Comments on the ISA are accepted year-round, and changes are made to the web version of the ISA frequently throughout the year, based on comments and other changes to the health IT standards environment as ONC becomes aware of them. An annual Review and Comment period also occurs each summer-fall, when a majority of comments are received. See the process timeline below for more details.
Annual ISA Process Timeline
- January: Current Year Reference Edition is published, web version of ISA is available for ongoing review and comments.
- Winter/Spring/Summer: Changes may be made to the web-version of the ISA throughout the year, while the ISA Reference Edition remains static.
- Late Summer/Early Fall: Annual Review and Comment Period opens for sixty days - site changes are on hold so all reviewers are seeing the same content.
- Fall: ONC and HHS staff review comments received, make site updates and prepare the following year's Reference Edition for publication by early January.
How to Comment on the ISA
- An ISA site account is required in order to comment on the ISA.
- If you have an account already, click the "Login" button at the top right of the ISA.
- To create an account, click the "Login" button, then "Create new account" tab above the login window. Account approval is required, and is generally completed within 1 - 24 hours.
- Once you're authenticated to the ISA site, you can submit comments on most ISA pages - just scroll to the bottom of the relevant page, enter the text of your comment (or provide attachments, if needed) and submit. Your comment will be reviewed by ONC or other HHS subject matter experts, and changes will be considered for publication to the ISA.
- While comments by topic (posted to individual Interoperability Need pages) are preferred, and allow greater visibility to your comments by other industry stakeholders, consolidated comment letters are also accepted. You may provide these comments on general information pages, and ONC staff will triage them, and assign them to subject matter experts.
Comment
Submitted by mphillips@caqh.org on 2023-10-06
CORE Response to the 2024 ISA Open Comment Period
Thank you for the opportunity to provide substantive recommendations that promote consistency and update the content of the ISA. Comprehensive responses from CORE can be found at this link: CORE Submission for the 2024 ISA Open Comment Period. This link has also been posted to relevant pages throughout the ISA, referencing page numbers where edits can be found.
Please note, on page 2 of the linked letter, CORE has made several recommendations that ensure consistency of Operating Rule nomenclature across all pages of the ISA.
Please do not hesitate to contact us with questions.
Submitted by Sanjeev_Tandon@CDC on 2023-10-05
Comments on ISA : Case Reporting to Public Health Agencies
Email: POC(s): Laura Conn lbk1@cdc.gov
URL in ISA: http://www.healthit.gov/isa/case-reporting-public-health-agencies
The comments for case reporting to public health agencies are included in the attached word document.
eCR-Comments_ONC_Interoperability_Standards_Advisory_(ISA) 10 2 2023.docx
Submitted by Jennie Harvell on 2023-10-05
Comments on the ISA and USCDI
The Washington State Medicaid Agency, the Health Care Authority (HCA), appreciates the opportunity to submit comments to the Office of the National Coordinator for Health IT (ONC) on the Interoperability Standards Advisory (ISA) and the United States Core Data for Interoperability (USCDI). The HCA submits comments in the attached letter on the following topics:
- Advance Directives/Mental Health Advance Directives
- Patient Demographic Record Matching and Patient Identity/Identification Management
- Patient Preference/Consent
- Race/Ethnicity
- Publish and Subscribe Message Exchange
SHCAPRCSP5523100414530 WA State HCA Comments ISA and USCDI.pdf
Submitted by mashafa on 2023-10-02
Academy of Nutrition and Dietetics comments on 2023 ISA
On behalf of the Academy of Nutrition and Dietetics, thank you for the opportunity to provide feedback on the Interoperability Standards Advisory. We have attached our comments for your consideration.
Submitted by bheale on 2023-09-16
Support of including genetic data elements and recommendations
The opportunity to provide input to streamline interoperability is much appreciated; thank you. My background extends from molecular biology and bioinformatics research to practical operational implementation within a hospital system (including clinical decision support).
Computable accessibility of genetic data is a requirement for accurate use in processes such as clinical decision support, discovery, operational intelligence, and business intelligence and for use in the care of patients who are moving away from traditional one-on-one relationships with their providers to more complex relationships with multiple systems. This is especially true in the case of patients with multiple chronic conditions. For utility in receiving more discrete genetic data, look no further than the TIER 1 conditions as a prime example of what can be done today (https://www.cdc.gov/genomics/implementation/toolkit/index.htm).
From an operational perspective, genetic data is largely being sent in a non-discoverable way through PDFs. As such, the data is typically lost to further use or clinical decision support. And, the data is very easy to miss during clinical care. Only the ordering provider is likely to know that a genetic test includes a specific region of genetic variation. And the ordering provider will find the data difficult to return to.
