MITA Says Copyright Office Recommendation Would Undermine Medical Device Safety and Put Patients at Risk

Oct 28, 2021, 14:09 PM

Washington, D.C – The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices – said today 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.  

In comments submitted to the Copyright Office, MITA explained that, while original equipment manufacturers (OEMs) are regulated by the Food and Drug Administration (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. 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,” said Patrick Hope, Executive Director, 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 pointed out that disabling of TPMs 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.  


MITA is the collective voice of manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging innovations. These products include: magnetic resonance imaging (MRI), medical X-Ray equipment, computed tomography (CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information systems. MITA Member company technologies are an important part of our nation’s healthcare infrastructure and are essential for the screening, diagnosis, staging, managing and effectively treating patients with cancer, heart disease, neurological degeneration, and numerous other medical conditions.