FDA Guidance Docs are topic-specific and should be read and evaluated for applicability. Generally, companies should consider Guidance docs to have same force as Sec 820 regulations. The FDA normally publishes Guidance to clarify issues in CFR, or to provide updated material. FDA archives Guidance docs on their website, but companies should keep important guidance items [...]
These are statutory laws published in the Code of Federal Regulations, CFR. Primarily documented in Sec 820, they create the legal foundation for compliance. Company management should be familiar the scope and content of this material. They are also the foundation of ISO 13485.
May 2017-----The U.S. Department of Health & Human Services(HHS), Office for Civil Rights (OCR), has announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement based on impermissible disclosure of protected health information (PHI). St. Luke’s-Roosevelt Hospital Center Inc. (St. Luke’s) has paid HHS $387,200 to settle potential violations of the HIPAA Privacy [...]
The University of Massachusetts Amherst (UMass) has agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. The settlement includes a corrective action plan and a monetary payment of $650,000, which is reflective of the fact that the University operated at a financial loss in [...]
St. Joseph Health (SJH) has agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules following the report that files containing electronic protected health information (ePHI) were publicly accessible through internet search engines from 2011 until 2012. SJH, a nonprofit integrated Catholic health care delivery [...]
