KnobbeMedical.com

In Medical Imaging & Technology Alliance v. Library of Congress, the D.C. Circuit recently affirmed a win for independent service organizations, upholding a Digital Millennium Copyright Act exemption permitting circumvention of technological protection measures on certain medical device software for the limited purpose of diagnosis, maintenance, or repair. The decision leaves in place the current version of the exemption, which is codified at 37 C.F.R. § 201.40(b)(17).

This decision sits at the intersection of copyright law with the broader right-to-repair movement. As more medical devices rely on embedded software and access controls, manufacturers have argued that unrestricted third-party repair can raise safety, cybersecurity, and intellectual property concerns. Repair advocates, by contrast, have emphasized that hospitals and other device owners need practical options for maintaining critical equipment.

In the decision, the D.C. Circuit rejected the trade associations’ challenge under the Administrative Procedure Act. The court concluded that the Librarian of Congress reasonably determined that the repair of medical devices was likely a fair use. The court reasoned that because the software at issue was primarily functional, the repair use was transformative, and the exemption was unlikely to harm a market for the embedded software separate from the devices themselves.

For medical device companies, the decision is a reminder that copyright and access-control strategies often do not fully foreclose third-party servicing. Companies should continue to evaluate how service software, diagnostic tools, manuals, cybersecurity safeguards, and contractual restrictions fit within a broader protection strategy. Rather than relying on copyright protection alone, manufacturers may benefit from a layered approach utilizing a combination of copyright, patent, and trade secret protection, as well as contractual restrictions and technical safeguards, to provide a broader web of protection around the service-related activities they seek to protect.