United States – October 17, 2026 -- AdvaMed has told the U.S. Copyright Office that software built to diagnose, configure and service a medical device is a distinct product and should not be treated like the software that operates the device.
AdvaMed separates clinician-facing software from servicing tools
The trade group's comments contrast two categories. One is software clinicians use to operate an imaging system. The other is software designed specifically to diagnose, configure and service that system. AdvaMed compares the split to a vehicle's operating software versus the specialized diagnostic tools technicians use to repair it. In its framing, one enables use of the product, while the other is a standalone tool with its own functions, users, protections and market.
Service software is licensed separately and moving to the cloud
In medical technology, servicing and diagnostic software is often licensed separately and protected by separate access controls. It is increasingly delivered through cloud-based platforms rather than residing on the device itself.
AdvaMed says lawful repair routes already exist
AdvaMed says the question before policymakers is not whether medical devices can be repaired. It states that lawful avenues for accessing service software and documentation exist today and are widely used. The open issue, as the group frames it, is whether software created, licensed and distributed as a separate product should receive the same legal treatment as software embedded in a device's operation.
AdvaMed says the answer will increasingly affect innovation, intellectual property rights, cybersecurity and patient safety as healthcare and other industries rely more on specialized software. The group adds that the classification question extends beyond healthcare, because how software is classified often determines how it is protected.