Augmenting death and cause of death ascertainment in observational data sources

Section 1: Use Case Identifiers

Use Case ID: HHS-FDA-00004
Agency: HHS
Op Div/Staff Div: FDA
Use Case Topic Area: Health & Medical
Is the AI use case found in the below list of general commercial AI products and services?
None of the above.
What is the intended purpose and expected benefits of the AI?
Augment assessment of mortality in electronic health records to support investigations to develop probabilistic estimates for causes of death in the Sentinel system.

The extraction of mortality information improves studies in Sentinel using mortality as an endpoint by enhancing on the quality of mortality data.
Describe the AI system's outputs.
Augment assessment of mortality (date of death, cause of death) by applying Natural Language Processing (NLP) on healthcare narrative text and administrative codes.
Stage of Development: Operation and Maintenance
Is the AI use case rights-impacting, safety-impacting, both, or neither?
Neither

Section 2: Use Case Summary

Date Initiated: 01/2022
Date when Acquisition and/or Development began: 01/2022
Date Implemented: 12/2023
Date Retired: N/A
Was the AI system involved in this use case developed (or is it to be developed) under contract(s) or in-house?
Developed with contracting resources.
Provide the Procurement Instrument Identifier(s) (PIID) of the contract(s) used.
75F40119D10037 - 7540119F19002
Is this AI use case supporting a High-Impact Service Provider (HISP) public-facing service?
N/A
Does this AI use case disseminate information to the public?
No
How is the agency ensuring compliance with Information Quality Act guidelines, if applicable?
N/A
Does this AI use case involve personally identifiable information (PII) that is maintained by the agency?
No
Has the Senior Agency Official for Privacy (SAOP) assessed the privacy risks associated with this AI use case?
ongoing

Section 3: Data and Code

Do you have access to an enterprise data catalog or agency-wide data repository that enables you to identify whether or not the necessary datasets exist and are ready to develop your use case?
Yes
Describe any agency-owned data used to train, fine-tune, and/or evaluate performance of the model(s) used in this use case.
`- National Death Index (NDI) data
- State Death Certificate Registery
Is there available documentation for the model training and evaluation data that demonstrates the degree to which it is appropriate to be used in analysis or for making predictions?
Documentation has been partially completed
Which, if any, demographic variables does the AI use case explicitly use as model features?
N/A
Does this project include custom-developed code?
Yes
If the code is open-source, provide the link for the publicly available source code.
N/A

Section 4: AI Enablement and Infrastructure

Does this AI use case have an associated Authority to Operate (ATO) for an AI system?
Yes
System Name: Sentinel
How long have you waited for the necessary developer tools to implement the AI use case?
6-12 months
For this AI use case, is the required IT infrastructure provisioned via a centralized intake form or process inside the agency?
No
Do you have a process in place to request access to computing resources for model training and development of the AI involved in this use case?
No
Has communication regarding the provisioning of your requested resources been timely?
Yes
How are existing data science tools, libraries, data products, and internally-developed AI infrastructure being re-used for the current AI use case?
None
Has information regarding the AI use case, including performance metrics and intended use of the model, been made available for review and feedback within the agency?
No documentation is available