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Characterizing industry payments for FDA-approved AI medical devices.

Alon Bergman1,2,3, Tej A Patel4,5, Kaustav P Shah3,6,7

  • 1Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA 19104, United States.

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Industry payments for artificial intelligence-enabled medical devices (AIMDs) are rising and concentrated in specialized fields. This trend may worsen healthcare access inequities, necessitating monitoring and support for equitable AIMD distribution.

Keywords:
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Area of Science:

  • Medical Technology
  • Health Informatics
  • Healthcare Economics

Background:

  • Artificial intelligence-enabled medical devices (AIMDs) are increasingly utilized globally.
  • Concerns exist regarding equitable access to AIMDs between well-resourced and under-resourced healthcare settings.
  • Industry-clinician partnerships within the AIMD ecosystem are not well understood.

Purpose of the Study:

  • To analyze the financial landscape of industry payments to clinicians for FDA-approved AIMDs.
  • To investigate the distribution, market concentration, and institutional affiliations associated with these payments.
  • To identify factors influencing the flow of payments within the AIMD sector.

Main Methods:

  • Utilized the Open Payments Database to extract payment data from 2017-2023.
  • Linked clinician payment data to hospital affiliations using the Medicare Provider Data catalog.
  • Employed regression analysis to correlate payments with hospital and county-level characteristics.

Main Results:

  • Total industry payments for AIMDs reached $59.3 million, paid to 46,315 clinicians.
  • AIMD payments represent a growing proportion of overall medical device industry payments.
  • Payments were concentrated in technologically advanced medical specialties and clinicians at large, urban teaching hospitals.

Conclusions:

  • Industry payments for AIMDs are increasing and concentrated in specialized medical fields.
  • Clinicians at larger, non-rural teaching hospitals are more likely to receive AIMD payments.
  • Equitable access to AIMDs may require ongoing payment monitoring, transparent reporting, and targeted support.