ISA Timeline and Comment Process

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 ASTP 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: ASTP 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 ASTP 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 ASTP staff will triage them, and assign them to subject matter experts. 

 

FormGuide

Help

1. Optional: Background Text / Cover Letter

The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.

This field is entirely optional and serves the following purposes:

  • Provides context for reviewers
  • Serves as an introduction if submitting multiple comments
  • Functions as a cover letter for formal submissions

If you are submitting a single comment for a specific data class or element, you may leave this field blank. For multiple comments, this space is useful for explaining the overall purpose or connection between your comments.
 

Optional Background Text / Cover Letter

Fig 1 The "Optional Background Text / Cover Letter" field allows users to provide contextual information or introductory remarks for their comment submission.

 2. Complete the Comment Form

The comment form contains several fields that require your input:

ISA Content: This field is automatically populated based on the page you are currently viewing. No action is required.

Standards and Implementation Specifications: This drop-down menu is pre-selected based on the topic you're commenting on. The selection reflects the relevant standard or implementation specification for your current page.

Subject: Enter a concise title that summarizes the focus of your comment. This helps reviewers quickly understand the nature of your feedback.

Comment: This is the main field where you provide your detailed feedback, concerns, or suggestions. The comment box includes a text editor with formatting options that allow you to:

  • Format text as bold or italic
  • Insert hyperlinks
  • Create bullet points
  • Create numbered lists
  • Apply strike-through formatting
  • Attach images
  • Insert tables

Use these formatting options as needed to clearly present your information.

text editor toolbar

Fig 2 The comment text editor toolbar provides formatting options including bold, italic, links, lists, tables, and image insertion capabilities.

3. Optional: Upload Supporting Files

The platform allows you to upload supporting documentation to enhance your comment:

  1. Locate the "File Upload" section at the bottom of the comment form.
  2. Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.

Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.

File Upload

Fig 3 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.

4. Optional: Save and Exit

If you need to pause your work and return to complete your comment later:

  1. Click the "Save and Exit" button at the bottom of the form.
  2. Your comment will be saved as a draft that you can access and complete later.
  3. When you return to the platform, you will see a red triangle with an exclamation mark next to the "Return to saved Comment" button, indicating that you have saved comments in draft status.
  4. Click the "Return to saved Comment " button to continue working on your draft.
  5. You will be taken to a review page where you can:
    1. Select "Submit Comment" to officially submit your feedback.
    2. Click "Edit" to return to the comment form and make changes
    3. Select "Discard Draft" to delete the saved draft and start fresh
Return to saved Comment

Fig 4 A red triangle with exclamation mark indicator appears next to the "Return to saved Comment" button when draft comments are saved in the system.

5. Review and Submit

Once you have completed your comment:

  1. Click the "Review and Submit" button at the bottom of the form.
  2. This will take you to a review screen displaying your comment(s) in full.
  3. Review all information for accuracy and completeness.
  4. On this review screen, you have three options:
    1. Click "Submit Comment" to officially submit your feedback
    2. Click "Edit" to return to the comment form and make changes
    3. Click "Discard Draft" to delete the comment and start fresh
  5. The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records.
  6. If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Review and Submit

Fig 5 The review screen includes a "Print" button that allows users to create a record of their comment submission.

ISA Comments

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Comment

Submitted by hhaskell on

Data Element: Medications

Challenge to capturing medications is those that medications that don't make the typical clinically documented med list such as herbal and at times OTC medications.  These often are documented narratively in nurses or physician notes dependent on the type of EMR or documentation system. 

Submitted by Solarf3050 on

HL7 Comments for ONC ISA 2021 Reference Edition

Please see HL7's updated comments on the ISA 2021 Reference Edition.  It contains an additional recommendation each under the following sections:

(Page 3)

Sharable Clinical Decision Support:

https://www.healthit.gov/isa/sharable-clinical-decision-support

(Page 10)

Providing Patient-Specific Assessments and Recommendations Based on Patient Data for Clinical Decision Support:

https://www.healthit.gov/isa/providing-patient-specific-assessments-and-recommendations-based-patient-data-clinical-decision

 

Thank you.

 

HL7 Response ISA Letter 11 12.20 FINAL v2.docx

Submitted by jeffcoughlin on

Organization and Usability of ISA

ISA is a critical resource to the community as we move forward with broader data exchange across the healthcare ecosystem.  HIMSS thanks ONC for ISA’s new section organization and the clarity that it provides with the removal of section numbers and clearer naming and alphabetizing.  However, there are still some issues with not being able to access major sections of ISA, specifically around the new “Specialty Care and Settings” section.  HIMSS recommends that ONC take several steps to maximize the value of ISA to community stakeholder supporting these efforts. 

Overall, ONC should work to promote and highlight ISA through additional means.  Creation of additional infographics that explain the purpose and benefits of utilizing ISA would be helpful.  Organizations like HIMSS could share those resources with our members and provide another opportunity to drive more utilization of ISA.  It may also be helpful to create brief video tutorials that provide examples of how different entities can access, use, and leverage ISA that furthers the goals of the program.  These resources could also point to previous ISA Reference Editions that are important for stakeholders to understand and see how standards have evolved over the course of several years to meet the requirements of the community.   

Another opportunity to better promote ISA is to ensure robust alignment with USCDI as well as other interoperability efforts underway across ONC.   ONC has an opportunity to cross-reference both ISA and USCDI in each resource document to help ensure better alignment.  There is also an opening for improved mapping across the USCDI data classes and ISA interoperability needs.   We see a clear overlap that could be of value to the community for greater understanding of associated standards within the interoperability need.  For example, there is a USCDI data set for clinical notes as well as an ISA interoperability need for that topic. Cross-linking can raise awareness of both and help consider additional standards/needs associated with each data element or use case.

In addition, we recommend ONC explore the concept of establishing a common evaluation process for ISA and USCDI on an annual basis, as a way of helping the community draw stronger connections between the resources.  Moreover, the idea of creating an ISA infographic resource could further tighten the linkages between ISA and USCDI by comparing and contrasting different sets of standards and describing what they have in common, where they diverge, and other distinguishing factors.  

Finally, in terms of the organization of ISA and the “Appendix II – Models and Profiles” section, we ask ONC to update the link to our new Interoperability in Healthcare Guide on the HIMSS webpage for a discussion on different types of standards.   

Submitted by mdoan on

FEHRM Comments on ISA

On behalf of the Federal Electronic Health Record Modernization (FEHRM) Program Office, we appreciated the opportunity to comment on the Interoperability Standards Advisory (ISA).

FEHRM 2020 ISA Comments.pdf

Submitted by wanda.govan-je… on

Thank you

Thank you for your 3 comments.  No action at this time.