Two months ago, a little-known rulemaking proceeding was underway at the U.S. Copyright Office which, depending upon the outcome, was poised to have favorable implications for the use of electronic medical device equipment manuals by servicers.
Today, the Librarian of Congress issued a ruling to accept for the next three years the recommendation of the Register of Copyrights concerning a new exemption to the Digital Millennium Copyright Act (“DMCA”) pertaining to medical equipment manuals.
The DMCA largely prohibits circumvention of technology measures that control access to copyrighted works. However, under what Congress characterized as a “fail-safe” mechanism, the Librarian of Congress after receiving the recommendation from the Register of Copyrights, is permitted to determine “non-infringing” uses of copyrighted works, which are likely to be adversely affected. The Librarian of Congress, after consideration of the Register of Copyrights lengthy recommendation ruled today favorably with respect to an exemption that otherwise prohibits circumvention of technological measures that control access to medical device manuals and servicing materials.
Equipment service companies Transtate Equipment and Summit Imaging had petitioned for access to data files stored on medical devices and systems including manuals and servicing materials. Opponents argued, among other things, that patient safety would be undermined and cybersecurity risks could be created. In a relatively rare action, the FDA advised that it did not share the view that an exemption to the DMCA for circumvention conducted solely for the purpose of diagnosis, maintenance or repair would necessarily jeopardize cybersecurity safety.
Testimony was received from a number of stakeholders, including Transtate’s CEO Steve Inacker, the online repair community iFixit, and myself as to the positions of non-infringing use and the adverse impact of the technology measures currently controlling access.
After weighing the factors, the submissions of opponents and lengthy deliberations, the Register concluded that “the prohibition on circumvention of TPMs [technical protection measures] is causing, or is likely to cause, an adverse impact on the non-infringing diagnosis, repair, and maintenance of medical devices and systems.”
This recommendation was accepted by the Librarian of Congress and (at least for the next three years) a new exemption has been allowed. This new DMCA exemption does not supplant the FDA’s statutory role or address other issues pertaining to access to service credentials and remanufacturing/modifications. Indeed, remanufacturing and possible modifications are not addressed or in any way permitted as part of the proposed DMCA exemption. However, the recommendation and subsequent ruling do acknowledge that the DMCA prohibition on circumvention of technical protection measures needs to be changed, as the current situation makes medical equipment software and manuals less available for use in non-infringing diagnosis, maintenance, and repair.
About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers. The above is a synopsis of the author’s understanding of extensive deliberations and is not legal advice. For legal advice concerning this matter, you are advised to contact your counsel.
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/56259