By Tom Leary MA, CAE, FHIMSS, executive director of HIMSS Foundation
When President Donald J. Trump signed into law the FY2026 National Defense Authorization Act (NDAA) in mid-December, the bill’s 65th consecutive passing had largely bipartisan support. Knowing the significant role the NDAA has in shaping national policy from my time working in the defense community early in my career, I am struck by the growing debate spilling beyond the defense sector into the healthcare ecosystem on the “right to repair” provision.
“Right to repair” refers to policies that require manufacturers to provide consumers and independent repair providers with access to the tools, parts, software, and documentation needed to repair products. Although right-to-repair provisions were ultimately removed from the final FY2026 NDAA, the debate unfolding on Capitol Hill underscores a critical truth: In some sectors, repair is a matter of public safety.
Nowhere is that more evident today than in healthcare. Over the past several decades, advances in medical technology have changed what modern healthcare can achieve. Robotic surgical equipment, complex monitoring devices, and artificial intelligence-enabled diagnostics are redefining patient care. As the world’s healthcare tools become more powerful, however, they also become more complex. Repairing and maintaining these devices is much more than just tightening a bolt. When it comes to intricate networks of software and data systems, the consequences of a less-than-perfect repair directly impacts patient safety. Safe repair sits at the very foundation of trust in our health system.
Broad proposals emerging across the country to extend “right to repair” mandates to medical equipment warrant careful scrutiny. In some cases, in other industries, expanding repair makes sense. For farming equipment, household appliances, and personal electronics, more repair options can empower consumers. But extending those same mandates to medical devices overlooks a fundamental reality: When lives are at stake, there is zero room for error. Fixing a cracked phone screen is not the same as updating an MRI machine, a task that requires expertise and precise standards. As our medical technology continues to evolve, so must our standards.
The global HIMSS community understands this well. With a membership of more than 135,000 clinicians, digital health experts, researchers, and healthcare leaders, we see every day the level of precision that medical devices require and the expertise needed to maintain them. In our digitally interconnected world, even small errors can lead to large failures, ultimately impacting patient outcomes and treatment plans.
This is where federal oversight comes in. Original medical equipment manufacturers are required to follow the Food and Drug Administration’s Quality System Regulations, which include rigorous training standards, mandatory adverse-event reporting, and detailed fixing protocols. These requirements are built-in safeguards that keep patients safe.
Yet right-to-repair mandates would open access to unregulated third-party repair options that are not held to these same high standards. They face no federal quality standards, no reporting requirements if a repair goes wrong, and no measures to ensure consistency.
As the devices the healthcare industry uses grow more advanced, the risks also increase. A single miscalibrated component can distort imaging results. An incomplete software update can expose hospitals to cybersecurity threats. A repair performed without full knowledge of the device’s inner mechanics can compromise its ability to work. When patient health and safety rely on precision, oversight matters just as much as innovation.
There is another cost to consider: the impact on the pace of technological advancement. Because many right-to-repair mandates are written broadly, imposing standards essentially requires device designs to be simplified so anyone can fix and maintain them. In practice, this discourages the very innovation that drives medical technology forward. Manufacturers may be pushed to limit design features to comply with repair access requirements. At a time when the global health community is moving toward smarter, more secure systems, policies that inadvertently constrain innovation are counterproductive.
The effects also impact the workforce. Maintaining today’s devices requires specialized knowledge of clinical awareness, engineering, and cybersecurity. Hospitals rely on repair personnel who understand the devices and the environments in which they operate. Introducing unregulated third parties into the system creates uncertainty and inconsistent repair quality, putting more burdens on our workforce. As a healthcare community, our goals should be to facilitate a resilient workforce. Lowering the qualification standards for those who service medical devices undermines that effort.
Policymakers do not need to decide between innovation and safety. They simply need to recognize that medical devices are different from consumer products. Applying right to repair to health technologies without proper safeguards jeopardizes patient safety and the healthcare system alike.
HIMSS was founded to create an informed and empowered community, one that bridges visionary ideas with practical execution. Our vision is to realize the full health potential of every human, everywhere. Our mission is to reform the global health ecosystem through the power of information and technology. That mission requires a repair environment that is accountable and grounded in the highest standards of safety, which a one-size-fits-all repair mandate cannot deliver. A commitment between lawmakers, manufacturers, and clinicians will ensure that every repair meets the level of precision that modern healthcare demands.
Safe repair is a matter of human health, and when lives are at stake, protecting patients must remain the highest priority.
