By Robert Kerwin
As the U.S. Copyright Office conducts its triennial Section 1201 rulemaking proceeding on DMCA exemptions this year, the FDA has issued a letter supporting the proposed renewal of the DMCA Exemption Regarding Repair of Medical Devices and Systems.
On June 21, 2024, Suzanne Schwartz, director of the FDA Office of Strategic Partnerships and Technology Innovation, informed the Copyright Office that the FDA stands behind the proposed exemption from the Digital Millennium Copyright Act that would apply “to circumvention [of technological protections] that is conducted solely to obtain data access for the purpose of diagnosis, maintenance or repair of devices.”
The letter makes clear that the FDA would not support circumvention for the purpose of device modification, noting “...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.”
To better understand the significance of the FDA’s letter of support, it is important to have a little legislative context as to why the U.S. Copyright Office is conducting its rulemaking proceedings.
Section 1201 of the Digital Millennium Copyright Act provides that 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.
As the Copyright Office notes, “[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 noninfringing uses due to the prohibition on circumventing access controls”. When these classes are identified, the Librarian of Congress may promulgate regulations exempting the classes from the prohibition for the following three years.
In this case, some opponents had argued that for cybersecurity reasons, renewal of the repair exemption was not appropriate. The FDA suggested otherwise 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…”
