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The Right to Repair Software-Dependent Medical Devices

Published online by Cambridge University Press:  08 March 2023

Lars Lindgren ,
Aaron S. Kesselheim  and
Daniel B. Kramer
Lars Lindgren
Affiliation:
PROGRAM ON REGULATION, THERAPEUTICS, AND LAW (PORTAL), DIVISION OF PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS, DEPARTMENT OF MEDICINE, BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD MEDICAL SCHOOL, BOSTON, MA, USA HARVARD LAW SCHOOL, CAMBRIDGE, MA, USA
Aaron S. Kesselheim
Affiliation:
PROGRAM ON REGULATION, THERAPEUTICS, AND LAW (PORTAL), DIVISION OF PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS, DEPARTMENT OF MEDICINE, BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD MEDICAL SCHOOL, BOSTON, MA, USA HARVARD MEDICAL SCHOOL CENTER FOR BIOETHICS, BOSTON, MA, USA
Daniel B. Kramer
Affiliation:
RICHARD A. AND SUSAN F. SMITH CENTER FOR OUTCOMES RESEARCH IN CARDIOLOGY, BETH ISRAEL DEACONESS MEDICAL CENTER, HARVARD MEDICAL SCHOOL, BOSTON MA, USA
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Abstract

The “right to repair” movement highlights opportunities to reduce health care costs and promote public health resilience through increased competition in the way in which medical devices are serviced and updated over their lifespan. We review legislative and legal facets of third-party repair of medical devices, and conclude with specific recommendations to help this market function more efficiently to the benefit of patients and health care systems.

Keywords

Medical Device RegulationHealth PolicyMedical SoftwareDigital Health
Type
Columns: Health Policy Portal
Information
Journal of Law, Medicine & Ethics , Volume 50 , Issue 4: Health Justice: Engaging Critical Perspectives in Health Law and Policy , Winter 2022 , pp. 857 - 859
Copyright
© 2023 The Author(s)

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Footnotes

About This Column

Aaron Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Harvard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at [email protected].

References

Burns, L. R., Housman, M. G., Booth, R. E., and Koenig, A. M., “Physician Preference Items: What Factors Matter to Surgeons? Does the Vendor Matter? Med Devices (Auckl) 11 (2018): 39–49, doi:10.2147/MDER.S151647.Google ScholarPubMed
Jamshidi, A., Rahimi, S. A., Ait-Kadi, D., and Ruiz, A., “Medical Devices Inspection and Maintenance: A Literature Review,” Proceedings of the 2014 Industrial and Systems Engineering Research Conference, (2014) available at <https://www.researchgate.net/publication/287176949_Medical_devices_inspection_and_maintenance_a_literature_review> (last visited December 1, 2022).+(last+visited+December+1,+2022).>Google Scholar
Proctor, N., “Right to Repair is a Simple Way to Cut Health Care Costs,” PIRG, (2018) available at <https://pirg.org/resources/right-to-repair-is-a-simple-way-to-cut-health-care-costs/> (last visited December 1, 2022).+(last+visited+December+1,+2022).>Google Scholar
U.S. PIRG Education Fund “Hospital Repair Restrictions: Manufacturer-Imposed Barriers to Fixing Medical Equipment Cause Inefficiencies and Delays,” July 8, 2020, available at <https://pirg.org/resources/hospital-repair-restrictions/> (last visited December 1, 2022).+(last+visited+December+1,+2022).>Google Scholar
U.S. Food and Drug Administration, FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices, (May 2018), available at <https://www.fda.gov/media/113431/download> (last visited December 1, 2022).+(last+visited+December+1,+2022).>Google Scholar
Federal Trade Commission, Nixing the Fix: An FTC Report to Congress on Repair Restrictions (May 2021), available at <https://www.ftc.gov/reports/nixing-fix-ftc-report-congress-repair-restrictions> (last visited December 1, 2022).+(last+visited+December+1,+2022).>Google Scholar
l. Adler, “Cost-Shifting in Drug Pricing, or the Lack Thereof,” USC-Brookings Schaeffer on Health Policy (September 24, 2021), available at <https://www.brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2021/09/24/cost-shifting-in-drug-pricing-or-the-lack-thereof/> (last visited December 1, 2022).+(last+visited+December+1,+2022).>Google Scholar