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§ 170.315(h)(1)
Direct Project
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Certification Companion Guide
Test Procedure
Certification Companion Guide
v1.1
View Changelog
Issued Date:
03-11-2024
07-23-2025
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product certification. The CCG is not a substitute for the requirements outlined in regulation and related ONC final rules. It extracts key portions of ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the
Certification Regulations
page for links to all ONC final rules or consult other regulatory references as noted. The CCG is for public use and should not be sold or redistributed.
Quick Overview
Required Updates
None
Design and Performance
Additional Criterion Information
Base EHR Definition
Included
Real World Testing
Yes
Insights Condition
No
SVAP Versions
Yes
CLARIFICATIONS
REGULATORY
STANDARDS
DEPENDENCIES
RESOURCES
CHANGELOG
IN THIS SECTION
Certification Clarifications
Technical Explanations and Clarifications
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Paragraph (h)(1)(i)
Paragraph (h)(1)(ii)
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Clarifications:
In order to meet the Base EHR Definition, a provider would need to possess technology that has been certified to either this criterion at § 170.315(h)(1) or the “Direct Project, Edge Protocol, and XDR/XDM” criterion at § 170.315(h)(2).
Use of the Applicability Statement for Secure Health Transport (“Direct”) is required to meet this certification criterion. There is no exemption or additional possible transport standard for certification to this criterion.
This certification criterion uses the Applicability Statement for Secure Health Transport, Version 1.2 standard. This new version of the specification includes updates that improve interoperability through the clarification of requirements that have been subject to varying interpretations, particularly requirements around message delivery notifications. This version also clarifies pertinent requirements in the standards underlying the Applicability Statement for Secure Health Transport. Refer to the standard for more details about the improvements it includes. [see also
80 FR 62679
Testing for this criterion will require the processing of invalid test cases that frequently occur in real-world situations so that Security/Trust Agents (STAs) can demonstrate error handling abilities, including handling XDM packages and message disposition.
As specified in § 170.550(j), an ONC-ACB can only issue a certification to a Health IT Module for § 170.315(h)(1) if the Health IT Module's certification also includes § 170.315(b)(1). For example, if Developer X seeks certification to (b)(1) and (h)(1) with its homegrown integrated health information service provider (HISP) solution, then their ONC-ACB can issue a certificate with (h)(1) included. Likewise, if Developer X seeks certification to (b)(1) and partners with/integrates a third party HISP for (h)(1) consistent with the “
relied upon software
” paradigm, then their ONC-ACB can issue a certificate with (h)(1) included. To note, in this instance, the certification would be specific to Developer X and the third party HISP. Each developer that would want to work with the third party HISP in a similar manner would need to seek the same type of relied upon software certification. Thus, HISPs may want to consider certifying to § 170.315(h)(2), which would not require separate testing/certifications with each developer certified to § 170.315(b)(1).
Consistent with the Implementation Guide for Delivery Notification in Direct, ONC's policy intent is that the receiving HISP must provide delivery notification messages either when it is also the sending HISP, or when it is specifically requested to do so by the sending HISP. A HISP is not compelled to request delivery notifications, but a certified HISP is required to produce them if requested.
Technical outcome – The health IT can electronically transmit (send and receive) health information to a 3
rd
party which must be formatted only as a “wrapped” message using the Applicability Statement for Secure Health Transport, Version 1.2.
Clarifications:
For certification to this criterion, ONC has made it a requirement to send and receive messages in only “wrapped” format even though the specification allows use of “unwrapped” messages. This requirement will further improve interoperability among Security/Trust Agents (STAs), while having minor development impact on health IT developers. [see also
80 FR 62679
STANDARDS REFERENCED
§ 170.202(a)(2)
Applicability Statement for Secure Health Transport, Version 1.2
Technical outcome – The health IT can electronically transmit (send and receive) health information to a 3
rd
party using Direct in accordance with the Implementation Guide (IG) for Delivery Notification in Direct, Version 1.0.
Clarifications:
The IG for Delivery Notification in Direct, Version 1.0, June 29, 2012 functionality supports interoperability and exchange, particularly for both sending and receiving parties. It provides guidance for enabling HISPs to provide a high level of assurance to senders that a message has arrived at its destination, a necessary component to interoperability. The IG also 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. [see also
80 FR 62729
For Delivery Notification in Direct, the capability to send and receive health information must be in accordance with the standard specified in § 170.202(e)(1).
