With changes in state and federal privacy law the need for security labeling and differential management of highly sensitive data has significantly increased warranting focused attention on the various data elements in the Security Label data class.
The information reflected under "Use Case Description", "Maturity Discussion", and "Potential Challenges" for the Security Label data element submissions seem to refer to a different use case for Controlled Unclassified Information (CUI) which may be an error or reflect of a lack of sufficient details. We suggest that these fields be reviewed and updated to reflect the specifics related to each type of security label being suggested.
We believe that Confidentiality and Purpose of Use codes are quite stable and at least a subset of the value sets have been implemented by some EHRs, especially considering that the Confidentiality Label has long been a required element in the DS4P standard for Composite CDAs at the document level. We therefore propose that the Confidentiality and Purpose of Use data elements be moved to Level 2. The values for the Confidentiality label that are most widely implemented are Restricted (R), Normal (N), and Unclassified (U) and could therefore be specified as an initial recommended value set within USCDI. The subset of values more likely to have been more widely implemented for Purpose of Use is the General Purpose of Use value set as defined by the FHIR DS4P IG and HL7 Terminology: https://terminology.hl7.org/ValueSet-v3-GeneralPurposeOfUse.html
We believe that a subset of the Sensitivity Tag value set has been implemented by some EHRs and directly supports major US-realm privacy use cases. Particularly, the use case of tagging and differentially managing data related to the treatment of Substance Use Disorder (SUD) based on 42 CFR Part 2 requirements. The use of these tags predates FHIR and we believe is widely implemented since at least source-based tagging (whether it is implemented using standard HL7 codes or internal proprietary tags) directly supports this long-standing compliance requirement. As such, we propose that the Sensitivity Tag data element be moved to Level 1 with the following subset of Sensitivity codes specified as an applicable value set: Substance Use Disorder (SUD), Sexual and Reproductive Health (SEX), Mental Health (MH).
The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.
If you wish to provide context, explanation, or an introduction to your comment, enter this information in the field labeled "Optional Background Text / Cover Letter." This is entirely optional and is most useful when submitting multiple related comments or when additional background would help reviewers understand your feedback.
If you are only commenting on a single data class or element, you may leave this field blank.
2. Select the Data Class
To specify which data class your comment addresses:
In the "Data Class" drop-down menu, select the appropriate data class you want to comment on.
If you are providing a general comment that is not specific to a data element, select "General" from the options. Comments with this designation will be displayed on the USCDI landing page.
Note that the Data Class field will automatically populate based on your current location in the platform:
If you are on a data class page, the field will be set to that specific data class
If you are on a data element page, the corresponding data class will be pre-selected
3. Select the Data Element
To specify which data element your comment addresses:
In the "Data Element" drop-down menu, select the specific data element you want to comment on.
The drop-down menu will display only the elements available under the data class you selected in the previous step.
You can use the search function within the drop-down to quickly locate a specific data element.
If you are commenting on the data class itself rather than a specific element, you may leave this field blank.
Note: Comments on a specific data element will appear on the respective data element page, while comments on a data class (without a specific element selected) will appear on the landing page for that data class.
Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.
4. Optional: Propose New Data Class or Element
If you cannot find the appropriate data class or element for your comment:
Instead of clicking the "Comment On An Existing Data Class Or Element" button, click the adjacent button labeled "Propose a New Data Class or Data Element."
This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.
5. Complete the Comment Form
Fill out the required fields in the comment form:
Subject: Enter a brief, descriptive title that summarizes your comment. This helps reviewers quickly understand the nature of your feedback.
Comment: In this field, provide the full details of your comment or feedback. Be as clear and specific as possible about your suggestions, concerns, or observations. Include any relevant details that support your position.
6. Optional: Add Additional Comments
If you need to comment on multiple data classes or elements:
After completing your first comment, click the link labeled "Comment on another data element" at the bottom of the form.
A new comment section will appear, allowing you to enter details for your additional comment.
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Complete the Subject and Comment fields for your additional comment.
Repeat this process for each additional comment you wish to submit.
Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.
7. Optional: Upload Supporting Files
The platform allows you to upload supporting documentation to enhance your comment:
Locate the "File Upload" section at the bottom of the comment form.
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.
Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.
8. Optional: Save and Exit
If you need to pause your work and return to complete your comment later:
Click the "Save and Exit" button at the bottom of the form.
Your comment will be saved as a draft that you can access and complete later.
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.
Click this button to continue working on your draft.
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Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.
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Click the "Review and Submit" button at the bottom of the form.
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Review all information for accuracy and completeness.
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If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.
Submitted by Steven.Lane on
Recommended updates to Security Label data class