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5 largest medical data breaches since 2009

Becker's Health IT

The healthcare industry has been a favorite target of hackers, with nearly 5,000 data breaches affecting more than 342 million medical records since 2009, according to an Aug. 24 analysis by researcher Comparitech.

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Changes to the Health Breach Notification Rule Include Regulations for Health Apps

Wyatt Law Blog

The Federal Trade Commission (“FTC”) has issued a Final Rule, finalizing changes to the Health Breach Notification Rule first issued in 2009 (the “2009 Rule”). Vendors who maintain personal health records will soon be subject to amended rules for notifying customers of data breaches.

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False Claims Act Retaliation Decision Calls into Question the Heightened Burden for Employees Whose Duties Include Compliance and Fraud Investigation

Hall Render

Since 2009, the FCA’s anti-retaliation provision,(codified at 31 U.S.C. Prior to 2009, the FCA’s anti-retaliation provision more simply prohibited retaliation against an employee for conduct that was “in furtherance of an action under this section.” This category of individuals is sometimes called a “fraud alert employee.”

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Advancing Nationwide, Trusted Health Information Networks

HealthIT Answers

By Seth Pazinski, Peter Karras, & Kim Lundberg - Health IT has become integral to health care delivery and this trend has accelerated since the passage of the HITECH Act of 2009.

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European Union Debates Further Patent Protections

Bill of Health

Currently, SPCs are being regulated by Regulation 469/2009. To resolve this problem, in 2009 the European Court of Justice has ruled that a second SPC for the same product can be granted on the basis of a different patent owned by a different patentee. This rule is also known as one certificate per product per patent per patent holder.

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Monthly Round-Up of What to Read on Pharma Law and Policy 

Bill of Health

Dose modification rules and availability of growth factor support: A cross-sectional study of head-to-head cancer trials used for US FDA approval from 2009 to 2021. Olivier T, Haslam A, Prasad V. Eur J Cancer. 2022 Sep;172:349-356. Epub ahead of print. Walia A, Haslam A, Prasad V. FDA validation of surrogate endpoints in oncology: 2005-2022.

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What is the FTC’s Revised Health Breach Notification Rule?

Compliancy Group

In 2009, the Federal Trade Commission (FTC) implemented the Health Breach Notification Rule (HBNR), to provide security protection for consumer digital health information. Since 2009, digital health platforms have grown more complex. The 2009 HBNR definitions of regulated technologies do not cover these newer forms.

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