In a statement, the Medical Imaging and Technology Alliance (MITA) argued that the U.S. Copyright Office recommendation to allow “unregulated independent service organizations (ISOs) to access and copy the technology that operates medical imaging devices would create unnecessary safety and security risks for patients.”

Moreover, in comments submitted to the Copyright Office, MITA asserts that, while original equipment manufacturers (OEMs) are regulated by the U.S. FDA, ISOs are not subject to the same quality control, training, and reporting requirements. Having disparate levels of FDA regulation, training, and quality control increases patient risk and the threat of cyberattacks on hospitals, the association argues. MITA also maintains that allowing ISOs to legally hack into imaging systems raises these risks exponentially. 

“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,” says Patrick Hope, executive director of MITA. “Current intellectual property protections for OEMs do not prevent ISOs from servicing equipment, and, in fact, OEMs can service other manufacturers’ equipment without hacking into it. This recommendation would increase the risk of harm for patients and healthcare providers since third-party servicers are not regulated by the FDA. We intend to continue to advocate against this misguided approach.” 

MITA further argues that disabling technological protection measures would expose intellectual property—including valuable know-how in addition to the copyrighted information—to competitors and the general public. That itself would severely harm OEMs by allowing competitors to view and replicate valuable innovations, the association asserts.

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