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Op-eds Rail Against ‘Right to Repair’ Legislation as ACA Begins New Support Campaign
“The Maine Right to Repair Committee drafted its ballot language with the help of a national auto parts special interest group and then went directly to the ballot to intentionally avoid the tough questions that would come with a legislative review. Not benefiting from critical scrutiny, the language put forward was poorly drafted and did not consider alternate points of view. This manipulation of the system was done knowing full well that voters would support the idea of ‘Right to Repair’ without being in a position to evaluate the rest of the ballot text. Despite the façade of being a locally grown ballot initiative designed to help independent repairers, this ballot question did not enjoy the financial support of Maine voters.”
Repairer Driven News
The Unique Cyber Vulnerabilities of Medical Devices
“A report from earlier in the decade indicates that 90% of hospitals were targeted by cyber attackers in the preceding two years. And 17% of those attacks were facilitated through Internet of Things (IoT) devices. Eighty-two percent of hospitals sustained an attack facilitated through such a device according to a 2019 survey. An average hospital room may have as many as 20 connected devices vulnerable to hacking. Approximately 385 million patient records were likely exposed in data breaches between 2010 and 2022, according to the Department of Health and Human Services. According to healthcare data security firm CloudWave (formerly Sensato), medical devices have an average of 6.2 vulnerabilities each. And more than 40% that are in use are at the end of their life cycles and thus do not receive regular security upgrades. Some 53% have known critical vulnerabilities, according to the FBI.”
Information Week
On Point – Two Wrongs Don’t Make a Right to Repair
“A major flaw of right to repair bills is their broad definition of “digital electronic equipment.” The model legislation defines such equipment as “any product that depends for its functioning, in whole or in part, on digital electronics embedded in or attached to the product.” The primary intention is to target everyday consumer electronics, like cell phones, tablets, and personal computers. Proponents of the model legislation may also be interested in regulating the repair of other home electronics, like televisions and smart home devices. However, distinctly different industries, like home appliances, medical devices, and agricultural equipment have also been at the focus of advocacy as traditional products become more digital.”
Competitive Enterprise Institute
’Right to Repair’ Legislation Opposition Letter Sent to the Honorable Michelle Mussman, Illinois House of Representatives
“Given the sophistication and technology powering these machines, it’s no surprise that medical device servicing and repair is complex. Repairs to any kind of modern technology brings its own complexities and training requirements and creates a variety of different risks when done incorrectly. For medical devices, if repairs are done incorrectly, patients can be directly endangered, care delayed, or diagnoses missed. That’s why the FDA regulates some servicers to follow quality-management processes, meet minimum training requirements and report incidents to enhance patient and user safety. ISOs, however, aren’t held to any regulatory standards or reporting requirements. An open-ended medical device “right to repair” law that forces the transfer of intellectual property to companies with little to no accountability makes this lack of oversight even more problematic.”
Patients Rising Now
The Economic Downsides of “Right-to-Repair”
“The various iterations of “right-to-repair” seek to procure short-term consumer gains in the form of lower
National Association of Manufacturers
service fees, but at a steep cost: the very real damage to the environment, consumer safety and manufacturing
innovation resulting from opening up unfettered access to complex equipment and devices.”
Nixing the Fix: An FTC Report to Congress on Repair Restrictions
“When deciding the scope of expanded repair rights, policymakers should think about whether the rights should be limited to consumer goods or include capital items. Given the complexity and variation among products, it seems unlikely that there is a one-size fits all approach that will adequately address this issue.”
Federal Trade Commission
Remanufacturing and Servicing Medical Devices
“Poor quality servicing may lead to poor device performance, device malfunction, and adverse events. Cybersecurity is also an important consideration in the servicing of medical devices.”
U.S. Food and Drug Administration
MAUDE Reporting – Manufacturer and User Facility Device Experience
“The incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.”
U.S. Food and Drug Administration