In June I reported that the U.S. Copyright Office on behalf of the Librarian of Congress, had opened a docket for consideration of petitions for exemption and renewals of existing exemptions from the Digital Millenium Copyright Act (DMCA) prohibitions against circumvention of technological protection measures. Petitions were to be filed by Monday, August 24, 2026.

Two of the nation’s largest independent servicers and several other companies operating in different parts of the country, and collectively supporting millions of medical devices, have petitioned the U.S. Copyright Office to renew the medical device repair exemption from the DMCA.

The current “medical device repair exemption” permits circumvention of technological protection measures on medical devices and systems for purposes of diagnosis, maintenance and repair. It addresses access to data files stored on medical devices and systems, including manuals and servicing materials. Although some manufacturers of medical devices and systems provide access to device software and servicing materials, the materials provided vary, and in some cases are inadequate to execute repairs.

Petitions to renew the medical device repair exemption were received by the U.S. Copyright Office from Trimedx, Crothall Facilities Management, East Coast Medical Systems, Caylor Equipment Services, Brown’s Medical Imaging, iFixit and Marshall Shannon. The scope of their operations demonstrates the exemption’s broad practical importance to hospitals, healthcare providers, and patients nationwide.

Further expressions of industry support would be welcome and would confirm the ongoing need and support for renewal of the exemption. Independent servicers that rely on the exemption, or recognize its importance to lawful diagnosis, maintenance, and repair, should file written comments explaining how loss of the exemption would affect their work and the healthcare organizations they serve.

Under the streamlined renewal process, the U.S. Copyright Office generally will recommend renewal when the record demonstrates a continuing need and justification for the exemption and the record presents no meaningful opposition or other evidence calling renewal into question. The governing statutory standard is whether users of copyrighted works are, or are likely to be, during the next three years, adversely affected by the DMCA’s prohibition on circumventing access controls in their ability to make noninfringing uses.

Written comments may be filed through Regulations.gov until 11:59PM Eastern Time on September 28, 2026.

About the author: Robert J. Kerwin is general counsel to the International Association of Medical Equipment Remarketers and Servicers (IAMERS). In the 2021 Section 1201 rulemaking record, IAMERS participated in the proceedings concerning the medical-device repair exemption, including the public hearing on Class 12.

 

This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/66737