Medical Imaging & Technology Alliance v. Library of Congress — Medical-Device Repair Access Is Fair Use

Background

The Digital Millennium Copyright Act generally prohibits bypassing technological measures that control access to copyrighted works. Congress also directed the Librarian of Congress to conduct rulemakings every three years and exempt classes of users who would otherwise be adversely affected in making noninfringing uses.

The Librarian adopted an exemption allowing independent service organizations to bypass access controls on computer programs and data embedded in medical devices when access is solely for diagnosis, maintenance, or repair. Medical-device trade associations challenged the exemption, arguing that independent repair companies commercially exploit manufacturers’ software and that the Librarian misapplied copyright’s fair-use factors. The district court upheld the rule, and the associations appealed.

The Court’s Holding

The D.C. Circuit affirmed. It held that the Librarian reasonably concluded that the covered repair activity is likely to be fair use and that the exemption is lawful, reasoned, and supported by the administrative record.

On the first fair-use factor, the panel accepted the agency’s distinction between operating a medical device and temporarily accessing its embedded software to restore the device’s functionality. Repair serves a different purpose and can be transformative even when an independent repair business earns money from the service. Commerciality matters, but it does not automatically defeat fair use.

The second factor favored fair use because the programs and data are functional and utilitarian, not used for expressive qualities. The third factor did not undermine the exemption: accessing an entire program can be reasonable when necessary for the valid repair purpose, and the challengers did not develop an argument tied to the actual clinical-operation software addressed by the rule.

The fourth factor also favored fair use. The record showed no independent market for the embedded software apart from the medical devices. Competition in a repair-services market is not the same as displacement of the copyrighted software or its derivatives. The exemption permits temporary access for repair; it does not allow repair companies to retain copies, resell the software, or build competing devices from it.

Key Takeaways

• A commercial repair service can make a transformative fair use when it accesses software for the distinct purpose of restoring a device’s functionality.
• Copyright does not necessarily protect a manufacturer from competition in a secondary repair market when the alleged harm is not harm to the market for the copyrighted work itself.
• Copying or accessing an entire functional program may be reasonable when the amount used is necessary for repair.
• The ruling preserves the DMCA exemption for diagnosis, maintenance, and repair of software-enabled medical equipment.

Why It Matters

The decision gives independent medical-equipment repair providers and healthcare facilities continued room to access device software for legitimate servicing without violating the DMCA’s anticircumvention rule. More broadly, it distinguishes copyright-market harm from a manufacturer’s loss of repair revenue. That distinction may influence future right-to-repair disputes involving software-controlled products, although the ruling concerns the defined limits and record of this triennial exemption rather than an unrestricted right to copy software.

Surfaced via Law360 IP.