HHS · no agency ID · record R0861

Medical Data Enterprise Artificial Intelligence (MDE AI)

Department of Health and Human Services · HHS/FDA/CDRH

Overview

Development stage: PilotSource: b) Pilot – The use case has been deployed in a limited test or pilot capacity.
High-impact designation: Not high-impactSource: c) Not high-impact
Impact justification: Not reported
Start date: 2023-09 (month precision)Source: Sep-23
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

Create efficiencies in the regulatory review processes for medical devices; reduce administrative burden to staff and allow them to focus their expertise on scientific and clinical work and not administrative processes

Expected benefits

Improved efficiency in the administrative overhead of regulatory review workflows

System outputs

Outputs support regulatory review and include deficiency text adherence to 4PH, insights to support premarket review, data integrity concerns, signal alerts, etc.

Technology

AI classification: Generative AISource: Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
System name(s): CEDh
Custom-developed code: Yes
Public source code: Not reported

Sourcing

How it was built: Developed in-houseSource: b) Developed in-house
Vendor (as reported): Not reported
Vendors (standardized): None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII: No
Privacy Impact Assessment: Not reported
Authorization to Operate: Yes
Demographic features: k) None of the above
Training and evaluation data: Labeled data sets of FDA-specific premarket and postmarket data
Federal Data Catalog: Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported