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Is Edward Snowden a Whistleblower?
Goldstein: Expect More Litigation in Wake of Myriad Gene Patent Decision
As More States Implement Social Media Password Laws, There’s Still Some Blind Spots
Patent Series: Protecting inventions
Trademark Series: Use-based trademark protection
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Mobile App Series: Privacy by Design
Unique Privacy Concerns for Mobile Apps
Instapundit: America's IP Laws Need to be "Pruned Back"
Unprecedented Global ATM Heist Presents a Number of Lessons for Companies
With Radical Changes, Law Firms Can Beat Recession
[Legal Perspective] When Is It NOT Okay to Delete Your Social Media Account?
Tips for Mobile App Privacy Compliance
Video Sharing App Vine Hit with Takedown Notice from Prince
Can You Patent Human Genes? ACLU Says No
Cybersecurity Lobbying Booming: How Law Firms Can Profit
Social Media Law Report - Who Owns Your LinkedIn Account, FTC Guidance on Social Ads, More...
Your Employer Doesn’t Own Your LinkedIn Account, and They Shouldn’t Try To
HHS OCR announced today its second resolution agreement of 2013. Shasta Regional Medical Center (SRMC) has agreed to pay $275,000 and enter into a comprehensive corrective action plan (CAP) to settle an investigation opened...more
FDA issues safety communication and draft guidance clarifying that manufacturers are responsible for addressing cybersecurity risks related to their medical devices....more
In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices....more
In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more
On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. ...more
In January 2013, The U.S. Department of Health and Human Services released the HIPAA Omnibus Rule in the Federal Register, the most significant changes to the HIPAA regulations since they were first promulgated. ...more
In an age in which safeguarding the privacy of a person’s information is becoming increasingly challenging, the National Institute of Standards and Technology (NIST) encourages organizations to devote time and resources to...more
For a Legal Perspective on today's much-anticipated U.S. Supreme Court "Myriad" decision that naturally occuring substances are not patentable, we turned to IP attorneys writing on JD Supra...more
Full text copy of the unanimous U.S. Supreme Court ruling in Association for Molecular Pathology v. Myriad Genetics that human genes may not be patented because they occur naturally in nature. From Greg Stohr writing for...more
HIPAA, as enacted in 1996, directed the U.S. Department of Health & Human Services (DHHS) to issue regulations requiring health plans to protect the privacy of health information and to provide reasonable and appropriate...more
In March 2013, the National People’s Congress of China formally changed the name of the State Food and Drug Administration (SFDA) to the China Food and Drug Administration (CFDA), elevating it back to a ministerial-level...more
In this issue: - Best Patent Practices Under the America Invents Act - CMS Issues Final Rule for Implementing Sunshine Act - New IP Litigation Team a Boon for Firm's Life Sciences and Technology Clients -...more
In This Issue: Leading the News; Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more
On May 17, 2013, the U.S. District Court for the Northern District of Georgia issued an order that joins an unsettling line of decisions suggesting that before filling prescriptions, pharmacies must serve as the arbiters of...more
Laboratory-developed tests (“LDTs”) appear to be under FDA’s microscope once again. These tests, which include genetic tests, companion diagnostics, and genetic tests, are developed and performed by a laboratory and have been...more
The Department of Health and Human Services recently amended the Health Insurance Portability and Accountability Act regulations (“HIPAA Rules”) in a way that may make many companies, particularly those in the technology...more
To incentivize whistleblowers to bring false claims promptly to the government’s attention, the False Claims Act (FCA) includes a so-called “first-to-file rule“ (31 U.S.C § 3730(b)(5)), which bars a person other than the...more
Idaho State University (ISU) was recently the target of an investigation and enforcement action for violations of the privacy and security rules of the Health Insurance Portability and Accountability Act (HIPAA)....more
Companies which fall under the enforcement axe usually learn from their mistakes....more
A small drug company that was bought last year by Bausch & Lomb has pleaded guilty to bribing doctors to prescribe eye pain drug Xibrom for unapproved uses and will pay $33.5 million in fines to settle both a criminal and...more
Starting June 17, state Medicaid Fraud Control Units (MFCUs) can use federal funding to pay for data mining, according to a final rule published by the Department of Health and Human Services Office of Inspector General in...more
As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more
In late May, the U.S. Food and Drug Administration took regulatory action against a mobile medical application or "mHealth" app for the first time. In its "It Has Come to Our Attention" letter to Biosense Technologies Private...more
The need for innovation in healthcare has arguably never been greater. Originally Published in Navigating The Capital Crunch - April 15, 2013. ...more
In an effort to improve patient care, the Centers for Medicare and Medicaid Services (“CMS”) established electronic health record (“EHR”) Incentive Programs, which provide financial incentives for the “meaningful use” of...more
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