Register of Copyrights Again Recommends Renewal of Medical Device Repair Exemption

By Robert J. Kerwin, IAMERS General Counsel

EDITOR’S NOTE: This article is for informational purposes only and cannot be construed as providing legal advice. Readers are advised to consult their own counsel relative to the DMCA and its exemptions. It was originally posted on TechNation

The U.S. Register of Copyrights has again recommended continuation of the Librarian of Congress’ 2020 approved Exemption from liability for the circumvention of medical device technology protection measures when the purpose is diagnosis, maintenance or repair of medical devices and systems.  See Section 1201 Rulemaking: Ninth Triennial Proceeding Recommendation of the Register of Copyrights.  The Register’s recommendation is part of the Library of Congress’ Triennial Proceeding’ process  relative to approving temporary Exemptions from the Digital Millenium Copyright Act,

In an October 2024 Report to the Librarian of Congress, the Register noted that renewal petitions for this important temporary Exemption were filed by Avante, Crothall, Metropolis Int’l, TriMedx and TTG Imaging. Oppositions were submitted by the American Consumer Institute, Medical Device Imaging Technology Alliance and Philips North America.

Though few  (understandably) fully appreciate this important but complicated power of the Librarian, this rulemaking power was put in place as a “fail-safe” mechanism to ensure that prohibitions on DMCA circumvention would not adversely affect the public’s ability to make lawful use of copyrighted works. This process has been in place since 2000.

The triennial process is administered by the U.S. Copyright Register, who after hearings and consideration of input from stakeholders,  makes recommendations. These recommendations are based on the Register’s  conclusions as to whether the prohibition against circumvention of the DMCA is having or is likely to have, adverse effects on the user’s ability to make noninfringing uses of a particular class of copyrighted works.

The Librarian of Congress will now consider the Register’s recommendation and issue her own determination. Usually, the Librarian adopts the Register’s recommendations though issues her own decision.

Though MITA and AdvaMed, according to the Register, had asserted that Congressional and FDA policies on medical device cybersecurity directly conflict with the proposed repair Exemption, the Register also  noted that the FDA had actually advised that  it did not share the [opponents’] view that an exemption from liability under 17 U.S.C. §1201 (DMCA) for circumvention….would… jeopardize the safety and effectiveness of medical devices….”. One knowledgeable observer, Nathan Procter, U.S. PIRG Campaign for the Right to Repair, commented :”once again, opposition comments were  not persuasive to decision-makers. It was an over-reach to use copyright to restrict repair. “ He went on to say: “Right to Repair continues to make gains.”

The Librarian’s decision, while ostensibly final, will be impacted by a federal case filed by MITA and AdvaMed. Though the U.S. District Court had dismissed the MITA/AdvaMed challenge by MITA and AdvaMed, in June 2024, the U.S. Court of Appeals reversed the dismissal and sent the case back holding that the Librarian’s decision is ‘reviewable’ by the U.S. District Court under the U.S. Administrative Procedures Act (“APA”). The parties have agreed to a briefing schedule which may push the final outcome to 2025. As IAMERS President Diana Upton succinctly noted: “Stay tuned. We will continue to fight for hospitals to have choices.”