The Right to Repair Medical Devices: A Right to Patient Needs

The laws governing the repair of medical devices, most notably §1201 of the Digital Millennium Copyright Act (DMCA), place unnecessary and harmful restrictions on healthcare access in the United States. As hospitals increasingly rely on complex medical technologies, manufacturers have relied on anti-circumvention laws to block independent and in-house repairs, effectively monopolizing the repair market. As a result, our current system is one that delays treatment, inflates costs, and leaves healthcare providers and consumers with fewer options during times of crisis and routine care alike. Drawing on legal analysis, policy critique, and lessons from the COVID-19 pandemic, this article shows how current repair restrictions compromise the autonomy of healthcare institutions and limit patient access to vital medical equipment. It also considers how intellectual property protections intersect with safety, commercial incentives, and global disparities in medical infrastructure. The article suggests a limited right to repair, including changes to §1201, standardized certification, and incentives for manufacturer transparency. These changes aim to find a balance between maintaining device integrity and ensuring that patients and providers are not limited when it comes to essential care tools.

Publication Details

Journal
eYLS (Yale Law School)
Published
2025-05-15
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
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article

The Right to Repair Medical Devices: A Right to Patient Needs

eYLS (Yale Law School)
Pharmaceutical Economics and Policy
article

The Right to Repair Medical Devices: A Right to Patient Needs

article en

Abstract

The laws governing the repair of medical devices, most notably §1201 of the Digital Millennium Copyright Act (DMCA), place unnecessary and harmful restrictions on healthcare access in the United States. As hospitals increasingly rely on complex medical technologies, manufacturers have relied on anti-circumvention laws to block independent and in-house repairs, effectively monopolizing the repair market. As a result, our current system is one that delays treatment, inflates costs, and leaves healthcare providers and consumers with fewer options during times of crisis and routine care alike. Drawing on legal analysis, policy critique, and lessons from the COVID-19 pandemic, this article shows how current repair restrictions compromise the autonomy of healthcare institutions and limit patient access to vital medical equipment. It also considers how intellectual property protections intersect with safety, commercial incentives, and global disparities in medical infrastructure. The article suggests a limited right to repair, including changes to §1201, standardized certification, and incentives for manufacturer transparency. These changes aim to find a balance between maintaining device integrity and ensuring that patients and providers are not limited when it comes to essential care tools.

eYLS (Yale Law School)
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Pharmaceutical Economics and Policy
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