Resources

Purpose: Software that satisfies the definition of a “medical device” under FDA regulations is subject to the same FDA regulatory oversight as any other medical device. This guidance document provides information regarding FDA requirements when investigating medical image-based software in clinical research. In most circumstances, such deployment activities should be conducted according to the FDA Investigational Device Exemption (“IDE”) regulations set forth in 21 CFR Part 812, as administered by the Institutional Review Board (“IRB”).

Purpose: As AI/ML research continues to expand, there are increasing privacy concerns stemming from the publication or dissemination of model code, hyperparameters, weights, and training datasets. This document provides guidance for researchers as they consider when to publish and what elements to share as part of a discrete individual research project (i.e. not part of an on-going open source activity).

The Defined Exam Retrieval Service enables Mass General Brigham investigators to obtain radiologic imaging studies for research purposes. Researchers may request retrieval of up to 1,000 imaging studies per request. Studies will be automatically retrieved from clinical imaging archives and stored in a temporary location that has security and access control based on IRB permissions. There is an option for images to be de-identified if required for the research protocol. The de-identification process follows the DICOM standard for de-identification and replaces/removes/modifies PHI following a standard workflow. A key to the de-identification will be provided so that the study staff can identify the studies as needed. Estimated image retrieval time is 5 days.

At MBG, we use the Nuance Precision Imaging Network (PIN) system to host AI models for radiology applications. This document describes the requirements and guidelines for deploying a model in PIN with MGB Enterprise Medical Imaging. You must be on the MGB network or VPN to access this resource.

This code repository contains the source code and documentation for a full worked example of a model deployed in the PIN system at MGB Enterprise Medical Imaging. This can serve as a template for your own model deployment. You must be on the MGB network or VPN to access this resource.