Last month, a Final Rule was adopted by the Library of Congress regarding access to medical device software as a means to diagnose, repair, and maintain the products; the ruling states that this accessibility is regarded as fair use under copyright law. The Librarian of Congress ruling in its entirety can be found here.
A recommendation came from the Copyright Office Registrar, advising exemption to the provision of the Digital Millennium Copyright Act (DMCA) which prohibited “circumvention of technical measures that control access to copyrighted works” according to the published document released on October 28, 2021.
Notably, the ruling exempts responsibility for medical device manufacturers accessing copyrighted software and associated data files on legally procured medical devices or systems when it’s imperative to maintaining and/or restoring a device to operate congruently with its original framework.
The ruling states that in order to, “establish the need for an exemption, proponents must show, at a minimum, (1) that uses affected by the prohibition on circumvention are or are likely to be non-infringing; and (2) that as a result of a technological measure controlling access to a copyrighted work, the prohibition is causing, or in the next three years is likely to cause, an adverse impact on those uses.”
Jay Crabtree, Auxo Medical’s President, said, “We feel that this is a great decision for both healthcare operators and independent service operators. This will give healthcare operators more choices, and will help keep cost of providing care at reasonable levels.”
A thorough overview of the rule making process, evidentiary record, as well as the Register’s analysis of proposed exemptions are available for review here.
Additionally, here are resources and links to better understand the ruling’s history and implications.
As always, stay tuned for relevant and timely healthcare content on the Auxo Medical blog. In our next post, with the pandemic in mind, we’ll review recommendations for safe travels during the 2021 holiday season.