About the author: Tom Leary is the Executive Director of the Healthcare Information and Management Systems Society (HIMSS) Foundation.
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So HTMs in hospitals and third parties are only able to “tighten a bolt” and are only able to perform “less than perfect repairs” compared to the manufacturer’s field service technician coming through our doors? How insulting! Minimizing the in-house and third-party technicians, then show how much more complicated the repairs are for the manufacturer’s technician is a complete and utter farce. How about this…allow us to obtain the tools to make “precise repairs” at an affordable amount (if we’re even making an imprecise repair in the first place)? Novel idea, huh? No, manufacturers don’t want to do that as they want to keep a stranglehold in this industry. This has nothing to do with patient safety and everything to do with money. If the manufacturers, you represent, are so worried about patient safety, why not provide us these same tools?
Apparently HIMSS is focused on fearmongering instead of the truth in our industry. Are all manufacturer representatives, who are performing the repairs AAMI Certified? If not, what independent regulatory agency is out there shows the manufacturer’s technicians are more qualified to perform these repairs? I passed my CBET exam as well as many others which shows we have a strong core foundation of knowledge yet the technicians the manufacturer hires have more qualifications and has a stronger foundation? Give me a break!
Studies have shown in 24×7 magazine, what you state in your article as completely false. The quality of repairs performed by the manufacturer vs an in-house group is negligible. HTMs have a pride of ownership to the customers/departments we serve. I’ve actually gone to third party in an instance not due to price; rather the manufacturer wasn’t paying anyone enough to take a job to cover our area, we (the customer) were waiting weeks, sometimes months to get a manufacturer’s field service technician through our doors. Third party technician came in and was able to find the manufacturer’s previous repair was performed incorrectly and was causing the malfunction. In addition, I’ve sent manufacturers repairs where I told them the exact issue, they find “nothing wrong”, send it back, during my initial examination of the equipment (right out of the box), the same problem persists when initially sending it out, so I send it out again and the bill was $4000 USD (new unit was $5500 mind you). Heck, one company charge $800 for a screw to be replaced and to put in their “magic poxy”. Leaving it up to the manufacturers to perform repairs gives them more of a monopoly than they already have, upcharge even more, and provide poorer service as they’re focused on margin than patient safety. Not giving us the right-to-repairis placing the fox in the hen house and our healthcare system will feel the pain.
Since HIMSS Conferences was acquired by Informa Markets, you know that HIMSS will no longer represent the needs of their members but will bend to the needs of Informa Markets and its major sponsors, such as Philips (which has been one of the biggest opponents of the Right to Repair).
The connection between Informa Markets and Philips (specifically Royal Philips) lies primarily in the healthcare, medical technology, and engineering sectors. Philips frequently participates as a major exhibitor, sponsor, and key speaker at Informa Markets’ global business-to-business (B2B) trade shows and conferences.The relationship between the two organizations centers around several key areas of collaboration:Global Healthcare Exhibitions: Philips is a leading presence at major Informa medical exhibitions worldwide, including Arab Health in the Middle East and the Global Health Exhibition in Saudi Arabia. At these events, Philips showcases its latest diagnostic equipment, artificial intelligence (AI) imaging, and virtual care platforms.MedTech Conferences & Thought Leadership: Informa Markets’ Engineering division (which produces events like Advanced Manufacturing and media like MD+DI) regularly hosts Philips executives. For instance, Philips regulatory and innovation leaders frequently deliver keynotes on topics like AI in medical devices and compliance.Industry Media Coverage: Informa Markets’ engineering and medical news portals provide continuous industry coverage of Philips’ corporate milestones—such as the FDA clearance of the Verida detector-based spectral CT machine—as well as market analyses of the company’s supply chain shifts.
Dear Mr. Leary,
Thank you for your thoughtful article on the importance of safe medical device repair and its role in advancing global health. I appreciate your focus on patient safety, increasing technological complexity, and the importance of maintaining high standards in device servicing, principles that those of us in healthcare technology management (HTM) fully share.
However, I believe the discussion would benefit from a more balanced representation of the capabilities, accountability, and real-world contributions of in-house clinical engineering teams and qualified independent service organizations (ISOs).
No one understands the patient, the clinical environment, and the realities of patient safety more intimately than HTM professionals working inside hospitals every day. Whether serving in-house or independent ISOs, these professionals operate within the environment of care, alongside clinicians, responding in real time to patient needs and ensuring that critical equipment is safe, functional, and ava