Everyone in the Right to Repair Fight Says There's No Data. They're Right.
Listen to both sides of the medical device right to repair debate long enough and you'll hear the same sentence from each of them.
Manufacturers say there's no proof that independent servicing is safe enough. Independent servicers and hospital teams say there's no proof that it isn't. AdvaMed's Jim Jeffries told 24x7 there is "no credible evidence" that providers face repair delays. Repair advocates point to a hospital whose only MRI sat down for months.
Both sides are arguing about evidence. And the evidence they're arguing about is supposed to live in one place: the service record. Most of the time, it isn't there.
Where does medical device right to repair stand today?
Short version: stuck, with medical devices mostly carved out.
As 24x7 reported, right to repair bills have been introduced in all 50 states, and seven states have passed laws. Those laws mostly cover consumer electronics and appliances. Colorado exempts medical devices except powered wheelchairs. Minnesota's law excludes medical equipment. No state law has opened up medical device servicing.
The federal side is a copyright fight. Since 2021, an exemption under the Digital Millennium Copyright Act has let independent servicers get past software locks "when necessary to diagnose, maintain or repair" medical devices. It was renewed in 2024. On September 1, 2026, a federal appeals court upheld it against a challenge from two manufacturer trade groups. The exemption now has to be renewed again, and AdvaMed has filed comments opposing renewal, saying the earlier record no longer supports it.
So the fight continues. What's interesting is what it keeps coming back to.
What did the FDA actually find?
In May 2018, Congress asked the FDA a simple question: is third-party servicing of medical devices a safety problem? The FDA's answer is worth reading in full.
Its headline finding: "many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices." It called the continued availability of third-party servicers "critical to the functioning of the U.S. healthcare system." It found that the available objective evidence was not enough to conclude there's a widespread public health problem, and it did not recommend new regulation of servicers.
But read the rest of the report and a second finding shows up, again and again. The FDA couldn't answer the question as fully as it wanted, because the records weren't good enough.
The agency searched its adverse event reports for ones that mentioned a third-party servicer and found thousands. In most of them, it couldn't tell whether the servicing caused the problem. In the FDA's own words, most reports "do not include detailed information concerning the servicing history of the medical device." It also noted that a missing service history can make troubleshooting harder in the first place.
That's the government's own finding, and it cuts both ways. The FDA couldn't show independent servicing is dangerous. It also couldn't show, with hard numbers, how good anyone's servicing is: the manufacturer's, the ISO's or the in-house team's. The evidence ran out at the work order.
Why does the service record keep coming up?
Because it's the only place the answer could be.
If you want to know whether a repair was done well, you need to know what was wrong, what was checked, what was replaced, how it was tested and whether the same fault came back. That's not a policy question. It's a documentation question.
Here's what a lot of HTM programs actually have instead. A resolution note that says "repaired, tested, returned to service." A failure cause code picked at closeout. A vendor visit that exists as a PDF attached to the work order, unread by any report. None of that is anyone's fault. Techs are busy, the notes get written at the end of the shift, and nobody designed the CMMS to hold the story of the repair. We've written before about why that gap matters for data quality and what gets lost when the vendor's report stays a PDF.
Multiply that by every hospital in the country and you get the FDA's problem. Thousands of adverse event reports, and no way to tie them back to the work.
Even the manufacturers' side wants better records. AuntMinnie reported that AdvaMed is asking for consistent standards for repair documentation, applied equally to manufacturers and third parties. People disagree about almost everything else in this debate. On the need for a better repair record, they mostly agree.
What does this mean for your shop?
You don't have to pick a side in the policy fight to feel it on your bench.
Ask your team a question: is your newer equipment harder to service than the gear it replaced? Is service software or access locked on systems where the older models came with an open manual? If the answer is yes, every decision about who services what, and whether a fleet can be kept running, will lean on your own history.
Whoever services a device, your team, an ISO or the manufacturer, you'll want a record that can answer:
What failed, in plain words, not just a code?
What did the tech check before finding the fix?
What parts went in, and did the same part keep coming back?
What did the vendor's engineer actually do on each visit?
If your records can answer those, you have something few programs have: evidence. It helps at survey time, it helps when a fleet nears end of support, and it helps any time someone asks whether service was done well.
Where does Leera AI fit?
Leera AI doesn't take a side in the right to repair debate. The record works the same for an OEM engineer, an ISO tech and your own team.
Leera AI is a voice copilot for HTM technicians. The tech talks through the repair while doing it: what the device was doing, what they checked, what didn't work, what did. Leera AI drafts complete notes in your shop's format, the tech reviews and approves, and the notes are written into your CMMS. Leera AI sits on top of your CMMS and syncs with it via API.
Vendor service reports work the same way. Forward the report by email and Leera AI turns it into work order fields: what was done, which parts, how long. A person approves before anything is written. The vendor's visit becomes part of the device's history instead of an attachment.
Leera AI is built in the field with HTM teams at major US health systems. The policy fight will take years. The record of what your team did this week can start today.
FAQ
Are medical devices covered by right to repair laws? Mostly not. Seven states have passed right to repair laws, and they mainly cover consumer products. Colorado and Minnesota explicitly exclude most medical equipment, and no state law has opened up medical device servicing.
What did the FDA's 2018 report on third-party servicing conclude? The FDA found that many manufacturers and third-party servicers provide high quality, safe and effective servicing, and that third-party servicing is critical to the US healthcare system. It also found the available evidence wasn't strong enough to conclude there's a widespread safety problem, partly because most adverse event reports lacked servicing history.
What is the DMCA medical device repair exemption? It's a rule from the US Copyright Office, first adopted in 2021 and renewed in 2024, that lets independent servicers get past software locks when needed to diagnose, maintain or repair medical devices. A federal appeals court upheld it in September 2026, and it is now up for renewal again.
Why does service documentation matter in the right to repair debate? Because both sides argue about evidence, and the evidence of how well a device was serviced lives in the service record. When records only say "repaired, tested, returned to service", nobody can show how good the work was, whoever did it.
Dima Okhrimchuk is the founder of Leera AI, which builds voice-first documentation for HTM teams. Leera AI is built in the field with HTM teams at major US health systems.