Staff report
Recently, the U.S. Copyright Office published a notice in the Federal Register that it is recommending that the Librarian of Congress consider some Petitions for Renewal of the Exemptions that were granted in 2021 from the Digital Millennium Copyright Act (DMCA) prohibition against circumvention of technological measures that control access to copyrighted work. The repair of medical devices is among the items listed.
In a summary on the Federal Register website it states, “The United States Copyright Office is conducting the ninth triennial rulemaking proceeding under the Digital Millennium Copyright Act (“DMCA”), concerning possible temporary exemptions to the DMCA’s prohibition against circumvention of technological measures that control access to copyrighted works. In this proceeding, the Copyright Office is considering petitions for the renewal of exemptions that were granted during the eighth triennial rulemaking along with petitions for new exemptions to engage in activities not permitted by existing exemptions. On June 8, 2023, the Office published a Notification of Inquiry requesting petitions to renew existing exemptions and comments in response to those petitions, as well as petitions for new exemptions. Having carefully considered the renewal petitions and comments received, in this Notice of Proposed Rulemaking (“NPRM”), the Office announces its intention to recommend all but one of the existing exemptions for renewal. This NPRM also initiates three rounds of public comment on the newly proposed exemptions. Interested parties are invited to make full legal and evidentiary submissions in support of or in opposition to the newly proposed exemptions, in accordance with the requirements set forth below.”
In a section titled “Q. Computer Programs—Repair of Medical Devices and Systems.”
The document reads, “Five organizations filed petitions to renew the exemption to access computer programs that are contained in and control the functioning of medical devices or systems, and related data files, for diagnosis, maintenance, or repair (codified at 37 CFR 201.40(b)(15)).
The Office received three comments opposing renewal, discussed further below.
Four of the petitions provide evidence of the continuing need and justification for the exemption.
For example, Avante states that “the use of TPMs in medical systems and devices is widespread among the types of systems and devices” and that manufacturers “have developed new systems that further restrict access to use of necessary software tools.”
TTG Imaging Solutions asserts that the exemption is “crucial to ensure the availability, affordability, and timely repair of medical devices, which directly impacts patient care and healthcare accessibility.”
And both Metropolis International and TriMedx testify that they relied on the current exemption to refurbish and repair medical systems.
The petitioners have personal knowledge of and experience with this exemption; each either repairs, maintains, services, or sells medical systems and devices for entities in the healthcare industry.
The Office received opposition comments from the nonprofit American Consumer Institute (“ACI”), the Medical Imaging & Technology Alliance (“MITA”), and Philips North America, LLC (“Philips”). Opponents assert that the repair exemption “undermines the maintenance and repair standards laid out by the U.S. Food Drug Administration (FDA) for the equipment employed in patient care” because independent servicers conducting repairs are “neither regulated nor monitored” by the FDA.[108]
The complete document, including all of Section Q, is available at <a href=”https://tinyurl.com/bddwr4zy” target=”_blank” rel=”noopener”>tinyurl.com/bddwr4zy</a>.
