An opinion piece by Robert J. Kerwin
Senator Ron Wyden (D-Ore) and Rep. Yvette Clark (D-NY) filed today in the U.S. Senate and the U.S. House of Representatives the first federal right-to-repair legislation.
“There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit the U.S. in 100 years,” Wyden said in a statement. “It is just common sense to say that qualified technicians should be allowed to make emergency repairs or do preventive maintenance, and not have their hands tied by overly restrictive contracts and copyright laws, until this crisis is over.”
Many are regarding this as the first formal recognition in Congress that some manufacturers are imposing undue restraints on hospital biomeds and independent servicers’ access to repair information in a manner which could be impeding hospitals treating their patients during a national health crisis.
Wyden and Clark are seeking that the legislation be given immediate consideration to aid medical providers grappling with shortages of critical equipment. Titled, “Critical Medical Infrastructure Right-To-Repair Act of 2020”, the bill seeks temporary relief during the pandemic emergency from provisions of the copyright and patent laws which could be used to limit rights to service access information.
Some manufacturers have previously used these provisions in lawsuits to claim copyright or patent infringement for accessing equipment maintenance information or circumventing technological measures that control access. If adopted, not only would this "Right-to-Repair" legislation enable lawful circumvention under the language of the legislation, but it would also allow incidental copies of service materials made during maintenance or repair of "critical medical infrastructure".
The language of the bill is narrow, and by its terms expires at the end of the declared public health emergency. By law, Public Health Emergencies expire at the end of 90 days unless renewed. The current renewal of the public health emergency was declared by HHS Secretary Azar on July 23, 2020 and will expire in October if it is not renewed at that time.
IAMERS has worked with Senator Wyden and U.S. P.I.R.G. and other industry leaders in a coalition to help fashion the legislation. Supporters of the bill include American College of Clinical Engineering (ACCE), National Rural Health Association (NRHA), National Association of Rural Health Clinics (NARHC), Alliance for Quality Medical Device Servicing (AQMDS), ISS Solutions Healthcare Technology Management, The Repair, Association Electronic Frontier Foundation (EFF), Color of Change, Public Knowledge, R Street Institute, Lincoln Network, Niskanen, Center Colorado Association of Biomedical Equipment Technicians (CABET), Maine General Medical Center, Pennsylvania Public Interest Research Group (PennPIRG), and the Center for Democracy & Technology (CDT).
“I’ve talked to over a hundred biomeds since the start of the crisis — all they want is to be able to fix broken equipment and protect the patients in their hospitals," said U.S. P.I.R.G. Right-to-Repair advocate Kevin O’Reilly. "By giving these frontline workers access to service materials, Sen. Wyden’s bill helps them get their job done.”
The legislation encompasses not just biomeds, but includes “any person engaged in the diagnosis of problems with respect to, or the service, maintenance, or repair, of critical medical infrastructure.” It provides relief from the copyright and patent laws to "covered service providers", which includes an owner or a licensee of a copy of service materials, or their agent.
The bill imposes a duty to disclose service materials upon manufacturers of "critical medical infrastructure" so that hospitals may readily obtain service access information for medical equipment being used for diagnosis and treatment. "Critical medical infrastructure" is defined as, “a device, computer program, or other product or equipment used to provide medical services.”
Service materials when used with respect to "critical medical infrastructure" includes any information or material that the manufacturer provides "directly, indirectly or wirelessly" to technicians of the manufacturer or repair facilities authorized by the manufacturer, and includes:
• Schematics, wiring diagrams, mechanical layouts, and other pertinent data with respect to the critical medical infrastructure;
• Computer programs used in diagnosing problems or in calibrating, repairing, or maintaining the critical medical infrastructure;
• Service keys that are required to access diagnostic information or otherwise authorize repairs;
• Access to error legs that are required to diagnose required repairs;
• Preventive and corrective maintenance, inspection and repair manuals;
• Safety alerts, recalls, service bulletins, specification updates and the need for adjustments to maintain efficiency safety and convenience;
• Any other information provided to diagnose the programs with respect to service, maintain, repair, activate, certify or install;
• Training materials
Manufacturers would be required to provide, on fair and reasonable terms, access to information and tools used to diagnose problems and service. Under the legislation, the information available to a “covered service provider” would include schematics, service keys, error logs, manuals, safety alerts, recalls, specification updates and other information to diagnose problems with respect to repairing critical medical infrastructure.
