THE U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) acts as the leading agency for the essential role of regulating telemedicine and telemedicine devices. The software and devices utilized in providing telemedicine services must safely and effectively provide medical consultation while protecting from the risk of breaching private information. Some of the center’s main responsibilities include the following:
• Premarket review
• Post market surveillance
• Quality systems and standards
• Science relating to telemedicine
To ensure the utmost privacy and safety when medical devices are used to diagnose or treat a disease or condition through telemedicine, the FDA’s requirements include, but are not limited to, the following:
• Registration and listing
• Premarket notification and/or approval
• Good manufacturing practices
• Post market surveillance
The FDA also regulates the software that is utilized in telemedicine, with a focus on defining software that is specifically intended for the storage, processing, and display of medical images.
In addition to the FDA’s Center regulations, each state may vary on telemedicine procedures, so it’s essential for providers to analyze both the FDA and state regulations to ensure compliance.
CREDIT
column by CELESTE JO WALLS
Celeste Jo Walls is managing editor of Central Florida Doctor magazine. She may be reached by e-mail at celeste.walls@centralfloridamediagroup.com.