The Librarian of Congress has adopted the Register of Copyright’s recommended exemption to the Digital Millennium Copyright Act that permits owners of medical devices and outside service organizations to access the system software for the purposes of diagnosing, maintaining, and repairing such devices, according to Avante Health Solutions, a Chicago-based provider of medical equipment, supplies, and services.
The ruling, published on October 28, specifically voids liability for working around medical device manufacturer access controls to copyrighted software and related data files on lawfully acquired medical devices or systems when access is a necessary step in maintaining or restoring a device to work in accordance with its original specifications. This includes restoring the device to updated specifications authorized for that device or system.
“This is significant to healthcare systems looking for affordable options to maintain and repair expensive medical equipment and associated devices,” says Steve Inacker, president and chief operating officer of Avante Health Solutions. “Avante is thrilled, as this ruling builds on the [U.S. Food and Drug Administration’s] recognition of the merits and safety of the services provided by independent service organizations, and we look forward to providing and expanding our high-quality repair and maintenance services to our customers.”
The complete document, “Exemption to Prohibition on Circumvention of Copyright Protection System for Access Control Technologies,” can be found here.