IP Law Daily, COPYRIGHT—D.C. Cir.: Transforming a medical device ‘from non-functional to functional‘ is transformative use under Copyright Act, (Sep 3, 2026)

By Matthew Hersh, J.D.

The Court of Appeals affirms a decision exempting medical device repair from the anti-circumvention provision of the DMCA.

The Librarian of Congress got it right when she ruled that accessing medical device software for the purpose of maintaining or repairing the underlying device qualified for an exemption from the anti-circumvention provisions of a landmark amendment to the Copyright Act, the Court of Appeals for the District of Columbia Circuit has held. The court, in affirming the district court ruling that, in turn, upheld the Librarian’s decision, underscored that transforming machines from nonfunctional to functional devices constituted a “fundamentally different” use of the underlying software (Medical Imaging & Technology Alliance v. Library Of Congress and Todd Blanche, No. 25-5328 (D.C. Cir. Sep. 1, 2026)).

Under the Digital Millennium Copyright Act (DMCA), the Librarian of Congress (Librarian) conducts a rulemaking every three years to consider requests for limited exemptions to the DMCA's copyright anticircumvention provision.

At issue in this case is a rule promulgated under the DMCA. Among other things, the DMCA amended the Copyright Act of 1976 to prohibit circumvention of a technological measure that “effectively controls access to” a work protected by copyright law. However, this anticircumvention provision is subject to a number of statutory and regulatory exemptions. Critically, the DMCA directs the Librarian to issue limited exemptions from the Act’s anticircumvention provision for persons “who are or are likely to be ‘adversely affected’... in their ability to make noninfringing uses of copyrighted materials.” 17 U.S.C. § 1201(a)(1)(C)–(D). The Librarian grants exemptions by conducting triennial rulemakings and acting upon the recommendation of the Register of Copyrights. The Librarian has completed nine triennial exemption determinations since 2000, most recently in 2024, and the Copyright Office is now conducting the tenth triennial proceeding.

When the Librarian issued her eighth round of exemptions in 2021, one of them applied to computer programs controlling advanced medical devices—CT scanners, MRI machines, surgical equipment, and the like—for purposes of diagnosis, maintenance, and repair. Many of the devices are designed so that only authorized service technicians have access to error logs, configuration files, and other data sources necessary for the devices to be maintained—making it impossible for hospitals and other medical providers to use independent service operators for repairs. The Librarian adopted the Register’s finding that this type of repair work was likely noninfringing, principally because it qualified as fair use under the Copyright Act, and adopted an exemption from the DMCA’s anticircumvention prohibition. In 2024, the Librarian accepted the Register’s recommendation to renew the medical device exemption.

The 2021 medical-device exemption brought on a lawsuit by two medical device trade associations: the Medical Imaging & Technology Alliance and the Advanced Medical Technology Association. Those organizations claimed, among other things, that the Librarian’s adoption of the Register’s recommendation violated the Administrative Procedure Act as arbitrary and capricious and not in accordance with the law. In 2023, the district court dismissed the lawsuit without reaching the merits, finding that the sovereign immunity doctrine precluded a challenge to the Librarian’s ruling because the Library of Congress was part of the legislative branch. But a year later, in a split decision, a panel of the D.C. Circuit reversed and remanded, finding that Congress had subjected copyright regulations under the Copyright Act to the APA and therefore the APA supplied the necessary waiver of sovereign immunity.

The district court, on remand from the court of appeals, ruled in favor of the Librarian and upheld the DMCA exemption. The trade organizations appealed, leading to this decision.

Fair use. The court of appeals affirmed. The court began by assessing the Librarian’s determination under the first fair-use factor, which concerns “the purpose and character of the use.” Critically, the court of appeals found, the record showed that the underlying software and the repair work exempted by the Librarian were “fundamentally different.” Independent service operators put the underlying operating software to a “new use” when they use it as a tool for repairing medical devices, the court of appeals noted, “transforming the machines from nonfunctional to functional devices—a use that is markedly different from the original, manufacturer-intended purpose.” Thus, since the primary use of the operating software by independent service operators was different from the primary purpose of the device manufacturers, that use was “not a substitutive use, but rather a transformative one.”

The second and third fair use factors did not change the outcome. As to the second factor, evaluating the nature of the copyrighted work, the computer programs at issue were “functional works which serve[d] to enable users to control and understand the operation of the equipment.” That favored fair use, the court of appeals found. As to the third factor, measuring the amount and substantiality of the portion used, while it was true that independent repair technicians used the “entire work” when carrying out their maintenance, the court emphasized, “even the copying of the entirety of a work can be justified if the amount and portion copied is central to a copier’s valid purpose.” That was the case here, the court found.

As to the fourth factor, measuring harm to the market, this too cut in favor of fair use. Critically, the court noted, this factor of fair use is concerned with market harm, specifically, “to the original work and its derivatives.” Here, the court noted, the Librarian appropriately found that the medical-device repair exemption was unlikely to harm the market for the embedded software because “medical device and system software and data files are sold with the equipment and have no independent value separate from the devices.” And although the trade associations disagreed, claiming market harm based upon loss of revenue from “copiers, healthcare providers, and higher cost manufacturer-affiliated technicians,” the court noted, they failed to introduce evidence into the administrative record to prove their claims. And while it was “certainly the case” that the medical device repair exemption enables competition in the maintenance and repair services market, the court noted, “that does not itself demonstrate an adverse effect on the market for the original device or its clinical operation software, which is the protected work.” The Librarian did not err, the court concluded, in finding that the fourth factor weighed in favor of fair use.

The Case is No. 25-5328.

Judge: Childs, J.

Attorneys: Michael B. Kimberly (Winston Taylor LLP) for Medical Imaging & Technology Alliance and Advanced Medical Technology Association. Laura E. Myron, U.S. Department of Justice, for Library of Congress and Todd Blanche.

Companies: Medical Imaging & Technology Alliance and Advanced Medical Technology Association

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