Issues & Insights: ‘Right To Repair’ Legislation Compromises Medical Device Cybersecurity

Oct 16, 2020, 09:17 AM

The COVID-19 pandemic has intensified various political and economic flashpoints. From health care to housing, drug pricing to food pricing, the societal strain of the pandemic has renewed the urgency and raised the stakes for long-standing issues. 

The increasingly heated debate about the rules and regulations governing medical device servicing is an exemplar of this new reality. Although the dispute between independent aftermarket repair businesses and original equipment manufacturers (OEMs) isn’t new, it has shifted from auto repair, farm equipment, and consumer electronics to high-tech medical devices. 

In the early days of the pandemic, aftermarket repair advocates and the businesses they represent leveraged the public health emergency to create a perceived political opening when they accused OEMs of withholding the resources and information necessary to properly repair ventilators and other medical devices used to treat COVID-19 patients. These baseless accusations were an opportunistic attempt to advance a false narrative that patients were endangered by a shortage of qualified personnel to maintain and repair medical devices.  

Now, months later, aftermarket servicers have successfully pressured federal lawmakers to introduce legislation that would make manufacturer-developed medical equipment and software more vulnerable, putting patients and hospitals at greater risk. The Critical Medical Infrastructure Right-to-Repair Act of 2020 (House Resolution 7956) would shatter a number of long-standing norms and precedents, including the rights of innovators to protect their intellectual property. Even beyond the bill’s myriad defects, what’s most telling is the disingenuous rhetoric of the legislation’s most vocal advocates. Supporters of HR 7956 have repeatedly downplayed the negative implications of the bill, both for patient safety and for the security of medical devices. 

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