• Staff Writer

CEO James Burroughs Presents to FDA Expert Panel on AI/ML Transparency in Healthcare

For Immediate Release

20 October 2021

In a live remote presentation to the United States Food and Drug Administration, Rev. James Burroughs, Chief Executive Officer at North Carolina Health Equity Project, Inc. presented findings, Thursday, October 14, 2021, on challenges to AI/ML-enabled medical devices, particularly for marginalized communities including racial, ethnic, sexual, and gender minorities. Additionally, he offered suggestions for an inclusive path forward, with science-backed findings on diversity and equity at the center of his presentation.

CEO James Burroughs, North Carolina Health Equity Project
James Burroughs, CEO, North Carolina Health Equity Project, Inc.

Rev. Burroughs’ presentation, “Reducing Bias in AI/ML Research: Standardization, Harmonization, and Interoperability for Multi-omic Data and EHR for Marginalized Community Subsets,” was presented to an expert FDA panel with an audience of over 3,000 global participants, representing industry, academia, and government.

Importantly, Rev. Burroughs pointed to the unique and fundamental “ontological, ethnocultural, and ethical considerations for the use of race and ethnicity data in AI/ML-based research.” Specifically, he spoke of the mutability (or changing nature) of self-identification along racial and ethnic strata, remarkably noted over the past three decades in demography and ethnocultural research. Moreover, Rev. Burroughs highlighted challenges for minority-serving institutions (MSIs) related to critical data science infrastructure.

Regarding technical aspects, Rev. Burroughs noted that,

Moreover, we have seen a lack of reporting for epidemiological data in a consistent fashion across state and local public health agencies, and across research institutions for relevant diseases, disproportionately concentrated among marginalized communities. We are troubled by the lack of participation in clinical trials and general medical research among these groups, perhaps because of our country's notorious history of systemic and institutional racism, manifested so often as poor health outcomes. Moreover, we are concerned about physiologic metrics that are so-called normal or canonical, which do not take into account the vast physiologic and multi-omic variability across racial and ethnic strata, especially regarding heretofore accepted standard training data. However, we are heartened by initiatives such as All of Us Research Program which, to date, is one of the most inclusive voluntary data collection and sharing platforms available. However, other challenges remain persistent, especially for researchers at MSIs, who often lack some of the most critical resources compared to non-MSI colleagues. Combined with inconsistent use of Z-codes in EHR and the aforementioned diversity, equity, and inclusion challenges, these problems work synergistically, perhaps unintentionally, resulting in suboptimal transparency, and are reflective of severe ethical and technical questions.

However, he concluding by encouraging the panel and other regulatory authorities to increase transparency of AI/ML-enabled devices by enacting,

Bold, consistent, and enforceable standards from regulatory authorities such as this body that address the deep philosophical questions, improve access for MSIs, build upon consensus of diverse thinkers, from diverse backgrounds, with diverse perspectives, and lastly, that such bold, consistent, and enforceable standards are derived under the leadership of those who have the most to lose from a lack of transparency, specifically racial, ethnic, sexual, and gender minorities.

View the presentation slides along with Rev. Burroughs' notes below.

Presentation to FDA by James Burroughs
Download PDF • 900KB


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North Carolina Health Equity Project, Inc., NCHEALTHEQ™, develops adaptive, intelligent, next-generation technologies to improve health outcomes for all people, especially those in marginalized communities. We leverage the power of cross-disciplinary innovation and disruptive technologies including AI/ML, “accelerating research and saving lives.” Learn more at https://www.nchealtheq.org/.

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