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

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

August 06, 2020
Business Affairs HTM Parts And Service
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.”

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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).

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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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