Electronic servicing materials could be more accessible if exemption is allowed
Knowledgeable observers suggest that the practical effect of allowance of this exemption would be to allow owners of medical devices and their authorized agents (i.e., third party servicers), to access and use the electronic servicing materials and perform servicing activities without the threat of legal action under DMCA.
Service materials for radiation emitting devices — A.I.A.T. (assembly, installation, adjustment and testing) — are already mandated to be supplied “at a cost not to exceed the cost of publication and distribution” under 21 U.S.C. §1020.30(g). Notwithstanding, some electronic service materials for basic servicing are not infrequently unavailable (behind the TPMs) unless a servicer obtains a key from a manufacturer. In any event, there may well be expense and other challenges to get the key. Hence, allowance of this exemption by the U.S. Copyright Office may greatly assist owners of medical devices and third-party servicers working on the devices.
U.S. Copyright Office hearings held to consider new possible exemptions and renewals
Earlier this year, on behalf of IAMERS, I testified in support of the proposed new exemption at the Register’s hearing together with Steve Inacker, president of Avante Health Solutions, and others. Comments had been received in opposition and some testimony mischaracterized in my view some of the supportive underpinnings of the favorable 2018 FDA Servicing Report. I noted that the FDA MAUDE reports (manufacturer and user facility device experience reports) confirm that under one percent of adverse events have been reported with respect to device servicing activities as described more fully in the FDA report.
During his testimony, Inacker acknowledged the proverbial "elephant in the room" with regard to the adverse effects to the patient if a manufacturer imposes the current prohibition against circumvention: “[w]e need to have the right to repair the equipment for our customers and have access to do so on a readily available basis. This is a patient safety issue. When we can’t get access to the equipment that we need to service, patients wait.”
U.S. Copyright asks FDA to weigh in
Faced with comments in opposition to the proposed exemption and claims that the FDA’s regulatory authority may be applicable, the Register of Copyrights made the FDA aware of the U.S. Copyright Rulemaking proceeding.
On August 13, 2021, the FDA Office of Strategic Partnerships and Technology Innovation issued a letter to the U.S. Copyright Office
acknowledging that opponents of the exemption have expressed concerns that the exemption may facilitate device servicing by unregulated entities with the potential to increase cybersecurity risks and result in harm to both patients and providers. The FDA noted in this regard that “device servicing entities may be well positioned to help identify and address security vulnerabilities, and observes that ISOs may play an important role in maintaining the overall quality, safety, and efficacy of medical devices.“