STANDARDS REFERENCED
§ 170.202(e)(1)
Implementation Guide for Delivery Notification in Direct v1.0
Regulation Text
§ 170.315 (h)(1) Direct Project—
(i) Applicability Statement for Secure Health Transport.
Able to send and receive health information in accordance with the standard specified in § 170.202(a)(2), including formatted only as a “wrapped” message.
(ii) Delivery Notification in Direct.
Able to send and receive health information in accordance with the standard specified in § 170.202(e)(1).
Standards & References
The following standards are referenced within the certification criteria for:
§ 170.315(h)(1) Direct Project
View By
Standard
Paragraph
§ 170.202(a)(2)
Applicability Statement for Secure Health Transport, Version 1.2
Referenced in the Following:
Paragraph (h)(1)(i)
SVAP-approved Versions:
Direct Project: ONC Applicability Statement for Secure Health Transport
§ 170.202(e)(1)
Implementation Guide for Delivery Notification in Direct v1.0
Referenced in the Following:
Paragraph (h)(1)(ii)
Paragraph (h)(1)(i)
Applicability statement for secure health transport
§ 170.202(a)(2)
Applicability Statement for Secure Health Transport, Version 1.2
Paragraph (h)(1)(ii)
Delivery notification in Direct
§ 170.202(e)(1)
Implementation Guide for Delivery Notification in Direct v1.0
Certification Dependencies
IN THIS SECTION
Dependent Criteria
An ONC-ACB can only issue a certification to a Health IT Module for this criterion at § 170.315(h)(1) if the Health IT Module’s certification also includes § 170.315(b)(1) “Transitions of care.”
§ 170.405
Real World Testing
Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Note: Enforcement discretion has been issued for CY 2025–2026. Refer to the
Enforcement Discretion Notices
for full details.
Privacy and Security
This certification criterion was adopted at § 170.315(h)(1). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(h) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (h) criterion unless it is the only criterion for which certification is requested.
As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
§ 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.
For more information on the approaches to meet these Privacy and Security requirements, please download the Privacy and Security CCG below:
Privacy and Security CCG
If choosing
Approach 1
Authentication, access control, and authorization (§ 170.315(d)(1))
Auditable events and tamper-resistance (§ 170.315(d)(2))
Audit reports (§ 170.315(d)(3))
Encrypt authentication credentials (§ 170.315(d)(12))
Multi-factor authentication (MFA) (§ 170.315(d)(13))
If choosing
Approach 2
For each applicable privacy and security certification criterion not certified for Approach 1, the health IT developer may certify using system documentation that is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces for each applicable privacy and security certification criterion that enable the Health IT Module to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the
21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
Final Rule at
85 FR 25710
for additional clarification.
Design and Performance
The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
Quality management system (§ 170.315(g)(4))
: When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
Accessibility-centered design (§ 170.315(g)(5))
: When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
Transitions of care (§ 170.315(b)(1))
: An ONC-ACB can only issue a certification to a Health IT Module for this criterion at § 170.315(h)(1) if the Health IT Module’s certification also includes § 170.315(b)(1) “Transitions of care.”
Resources
The following resources can offer assistance or additional information:
§ 170.315(h)(2) Direct Project, Edge Protocol, and XDR/XDM
PDF DOCUMENT
Real World Testing Resource Guide
2025-10-01
PDF DOCUMENT
Real World Testing Fact Sheet
Certification Companion Guide Changelog
The following changelog applies to:
§ 170.315(h)(1)Direct Project
Changelog functionality is not available.
Revision History
Version #
Description of Change
Version Date
1.0
Initial publication
03-11-2024
1.1
Added update to Certification Dependencies section to reflect recent Real World Testing enforcement discretion notice.
07-23-2025
Test Procedure
v1.2
View Changelog
Issued Date:
03-11-2024
03-21-2025
This Test Procedure illustrates the test steps required to certify a Health IT Module to this criterion. Please consult the most recent ONC Final Rule on the
Certification Regulations
page for a detailed description of the certification criterion with which these testing steps are associated. ONC also encourages developers to consult the Certification Companion Guide in tandem with the test procedure as it provides clarifications that may be useful for product development and testing.