There are other key provisions in the legislation designed to facilitate equipment repair. Provisions in existing contracts with manufacturers are to be deemed null and void during the emergency if they prohibit or restrict repair or maintenance options for the healthcare provider. There is even a provision which permits a covered healthcare provider to fabricate a part on a non-commercial basis, and as needed, for the repair or maintenance of critical medical infrastructure. The legislation is silent as to whether other regulatory authorities such as the FDA may have to be notified, as presumably, the FDA could perceive these actions as some form of adulteration of the device and need to weigh in on safety issues.
The legislation also states that it is not a violation of the copyright law for a covered healthcare provider to manufacture, import, or otherwise traffic in technological means to circumvent a technological measure that effectively controls access to a work protected under the copyright laws if that action by a covered healthcare provider enables a repair or maintenance permitted under this legislation to occur.
The U.S. Federal Trade Commission is charged under the proposed legislation with promulgation of regulations and enforcement. Violations of this act and any rule-making will be treated under the legislation as unfair or deceptive acts or practices under existing FTC laws and regulations. Manufacturers would presumably be monitored by the FTC for compliance with the legislation or at least wary that conduct violative of this legislation could be reported by the hospitals or their agents. The legislation also calls for the FTC to conduct a study within one year regarding the impact and effectiveness of the Act, with respect to innovation and anti-competitive practices in the market and enforcement.
Some industry thought leaders, while applauding this legislation, have noted that this legislation, if adopted, would be in effect for a limited period of time.
“This legislation is a good first step during the pandemic," said Marc Schaefer, president of Alabama-based Medical Imaging Systems. "We do feel that this level of access needs to be granted permanently and not just for a crisis. In many ways you add to the crisis by limiting supporting information.” Schaefer added, “all discussions on healthcare should start with one focus: will this affect the patient? Greater cooperation [on access] means more resources for better patient outcomes.”
As Jimmy Kallam, president of East Coast Medical, observes, “it should always just be about helping the patient.”
“We need to do more to help the rural communities and we are hoping that there will be other steps taken to ensure that rural communities have better access," said Jason Kitchell, president of Missouri-based Universal Medical Resources.
Some detractors have said that the bill offers no answers for what happens to the service access information when the national emergency ends. However, IAMERS president Diana Upton observed that, “the hospital accrediting organization, The Joint Commission, already requires this information to be provided anyway."
Joint Commission Standard EC.01.01.01 requires that a hospital have a library of information regarding inspection, testing and maintenance of equipment. Moreover, there are appropriate compliance/risk reasons for the Joint Commission’s requirement. Among them is the need for the hospital to address potential natural disasters. As many have recently experienced power outages with seasonal storms and bad weather, this equipment maintenance information should be available when an emergency arises. As FEMA has noted, when there is a disruption of power hospitals should have an emergency plan for restoration. (See FEMA info at p.9
). Manufacturers are not always readily available during a disaster or emergency as they may be geographically unable to assist. In any event, in addition, hospitals should have choices to either use in-house biomeds or independent servicers.
This legislation addresses the elephant often in the room when manufacturers claim that they are permitted to withhold service access information as the equipment maintenance information is a trade secret. The legislation provides that the a manufacturer of critical medical infrastructure may not withhold information on the ground that disclosing the information would divulge methods or processes entitled to protection as trade secrets if that information is provided directly or indirectly to authorized dealers or service providers. Tools including software must likewise be made available on fair and reasonable terms.
Among the bill's detractors is the Medical Imaging Technology Alliance (MITA), which represents the interests of medical equipment manufacturers and argued that patient safety could be compromised by the legislation.
"While the intention of the bill's sponsors is to protect patients, the unintended consequences of this legislation would increase the risk to patient safety, said Patrick Hope, executive director of MITA. "Especially during the pandemic, we should want the most qualified, trained experts servicing essential medical equipment, not third-party servicers unknown to the FDA who are not held to any requirements."
A 2018 FDA report determined there was insufficient evidence of a safety issue with non-OEM service entities to warrant increased oversight.
About the author: Robert Kerwin is general counsel to IAMERS and has served in that capacity for over twenty-five years.