Merge pull request #64 from onc-healthit/ccg-pull-march-2024

HTI-1 Updates and March 2024 CCG Pull
onc-healthit · Mar 22, 2024 · 88cf8a1 · 88cf8a1
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diff --git a/docs/404-conditions-maintenance.md b/docs/404-conditions-maintenance.md
diff --git a/docs/g10-criterion.md b/docs/g10-criterion.md
diff --git a/docs/helpful-links.md b/docs/helpful-links.md
@@ -15,10 +15,16 @@
 - Inferno Program Edition (§ 170.315(g)(10))
     - <a target = "_blank" href = "https://inferno.healthit.gov/onc-certification-g10-test-kit">Inferno Framework: (g)(10) Standardized API Test Kit Online Demonstration Instance</a>
     - <a target = "_blank" href = "https://github.com/onc-healthit/onc-certification-g10-test-kit/releases">Inferno Framework: (g)(10) Standardized API Test Kit Source Code</a>
-- <a target = "_blank" href = "https://www.drummondgroup.com/compliance/payer-and-patient-access-certification/">Drummond G10+ FHIR API powered by Touchstone</a>
+    - <a target = "_blank" href = "https://www.drummondgroup.com/compliance/payer-and-patient-access-certification/">Drummond G10+ FHIR API powered by Touchstone</a>
 
 ## **Rules and regulations links**
 
+=== "HTI-1"
+    - <a target = "_blank" href = "https://www.federalregister.gov/documents/2024/01/09/2023-28857/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and#h-105">§ 170.315(g)(10) Preamble</a>
+    - <a target = "_blank" href = "https://www.ecfr.gov/on/2023-10-04/title-45/part-170#p-170.315(g)(10)">§ 170.315(g)(10) Regulation text</a>
+    - <a target = "_blank" href = "https://www.federalregister.gov/documents/2024/01/09/2023-28857/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and#h-108">§ 170.404 Preamble</a>
+    - <a target = "_blank" href = "https://www.ecfr.gov/current/title-45/section-170.404">§ 170.404 Regulation text</a>
+
 === "Cures Act Final Rule"
     - <a target = "_blank" href = "https://www.federalregister.gov/d/2020-07419/p-1162">§ 170.315(g)(10) Preamble</a>
     - <a target = "_blank" href = "https://www.federalregister.gov/d/2020-07419/p-3456">§ 170.315(g)(10) Regulation text</a>
@@ -44,17 +50,16 @@
 === "§ 170.315(g)(10)"
     - <a target = "_blank" href = "https://www.healthit.gov/isa/us-core-data-interoperability-uscdi">§ 170.213: United States Core Data for Interoperability (USCDI)</a>
     - <a target = "_blank" href = "http://hl7.org/fhir/directory.html">§ 170.215(a)(1): Health Level 7 (HL7®) Version 4.0.1 Fast Healthcare Interoperability Resources Specification (FHIR®) Release 4, October 30, 2019</a>
-    - <a target = "_blank" href = "http://hl7.org/fhir/us/core/STU3.1.1/">§ 170.215(a)(2): FHIR® US Core Implementation Guide STU V3.1.1</a>
-    - <a target = "_blank" href = "https://hl7.org/fhir/smart-app-launch/1.0.0/">§ 170.215(a)(3): HL7® SMART Application Launch Framework Implementation Guide Release 1.0.0</a>
-    - <a target = "_blank" href = "https://hl7.org/fhir/uv/bulkdata/STU1.0.1/">§ 170.215(a)(4): HL7® FHIR® Bulk Data Access (Flat FHIR®) (V1.0.1:STU 1)</a>
-    - <a target = "_blank" href = "https://openid.net/specs/openid-connect-core-1_0.html">§ 170.215(b): OpenID Connect Core 1.0 incorporating errata set 1</a>
+    - <a target = "_blank" href = "http://hl7.org/fhir/us/core/STU3.1.1/">§ 170.215(b)(1)(i): HL7® FHIR® US Core Implementation Guide STU 3.1.1.</a> The adoption of this standard expires on January 1, 2026.
+    - <a target = "_blank" href = "https://hl7.org/fhir/us/core/STU6.1/">§ 170.215(b)(1)(ii): HL7® FHIR® US Core Implementation Guide STU 6.1.0</a>
+    - <a target = "_blank" href = "https://hl7.org/fhir/smart-app-launch/1.0.0/">§ 170.215(c)(1): HL7® SMART Application Launch Framework Implementation Guide Release 1.0.0</a>. The adoption of this standard expires on January 1, 2026.
+    - <a target = "_blank" href = "https://hl7.org/fhir/smart-app-launch/STU2/">§ 170.215(c)(2): HL7® SMART App Launch Implementation Guide Release 2.0.0</a>
+    - <a target = "_blank" href = "https://hl7.org/fhir/uv/bulkdata/STU1.0.1/">§ 170.215(d)(1): HL7® FHIR® Bulk Data Access (Flat FHIR®) (V1.0.1:STU 1)</a>
+    - <a target = "_blank" href = "https://openid.net/specs/openid-connect-core-1_0.html">§ 170.215(e)(1): OpenID Connect Core 1.0 incorporating errata set 1</a>
 