Quick Overview
Required Updates
None
Design and Performance
Additional Criterion Information
Base EHR Definition
Included
Real World Testing
Yes
Insights Condition
No
SVAP Versions
Yes
TESTING STEPS
TOOLS AND DATA
TESTING COMPONENTS
CHANGELOG
IN THIS SECTION
View Regulation Text
Testing Steps
Note: The test step order does not necessarily prescribe the order in which the tests should take place.
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Testing Steps
System Under Test
Discover Certificates
The user performs setup tasks by visiting ONC Standards Implementation & Testing Environment (SITE)’s Direct Tooling for H1. In the dropdown menu, select paragraph (i) Certificate Discovery / Hosting (DCDT) and download the DCDT Trust Anchor. Then, upload it into the Health IT Module’s Direct instance, and map the Direct address to a non-Direct email address for receiving results so that the user can discover and use address-bound and domain-bound certificates hosted in both DNS and LDAP in DCDT using identified health IT function(s).
Register Direct Address
The user selects “Register Direct” within SITE: Direct Tooling for H1 and registers a Direct address within SITE and corresponding Contact Email address for receipt of the SITE validation report.
Send Health Information Using Direct
The user identifies the payload for sending to SITE. ONC-supplied payloads are available for download from SITE: Direct Tooling.
The user sends encrypted and signed health information to a third party (SITE) using Direct in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2 using identified health IT function(s).
Based upon the types of Direct messages the Health IT Module supports for sending of information (“wrapped” RFC-5751, messages only), the user sends health information to a third party using Direct in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2.
Approved SVAP Version(s)
Complete step 1 using DCDT as described above.
Complete steps 3-4 using SITE: Direct Tooling for H1, paragraph (i) Send Direct Message, using Direct v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Test Lab Verification
Discover Certificates
The tester verifies the Health IT Module can discover and use address-bound and domain-bound certificates hosted in both DNS and LDAP in order to create and store a listing of Direct recipients using DCDT. All listed certificates listed in both DNS and LDAP must be tested corresponding to the standard at § 170.202(a)(2).
Register Direct Address
The tester verifies the Health IT Module can register a Direct email address using SITE and has supplied a corresponding Contact Email address for receipt of the SITE validation report.
Send Health Information Using Direct
Using the SITE validation report, the tester verifies the payload sent to SITE is encrypted using the SITE’s Public Key and signed using the Health IT Module’s Private Key.
Using the SITE validation report, the tester verifies the identified health information is successfully transmitted to a third party using Direct, in accordance with the standard specified at § 170.202(a)(2), and using the RFC-5751, “wrapped” message format.
Using the validation report, the tester verifies that SITE was able to successfully decrypt the message, and that the payload was successfully received by SITE.
Testing Steps
System Under Test
Hosting Certificates
The user performs setup tasks to test hosting of certificates (by entering the Health IT Module’s Direct address within SITE: Direct Tooling for H1) and executes test cases based upon whether the Health IT Module is able to host either address-bound or domain-bound certificates in either DNS or LDAP servers using the DCDT tool.
SUT Connection
The user selects “Send Direct Message” within SITE: Direct Tooling for H1 and performs setup tasks to enable the receipt of Direct Messages including:
Completion of the required information, identifying the Direct Address for testing receipt and digital signing of health information in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport v1.2.
Installation of the SITE/Direct Tooling's Valid Trust Anchor within the Health IT Module.
Identification of the Health IT Module’s Public Key for encryption of messages to be sent by SITE to the Health IT Module.
Receive Direct Message
The user receives RFC-5751, “wrapped” health information sent from SITE using Direct in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport v1.2, and sends corresponding Message Delivery Notifications (MDNs).
Reject Receipt of Direct Message (Negative Testing)
The user rejects health information not in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2, sent from the SITE to the Health IT Module using the following tool option: Invalid Certificate.
The user rejects health information not in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2, sent from the SITE to the Health IT Module using the following tool option: Expired Certificate.
The user rejects health information not in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2, sent from the SITE to the Health IT Module using the following tool option: Invalid Trust Relationship (Different Trust Anchor).
The user rejects health information not in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2, sent from the SITE to the Health IT Module using the following tool option: No Authority Information Access (AIA) Extension.
The user rejects health information not in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2, sent from the SITE to the Health IT Module using the following tool option: Invalid Message Digest.
Approved SVAP Version(s)
Complete step 1 using DCDT as described above.
