June 11, 2024

Arlington, Va.— The Medical Imaging Technology Association (MITA), a division of the National Electrical Manufacturers Association (NEMA), applauds a decision by the U.S. Court of Appeals for the District of Columbia Circuit in the case Medical Imaging & Technology Alliance, et al. v. Library of Congress and Carla Hayden (Case No. 23-5067). The court upheld MITA’s position that a rulemaking that could allow unauthorized and unregulated third-party servicers of medical devices to break into and exploit copyrighted software for commercial purposes should be subject to judicial review.

MITA members develop lifesaving technology like surgery assisting robots, CT scanners and MRI machines. Preserving the ability for those same manufacturers to repair the products they create is essential to advancing medical innovation and securing patient safety. The suit argued that under the Digital Millennium Copyright Act (DMCA), the Library of Congress was subject to the Administrative Procedure Act (APA) when it engaged in rulemaking. MITA’s claim, which was validated with this decision, was that the Library of Congress is an “agency” subject to APA, thus allowing for judicial review of its rulemakings. 

“This is a win for the industry, patients and for our system of checks and balances,” said Karin Moore, Senior Vice President, Legal and Regulatory Affairs, General Counsel & Corporate Secretary, NEMA. “Our lifesaving technologies depend on copyright protections that ensure repairs are made by approved technicians, and government rulemakings impacting those protections should be subject to judicial review. With this decision, they are.”

DC Circuit Judges Neomi Rao, J. Michelle Childs and Harry T. Edwards presided over the case.