Skip to Main Content
HBS Home
  • About
  • Academic Programs
  • Alumni
  • Faculty & Research
  • Baker Library
  • Giving
  • Harvard Business Review
  • Initiatives
  • News
  • Recruit
  • Map / Directions
Faculty & Research
  • Faculty
  • Research
  • Featured Topics
  • Academic Units
  • …→
  • Harvard Business School→
  • Faculty & Research→
Publications
Publications
  • 2022
  • Working Paper

The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives

By: Ariel Dora Stern
  • Format:Print
  • | Language:English
  • | Pages:26
ShareBar

Abstract

For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with AI-driven tools already in use in basic science, translational medicine, and numerous corners of health care delivery, including administrative work, diagnosis, and treatment. In diagnosis and treatment, a large and growing number of AI tools meet the statutory definition of a medical device or that of an in-vitro diagnostic. Those that do are subject to regulation by local authorities, resulting in both practical and strategic implications for manufacturers, along with a more complex set of innovation incentives. This chapter presents background on medical device regulation—especially as it relates to software products—and quantitatively describes the emergence of AI among FDA-regulated products. The empirical section of this chapter explores characteristics of AI-supported/driven medical devices (“AI devices”) in the United States. It presents data on their origins (by firm type and country), their safety profiles (as measured by associated adverse events and recalls), and concludes with a discussion of the implications of regulation for innovation incentives in medical AI.

Keywords

AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry

Citation

Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
  • Find it at Harvard
  • Purchase

About The Author

Ariel D. Stern

Technology and Operations Management
→More Publications

More from the Author

    • 2023
    • JAMA, the Journal of the American Medical Association

    Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

    By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
    • 2022
    • Faculty Research

    Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data

    By: Alexander O. Everhart and Ariel D. Stern
    • 2022
    • Faculty Research

    Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

    By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
More from the Author
  • Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
  • Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data By: Alexander O. Everhart and Ariel D. Stern
  • Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
ǁ
Campus Map
Harvard Business School
Soldiers Field
Boston, MA 02163
→Map & Directions
→More Contact Information
  • Make a Gift
  • Site Map
  • Jobs
  • Harvard University
  • Trademarks
  • Policies
  • Accessibility
  • Digital Accessibility
Copyright © President & Fellows of Harvard College