HIPAA Journal

DECEMBER 8, 2022

Mark Warner (D-Va) recently published a white paper framing cybersecurity as a patient safety issue. Warner says the white paper is a starting point to open up a discussion about changes that can be implemented to improve cybersecurity in the sector, rather than a blueprint for change.

HIPAA 104

HIPAA FDA Governance Hospitals 104

HIPAA Journal

NOVEMBER 16, 2022

healthcare organizations, the Food and Drug Administration (FDA) asked MITRE to develop a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook to help hospitals and healthcare delivery organizations (HDOs) develop a cybersecurity preparedness and response framework.

FDA 82

FDA Ransomware HIPAA Hospitals 82

HIPAA Journal

NOVEMBER 4, 2022

The white paper suggests several areas where policies could be changed to improve cybersecurity in the healthcare industry. Cybersecurity can no longer be viewed as a secondary concern; it must become incorporated into every organization’s – from equipment manufacturers to health care providers – core business models.”.

HIPAA 114

HIPAA Governance FDA Medicaid 114

Dot Compliance

FEBRUARY 23, 2024

For instance, a user could query a generative AI model trained on FDA life sciences regulations about AI use in drug development, and the model would provide a summary based on its training data. Choose an eQMS provider with proven life sciences industry expertise and a platform preconfigured to industry standards like FDA, ISO, and GxP.

FDA 52

FDA Regulatory Compliance Compliance 52

Health Populi

JUNE 5, 2022

Its longer more formal name was The Drug Price Competition and Patent Term Restoration Act of 1984, and it created a pathway for generic drug applications to the FDA. the good old days of bipartisan policy making…another topic for another post]. This turbocharged a viable market for generic drugs in the U.S.,

Overpayments 149

Overpayments Overpayment Medicare Medicare 149

Dot Compliance

MARCH 7, 2023

FDA 21 CFR part 11 requires a manufacturer to perform “Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.” This should include an initial test of the system permission settings for performance and functionality.

Compliance 40

Compliance FDA 40