     **Standards Version Advancement Process (SVAP) Version(s) Approved**
 
-    - <a target = "_blank" href = "https://www.healthit.gov/isa/sites/isa/files/2021-07/USCDI-Version-2-July-2021-Final.pdf">United States Core Data for Interoperability (USCDI), Version 2, July 2021</a>
     - <a target = "_blank" href = "http://hl7.org/fhir/us/core/STU4/">HL7® FHIR® US Core Implementation Guide STU 4.0.0, June 2021</a>
-    - <a target = "_blank" href = "http://hl7.org/fhir/us/core/STU5.0.1/">HL7® FHIR® US Core Implementation Guide STU 5.0.1, June 2022 </a>
-    - <a target = "_blank" href = "http://hl7.org/fhir/smart-app-launch/STU2/">HL7® FHIR® SMART Application Launch Framework Implementation Guide Release 2.0.0, November 26, 2021</a>
     -  <a target = "_blank" href = "http://hl7.org/fhir/uv/bulkdata/STU2/">HL7® FHIR® Bulk Data Access (Flat FHIR®) (v2.0.0: STU 2), November 26, 2021</a>
 
 --8<-- "includes/abbreviations.md"
diff --git a/docs/index.md b/docs/index.md
@@ -2,9 +2,9 @@
 
 ## How to use this resource guide
 
-This informative resource supplements other public documentation available to help health IT developers certify to the API criteria in the ONC Health IT Certification Program and meet the requirements under the API Conditions and Maintenance of Certification. At the highest level, this document mirrors the organization of paragraphs in the Code of Federal Regulations, including headers for “§ 170.315(g)(10) Standardized API Certification Criterion” (the FHIR®-based standardized API), “§ 170.404 Conditions and Maintenance of Certification” (the broader API behavior requirements), and sub-paragraphs. Efforts have been made to make this resource easily navigable, searchable, and consumable. If you have recommendations to improve this resource, please submit an inquiry to the <a target = "_blank" href = "https://inquiry.healthit.gov/support/plugins/servlet/desk/portal/2">Health IT Feedback and Inquiry Portal</a> or submit an <a target = "_blank" href = "https://github.com/onc-healthit/api-resource-guide/issues">issue on GitHub</a>.
+This informative resource supplements other public documentation available to help health IT developers certify to the API criteria in the ONC Health IT Certification Program and meet the requirements under the API Conditions and Maintenance of Certification. At the highest level, this wesbite mirrors the organization of paragraphs in the Code of Federal Regulations, including pages for “HL7 FHIR API Criterion - § 170.315(g)(10)” (the FHIR®-based standardized API), “API Conditions and Maintenance of Certification - § 170.404” (the broader API behavior requirements), and sub-paragraphs. Efforts have been made to make this resource easily navigable, searchable, and consumable. If you have recommendations to improve this resource, please submit an inquiry to the <a target = "_blank" href = "https://inquiry.healthit.gov/support/plugins/servlet/desk/portal/2">Health IT Feedback and Inquiry Portal</a> or submit an <a target = "_blank" href = "https://github.com/onc-healthit/api-resource-guide/issues">issue on GitHub</a>.
 
