Federal Appeals Court Upholds Medical Device Repair Exemption

A federal appeals court has upheld a copyright exemption that allows independent service organizations (ISOs) to circumvent certain technological protection measures when necessary to diagnose, maintain or repair medical devices and systems.

The U.S. Court of Appeals for the District of Columbia Circuit issued its decision September 1 in a case brought by the Medical Imaging & Technology Alliance (MITA) and Advanced Medical Technology Association (AdvaMed) against the Library of Congress and acting Librarian of Congress Todd Blanche.

The decision has implications for healthcare technology management (HTM) professionals, independent service organizations and medical imaging service providers that maintain and repair software-enabled medical equipment.

At the center of the dispute is an exemption to the Digital Millennium Copyright Act’s prohibition against circumventing technological protection measures, or TPMs. The exemption allows access to certain copyrighted computer programs and data files used in medical equipment when that access is necessary for the diagnosis, maintenance or repair of a medical device or system. The appeals court affirmed a lower court’s decision finding the exemption lawful under the DMCA.

The exemption originated with the Copyright Office’s eighth triennial rulemaking. Independent service organizations sought permission to circumvent TPMs on software-enabled medical devices and systems for diagnosis, maintenance and repair and to access related data files, including servicing materials. In 2021, the Register of Copyrights recommended creation of the exemption, and the Librarian of Congress adopted it.

The exemption was renewed in 2024 after MITA and other opponents submitted comments challenging its continuation. The Register recommended renewal, and the Librarian accepted that recommendation.

Gay Gordon-Byrne, executive director of The Repair Association, said the ruling maintains the status quo.

“The ruling is consistent with all other DMCA requests (repair.org has been an active participant in 1201 requests since 2015),” she said. “I would have been stunned if the USCO unwound previous rulings on the basis that they didn’t follow the law or the rules. I think the MITA request was a last minute ‘Hail Mary’ intended to bolster opposition to Right to Repair legislation that would inevitably come to include medical imaging equipment as it has already come to include durable medical equipment such as powered wheelchairs.”

“The decision doesn’t change how the repair business currently operates,” Gordon-Byrne said. “Biomeds and owners will still have difficulty getting access to repair documentation, but this ruling will certainly help if there is a legal challenge. I’m most hopeful that if the military gets their own Right to Repair, it will be easier for legislators at the state or federal level to pass the same options for the private sector.”

Wayne Moore, B.Sc., MBA, FASE, FAIUM, is a founder partner of Acertara Acoustic Laboratories. He also serves as the 2026 Ultrasound Chair for AdvaMed Imaging, 2026 Chair for the AdvaMed Imaging Service Committee, and is on the Technical Standards and Bioeffects Committees of the American Institute of Ultrasound in Medicine (AIUM).

Moore said the ruling “means that the DMCA repair exemption previously granted remains in effect.”

He was asked if the ruling is a positive or a negative for the nation’s healthcare system.

“As a stand-alone measure it is difficult to assess if it is a net positive or negative given that the exemption only allows a third-party to circumvent the OEM protective measures to access items related to servicing and maintenance,” Moore said. “This circumvention is not trivial to do and could realistically only be accomplished by a handful of third parties. It might have a net positive for rural hospitals and clinics. Remember this has been in effect for more than three years now and there has been no study conducted on its impact.”

Moore said the ruling could create a more competitive repair environment.

“Again, for those who successfully circumvented the service-related barriers they could potentially be able to basically perform all the service/maintenance functions that only OEM field service engineers can currently perform,” Moore said. “If their costs are lower than the OEMs and if they can provide faster response time (especially in rural areas) to a down system, it could potentially make them more competitive with the OEM offering.”

Court Examines Fair Use

A key issue in the appeal was whether the Librarian properly applied copyright law’s four fair-use factors when adopting and renewing the exemption.

MITA and AdvaMed argued, among other things, that independent service organizations use manufacturer-created software and data files commercially when servicing medical equipment. The court, however, concluded that the Librarian reasonably determined that using clinical operation software as a tool to repair medical devices constituted a different use from the software’s original purpose of operating the equipment.

The court also addressed the commercial nature of independent repair. It noted that independent service organizations are not making copies of embedded software and reselling those copies. Instead, the commercial transaction involves the labor and technical expertise required to repair the equipment.

The appeals court also found support for the Librarian’s conclusion that the software at issue is functional rather than primarily expressive. According to the ruling, the computer programs enable users to control and understand equipment operation, a consideration that favored fair use.

Repair Competition Distinguished from Software Market

The potential effect of independent repair on the market was another significant issue.

MITA and AdvaMed argued that independent service organizations take repair market share from manufacturers and affect the licensing market for protected software. The court noted, however, that the Librarian had determined the exemption was unlikely to harm the market for embedded software because medical device software and data files are sold with the equipment and do not have independent value separate from the devices.

“Repairing equipment doesn’t add, delete or modify copyrighted materials – it only replaces failed physical parts and reloads/restores software that may have been lost or corrupted,” Gordon-Byrne said. “The DMCA very clearly allows for backup and restoration of copyrighted materials for purposes of repair. There is no other way for a customer to acquire lost or corrupted software without being able to make a legal copy. Staples doesn’t have a section for MRI or X-ray software for purchase.”

The court further distinguished competition in medical equipment repair from harm to the market for copyrighted software. Although the exemption enables competition in maintenance and repair services, the court said that fact alone does not establish an adverse effect on the market for the original medical device or its clinical operation software.

The ruling also emphasized the limits of the exemption. Independent service organizations cannot retain copies of copyrighted materials for use with other devices. The permitted purpose is restoring a medical device or system’s functionality rather than commercializing the embedded software or servicing materials.

Ultimately, the three-judge panel upheld the medical device repair exemption, concluding that it was consistent with the law, supported by the administrative record and based on reasoned decision-making. The appeals court affirmed the district court’s grant of summary judgment to the Librarian and Library of Congress.

The decision comes as the Copyright Office conducts its 10th triennial rulemaking. According to the ruling, the Copyright Office began that process in June 2026, with written comments responding to petitions for renewal of current exemptions due Sept. 28.