By Robert J. Kerwin
On July 21, 2025, the U.S. District Court confirmed again the propriety of the Librarian of Congress granting of a medical device repair exemption from the Digital Millennium Copyright Act (“DMCA”).
The rule exempts parties accessing copyrighted software for the purpose of diagnosis, maintenance and repair of medical devices from the DMCA proscription barring circumvention of technological protection measures limiting access.
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In a 60-page decision, U.S. District Court Judge Howell determined that the Librarian of Congress properly followed the procedural steps under, among other things, the Administrative Procedures Act (APA) and the Triennial consideration of Exemption requests from DMCA liability. The U.S. District Court dismissed lawsuits
filed by MITA and AdvaMed, finding that the Librarian together with the Registrar of Copyrights had determined properly that there was a need for this exemption.
Some medical device original equipment manufacturers (OEMs) had used the DMCA to pursue liability claims against independent service organizations (ISOs) for circumventing the technological protection measures installed (“TPMs”) to preclude access to copyrighted equipment manuals for conducting maintenance of medical devices. In that context, the decision from Judge Howell will be welcome news to ISOs.
Last year, the U.S. Circuit Court of Appeals found that the District Court had failed to fully consider MITA and AdvaMed’s claims that the Librarian had not followed the APA. Judge Howell, with considerable reference to the record of submissions made to the Librarian and the Registrar, has now found otherwise.
On June 21, 2024, Suzanne Schwartz, director of the FDA Office of Strategic Partnerships and Technology Innovation, informed the Copyright Office that the FDA
stands behind the proposed exemption from the Digital Millennium Copyright Act that would apply “to circumvention [of technological protections] that is conducted solely to obtain data access for the purpose of diagnosis, maintenance or repair of devices.”
At the time of publication it is not known whether MITA or AdvaMed may further appeal.
About the author: Robert J. Kerwin is general counsel to the International Association of Medical Equipment Remarketers and Servicers (IAMERS).
