The FDA announced that it stands behind the proposed exemption from the Digital Millennium Copywrite Act that would apply “to circumvention (of technological protections) that is conducted solely to
However, a letter written by Suzanne Schwartz, Director of the FDA Office of Strategic Partnerships and Technology Innovation stated that the FDA would not support circumvention for the purpose of device modification, stating “…FDA’s view is that an exemption from liability under 17 U.S.C. §1201 for circumvention conducted solely for [repair] purposes would not necessarily and materially jeopardize the safety and effectiveness of medical devices in the United States with respect to cybersecurity.”
According to Section 1201 of the Digital Millennium Copyright, the Librarian of Congress, upon the recommendation of the Register of Copyrights, may adopt temporary exemptions to the Section 1201 prohibition against circumvention of technological measures that control access to copyrighted works. The Copyright Office noted, “[t]he ultimate goal of the proceeding is to determine whether there are particular classes of works as to which users are or are likely to be in the next three years, adversely affected in their ability to make non-infringing uses due to the prohibition on circumventing access controls.” When these classes of works are identified, the Librarian of Congress may promulgate regulations that would exempt the classes from the prohibition for the following three years.
There were opponents that had argued that renewal of the repair exemption was not appropriate for cybersecurity reasons.
The FDA disagreed and even included in its letter to the U.S. Copyright Office a copy of its 2021 letter of support, in which it stated that “FDA, therefore, does not share the view that an exemption from liability under 17 U.S.C.§1201 for circumvention conducted solely for the purpose of diagnosis, maintenance, or repair of medical devices would necessarily and materially jeopardize the safety and effectiveness of medical devices in the United States with respect to cybersecurity…”
The FDA will continue to engage with stakeholders and evaluate its approach relating to cybersecurity and medical device servicing, according to Schwartz’s letter.
Valuable input to the process of renewing the repair exemption is from the FDA, which referred the Copyright Office to the FDA Guidance on “Remanufacturing of Medical Devices” for additional recommendations on activities that it considers to be servicing.
The FDA’s 2024 letter of support for renewal of the exemption could appear contradictory in light of the U.S. Court of Appeals June 7 decision which reversed the U.S. district Court denial of challengers to the Librarian of Congress’ granting of an exemption. However, it’s felt that this would be comparing apples to oranges.
The court determined that the copyright rules promulgated under the DMCA in the U.S. Court of Appeals decision are reviewable under the U.S. Administrative Procedures Act. As a result, the Court sent the matter back to the U.S. District Court for review under the APA, which did not decide the issue of propriety of the repair exemption or deny the Librarian the right to decide the 3exemption. The Court of Appeals returned the matter to the U.S. District Court for the APAP analysis.
It appears the continuation of the medical device exemption is well supported, including by the FDA. However, a final decision has not been made.
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Meet the author: Vikki Harmonay