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Health Update - July 2014

Avoiding the Regulatory Land Mines of Commercial ACOs - While providers are showing great interest in creating ACOs to participate in the Medicare Shared Savings Program (MSSP), they are showing even greater enthusiasm...more

How is Graphene Currently Used and What is the Hope for the Future? [Video]

In the second video of a three-part series, Fenwick attorney Paul Smith talks about the growing anticipation surrounding this strong, conductive and flexible material. Why the excitement? Simply put, graphene is easy. It’s...more

What is Graphene? Fenwick Patent Attorney Has the Answer [Video]

The technology and life sciences communities alike have been raving about new "wonder material" graphene for the past year. From applications for wearable devices to the creation of lightweight, bendable televisions and...more

Two Tips for Inventors Filing Patent Applications [Video]

The intense patent activity in graphene stems from its enormous technological and commercial potential. But because much of the territory underlying the graphene cross-roads has already been claimed, patenting graphene poses...more

FDA Plays Catch Up in the Digital Age

Part of JD Supra's series on innovation and the law. A look at how, as pharmaceutical manufacturers increasingly turn to social media to exchange information, laws and regulations that are decades old struggle to keep pace...more

Perspectives - January 2014

In This Issue: - Considerations in the Cloud: Managing the Risks - United States V. Sperry: A Revived Threat to Owners, Directors, Managers and Directors of Distressed Organizations - Board Membership &...more

Health Update - Jan 27, 2014

Going Digital with Patients: Managing Potential Liability Risks of Patient-Generated Electronic Health Information - Patients are increasingly using new electronic tools, such as personal health records and mobile...more

HHS-OIG Corporate Integrity Agreements Are Now Aiming at Corporate Directors and Executives

Corporate integrity agreements (CIAs) are a familiar feature of many civil False Claim Act and joint civil/criminal resolutions in healthcare fraud cases. These agreements are entered into between the defendant company and...more

Innovative Exit Strategies for Life Sciences Companies – Interview with Bill Whelan, Member, Mintz Levin [Video]

Attorney Bill Whelan, Co-chair of Mintz Levin's Life Sciences Practice, discusses exit strategies in the life sciences....more

The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin [Video]

Attorney Karen Lovitch, Practice Leader of Mintz Levin's Health Law Practice, discusses the challenges facing pharmaceutical and medical device manufacturers in complying with the Sunshine Act....more

Cloud Storage Providers Storing Protected Health Information May Be Obligated to Comply with HIPAA Regulations

A recently issued government rule may unknowingly create significant liability and legal risk for many technology enterprises. The expanded definition of "business associates" and related interpretations by the Department of...more

Physician Payment Sunshine Act Final Rule Released

In This Issue: - Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ...more

Digital Health: Revolutionizing Healthcare [Video]

What is digital health? What sort of action is digital health seeing? According to Fenwick client and digital health incubator Rock Health, digital health funding was up 65 percent mid-year in 2012 and up 45 percent over the...more

HIPAA Final Omnibus Rule Brings “Sweeping Change” to Health Care Industry

On January 17, 2013, the U.S. Department of Health and Human Services (HHS) announced the release of the HIPAA final omnibus rule, which was years in the making. The final rule makes sweeping changes to the HIPAA compliance...more

One Week to Get Business Associate Agreements Executed Under HIPAA Omnibus Rule’s Grandfather Clause

On Jan. 17, 2013, the long-awaited HIPAA “Omnibus Rule” went on display at the Federal Register, finalizing changes to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules....more

Hot Companies in Digital Health [Video]

With venture capital funding of digital health up 45 percent in 2012, according to Rock Health, we’re hearing a lot about mobile health apps and healthcare IT. You may be asking yourself what is digital health? Michael...more

Digital Health: Where is the Action for Entrepreneurs? [Video]

As CES 2013 draws to a close, Michael Esquivel, a partner in Fenwick’s Start-ups and Venture Capital Group, identifies where the action is for entrepreneurs and investors in digital health and healthcare IT. According to...more

Articles in Legal Industry Publications Continue to Qualify as Public Disclosure Under the False Claims Act

A Texas federal judge recently tossed a Federal False Claims Act (FCA) qui tam because the substance of the underlying allegations was previously disclosed in several legal industry publications, U.S. ex rel. Pharma Fraud...more

Health Innovation Summit Begs the Question - Is Digital Health at a Tipping Point?

From the minute you stepped off the elevator at Rock Health’s annual Health Innovation Summit on Tuesday, there was an undeniable energy. The sold out event was jam-packed with entrepreneurs, investors and health and...more

Telemedicine Amidst Healthcare Reform: Practicalities and Pitfalls

The Supreme Court’s recent decision upholding the Patient Protection and Affordable Care Act underscores the need to deliver and make accessible quality healthcare to patients throughout the United States in an efficient and...more

Venture Investment in Digital Health Effectively Doubles in H1 2012

Venture investment in healthcare convergence technologies soared in the first half of 2012. According to a recent report from Burrill & Co, digital health, into which they group healthcare IT, mobile health and wireless...more

340B Drug Pricing Program Experiencing Unprecedented Compliance Scrutiny

Participants in the 340B Drug Pricing Program (340B Program) should be aware that over the last several months, the 340B Program has witnessed an unprecedented focus on oversight, integrity and enforcement. Although the 340B...more

Medical Device Compliance Solutions - May 2012

In This Issue: - Risky Business? Assessing Risks with A Risk Assessment Checklist - Haunting Prose: Ghostwriting and Transparency in Pharmaceutical and Medical Device Publications - 2012 In The Line Of Fire:...more

G2 Compliance Report -- Keeping the Whistle Away From the Whistleblower: The Laboratory Compliance Officer’s Role in Qui Tam...

Do you, as a laboratory compliance officer, want to spare your employer the disruption, expense, and burden of a government enforcement action? The answer, of course, is “yes.” The most effective and efficient way of doing so...more

Evolution and Refinement: Recent Texas Legislative Efforts on Medical Records, Corporate Practice, and Other Issues

In This Presentation: Question 1: • If a physician complies with HIPAA, he or she has also complied with all requirements of Texas’ medical privacy laws. • True •...more

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