MEDICAL DEVICE STANDARDS – FDA Guidance
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 [...]
MEDICAL DEVICE STANDARDS – FDA Regulations
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 [...]
Careless Handling of PHI Violates Patient Privacy
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 [...]
UMASS Settles Potential HIPAA Violations Following Malware Infection
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 [...]
$2.14 million HIPAA settlement underscores importance of managing security risk
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 [...]