Advanced Medical Technology Association (AdvaMed) commended a U.S. Court of Appeals District of Columbia Circuit ruling that the trade group said will prevent "unauthorized and unregulated repair companies from hacking into life-saving medical devices."
AdvaMed and the Medical Imaging and Technology Alliance (MITA) filed the lawsuit against the U.S. Library of Congress and its librarian, Carla Hayden, to prevent independent repair companies and service operators from circumventing technology barriers in medical devices. Specifically, the lawsuit challenges a Digital Millennium Copyright Act (DMCA) rule that allows access, according to AdvaMed.
Some manufacturers provide limited software access to independent service operators so they can perform repairs, a copy of the lawsuit on AdvaMed's website states. In general, however, medical device manufacturers have resisted allowing third-party servicers to access their software to perform diagnosis, maintenance, and repairs on medical devices.
“This decision is a significant victory for the medical technology industry and the principles of good governance,” said Christopher White, chief policy officer and general counsel of AdvaMed. “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.”
AdvaMed said it looks forward to a decision on remand that vacates the rule to resolve the matter. The trade group said a favorable decision will "protect the integrity of complex [U.S. Food and Drug Administration] FDA-regulated medical devices."