-This resource is intended to provide clarifications to assist developers in implementing applicable provisions contained in <a target = "_blank" href = "https://ecfr.federalregister.gov/current/title-45/subtitle-A/subchapter-D/part-170">45 CFR part 170</a>. In developing and implementing APIs and other health IT, developers should remain mindful of the information blocking provisions of the ONC Cures Act Final Rule contained in <a target = "_blank" href = "https://ecfr.federalregister.gov/current/title-45/subtitle-A/subchapter-D/part-171">45 CFR part 171</a>. **This resource does not supersede existing statutory or regulatory requirements**. The use of the term “Health IT Module(s)” or “Certified Health IT Module(s)” in this resource refers to Health IT Modules certified through the ONC Health IT Certification Program.
+This resource is intended to provide clarifications to assist developers in implementing applicable provisions contained in <a target = "_blank" href = "https://ecfr.federalregister.gov/current/title-45/subtitle-A/subchapter-D/part-170">45 CFR part 170</a>. In developing and implementing APIs and other health IT, developers should remain mindful of the information blocking provisions contained in <a target = "_blank" href = "https://ecfr.federalregister.gov/current/title-45/subtitle-A/subchapter-D/part-171">45 CFR part 171</a>. **This resource does not supersede existing statutory or regulatory requirements**. The use of the term “Health IT Module(s)” or “Certified Health IT Module(s)” in this resource refers to Health IT Modules certified through the ONC Health IT Certification Program.
 
 This resource encompasses clarifications from the <a target = "_blank" href = "https://www.healthit.gov/test-method/standardized-api-patient-and-population-services">§ 170.315(g)(10) Certification Companion Guide</a> and <a target = "_blank" href = "https://www.healthit.gov/condition-ccg/application-programming-interfaces">§ 170.404 CCG</a>. Within each regulation paragraph, there is a section titled “Clarifications Included in [name of CCG],” which includes clarifications from the respective CCG, and “Additional Clarifications to the [name of CCG],” which includes additional clarifications not included in the respective CCG. This documentation accompanies the Certification Companion Guides and Test Procedures for the API certification criterion finalized in § 170.315(g)(10) and the CCG for API Conditions and Maintenance of Certification requirements finalized at § 170.404.
 

diff --git a/docs/inquiry-portal/404-inquiries.md b/docs/inquiry-portal/404-inquiries.md
@@ -7,7 +7,7 @@ This section contains anonymized feedback and inquiries, related to the API Cond
     The date headers provide important context as some information may have changed since the time of an inquiry and response.
 
 ## Paragraph (a)(3)(iv): API Fees - Permitted Fee (Value-Added Services)
-### July 2021
+### 2021 Inquiries
 **Stakeholder Inquiry**: If an EHR developer’s API includes both certified and non-certified capabilities, does the entire API fall within the requirements of § 170.404?
 
 - Can an API be certified if it also contains non-certified capabilities so long as it also meets the certification criteria?  
@@ -26,8 +26,10 @@ We are not able to provide individualized advice on whether a specific fact patt
 
 Anyone who believes they may have experienced or observed information blocking by <a target = "_blank" href = "https://www.healthit.gov/cures/sites/default/files/cures/2020-03/InformationBlockingActors.pdf">any health care provider, health IT developer of Certified Health IT, or health information network or health information exchange</a> is encouraged to share their concerns with us through the <a target = "_blank" href = "https://healthit.gov/report-info-blocking">Information Blocking Portal</a> on ONC’s website, HealthIT.gov.
 
+***
+
 ## Paragraph (b)(2): Service base URL publiciation
-### June 2023
+### 2023 Inquiries
 **Stakeholder Inquiry**: I have questions about the regulatory text in the ONC Cures Act Final Rule found here: <a target = "_blank" href = "https://www.federalregister.gov/d/2020-07419/p-1405">https://www.federalregister.gov/d/2020-07419/p-1405</a>.
 
