How does the law regulate the use of medical imaging technology in biomedical research?

In Nebraska, biomedical research involving medical imaging technology is regulated by both state and federal laws. Nebraska Revised Statute 71-3,071 requires biomedical researchers to obtain written informed consent from subjects for any research involving the use of medical imaging technology. This includes any research activities that involve exposure to radiation, such as X-rays, computed tomography (CT), or magnetic resonance imaging (MRI). The U.S. Food and Drug Administration (FDA) has issued guidance to ensure compliance with its imaging device standards. The FDA’s regulations require the use of trained personnel for all inquiries involving medical imaging technology and the use of properly labeled software and equipment. In addition, the Nebraska Department of Health and Human Services (DHHS) has adopted policies to ensure the proper use of medical imaging technology in biomedical research. These policies include requirements on the use of medical imaging technology in research, such as safety protocols, proper training, and protective equipment for personnel and research subjects. The Nebraska Radiation Control Act requires the DHHS to license, inspect, and monitor the use of medical imaging technology within the state. Licensing of medical imaging technology requires approval from the DHHS in order to use the technology in biomedical research. Furthermore, the DHHS requires reported incidents related to medical imaging technology use to be reviewed and investigated. By following the laws and regulations outlined by the Nebraska state government and the FDA, biomedical researchers in Nebraska are held accountable for the proper use and handling of medical imaging technology for research purposes. This helps ensure the safety of both research personnel and research subjects.

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