AI & Health Regulatory Policy Conference

Monday, December 4, 2023

8:30am - 3:30pm

Kiva Seminar Room, Stata Center

MIT

Our Mission

Regulating AI in healthcare requires an agile framework capable of adapting to the rapid evolution of machine learning technologies, which ensures health AI tools that are ethical, effective and safe in improving healthcare outcomes. The objective of this conference is to address the challenges posed by the existing regulatory framework for AI tools in today’s rapidly changing technological environment. To that effect we will examine the current process surrounding the exemption and regulation of these tools. We will also present an array of such AI tools for healthcare currently in development. We will then delve into the role of algorithmic checks in both pre-approval testing and post-deployment scenarios, with a specific focus on the context of the US and the FDA. Beyond the US perspective, this conference will provide a comprehensive global view on the regulation of AI tools in national health systems, showcasing clinical examples from Africa, Europe, and the Middle East.

Featured Speakers

Sajid Ahmed

CEO

Wise Healthcare

Fotini Christia

Ford International Professor of Social Sciences

MIT

Bülent Kızıltan

VP and Global Head of AI & Computational Sciences

Novartis

Philip Huang

Director & Health Authority

Dallas County HHS

Ziad Obermeyer

School of Public Health Distinguished Professor

UCSF & UC Berkeley

Kailash Swarna

Managing Director, R&D Practice

Accenture

Xiaoying Wu

VP of Data & Digital Health

J&J Innovative Medicine

Hutan Ashrafian

Honorary Senior Research Fellow, Faculty of Medicine, Department of Surgery & Cancer

Imperial College London

Glenn Cohen

Professor of Law & Petrie-Flom Center Faculty Director

Harvard Law

Tala Fakhouri

Associate Director for Policy Analysis

FDA

Marzyeh Ghassemi

Assistant Professor of EECS & IMES & Jameel Clinic Principal Investigator

MIT

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Katie Palmer

Health Tech Correspondent

STAT

Moderator

Troy Tazbaz

Director of Digital Health Center of Excellence

FDA

Adam Yala

Assistant Professor of Computational Precision Health & EECS

UCSF & UC Berkeley

Regina Barzilay

School of Engineering Distinguished Professor &

Jameel Clinic AI Faculty Lead

MIT

Elazer Edelman

Edward J. Poitras Professor in Medical Engineering and Science, IMES Director & Jameel Clinic Principal Investigator

MIT

Pamela Forrest

FDA/Medical Device Regulatory Partner

Covington & Burling LLP

Kashifu Inuwa Abdullahi

Director-General, CEO

National Information Technology Development Agency

Daniela Rus

Andrew and Erna Viterbi Professor of Computer Science & CSAIL Director

MIT

Yiannos Tolias

Legal Lead AI and AI Liability in Healthcare & European Health Data Space (EHDS) Team

DG SANTE, European Commission

Constance Berghs-Clairmont

Global Head, Early Development Regulatory Affairs

Novartis

Dina Katabi

Thuan and Nicole Pham Professor of EECS & Jameel Clinic Principal Investigator

MIT

Danielle Friend

Senior Director, US Head Regulatory Policy and Intelligence

J&J Innovative Medicine

Lisbeth Nielsen

Former Director General

Danish Health Data Authority

Brandon Rufino

Director of Integrative Clinical Data

Sanofi

Kevin Wu

PhD Student, Computer Science Department

Stanford University

Areas of Focus

Regulatory Issues in Health AI

Fairness and Equity

Clinical Translation of AI Tools

AI Tools in National Health Systems

2023 Agenda

8:30AM

Breakfast & Check-In

9:00AM

Welcome

Regina Barzilay (MIT)

9:10AM

Fireside Chat - FDA Perspectives on Clinical AI

Moderator: Regina Barzilay (MIT)

Troy Tazbaz (FDA)

9:45AM

Showcasing Clinical AI Technologies

Moderator: Regina Barzilay (MIT)

Marzyeh Ghassemi (MIT)

Dina Katabi (MIT)

Ziad Obermeyer (UCSF, UC Berkeley)

Adam Yala (UCSF, UC Berkeley)

10:45AM

Fireside Chat - Legal Perspectives on Clinical AI Regulation

Moderator: Katie Palmer (STAT)

Glenn Cohen (Harvard Law)

Pamela Forrest (Covington & Burling LLP)

Danielle Friend (J&J)

11:30AM

Working Break

11:45AM

Fireside Chat - Regulating Clinical AI: Cases from the Field

Moderator: Katie Palmer (STAT)

Sajid Ahmed (Wise Healthcare)

Philip Huang (Dallas County HHS)

12:15PM

Fireside Chat - Who Pays for Clinical AI

Moderator: Elazer Edelman (MIT)

Ziad Obermeyer (UCSF, UC Berkeley)

Kevin Wu (Stanford University),

12:45PM

Working Lunch - African and European Perspectives

Moderator: Daniela Rus (MIT)

Hutan Ashrafian (Imperial College London)

Kashifu Inuwa Abdullahi (National Information Technology Development Agency)

Lisbeth Nielsen (Danish Health Data Authority)

Yiannos Tolias (DG SANTE, European Commission)

1:15PM

Fireside Chat - FDA Perspectives on AI for Drug Development

Moderator: Constance Berghs-Clairmont (Novartis)

Tala Fakhouri (FDA)

2:00PM

Panel Discussion - Regulation of AI for Drug Development

Moderator: Kailash Swarna (Accenture)

Bülent Kızıltan (Novartis)

Brandon Rufino (Sanofi)

Xiaoying Wu (J&J)

3:00PM

General Discussion on the Future of Regulating AI in Health

Moderators: Elazer Edelman (MIT)

FAQ

When and where is this conference taking place?

The conference will take place in the Kiva Seminar Room on the 4th floor of the Stata Center (Building 32). The map at the bottom of the page has links to help you locate the building and the room.

Where can I stay if I want to attend?

Boston Marriott Cambridge and The Kendall Hotel are hotels that are within 5 minutes walking distance of the venue.

Will this conference be recorded or streamed?

There are no plans to record the conference or stream it online.

I'd like to attend, where can I get a ticket?