Pathways' Pick of the Week: Device Industry v. Library of Congress

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US industry groups will get their day in court against the Library of Congress. Excerpted from Pathways’ Picks June 12: China Reforms, Digital Health Picks, Cures 2.0 Reboot, and More.

A federal court must review the Library of Congress’ decision to grant an exception that allows independent servicing companies to circumvent security in medical device software to perform repairs, an appeals court ruled June 7. The ruling is tied to a case brought by manufacturers to challenge a 2020 copyright exemption for devices granted by the Library under the Digital Millenium Copyright Act. A DC district court ruled last year that the Library’s exemption was not reviewable by the courts because the Library is technically part of Congress, which is not subject to the Administrative Procedures Act. But a majority of the appeals court disagreed and has remanded the case back to the district court for substantive review. “The ruling ensures that regulatory actions affecting our industry are subject to judicial review, thereby protecting the innovation and safety standards that are critical to our mission of advancing medical technology for better patient outcomes,” said Christopher White, general counsel of AdvaMed, which filed the suit along with the Medical Imaging and Technology Alliance.

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