Complete step 2 using SITE: Direct Tooling for H1, paragraph (i) Receive - Message Status, v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Complete step 3 using SITE: Direct Tooling for H1, paragraph (i) Receive - Message Status, v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Complete following additional steps:
The user receives messages using certificates with 3072 bits sent from SITE using Direct in accordance with ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct) adopted via the SVAP 2022, and sends corresponding Message Delivery Notifications (MDNs).
The user receives messages using certificates with 4096 bits sent from SITE using Direct in accordance with ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct) adopted via the SVAP 2022, and sends corresponding Message Delivery Notifications (MDNs).
The user receives messages created using different signature algorithms specified on SITE using Direct in accordance with ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct) adopted via the SVAP 2022, and sends corresponding Message Delivery Notifications (MDNs).
Complete steps 4-8 using SITE: Direct Tooling for H1, paragraph (i) Receive - Message Status, v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Complete the following additional steps:
The user rejects health information not in accordance with the ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct) adopted via the SVAP 2022 sent from SITE to the Health IT Module using the following tool option: WILD_CARD_DOMAIN_CERT.
The user rejects health information not in accordance with the ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct) adopted via the SVAP 2022 sent from SITE to the Health IT Module using the following tool option: CERT_WITH_EMAIL_ADDRESS
The user rejects health information not in accordance with the ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct) adopted via the SVAP 2022 sent from SITE to the Health IT Module using the following tool option: CERT_LESS_THAN_2048_BITS
The user rejects health information not in accordance with the ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct) adopted via the SVAP 2022 sent from SITE to the Health IT Module using the following tool option: CERT_WITH_NO_CRL
The user rejects health information not in accordance with the ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct) adopted via the SVAP 2022 sent from SITE to the Health IT Module using the following tool option: CERT_WITH_NO_NOTBEFORE_ATTR.
The user rejects health information not in accordance with the ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct) adopted via the SVAP 2022 sent from SITE to the Health IT Module using the following tool option: CERT_WITH_NO_NOTAFTER_ATTR
Test Lab Verification
Hosting Certificates
The tester verifies the Health IT Module’s hosted certificates are discoverable as displayed on screen for the DCDT test cases executed.
SUT Connection
No action required.
Receive Direct Message
The tester verifies health information can be successfully received by the Health IT Module from SITE, in accordance with the standard specified at § 170.202(a)(2), using “wrapped” RFC-5751, messages and that a MDN from the Health IT Module was received on SITE for all messages SITE sent.
Reject Receipt of Direct Message (Negative Testing)
Invalid Certificate: The tester verifies the Health IT Module rejects a Direct message received with an invalid Trust Anchor and no corresponding MDN was received by SITE from the Health IT Module.
Expired Certificate: The tester verifies the Health IT Module rejects a Direct message received with an expired certificate and no corresponding MDN was received by SITE from the Health IT Module.
Invalid Trust Relationship (Different Trust Anchor): The tester verifies the Health IT Module rejects a Direct message received with an invalid Trust Relationship. The tester verifies no corresponding MDN was received by SITE from the Health IT Module.
No Authority Information Access (AIA) extension: The tester verifies the Health IT Module rejects a Direct message received without an Authority Information Access (AIA) extension and no corresponding MDN was received by SITE from the Health IT Module.
Invalid Message Digest: The tester verifies the Health IT Module rejects a Direct message received with an invalid message digest that no corresponding MDN was received by SITE from the Health IT Module.
Approved SVAP Version(s)
Complete step 1 verification for the DCDT SVAP 2022 test cases executed.
Complete step 3 verification using SITE: Direct Tooling for H1, paragraph (i) Receive – Message Status, v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Complete the following additional verifications:
The tester verifies health information can be successfully received by the Health IT Module from SITE, in accordance with the ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct), and a MDN from the Health IT Module was received on SITE for all messages the SITE sent using certificates with 3072 bits.
NOTE: This is an optional requirement, so not receiving a MDN amounts to only a WARNING and not a failure.
The tester verifies health information can be successfully received by the Health IT Module from SITE, in accordance with the ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct), and a MDN from the Health IT Module was received on SITE for all messages SITE sent using certificates with 4096 bits.
NOTE: This is an optional requirement, so not receiving a MDN amounts to only a WARNING and not a failure.
The tester verifies health information can be successfully received by the Health IT Module from SITE, in accordance with the ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct), and a MDN from the Health IT Module was received on SITE for all messages SITE sent using different signature algorithms specified on SITE.
