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US Copyright Office to recommend renewing medical device exemption

October 25, 2023
Parts And Service
The Library of Congress (Courtesy: Wikimedia Commons)
By Robert J. Kerwin

On October 19, 2023, the U.S. Copyright Office published notice in the Federal Register that it was recommending to the Librarian of Congress certain Petitions for Renewal of the Exemptions that were granted in 2021 from the Digital Millennium Copyright Act (“DMCA”) prohibition against circumvention of technological measures that control access to copyrighted work.

The exemptions are in force for three years and are subject to renewal. Among the exemptions which were previously granted by the Librarian (after adoption of the Copyright Office’s recommendations) was the exemption to "access computer programs that are contained in and control the functioning of medical devices or systems, and related data files, for diagnosis, maintenance or repair."

According to the Federal Register notice, five organizations filed petitions to renew the medical device repair exemption including: Avante Health Solutions, Crothall Facilities Management Inc., Metropolis Int’l, TRIMEDX and TTG Imaging Solutions LLC.

Oppositions were received from the American Consumer Institute, the Medical Imaging & Technology Alliance (“MITA”) and Philips North America LLC. (“Philips”). MITA, AdvaMed and Philips had filed an opposition three years ago to the exemption petition. MITA subsequently filed, together with AdvaMed, an action in the U.S. District Court seeking effectively to overrule the Librarian’s decision to allow the exemption. This lawsuit was subsequently dismissed and is on appeal.

In the current proceeding, according to the published notice, Opponents assert that the medical device repair exemption undermines the maintenance of and repair standards laid out by the FDA because independent servicers who are conducting repairs are “neither regulated nor monitored” by the FDA. Opponents also contended that Congress and the FDA have announced new policies on medical device cybersecurity that directly conflict with the 2021 exemption permitted by the librarian. In addition, opponents apparently argued that the Supreme Court’s recent decision in Andy Warhol Foundation For the Visual Arts v. Goldsmith constitutes a new legal development that undermines the validity of the previous rulemaking analysis.

After consideration of these positions, the Copyright Office stated that, with the exception of the points raised as to the Andy Warhol case, it previously addressed (and declined) the opposition arguments in the prior proceeding. The Copyright Office does not consider, typically, other regulatory schemes as part of its "adverse effects" analyses of the potential exemption because it is focused on copyright-related considerations. The Copyright Office also pointed out that a user availing themselves of the temporary exemption is not absolved of noncompliance with other laws.

While noting that the safety and cybersecurity arguments do not demonstrate relevant legal or factual circumstances justifying changing the exemption, it also reaffirmed that it considered the 2018 FDA Servicing Report conclusions in its prior granting of the exemption. Specifically, it acknowledged the FDA conclusion as to independent medical service repair that “the continued availability of ISOs to service and repair medical devices is critical to the functioning of the healthcare system in the United States.”

The Copyright Office also pointed out that although the FDA was continuing to evaluate its approach to cybersecurity and medical device servicing, and although Congress had imposed additional cybersecurity requirements, these developments did not change the Copyright Office’s analysis.

Robert J. Kerwin
With regard to the Andy Warhol decision, the Copyright Office noted that the Warhol opinion did not overrule prior Supreme Court decisions of “fair use” of copyrighted materials, and accordingly did not cause the Copyright Office to deny the renewal. Importantly, the Copyright Office noted that “the conditions that led to adoption of this exemption are likely to continue during the next triennial [three year] period” and that the lack of evidence in the oppositions to the effect that the relevant factual or legal record had changed, supported its recommendation of renewal.

About the author: Robert J. Kerwin is general counsel to IAMERS, the International Association of Medical Equipment Remarketers and Servicers.

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