As part of GenomeX (within CodeX), pilots are providing implementation lessons in genomic data implementation of the HL7 FHIR Genomics Reporting Implementation Guide and FHIR Genomics Operations for exchange between systems. Additionally, both the HL7 FHIR Genomics Reporting Implementation Guide and FHIR Genomics Operations have been used in the Sync for Genes pilots.
To close, EPIC is an example of a system receiving genetic data as more discrete data elements today, in line with the recommendations below. Please consider these recommendations, and thank you for your time.
Recommendations:
Variant data - Further clarify constituent parts in the definition or break into fields as indicated in sections 4.2.1, 4.2.2, and 4.4 of http://hl7.org/fhir/uv/genomics-reporting/sequencing.html. The HL7 FHIR Genomics Reporting standard is a product of decades and thousands of hours of input by experts in healthcare systems, laboratories, bioinformatics, and clinical practice. It is the vehicle used in the Sync4Genes ONC pilots. The data elements identified provide a discrete representation of genetic positional data.
Gene Studied – note that the gene symbol is not sufficiently unique to disambiguate between genes. The HGNC provides a gene ID# (e.g HGNC:3236 for EGFR, https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:3236. E.g of overlap HGNC:1325 and HGNC:1328), which is unique and positively identifies a gene. Using the symbol alone risks confusion between genes whose previous or alias symbols match an approved symbol (this comes from the historical use in publications).
Variant Interpretation – This has been modeled by the HL7 FHIR Clinical Genomics working group to parse out several types of interpretation. Recommend review and determine how to incorporate in the definition or consider breaking into sub-elements. Molecular implication http://build.fhir.org/ig/HL7/genomics-reporting/StructureDefinition-molecular-consequence.html In interpreting variants, it is common practice to indicate ‘feature-consequence’ (change to a molecular component of gene expression) or ‘functional-effect’ (higher-level functional outcome on the functional aspects of the gene product). Therapeutic implication http://build.fhir.org/ig/HL7/genomics-reporting/StructureDefinition-therapeutic-implication.html In interpreting variants, it is common practice to indicate potential therapeutic indications or counter-indications. Diagnostic implication http://build.fhir.org/ig/HL7/genomics-reporting/StructureDefinition-diagnostic-implication.html In interpreting variants, it is common practice to indicate a potential diagnosis or the effect the variant has on a possible diagnosis. This includes the important concept of ‘clinical significance.’
Variant Type – consider renaming to Molecule type. Typically, the type of molecule sequenced (amino-acid, RNA, DNA, polysaccharide, etc…) appears within reports. It is a very useful atomic data element. Sometimes, the phrase variant type is used to mean the structural type of the change. The current element name could be confusing.
Submitted by LGarber on 2023-08-08
ePOLST Advanced Care Planning standard
The ePOLST: Portable Medical Orders about Resuscitation and Initial Treatment is listed as "In Development". Actually, it was
successfully balloted and was published in early October 2022:
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=600
Submitted by FEHRM.ENGAGEMENT on 2022-10-12
ISA 2022_FEHRM Formal Comment Coordination (Final) 20221007_v2.0
Please see attached for FEHRM comments.
ISA 2022_FEHRM Formal Comment Coordination (Final) 20221007_v2.0.xls
Submitted by Chris Shawn on 2022-09-29
USCDI Data Element to Level 2: Veteran Status
Based on our recent work completed by the VHA Knowledge Based Systems (KBS), Clinical Informatics and Data Management Office (CIDMO) in collaboration with the Department of Defense, the Federal EHR Modernization, CDC NIOSH, and HL7 it is timely to promote the Veteran Status (https://www.healthit.gov/isa/uscdi-data/veteran-status) to Level 2. Veteran Status as well as combat history are relevant to assessing certain health risks. The proposed change is supported by approved HL7 FHIR Implementation Guide and Connectathon activities illustrating the use of this data element to support Social Determinants of Health and the Gravity Project HL7 accelerator. Connectathon reference: https://confluence.hl7.org/display/FHIR/CMS2021-07+Military+and+Veteran+SDOH
FHIR IG: https://hl7.org/fhir/us/military-service/2021sep/index.html. USCDI: Veteran Status | Interoperability Standards Advisory (ISA) (healthit.gov)
Submitted by MeganBoyd_Invitae on 2022-09-27
Support including Genomics in USCDI v4
Invitae comments in support of elevating the Genomics Data Class to Level 2 and including in USCDI v4. Please find our comments attached.
Submitted by ScottStuewe on 2023-10-06
DirectTrust ISA Updates - 2023
Updates to links for permanence. Updates to adoption levels. Inclusion of Context IG now that it is in use in the Notifications Standard. ANSI Naming added to ANSI approved standards.
ISA Updates 2023 0 DirectTrust.xlsx