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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
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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.
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More from the Author
  • Maven Clinic: Women's Health in the Digital Age By: Ariel D. Stern and Sarah Mehta
  • Aidoc: Building a Hospital-Centric AI Platform By: Ariel D. Stern and Susan Pinckney
  • Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms By: Caroline Marra and Ariel D. Stern
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