First federal 'right to repair' legislation filed in US to help hospitals through pandemic

First federal 'right to repair' legislation filed in US to help hospitals through pandemic

August 06, 2020
Business Affairs HTM Parts And Service

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.

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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.”
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Wayne Webster

It's a good start

August 10, 2020 10:02

The OEM's are working hard to eliminate the ISO and the medical center biomedical engineers. This Bill is the first large Congressional step in the right direction. Let's get this approved and then let's see if we can make it permanent.

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Jacob Lien

Curious about patient harm

August 17, 2020 11:21

I'm definitely curious about the inevitable scenario when an authorized service agent outside the manufacturer, with the best intentions, repairs the system inadequately and down the road results in patient harm. I'm usually not one to bring up what-ifs...and am usually an advocate for right-to-repair fights, but this seems over the top. Especially when it comes to the topic of this being extended post pandemic.

When are system warranties void?
Is biomed immediately fully responsible for the system once opened up?

Small business medical device manufacturers would be hard pressed to support anything like this when it comes to negligence from third parties effecting product support and ultimately patient safety.

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Wayne Webster

re: Curious about patient harm

August 18, 2020 02:12

In its response to Congress on this matter within the last two-years, the FDA concluded third parties “provide high-quality, safe and effective servicing of medical devices”. This outcome was as a result of a year-long study about safety of service performed by third parties. But, the larger point is that by withholding key information from commercial third parties and hospital biomedical engineers, the OEM's bring on the very safety concerns they grouse about. Therefore, one can only make a single conclusion...it's not about safety it's about eliminating the independents from the market and thus controlling all the revenue from the medical marketplace. It's time to stop monopolistic practices that result in less competition and higher costs.

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