Final Rule on Fair Use of Medical Device Software

The Library of Congress has published a Final Rule that accessing medical device software for the purpose of diagnosing, repair and maintenance is considered fair use under copyright law.

Avante Health Solutions is pleased to share that the Librarian of Congress has adopted the Copyright Office Registrar’s recommended exemption to the Digital Millennium Copyright Act (“DMCA”) 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.

The ruling, published October 28, 2021, 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” said Steve Inacker, President and Chief Operating Officer of Avante Health Solutions.

“Avante is thrilled, as this ruling builds on the FDA’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,” Inacker added.

The complete document, “Exemption to Prohibition on Circumvention of Copyright Protection System for Access Control Technologies” can be found at federalregister.gov/d/2021-23311 and govinfo.gov.

Commentary on the ruling can also be found in the article, “Copyright Ruling May Pave Way for Greater Access to Medical Device Service Manuals” by Robert J. Kerwin, General Counsel for the International Association of Medical Equipment Remarketers and Servicers.

About Avante Health Solutions

Avante is a single source provider of medical, surgical, diagnostic imaging, and radiation oncology equipment, including sales, service, repair, parts, refurbishing, and installation. Avante is making it easier and more affordable for every hospital, clinic, and medical practice to have the very best equipment, supplies and service. For more information, visit www.avantehs.com.