By K. Richard Douglas
The DIY movement could be said to have expanded and contracted simultaneously. The expansion can be found in the sheer numbers of resources available to DIY’ers in terms of information found on the Internet and video content created for that population.
The contraction has come by way of the decreasing number of people interested in working with their hands, using tools and learning the trades. Thankfully, there is still a faction of people who enjoy fixing things and completing home improvement projects by working with their hands. They keep companies that sell tools, calibration equipment and raw materials in business.
Many in the DIY community also like to repair and maintain items they own to extend a device’s usable lifespan, or to simply repair something that has stopped working. Often, information to achieve this end can be found online in content that other DIY’ers or professionals in the trades have posted as written content or as videos.
These home-fixit DIY’ers, along with technicians in repair shops and biomedical technicians all believe that they have a right to repair, with access from the manufacturer to the information and parts needed to achieve that end.
Manufacturers have often argued that the parts and repair information for their products, such as farm equipment, cellphones, tablets and other products is proprietary.
The only way to compel manufacturers to share the information and parts needed to do many repairs is through legislation. Lawmakers are working throughout the year in state legislatures and at the federal level to craft new laws and review regulations.
Lawmakers can also address the growing threat of cyberattacks and craft laws that address the many needs of cybersecurity and codify cybersecurity practices into health care practices and everywhere else that feels the impact of cybercriminals. Other regulations and policies are either enacted, sunsetted, revised or proposed. Some of these may impact biomeds and many don’t go through the legislative process, but result from actions by government agencies.
Some Successes
Those who have been actively lobbying legislators on behalf of the Right to Repair movement have seen some victories result from their efforts in the past year.
“Right to Repair had a banner year,” says Nathan Proctor, senior director, U.S. PIRG Campaign for the Right to Repair, referring to 2023.
He says that 30 states had active legislation and five states enacted new laws.
“First a consumer electronics Right to Repair bill was signed in New York, followed by a farm equipment law in Colorado. Minnesota then passed the broadest consumer and commercial equipment law to date. Next, California passed the strongest consumer device Right to Repair law we’ve seen so far. Next, voters in Maine decided, by a margin of 84 to 16 percent, to require car makers to allow access to repair data transmitted wirelessly,” Proctor says.
Although the trend bodes well for right to repair in the general sense, Proctor says that so far, medical devices have not been included, other than a measure concerning power wheelchairs in Colorado.
“But as more and more people become comfortable with the idea of right to repair, it has opened opportunities for us to make the case around medical devices,” he adds.
Medical Device Right to Repair Stalled
Many biomeds have experienced that moment in their careers where there is a sense of frustration as they are handcuffed figuratively by restrictions on access to parts or schematics/diagrams and the phrase “right to repair” becomes very real.
Just like the frustration of the DIY enthusiast, who just wants to repair something themselves, or the electronics technician who relies on information or parts from the manufacturer to make repairs, the biomed may just need to get a repair done quickly and outside forces hamper their best efforts.
The only solution is legislation that would compel the manufacturer to change their policies and recognize those in the after-market or repair industry with support to facilitate repairs.
While there hasn’t been much movement in legislation that directly benefits biomeds, there have been important developments within the Right to Repair movement, and as the old saying goes, “a rising tide lifts all boats.” The momentum gained in some areas improves the chances for favorable results in others.
Yet, those who go to bat for the entire Right to Repair movement have been disappointed that more focus hasn’t been put on medical device repair and maintenance. With the recent victories in car repair and farm equipment repair, the focus for legislators needs to be on the smaller, yet equally important, medical device repair and maintenance industry.
“Although it varies by state, momentum has been building at a federal level regarding the Right to Repair, pertaining to medical devices.
The DIY movement could be said to have expanded and contracted simultaneously. The expansion can be found in the sheer numbers of resources available to DIY’ers in terms of information found on the Internet and video content created for that population.
The contraction has come by way of the decreasing number of people interested in working with their hands, using tools and learning the trades. Thankfully, there is still a faction of people who enjoy fixing things and completing home improvement projects by working with their hands. They keep companies that sell tools, calibration equipment and raw materials in business.
Many in the DIY community also like to repair and maintain items they own to extend a device’s usable lifespan, or to simply repair something that has stopped working. Often, information to achieve this end can be found online in content that other DIY’ers or professionals in the trades have posted as written content or as videos.
These home-fixit DIY’ers, along with technicians in repair shops and biomedical technicians all believe that they have a right to repair, with access from the manufacturer to the information and parts needed to achieve that end.
Manufacturers have often argued that the parts and repair information for their products, such as farm equipment, cellphones, tablets and other products is proprietary.
The only way to compel manufacturers to share the information and parts needed to do many repairs is through legislation. Lawmakers are working throughout the year in state legislatures and at the federal level to craft new laws and review regulations.
