The feds issued a final rule on Thursday that will pave the way for device owners to maintain and repair their medical imaging equipment, quashing a previous copyright barrier.
Under the exemption to the Digital Millennium Copyright Act, servicers can now work around medical device security controls to access software for the purposes of maintaining or restoring a system. The Library of Congress has opted to move forward with the change, as recommended by the Copyright Office Registrar.
Avante Health Solutions, a provider of diagnostic imaging equipment and repair services, praised the decision Friday.
“This is significant to healthcare systems looking for affordable options to maintain and repair expensive medical equipment and associated devices,” President and CEO Steve Inacker said in a statement. “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.”
Meanwhile, the Medical Imaging & Technology Alliance, which represents the original imaging equipment manufacturers, slammed the Copyright Office Registrar’s recommendations. MITA believes that allowing independent service organizations to access the technology operating imaging devices will lead to “unnecessary safety and security risks” for patients.
The lobbying group maintained that manufacturers are regulated by the Food and Drug Administration, while independent servicers do not face the same scrutiny. It’s also concerned this change would expose manufacturers’ intellectual property to competitors and the public, allowing for replication that could “severely” harm the industry.
“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,” MITA Executive Director Patrick Hope said Oct. 28. “We intend to continue to advocate against this misguided approach,” he added later.
The Library of Congress published the final rule Thursday, listing Oct. 28 as the effective date. You can read the full exemption in the Federal Register here.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.