Description (*Please confirm or update this field for the new USCDI version*)
Actor that created or revised the data.
Usage note: The actor may be a provider, a patient, a device, an outside medical record, or something else. The source of the information can be used to form assessments about its quality, reliability, trustworthiness, or can indicate where to go to determine the origins of the information.
Submitted By: KarenP-SSA
/ Social Security Administration (SSA)
Data Element Information
Use Case Description(s)
Use Case Description
SSA’s disability determination process requires the review of detailed medical records of disability applicants.
Due to the COVID-19 pandemic, SSA field offices are closed. This prevents disability applicants from submitting paper medical records they hold to those field offices. An alternative would be submitting this information to SSA electronically. A matter of convenience that would be used by few in normal times, the demand for this submission channel has mushroomed during the pandemic.
However, SSA cannot accept electronic medical records submitted by applicants because the integrity of those records cannot be verified without knowing the author and without (cryptographic) digital signatures of the content. Adding the Signature element to Provenance would provide content integrity verification and resolve this blocker for SSA disability applicants.
Estimate the breadth of applicability of the use case(s) for this data element
3 million disability applicant (patients) interact with SSA annually, involving 15-20 million medical records from almost 500,000 providers.
As consumer-directed health information exchange becomes more prevalent, verifying the
integrity of patient-supplied medical information will become an imperative. When EHI obtained
by a patient that is digitally signed is provided to a third party along with the chain of trust from its
origin, that third party can have confidence in the integrity of that EHI. Consumer apps facilitating
the submission of sports physicals and immunization record to schools are inevitable—as are
apps driving patient-driven care coordination. Consumers will demand this access to their data,
and providers receiving that data will need to know it is unaltered.
Estimate the breadth of applicability of the use case(s) for this data element
Health records are exchanged between millions of providers (and, increasingly, payers) through
dozens of health information exchanges (HIEs) in support of millions of patients every year.
Healthcare Aims
Improving patient experience of care (quality and/or satisfaction)
Improving the health of populations
Reducing the cost of care
Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
FHIR Provenance Resource (v4.0.1) (https://www.hl7.org/fhir/provenance.html)
6.3.4.3 Signatures
The Provenance resource includes a signature element (digital signature) which can be used for standards based integrity verification and non-repudiation purposes. The Signature datatype provides details on use of the signature element. The Signature.type coded value of "Source" should be used when the signature is for simply proving that the resource content is the same as it was when the resource was updated or created.
Also: https://www.hl7.org/fhir/datatypes.html#Signature (2.24.0.17)
• Both XML and JSON cryptographic signatures are supported.
Not currently captured or accessed with an organization
Extent of exchange
N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)
None
Restrictions on Use (e.g. licensing, user fees)
None
Privacy and Security Concerns
Using these data elements will reduce privacy and security concerns about the EHI being exchanged.
Estimate of Overall Burden
Author information should be readily available to implementers already populating Provenance data elements. Although Cryptographic signatures of content (“hashing”) is not widely practiced, the methodology for doing this is straightforward (and specified in detailed in the above-reference FHIR Provenance IG). Implementation should not require more than two two-week sprints.
The Texas Health Informatics Alliance (THIA) Policy and Standards Working Group support including legal author and author role to provide important information for better clinical decision-making. We recommend a national definition for legal author as various states may have different definitions. This is especially critical for institutions that provide clinical services between/across states or provide care to patients from other states.
Every USCDI task force / workgroup has recommended the addition of this data element to USCDI.
Essentially all HIT systems record and maintain the identity of the user who enters/authors clinical data into the system. The author of specific information can impact the manner in which data is used by others. Knowing the identity of the author is particularly important when the author is the individual/patient themselves, a family member, or a caregiver. For many data classes, information authored by the patient will be considered to be the most reliable, e.g., when verifying current medications taken, allergies, etc., whereas for other data classes, such as detailed diagnosis specification, just the opposite may be true, depending on the individual interpreting the data.
CMS-CCSQ recommends this Level 2 data element be added to USCDI v5. It is important to know who the author of the medical notes and information is for effective care coordination and care transitions. With the move toward patient-centered care, there could be multiple contributors of data including patients and other caregivers. The Author data element will provide a complete picture of information from an outside entity. The current data elements in the Provenance data class, Author Time Stamp and Author Organization, will be more meaningful if they can be attributed to the source of the information i.e., the Author. Specifically, CMS recommends including all authors who contribute to the care and documentation of care of a patient, or at least the final legal author.
Please add/update reference to HL7 FHIR Record Lifecycle Event Implementation Guide, published December 2023: http://hl7.org/fhir/uv/ehrs-rle/Informative1/
CMS-CCSQ recommends the addition of the Author data element to USCDI. It is important to know who the author of the medical notes and information is for effective care coordination and care transitions. Provenance statements indicate clinical significance in terms of confidence in authenticity, reliability, and trustworthiness, integrity, and stage in lifecycle, all of which may impact security, privacy, and trust policies. The Author information is required for billing and therefore, is accurate and can support audit trails. With the move toward patient- centered care, there could be multiple contributors of data including patients and other caregivers. The Author data element will provide a complete picture of information from an outside entity. The current data elements in the Provenance data class, Author Time Stamp and Author Organization, will be more meaningful if they can be attributed to the source of the information i.e., the Author. Specifically, CMS recommends including all authors who contribute to the care and documentation of care of a patient, or at least the final legal author. For example, a medical student may initiate a note; it may then be reviewed and signed by the nurse, and ultimately signed off by the attending physician. This type of author trail is meaningful, and the attending physician is the clinician ultimately responsible for the care of the patient.
Maturity:
Current standards: o HL7 FHIR R4 (v4.01: R4 – Mixed Normative and STU) (https://www.hl7.org/fhir/provenance-definitions.html)
Current uses, exchange, and use cases: Author information is routinely captured in electronic health record (EHR) systems used by hospitals, providers, and other healthcare stakeholders, and should be readily available. Knowing the author of notes and records will allow for validation of the integrity of the data used in quality measures. This is meaningful information needed to ensure efficient care coordination along with the current Provenance data elements in USCDI.
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.
For each additional comment, you must select the appropriate data class and data element from the drop-down menus.
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.
You will be taken to a review page where you can:
Select "Submit Comment" to officially submit your feedback.
Click "Edit" to return to the comment form and make changes
Select "Discard Draft" to delete the saved draft and start fresh
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.
9. Review and Submit
Once you have completed your comment:
Click the "Review and Submit" button at the bottom of the form.
This will take you to a review screen displaying your comment(s) in full.
Review all information for accuracy and completeness.
On this review screen, you have three options:
Click "Submit Comment" to officially submit your feedback
Click "Edit" to return to the comment form and make changes
Click "Discard Draft" to delete the comment and start fresh
The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records.
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 hswmin on
THIA Support for Author, Author Role
The Texas Health Informatics Alliance (THIA) Policy and Standards Working Group support including legal author and author role to provide important information for better clinical decision-making. We recommend a national definition for legal author as various states may have different definitions. This is especially critical for institutions that provide clinical services between/across states or provide care to patients from other states.
THIA Policy & Standards WG - USCDI v5 Recommendations - Provenance - Author, Author Role_0.pdf