US Copyright Office Sends Medical Device Repair Exemption Back for Full Review

By Ozan Attas

Photo: Anna Shvets / Pexels

Independent technicians who fix hospital equipment will have to argue their case again. In a notice of proposed rulemaking published in the Federal Register on 28 October 2026, the US Copyright Office said it intends to renew every existing exemption from the anti-circumvention rule in the Digital Millennium Copyright Act (DMCA) except one: the exemption for repairing medical devices and systems.

What Section 1201 does

Section 1201 of the US Copyright Act makes it unlawful to get around technological measures, such as passwords and encryption, that control access to copyrighted works, including the software inside devices. Every three years the Librarian of Congress, on the recommendation of the Register of Copyrights, can grant temporary exemptions for classes of works where the ban harms lawful uses. This is the tenth such cycle and will produce exemptions for the period starting in 2027.

Renewals and the one exception

Under the Office's streamlined renewal process, if a current exemption is petitioned for renewal and nobody meaningfully opposes it, it can be readopted without a fresh record. This time the Office found sufficient petitions for every current exemption. It saw no meaningful opposition except for medical device repair.

That exemption allows access to software that controls medical devices and systems, and related data files, for diagnosis, maintenance or repair. Eight petitions sought renewal (seven of them argued a continuing need) and one comment supported it, but four comments opposed it. Repair organisations told the Office the exemption is essential. They described password-protected service software and locked error logs that block timely repairs, and one servicer described being forced to choose between manufacturer-only servicing at high cost and leaving equipment unrepaired.

Because of the opposition, the Office will not renew the exemption automatically. It will treat it as a new proposed class so the record can be developed fully. The exemption is not dropped. Its supporters now carry the full burden of proof in the regular process.

A separate exemption that lets patients access data from their own medical devices drew no opposition and is set for renewal. The Office also found the case for renewing a text and data mining exemption still made out, saying commercial licensing offers do not yet meet researchers' needs.

New proposals and deadlines

The notice lists ten proposed classes, including the reopened medical repair class. Others cover accessibility and captioning, criticism and comment, device repair, jailbreaking and video game interoperability. Comment deadlines:

• supporters and neutral parties: 7 December 2026;
• opponents: 22 February 2027;
• replies: 22 March 2027.

Trade press picked up the fight this week: MLex reported on 30 October that manufacturers had scored an early win by forcing a fuller evidentiary review.

Why it matters outside the US

The DMCA rules shape how device makers worldwide lock their software, and how repair markets and researchers can work around those locks. Medical equipment makers, hospital groups and independent service companies with US operations should follow the medical repair class closely. Copyright owners in other sectors should check whether any new class touches their technology.

Sources

• US Copyright Office, "Tenth Triennial Section 1201 Proceeding, 2027 Cycle"
• MLex, "Medical device repair to face fresh copyright scrutiny despite US court victory" (30 Oct 2026)
• Federal Register, "Exemptions To Permit Circumvention of Access Controls on Copyrighted Works" (28 Oct 2026)
• US Copyright Office, NewsNet Issue 1097 (28 Oct 2026)