AI in Digital Pathology

Overview

Development stage

In development or acquisitionSource: a) Pre-deployment – The use case is in a development or acquisition status.

High-impact designation

High-impactSource: a) High-impact

Impact justification

Not reported

Start date

Not reported

Withheld from public reporting

Not reported

Mission

Topic area

Health and Medical

Operational functions

Document processing and extraction, Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

Galen Second Read's key functionalities include image upload and analysis, flagging slides with high likelihood to contain AdC and displaying WSIs uploaded to the system along with the analysis results. Flagged findings constitute a recommendation for additional review by a pathologist.

Expected benefits

Increased productivity which will provide pathologists more time with complex cases

System outputs

The Galen Second Read is cloud-hosted and utilizes scanned whole slide images (WSIs) generated from the Philips Ultra Fast scanner (UFS). For each WSI input, the Galen Second Read automatically analyzes the WSI and outputs the following: - Binary classification of the likelihood (high/low) to contain prostate adenocarcinoma (AdC) based on a predetermined threshold of the neural network output. - For slides classified as high likelihood to contain AdC, slide-level findings are flagged and visualized (AdC score and heatmap) for additional review by a pathologist. - For slides classified as low likelihood to contain AdC, no additional output is available. Galen Second Read's key functionalities include image upload and analysis, flagging slides with high likelihood to contain AdC and displaying WSIs uploaded to the system along with the analysis results. Flagged findings constitute a recommendation for additional review by a pathologist.

Technology

AI classification

Computer visionSource: Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

System name(s)

Not reported

Custom-developed code

Not reported

Public source code

Not reported

Sourcing

How it was built

Not reported

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

Not reported

Privacy Impact Assessment

Not reported

Authorization to Operate

Not reported

Demographic features

Not reported

Training and evaluation data

Not reported

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.

Potential impacts and how they were identified

Not reported