arrived at its destination. This document provides implementation guidance enabling STAs to provide a high level of assurance that a message has arrived at its destination and outlines the various exception flows that result in compromised message delivery and the mitigation actions that should be taken by STAs to provide success and failure notifications to the sending system.
ONC	Implementation Guide for Direct Edge Protocols	Direct Project’s Applicability Statement for Secure Health Transport establishes the standard protocols, along with message formats and processing requirements, for communication between Security/Trust Agents (STAs), which are commonly referred to by the name of the entities that operate STAs on behalf of others: Health Information Service Providers (HISPs). For the sake of uniformity, the term HISP will be used throughout this document. The communication protocol between HISPs is known as the Direct backbone protocol and is based on SMTP. While the Direct project has standardized the backbone protocol for communication between HISPs, currently there is minimal implementation guidance on how HISPs’ clients’ Edge systems should communicate with their respective HISP. In this document, the protocols used between HISP clients and the HISP are called “Direct Edge protocols,” and the HISP clients are referred to as Edge systems. Establishing standards between Edge systems and HISPs will enable CEHRT (Certified EHR Technology) to more easily interoperate with a variety of different HISP partners. In addition organizations such as HISP vendors, HIOs and RHIOs can support the standardized edge protocols as part of their HISP solution and expect Edge systems to integrate using the standardized edge protocols. The absence of these standardized edge protocols lead to custom solutions between HISPs and the Edge systems and negatively affect interoperability between systems. This document provides guidance for standardizing Direct edge protocols and improving interoperability between HISPs and Edge systems. This implementation guidance is complementary to currently existing Direct project specifications.
DirectProject.org	XDR and XDM for Direct Messaging Specification	This specification addresses use of XDR and XDM zipped packages in e-mail in the context of directed messaging to fulfill the key user stories of the Direct Project. Note that while the XDM specification includes transport options for USB-Memory and CD-ROM, in this specification XDM always means the XDM e-mail transport option (i.e., XDM file system specification in a zip package as an S/MIME attachment). This specification defines: 1. Use of XD* Metadata with XDR and XDM in the context of directed messaging 2. Additional attributes for XDR and XDM in the context of directed messaging 3. Issues of conversion when endpoints using IHE XDR or XDM specifications interact with endpoints utilizing SMTP for delivering healthcare content.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Health Care Standard	Health Care Standards
Collaboration and Electronic Workplace Productivity Software	Health Care

Technologies/Standards Relationships

Implemented By/Verified With:

No technologies have been identified with this standard.

Comparable Standards:

No comparable entries have been identified.

Associated Standards:

General Analysis

Adoption Benefits

Standard(s) and implementation specification(s) are approved by the National Coordinator to meet the ONC Health IT Certification Program (Certification Program).
This is a required standard in the VA/DoD Health Standards Profile data sharing. It is also required to to send authenticated, encrypted health information directly to known, trusted recipients over the Internet for 2014 ONC EHR Certification and the 2015 ONC Interoperability Standards Advisory.

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VA Technical Reference Model v 24.3

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Vendor Release Information

Current Decision Matrix (02/23/2023)

References

Standard Components

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Comparable Standards:

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VA Technical Reference Model v 24.3

General Information

Vendor Release Information

Current Decision Matrix (02/23/2023)

References

Standard Components

VA Categories View the VA Categorization Framework

Technologies/Standards Relationships

Implemented By/Verified With:

Comparable Standards:

Associated Standards:

General Analysis

Adoption Benefits

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