The Food and Drug Administration (FDA) regulates software functions that allow for a practitioner to manage patient care through the processing, manipulation, enhancement, or review of:

• A. Medical records
• B. Doctor's orders
• C. Patient images
• D. Patient referrals

Answer: (C)

Software that processes, manipulates, enhances, or reviews patient images is regulated by the FDA because it can directly change how an image is interpreted and, therefore, influence clinical decisions. When imaging software performs those kinds of operations, it functions as a medical device and must meet safety and effectiveness standards to ensure accurate, reliable results. By contrast, medical records, doctor’s orders, and patient referrals are administrative or data-management tasks that don’t typically alter the imaging data used for diagnosis, so they aren’t the focus of FDA medical device regulation.