The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was adopted to ensure health insurance coverage after leaving an employer and also to provide standards for facilitating health-care--related electronic transactions. To improve the efficiency and effectiveness of the health-care system, HIPAA included administrative simplification provisions that required DHHS to adopt national standards for electronic...
FDA Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries, with some specific exceptions, to implement controls, including...
The new regulations require health care providers, health plans and other entities covered by HIPAA (Health Insurance Portability and Accountability Act) to inform individuals when their protected health information (PHI) is compromised. In cases where more than 500 people are affected by a data breach, health care providers and other HIPAA-covered entities must promptly inform...