Lawmakers can also address the growing threat of cyberattacks and craft laws that address the many needs of cybersecurity and codify cybersecurity practices into health care practices and everywhere else that feels the impact of cybercriminals. Other regulations and policies are either enacted, sunsetted, revised or proposed. Some of these may impact biomeds and many don’t go through the legislative process, but result from actions by government agencies.
Some Successes
Those who have been actively lobbying legislators on behalf of the Right to Repair movement have seen some victories result from their efforts in the past year.
“Right to Repair had a banner year,” says Nathan Proctor, senior director, U.S. PIRG Campaign for the Right to Repair, referring to 2023.
He says that 30 states had active legislation and five states enacted new laws.
“First a consumer electronics Right to Repair bill was signed in New York, followed by a farm equipment law in Colorado. Minnesota then passed the broadest consumer and commercial equipment law to date. Next, California passed the strongest consumer device Right to Repair law we’ve seen so far. Next, voters in Maine decided, by a margin of 84 to 16 percent, to require car makers to allow access to repair data transmitted wirelessly,” Proctor says.
Although the trend bodes well for right to repair in the general sense, Proctor says that so far, medical devices have not been included, other than a measure concerning power wheelchairs in Colorado.
“But as more and more people become comfortable with the idea of right to repair, it has opened opportunities for us to make the case around medical devices,” he adds.
Medical Device Right to Repair Stalled
Many biomeds have experienced that moment in their careers where there is a sense of frustration as they are handcuffed figuratively by restrictions on access to parts or schematics/diagrams and the phrase “right to repair” becomes very real.
Just like the frustration of the DIY enthusiast, who just wants to repair something themselves, or the electronics technician who relies on information or parts from the manufacturer to make repairs, the biomed may just need to get a repair done quickly and outside forces hamper their best efforts.
The only solution is legislation that would compel the manufacturer to change their policies and recognize those in the after-market or repair industry with support to facilitate repairs.
While there hasn’t been much movement in legislation that directly benefits biomeds, there have been important developments within the Right to Repair movement, and as the old saying goes, “a rising tide lifts all boats.” The momentum gained in some areas improves the chances for favorable results in others.
Yet, those who go to bat for the entire Right to Repair movement have been disappointed that more focus hasn’t been put on medical device repair and maintenance. With the recent victories in car repair and farm equipment repair, the focus for legislators needs to be on the smaller, yet equally important, medical device repair and maintenance industry.
“Although it varies by state, momentum has been building at a federal level regarding the Right to Repair, pertaining to medical devices.
Manufacturers use copyright laws to protect service information so users may not have access to important service information. Some states may have a Right to Repair law that may or may not include medical equipment. However, many states may not have enough leverage to induce manufacturers to comply,” says Barry Kohler, senior project officer in device evaluation at ECRI.
He says, for example, ECRI is aware that California and New York opted to not include medical devices in their right to repair laws.
“The Federal Trade Commission solicits input on renewing the Digital Copyright Act every three years. There is a window open for comments until December 22, 2023. The current administration seems more amenable to Right to Repair issues than previous ones. An exception to the digital copyright act for medical devices may reduce barriers to obtaining manuals and passwords required to properly service medical equipment,” Kohler says. (He was interviewed in early December for print deadline purposes.)
But, while the environment is becoming more favorable for the Right to Repair movement at the federal level, many states continue to exclude medical devices.
“Medical Right to Repair remains stubbornly elusive. We had a comprehensive bill which included medical equipment filed in Delaware by the Minority Leader (Republican), but the Speaker (Democrat) refused to move to a vote for purely political reasons. Bills in North Carolina and California for medical failed to advance. AdvaMed has been a very aggressive opponent and has really dominated in lobbying. More comprehensive bills which may be able to retain medical equipment are possible, but we doubt they will survive the first set of lobbying where legislators will be told that consumers will do their own pacemaker repair. Not joking,” says Gay Gordon-Byrne, executive director of The Repair Association.
Apart from state legislatures, the federal government hands down rules and regulations that impact HTM.
Proctor says that the impacts of a potential rule from the FDA on remanufacturing or cyber are significant.
“The remanufacturing rule would outline the conditions under which a device repair crosses the line and involves alteration. Because alteration might result in a device being unsafe or unpredictable, it would then be subjected to the standards the FDA puts on new devices (which also includes paying FDA device manufacturer fees),” he says.
Proctor says that the idea that people shouldn’t be deploying unpredictable and untested medical devices is not controversial, but there is controversy in this rule.
“It stems from the fact that the FDA doesn’t direct manufacturers to share enough technical information to biomeds to know exactly what might alter the device – and the draft rule gives manufacturers the ability to tattle on biomeds who they feel are in violation. This creates a terrible incentive for manufacturers to restrict critical information, retaliate against competitors by accusing them of altering devices when the biomeds servicing them don’t even have the information to perform service work exactly as the manufacturers would recommend,” he says.
