The Librarian of Congress, upon the recommendation of the Register of Copyrights, has published a final rule in the Federal Register adopting exemptions to the statutory prohibition on circumvention of technological measures that control access to copyrighted works. Publication of the final rule marks the completion of the eighth triennial rulemaking proceeding under Title 17, section 1201, of the United States Code.
As in prior section 1201 proceedings, the Copyright Office administered the rulemaking through an extensive public process.
In addition to the petitions to renew existing exemptions, the Copyright Office considered petitions for expanded or new exemptions, which it organized into 17 classes.
Summit Imaging Inc. and Transtate Equipment Co. Inc. petitioned to exempt circumvention of TPMs on software-enabled medical devices and systems for purposes of diagnosis, maintenance, and repair. Petitioners also sought access to related data files stored on medical devices and systems, including manuals and servicing materials.
Opponents argued that this exemption is unnecessary because adequate authorized repair services are available. They also contended that the proposed uses are commercial in nature, would harm the market for medical devices and systems, may undermine patient safety and create cybersecurity risks, and would interfere with manufacturers’ regulatory compliance obligations.
For the reasons discussed in the Register’s Recommendation, the Register recommended a new exemption allowing circumvention of TPMs restricting access to firmware and related data files on medical devices and systems for the purposes of diagnosis, maintenance, and repair.
The final rule states:
“Computer programs that are contained in and control the functioning of a lawfully acquired medical device or system, and related data files, when circumvention is a necessary step to allow the diagnosis, maintenance, or repair of such a device or system. For purposes of this paragraph (b)(15):
(i) The “maintenance” of a device or system is the servicing of the device or system in order to make it work in accordance with its original specifications and any changes to those specifications authorized for that device or system; and
(ii) The “repair” of a device or system is the restoring of the device or system to the state of working in accordance with its original specifications and any changes to those specifications authorized for that device or system.”
The final rule, Register’s Recommendation, record materials in this proceeding, and general information about the section 1201 rulemaking process are available on the Copyright Office website.