 Should this list be published on CHPL? We see the "place" for the information on CHPL, but we are seeing that many EHRs have very little to no information published and most don't have their customer list. Is this a violation of the requirements? Are there any exceptions to publishing this information?
@@ -42,7 +44,9 @@ To be open and transparent to the public, developers must provide a hyperlink to
 
 There are no exceptions to the requirement that Certified API Developers must publish service base URLs for all Health IT Modules certified to § 170.315(g)(10) that can be used by patients to access their EHI.
 
-### October 2022
+***
+
+### 2022 Inquiries
 **Stakeholder Inquiry**: If an EHR vendor chooses to obtain and integrate a 3rd party solution that is certified to 170.315(g)(10), who is responsible for publish the service base URLs?
 
 **ONC Response**: The API Maintenance of Certification requirement at § 170.404(b)(2) requires a Certified API Developer to publish the service base URLs for all Health IT Modules certified to § 170.315(g)(10) that can be used by patients to access their electronic health information. This includes publishing the service base URLs for all of its customers regardless of whether the Health IT Modules certified to § 170.315(g)(10) are centrally managed by the Certified API Developer or locally deployed by an API Information Source.
@@ -51,8 +55,10 @@ ONC provides discussion regarding Certified API Developer publication of service
 
 The ONC Cures Act Final Rule at <a target = "_blank" href = "https://www.federalregister.gov/d/2020-07419/p-1909">85 FR 25813</a> provides an example which discusses API Information Sources providing Certified API Developers service base URLs in the context of Information Blocking.
 
+***
+
 ## Paragraph (b)(3): Rollout of (g)(10)-Certified APIs
-### May 2022
+### 2022 Inquiries
 **Stakeholder Inquiry**: According to the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule) timeline, ONC Cures Update Certification Criteria must be made available by 12/31/2022. Can you clarify what "made available" means?
 
 **ONC Response**: The API Maintenance of Certification requirement at 45 CFR 170.404(b)(3) requires that a Certified API Developer with certified API technology previously certified to the certification criterion in § 170.315(g)(8) must deploy to all of their API Information Sources (e.g., customers) API technology certified to the criterion in § 170.315(g)(10) no later than December 31, 2022.
@@ -63,7 +69,8 @@ Additional context and background discussion of this Maintenance of Certificatio
 
 We encourage all Certified Health IT Developers to work with their ONC-ACBs and customers to develop a certification and roll-out strategy to meet ONC Health IT Certification Program requirements by the required regulatory deadlines.
 
-### April 2022
+***
+
 **Stakeholder Inquiry**: If an EHR system that is currently certified to (g)(7)-(g)(9) is unable to get certified to (g)(10) by January 1, 2023, what is the outcome with respect to their certification? 
 
 - If they then certify to (g)(10) at some point in CY 2023 how is their CHPL entry effected? 
@@ -82,7 +89,8 @@ Additionally, if a Certified Health IT Developer does not comply with the Condit
 
 We encourage all Certified Health IT Developers to work with their ONC-ACBs and customers to develop a certification and roll-out strategy to meet all ONC Health IT Certification Program requirements by the required regulatory deadlines.
 
-### February 2022
+***
+
 **Stakeholder Inquiry**: Can you provide some more information on what the requirement below entails?
 
 *A Certified API Developer with certified API technology previously certified to the certification criterion in § 170.315(g)(8) must provide all API Information Sources with such certified API technology deployed with certified API technology certified to the certification criterion in § 170.315(g)(10) by no later than December 31, 2022.*
@@ -93,7 +101,9 @@ If a health IT developer currently has Health IT Modules certified to 45 CFR 170
 
 We encourage health IT developers to work with their ONC-ACB and customers to develop a certification and roll-out strategy to meet ONC Health IT Certification Program requirements by the required regulatory deadlines.
 
-### October 2021
+***
+
+### 2021 Inquiries
 **Stakeholder Inquiry**: Do all products have to be HL7® FHIR capable by Dec 31, 2022, or just the certified products?
 
 **ONC Response**: The API compliance requirement for certified products is contained in 45 CFR 170.404: API Conditions and Maintenance of Certification requirements. According to 170.404(b)(3):