WASHINGTON — The U.S. Copyright Office said Wednesday that it will not automatically renew a legal exemption that lets hospitals and independent technicians get around software locks to repair medical equipment, reopening a fight that medical device manufacturers have pursued in court, in comments to the agency and on Capitol Hill.
In a notice of proposed rulemaking published in the Federal Register, the office said it intends to recommend renewal of every existing exemption from the Digital Millennium Copyright Act’s ban on circumventing “technological protection measures” — except one. The medical device repair exemption, the office wrote, faces “meaningful opposition” and will be considered as a new proposal “so that interested parties can develop the record further.”
The office laid out its reasoning in the notice. Opponents, it said, offered “new evidence and arguments that may cast uncertainty on the current reliability of the existing administrative record,” including evidence of “different types of medical device software that are configured differently depending on the purpose of the software and, in some cases, may not be stored on the device.” That evidence, it said, “raises questions about whether the scope of the current exemption” is “defined with sufficient specificity.” At the same time, the office noted that petitioners “provided evidence that diagnosis, maintenance, and repair of medical devices and systems continue to be adversely affected” by the circumvention ban.
The Washington Inquisitor sought comment from the Copyright Office, AdvaMed, Philips, iFixit and Public Knowledge, and the story will be updated with any responses.
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