“I, and other Right to Repair advocates, feel the only responsible path forward is to require manufacturers to share all the necessary service documentation with biomeds, so they have clear information about what the intended service is supposed to look like. Then, if the biomeds have that information and still make changes to the device, the FDA could step in and stop that,” Proctor adds.
Recent Legislation
A breakout of the initiatives voted on by state legislatures, and the more limited laws added to the books, finds that many include a narrow interpretation of what the consumer can do or which market the law applies to. Also, it appears that some politics have crept into the process.
“Colorado has statute now covering ag (agriculture) and a separate law for powered wheelchairs,” Byrne says.
She says that New York has a law unclearly limited to consumer electronics.
“It is unclear because the law that was passed by the legislature included electronics used by business, industry, government, education, etc. but the governor wouldn’t sign it unless B2B and B2G products were exempted. The dilemma is obvious – if I buy a business-class laptop for my LLC consulting business – is that product covered by statute? What about a doctor, lawyer, baker or deli,” Byrne says.
Byrne says that Minnesota has the broadest statute of all – including most everything in high-tech used by consumers and business under the logic that the buyer of the equipment is entitled to fix their owned equipment.
“For purely political reasons, the statute does not include agricultural equipment, medical equipment, fire alarm equipment and a few other oddities,” she says.
Byrne says that California passed a law covering mostly consumer products, including CE and home appliances.
“Several of the largest of the Silicon Valley OEMs changed their marketing to support legislation, in exchange for some not so wonderful concessions. We won’t know how these concessions will function in the real world. Two of the largest loopholes were pushed by Apple – one to allow Apple to continue to require they control ‘parts pairing’ and the other to set the start date back to July of 2021 – which only makes sense of requiring access to spare parts in the context of late-model equipment,” Byrne says.
She adds that there are several bills that were partially passed in 2023 and expect to finish up in 2024.
“Both Vermont and West Virginia are halfway done with bills to restore repair options for agricultural equipment. Most states are in the ‘short’ session of a two-year legislature – so relatively few new bills will be filed although we will see several filings that have been underway for a while,” Byrne says.
New Rules and Cybersecurity Considerations
Beyond Right to Repair legislation, other rules, regulations and policies may impact HTM professionals or point to best practices.
“Section 3305 of the 2023 Omnibus spending bill placed new requirements on medical device manufacturers, mostly as it pertains to approval for new or significantly updated devices. One change to be aware of is the FDA now requires a Software Bill of Materials (SBOM) from medical device manufacturers,” Kohler says.
He says that the SBOMs are lists of the software components within a device.
“Collecting this may aid in the risk assessment of medical devices. End users may be able to obtain them from their device manufacturers,” Kohler says.
On the topic of cybersecurity, he says that the Cybersecurity & Infrastructure Security Agency (CISA) maintains a list of cybersecurity vulnerabilities. These vulnerabilities are often tied to software components which can be used in medical devices.
“When CISA reports a known vulnerability, it can be difficult to identify the devices impacted. Often there is a delay while that information trickles from the discovery of the zero-day exploit, to the device manufacturer, to the end user. The SBOMs may allow faster notification to the manufacturers and allow end users to link devices to software components to known vulnerabilities in a more timely manner,” Kohler says.
He says that the new requirements apply to new device approvals.
“It would be easier for manufacturers to simply apply the same policies for cybersecurity to all their devices. So SBOMs may be submitted for legacy devices, as well as new submissions. Currently it is not well understood how the gathering of SBOMs will be implemented in a way that disperses actionable intelligence. ECRI has received reports that some manufacturers are providing SBOMs to customers,” Kohler adds.
Adding to what he has already stated about manufacturers providing biomeds with service documents, Proctor says that the risks on the cybersecurity guidance are very similar, but there are some key differences.
“If we set up a cybersecurity best practice that allows the manufacturer to control who accesses the equipment, say through a proprietary service key, that increases their ability to monopolize service. True cybersecurity best practices involve all hands-on deck – a hospital might be more able to manage cyber risk than the manufacturer – they certainly have more incentive,” Proctor says.
He says that it’s the hospitals and other health delivery organizations that are targeted in the attacks.
“We see manufacturers in the marketplace with a clear business plan to capture as much connected service revenue as possible, and in order to ensure a healthy marketplace, we can’t let cybersecurity become an excuse for manufacturers to monopolize access to devices. This model, known by security experts as ‘security through obscurity’ is both a bad business practice, and a bad security practice,” Proctor says.
On the Right to Repair front, hope can remain that a rising tide is set to benefit the HTM community, so it can join farmers and home mechanics. Cybersecurity will remain a growing concern and will evolve into the need for a growing body of knowledge. Some of that information will be the topic of the March TechNation cover story. In both Right to Repair and cybersecurity, there are experts working tirelessly to move the needle forward.