Tag Archive: privacy

Data Security, Protection and the US-EU Privacy Shield: Part 2

Data Security, Protection and the US-EU Privacy Shield: Part 2

Bart Cobert reviews the key requirements for the US-EU Privacy Shield, including implications for US Firms, Pharma Companies, and Drug Safety & Pharmacovigilance

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Data Security and Privacy Part 1

Data Security, Protection and the US-EU Privacy Shield: Part 1

Bart Cobert reviews the HIPAA and current EU data privacy system and their impacts on drug safety and PV.

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Bart’s Corner: The Sentinel and Mini-Sentinel Initiatives

In 2008 in response to criticism and some safety issues and product withdrawals, FDA took a look at itself – with some outside help such as the FDA Amendments Act (FDAAA). This new law mandated the FDA to establish an active surveillance system for monitoring drugs using electronic data from[…]

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Safeguarding Patient Data – Part Two: 5 Tips for Maintaining a Constant Working Posture for Privacy

In our last post on safeguarding patient data, we discussed the opportunities and challenges facing healthcare companies with today’s increase focus on data, including the high stakes of a patient data security breach. For every industry, there are multiple entities that proactively assist a corporation in their recognition and enforcement[…]

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Safeguarding Patient Data – Part One: More Data, More Opportunities for a Breach

Data. Indeed, it may be one of year’s biggest buzzwords, but data’s impact and possibilities for the healthcare industry continue to have many insiders, myself inclused, very excited. Its potential for increased efficiencies and effectiveness in providing a more comprehensive care is vast. But many questions still remain: how do[…]

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Operational Tweaks Can Greatly Reduce PHI Breach Risk

After four years of anticipation, 45 CFR Parts 160 and 164, or HIPAA’s Ominibus Rule as it is more commonly known, went into effect on March 26, 2013, with corporate compliance required by September 23, 2013. Omnibus puts into law many things left unclear in previous HIPAA-related rulings, including requiring[…]

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