NOTE: ECDSA based signature algorithms are optional requirement, so not receiving a MDN amounts to only a WARNING and not a failure.
Complete step 4-8 verifications in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Complete the following additional verifications:
WILD_CARD_DOMAIN_CERT: The tester verifies the Health IT Module rejects a Direct message received with an invalid message digest that no corresponding MDN was received by the Health IT Module from SITE.
CERT_WITH_EMAIL_ADDRESS: The tester verifies the Health IT Module rejects a Direct message received with an invalid message digest that no corresponding MDN was received by the Health IT Module from SITE.
CERT_LESS_THAN_2048_BITS: The tester verifies the Health IT Module rejects a Direct message received with an invalid message digest that no corresponding MDN was received by the Health IT Module from SITE.
CERT_WITH_NO_CRL: The tester verifies the Health IT Module rejects a Direct message received with an invalid message digest that no corresponding MDN was received by the Health IT Module from SITE.
CERT_WITH_NO_NOTBEFORE_ATTR: The tester verifies the Health IT Module rejects a Direct message received with an invalid message digest that no corresponding MDN was received by the Health IT Module from SITE.
CERT_WITH_NO_NOTAFTER_ATTR: The tester verifies the Health IT Module rejects a Direct message received with an invalid message digest that no corresponding MDN was received by the Health IT Module from SITE.
Testing Steps
System Under Test
Disposition-Notification-Options Header
Using SITE: HISP Testing Portal “Message Tracking” using “Your system as “Receiver”, the Health IT Module is able to receive and successfully process a message from SITE (as Sending HISP) that contains a valid Disposition-Notification-Options Header and includes it in the message to the destination via SMTP MT Test 39.
Negative Testing: The Health IT Module is able to receive and successfully process a message from SITE (as Sending HISP) that contains an invalid Disposition-Notification-Options Header and includes it in the message to the destination via SMTP MT Test 40.
Approved SVAP Version(s)
Complete steps 1-2 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct v1.3).
Test Lab Verification
Disposition-Notification-Options Header
SITE test results for SMTP MT Test 39 are successful.
SITE test results for SMTP MT Test 40 are successful.
Approved SVAP Version(s)
Complete verifications against the test outcome by SITE: Direct Tooling for H1, paragraph (ii) Delivery Notifications, v1.3 for SMTP MT Test 39 and 40.
Testing Steps
System Under Test
Failure Notification
Using SITE: HISP Testing Portal “Message Tracking” using “Your system as “Receiver”, the Health IT Module successfully validates security and trust returning a Processed MDN, but cannot deliver the message to its final destination (mailbox full, unavailable, mailbox does not exist) - generating a MDN failed or a failure Delivery Status Notification via SMTP MT Test 41.
Approved SVAP Version(s)
Complete this test using SITE: Direct Tooling for H1 paragraph (ii) Delivery Notifications, v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Test Lab Verification
Failure Notification
The SITE test results for SMTP MT Test 41 are successful.
Approved SVAP Version(s)
Complete verifications against the test outcome using SITE: Direct Tooling for H1 paragraph (ii) Delivery Notifications, v1.3 for this test.
Required Enhanced Testing
The Health IT Module submits evidence of multi-partner testing with three different and unrelated partner HISPs using SITE: Direct Tooling for H1 v1.2, (in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2), formatted only as a “wrapped” message.
Approved SVAP Version(s)
The Health IT Module submits evidence of multi-partner testing with three different and unrelated partner HISPs using SITE: Direct Tooling for H1, v1.3, (in accordance with the standard specified at ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct)), formatted only as a “wrapped” message.
Testing Steps
System Under Test
The Health IT Module provides evidence and demonstration of successful send of encrypted and signed health information from the Health IT Module to three partners (e.g., other vendor Health IT Modules (HISPs) that have implemented (h)(1) or (h)(2) capabilities), using Direct v1.2, in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2, which includes:
Documentation of the Health IT Module sending “Wrapped” RFC-5751, messages to three partner HISPs; and
Documentation of the Health IT Module receiving processed MDNs from each of the three partner HISPs, generated by the partner HISPs upon receiving the Direct message from the Health IT Module.
Approved SVAP Version(s)
Complete this test using SITE: Direct Tooling for H1, paragraph (i) Send Direct Message, v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Test Lab Verification
The tester verifies the Health IT Module has successfully sent encrypted and signed health information to three partner HISPs using Direct v1.2, in accordance with the standard specified at § 170.202(a)(2). The verification includes:
Indication through documentation that the Health IT Module sent “Wrapped” RFC-5751, messages to three separate and unrelated HISP partners.
