Deadline for renewal of DMCA exemption for medical devices looming

June 22, 2023
Editorial by Robert J. Kerwin

In 2021 the Library of Congress adopted an exemption to the Digital Millennium Copyright Act (DMCA) prohibition of the circumvention of technological measures that control access to medical device software needed to diagnose, maintain, or repair medical devices.

This was critical in limiting manufacturer claims for DMCA damages in lawsuits and potential lawsuits against independent servicers of medical equipment and for giving hospitals choices for device servicing. To state what is widely known in the industry: some manufacturers continue to withhold or delay access to medical equipment servicing information for medical equipment owned by hospitals when these hospitals choose to use independent servicers.

However, the exemption lasts only for three years and is up for renewal this summer. A petition for renewal of the exemption must be filed by July 7, 2023. No extension of the due date is possible. If no petition for renewal is filed, the most likely, if not inevitable, outcome is that the exemption will expire in 2024, again giving some manufacturers the ability to make certain DMCA violation claims when software is accessed or just used for medical device servicing.

"The exemption is important for the ability of ISOs to use software and information to fully service medical systems and devices for, among others, rural hospitals and other vital medical service providers," said Diana Upton, IAMERS president. "Renewal of the exemption will aid hospitals and group medical practices who require these services."

IAMERS believes the more petitions and statements in support that can be filed for renewal, the more the Copyright Office, the Library of Congress, and interested parties, will understand the need for continuing this important exemption. The Copyright Office maintains a resource page here. The petitions must be submitted on this form and submitted using the portal.

About the author: Robert J. Kerwin is general counsel to IAMERS and participated on behalf of IAMERS in the April 2021 hearing held before the United States Copyright Office.