Repair, maintenance, and diagnosis of medical devices have received significant support as the U.S. Copyright Office conducts its triennial Section 1201 rulemaking proceeding on DMCA exemptions. The FDA has issued a letter backing 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 supports the exemption from the Digital Millennium Copyright Act (DMCA) that would apply to circumvention of technological protections conducted solely for the purpose of diagnosis, maintenance, or repair of devices. The FDA’s letter explicitly states that it does not support circumvention for the purpose of device modification, noting that an exemption for repair purposes would not jeopardize the safety and effectiveness of medical devices in the United States regarding cybersecurity.
Legislative Context and the Importance of Repair Exemptions in Healthcare
To understand the significance of the FDA’s letter of support, it’s essential to grasp the legislative background of the U.S. Copyright Office’s rulemaking proceedings. Section 1201 of the Digital Millennium Copyright Act allows the Librarian of Congress, upon the recommendation of the Register of Copyrights, to adopt temporary exemptions to the prohibition against circumvention of technological measures controlling access to copyrighted works. The Copyright Office’s goal is to identify particular classes of works where users are adversely affected in their ability to make noninfringing uses due to the prohibition on circumventing access controls. Once identified, the Librarian of Congress can exempt these classes from the prohibition for three years.
In this case, some opponents argued against renewing the repair exemption for cybersecurity reasons. However, the FDA countered this argument, including in its letter a copy of its 2021 support letter. The 2021 letter stated that an exemption for diagnosis, maintenance, or repair would not materially jeopardize the safety and effectiveness of medical devices regarding cybersecurity. Schwartz reiterated that the FDA would continue engaging with stakeholders and evaluating its approach to cybersecurity and medical device servicing.
FDA’s Endorsement Highlights Critical Role of Repair Exemption in Medical Device Maintenance
“The support of the FDA for continuation of this exemption cannot be overstated,” said Diana Upton, IAMERS president, emphasizing the letter’s significance. The FDA’s position underscores the importance of maintenance and repair activities to restore or ensure medical devices work according to their original specifications and any authorized changes. This is critical for the continued safe and effective use of devices post-market.
The FDA referred the Copyright Office to the FDA Guidance on “Remanufacturing of Medical Devices” for additional recommendations on activities considered to be servicing. This conclusion is valuable input for renewing the repair exemption.
In light of the U.S. Court of Appeals’ June 7, 2024 decision reversing the U.S. District Court’s denial of challenges to the Librarian of Congress’ granting of an exemption, the FDA’s June 10, 2024 letter of support for renewal may appear contradictory. However, this would be comparing proverbial apples to oranges, as the FDA’s support is specific to the context of ensuring safe and effective repair, maintenance, and diagnosis of medical devices. The agency’s endorsement highlights the necessity of the exemption to facilitate necessary repairs while maintaining stringent safety and cybersecurity standards.
Overall, the FDA’s support for the continuation of the DMCA exemption for the repair of medical devices highlights the balance between facilitating essential repairs and ensuring the safety and cybersecurity of medical devices. This position reflects the agency’s commitment to maintaining public health while addressing the practical needs of medical device maintenance and repair.
Resource: Dotmed, July 17, 2024
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