Indication through documentation of the Health IT Module receiving processed MDNs from each of the three partner HISPs, generated upon receiving the Direct message from the Health IT Module.
Approved SVAP Version(s)
Complete verifications against the test outcome by using SITE: Direct Tooling for H1, paragraph (i) Send Direct Message, v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Partners the Health IT Module chooses to test with do not have to be certified at the time of testing as long as the testing uses the Direct v1.2, (in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2), formatted only as a “wrapped” message.
Approved SVAP Versions
Partners who the Health IT Module chooses to test with do not have to be certified at the time of testing as long as the testing uses the Direct v1.3 (in accordance with the standard specified at ONC Applicability Statement for Secure Health Transport, Version 1.3, May 2021 (Direct)), formatted only as a “wrapped” message.
Testing Steps
System Under Test
The user provides evidence of successful receipt of encrypted and signed health information from three partners (e.g., other vendor Health IT Modules (HISPs) that have implemented (h)(2) capabilities) using Direct v1.2, in accordance with the standard specified at § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2. The evidence includes:
Documentation of the Health IT Module receiving “Wrapped” RFC-5751 messages from three partner HISPs; and
Documentation that the Health IT Module generates and sends processed MDNs that are transmitted to each of the three partner HISPs, generated upon successfully receiving a Direct message from the Health IT Module.
Approved SVAP Version(s)
Complete this test using SITE: Direct Tooling for H1, paragraph (i) Receive – Message Status, v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
Test Lab Verification
The tester verifies the Health IT Module has received encrypted and signed health information from three partner HISPs using Direct v1.2, in accordance with the standard specified at § 170.202(a)(2). The documentation includes:
Indication that the Health IT Module successfully received “Wrapped” RFC-5751, messages from three separate and unrelated HISP partners; and
Indication of the Health IT Module generating and transmitting processed MDNs to each of the three partner HISPs, generated upon receiving the Direct message from each partner HISP.
Approved SVAP Version(s)
Complete verifications against the test outcome using SITE: Direct Tooling for H1, paragraph (i) Receive – Message Status, v1.3 in accordance with the standards specified in ONC Applicability Statement for Secure Health Transport, v1.3, May 2021 (Direct).
TEST TOOL DOCUMENTATION
Testing Tools
§ 170.315(h)(1) Direct Project
Standards Implementation & Testing Environment (SITE)
Direct Certificate Discovery Tool (DCDT)
SITE is a centralized collection of testing tools and resources designed to assist health IT developers and health IT users fully evaluating specific technical standards and maximizing the potential of their health IT implementations. SITE is organized in a collection of sandboxes that provide test tools, sample data, collaboration resources, and useful links.
Test Data
Test data for implementation and validation.
(h)(1)
Refer to the
Standards Implementation & Testing Environment (SITE)
Testing Components
§ 170.315(h)(1) Direct Project
Documentation is an approved method to demonstrate conformance. This may include documents from the health IT developer or third-party that demonstrate/attest to the compliance with the criterion.
Visual inspection is an approved method to demonstrate conformance. Most commonly, this will be accomplished via a live demonstration of functionality that meets the criterion.
Testing Tools
Testing tools indicate that a test tool(s) exists and must be used to test a portion or all of a Health IT Module's conformance to the criterion.
SVAP
Indicates that the Standards Version Advancement Process (SVAP) is applicable to the criterion.
Test Data
The test data for this criterion is provided within the testing tools tab. Click the link below to be directed to the testing tools tab.
Review Test Data
Test Method Changelog
The following changelog applies to:
§ 170.315(h)(1)Direct Project
Changelog functionality is not available.
Revision History
Version #
Description of Change
Version Date
1.0
Initial publication
03-11-2024
1.1
Updated test tool link
12-02-2024
1.2
Updated tool references to reflect new SITE tool names
03-21-2025
The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
Additional Criteria:
§ 170.315(g)(4)
Quality management system
Description:
When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
§ 170.315(g)(5)
Accessibility-centered design
Description:
When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
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Standards Version Advancement Process (SVAP)
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.
Learn More About SVAP
SVAP Approved Version:
MAY 2021
Direct Project: ONC Applicability Statement for Secure Health Transport
Version 1.3
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