On June 7, 2024, the U.S. Court of Appeals issued a decision reversing the U.S. District Court dismissal of the challenge by MITA and AdvaMed to the Librarian of Congress’ granting of an exemption from the Digital Millenium Copyright Act’s (“DMCA”) anti-circumvention provision pertaining to medical device manuals. Two independent medical device servicers had sought the exemption. The matter will now go back to the U.S. District Court for review of the exemption under the U.S. Administrative Procedures Act (“Act”).

In their challenge, which was originally dismissed in March 2023, MITA and AdvaMed claimed that the Librarian’s decision to allow the exemption was manifestly unlawful, unconstitutional and did not comply with, among other things, the Administrative Procedures Act.

To appreciate the U.S. Court of Appeals decision, it is important to understand the context of the legislative/regulatory powers. Although the Librarian of Congress is best known for maintaining the Nation’s library, the Librarian exercises “quietly” (as acknowledged by the Court) significant regulatory authority over copyrights including with respect to the DMCA. Among its duties, the Librarian was authorized by Congress to identify every three years classes of copyrighted works to which the DMCA anti-circumvention provision “shall not apply”.

In 2020 the Librarian of Congress, during its triennial review of the DMCA, had allowed, at the formal request of two independent medical device service companies, an exemption to permit ‘circumvention of technological protections’ which were blocking access on medical devices to “error logs, configuration files, and other unprotected works” . The Librarian, in granting a medical device electronic manual repair exemption, had essentially concluded that the DMCA anti-circumvention provision was likely causing “an adverse impact on the non-infringing diagnosis, repair and maintenance of medical devices and systems.”

While the Court of Appeals has not now in its decision decided (in sending the case back to the District Court), the merits of the underlying case brought to the U.S. District Court by MITA and AdvaMed, the Appeals Court, did determine that the DMCA rules are ‘reviewable’ under the Administrative Procedures Act because the Library is an “agency” within the APA . The District Court had previously determined that the Librarian’s decision was not reviewable.

The Appeals Court decision would seem to treat the Librarian’s decision- making authority as mere ‘recommendations’. However, it should be observed that the specific provisions of the DMCA do seem to suggest, prior to the Appeals Court decision that Congress did not intend for judicial review of the Librarian’s rulemaking. Nonetheless, the U.S. District Court will now consider whether the exemption is ‘fair use’.

Strong reasons still exist for the ‘fair use’ determination, and it remains to be seen how the U.S. District Court will evaluate the Librarian’s decision under the APA and of course, the Librarian’s most recent consideration of the exemption under the latest triennial review which is now occurring. The Registrar has recommended to the Librarian renewal of this exemption. To re-state what the U.S. Court of Appeals has readily acknowledged, some medical device manufacturers continue to resist allowing third-party servicers to access their software.

 

 

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/63146