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.

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HIPAA FDA Governance Hospitals 115

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.”.

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HIPAA Governance FDA Medicaid 125

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.

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FDA Ransomware HIPAA Hospitals 96

HIT Consultant

JUNE 26, 2024

” – The paper sheds light on the critical issue of racial and ethnic diversity in clinical trials, exploring current industry initiatives, their effectiveness, and the future landscape shaped by the FDA’s evolving guidance. .

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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.,

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Overpayments Overpayment Medicare Medicare 154

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.

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FDA Regulatory Compliance Compliance 52

Dot Compliance

OCTOBER 11, 2024

Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers. Download our white paper , “A Step-b-Step Guide to Choosing an eQMS,” to learn more about CAPA and other key capabilities you need in your solution.

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Pharmaceutical Industry Regulatory Compliance Compliance FDA 52