Course Description

410.702 - Biomedical Software Regulation

Software continually grows more complex and is becoming relied upon by health care professionals in the treatment of patients. This course describes how the U.S. government regulates software used in delivering health care, including the regulations utilized by the Food and Drug Administration (FDA), as well as, the Center for Medicare and Medicaid Services (CMS). This course covers a wide range of topics, including: FDA regulation of software as a medical device and software validation, medical imaging software regulation, electronic recordkeeping and software used in clinical trials, laboratory information management systems (LIMS), and HIPAA privacy rules and security standards.