A final rule was recently granted by the federal government that allows medical imaging equipment owners to repair their machines without intervention from the maker. This new rule shatters a copyright barrier that was previously in place.
An exemption to the Digital Millennium Copyright Act (DMCA) allows servicers to work around medical device security controls for the purpose of accessing software required to maintain or restore the system. The Copyright Office Registrar recommended the Library of Congress move forward with the change.
The Medical Imaging & Technology Alliance represents the original imaging equipment manufacturers and released a statement saying the recommendation to move forward will lead to “unnecessary safety and security risks” for patients.
In a statement, President and CEO of Avante Health Solutions said, “This is significant to healthcare systems looking for affordable options to maintain and repair expensive medical equipment and associated devices. Avante is thrilled, as this ruling builds on the FDA’s recognition of the merits and safety of the services provided by independent service organizations.”
The Medical Imaging & Technology Alliance (MITA) outlined that manufacturers are regulated by the Food and Drug Administration and independent technicians are not held to the same standards as they have a lower amount of scrutiny associated with their position.
Moreover, the alliance also voiced concern over whether manufacturers’ intellectual property would be exposed to the public, which would be detrimental to the industry.
“MITA Executive Director Patrick Hope said, “If this recommendation is ultimately accepted and implemented, it would amount to a license for unregulated third-party servicers to hack sensitive technology, creating grievous cybersecurity and patient safety risks. We intend to continue to advocate against this misguided approach.”
RadParts is the world’s largest independent distributor of OEM replacement parts. We specialize in low-cost parts for repairing linear accelerator and radiation equipment. Our mission is to provide high-quality, user-friendly, low-cost parts and support for linear accelerators and radiation equipment. Contact RadParts at 877-704-3838 or visit us on the web: https://www.radparts.com.
Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.