A US District Court has upheld a rule allowing limited circumvention of copyright protections for the repair and maintenance of medical devices.
A US District Court has upheld a federal rule that allows circumvention of copyright protections for the purpose of diagnosing, maintaining, and repairing medical devices—rejecting a legal challenge brought by medical device associations.
In a July 21 decision, Judge Rudolph Contreras ruled in favor of the Library of Congress and its Copyright Office, which in 2021 granted an exemption to Section 1201 of the Digital Millennium Copyright Act. The exemption allows healthcare providers, technicians, and independent servicers to bypass software locks on medical devices and systems strictly for repair-related purposes.
The lawsuit—filed by the Advanced Medical Technology Association and the Medical Imaging and Technology Alliance—was initially dismissed by the district court, which found that the Administrative Procedure Act (APA) did not apply and that the Librarian’s actions were not subject to judicial review. But in 2024, the U.S. Court of Appeals for the D.C. Circuit reversed that decision, holding that the associations could challenge the rulemaking under the APA.
In the latest decision, the court disagreed with the plaintiffs, finding that the Librarian of Congress acted within statutory authority and followed proper procedures in adopting the rule. The decision affirmed that the exemption was consistent with the Copyright Act’s fair use doctrine. The court accepted the Librarian’s finding that using embedded software and related materials to repair medical devices serves a different purpose than the software’s original function and may therefore qualify as transformative use.
The court also found that safety and cybersecurity concerns raised by the plaintiffs were considered during the rulemaking process and did not invalidate the exemption. It held that the Librarian’s decisions were based on a fair and reasoned analysis.
The court entered judgment in favor of the defendants on all counts, allowing the exemption for medical device repair to remain in effect.
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