The DC Circuit ruled that the Librarian of Congress acted lawfully in permitting independent service organizations to bypass digital locks for medical device diagnosis, maintenance, and repair.
The US Court of Appeals for the District of Columbia Circuit upheld a federal rule allowing access to certain software and data files on medical equipment by circumventing digital locks when necessary for diagnosis, maintenance, or repair.
In a unanimous decision issued Sept 1, 2026, a three-judge panel affirmed a lower court summary judgment favoring the Library of Congress and Todd Blanche, in his official capacity as acting Librarian of Congress. The ruling rejected an administrative challenge brought by original equipment manufacturer trade groups, specifically the Medical Imaging & Technology Alliance and the Advanced Medical Technology Association.
The disputed exemption, codified under the Digital Millennium Copyright Act (DMCA) at 37 CFR Section 201.40(b)(17), permits the circumvention of technological protection measures that restrict access to computer programs and data files controlling lawfully acquired medical systems, provided the circumvention is conducted strictly for “diagnosis, maintenance, or repair.”
Court Backs Fair-Use Rationale for Repair Exemption
According to the opinion authored by circuit judge J Michelle Childs, the trade associations contended that the Librarian of Congress misapplied federal fair-use factors under the Copyright Act of 1976. The trade associations asserted that independent service organizations use manufacturer-developed servicing software in a commercially substitutive manner, arguing that the practice infringes copyrights and undercuts OEM service revenue.
The appellate panel found that the librarian’s adoption and 2024 renewal of the exemption complied with the Administrative Procedure Act and rested on a well-supported administrative record.
Addressing the first fair-use factor regarding the purpose and character of the use, the court noted that service providers employ operational software as a tool to return malfunctioning systems to working order, an application the agency determined to be “transformative” rather than purely substitutive. The court emphasized that independent service organizations do not resell copies of embedded software or use the code to manufacture competing equipment; instead, the value of the transaction centers on the technical labor and expertise of the service technicians.
Furthermore, the court evaluated the effect on the potential market for copyrighted works, agreeing with the agency that the repair exemption is unlikely to harm the market for embedded device software. The court pointed to the librarian’s finding that medical device software and data files are sold with the equipment and have no independent value separate from the devices, noting that the trade groups had not introduced evidence into the administrative record establishing otherwise.
Implications for Healthcare Technology Management
The decision concludes a multiyear legal dispute that began in February 2022 after the librarian adopted the medical device repair exemption during the eighth triennial DMCA rulemaking.
The opinion noted that the US Copyright Office initiated its tenth triennial rulemaking proceeding in June 2026, which includes petitions regarding the future renewal of existing exemptions. For hospital clinical engineering departments and third-party service providers, the ruling preserves the exemption allowing circumvention of technological protection measures when necessary to access covered medical device software and data files for diagnosis, maintenance, or repair.
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