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Record $5.5 Million HIPAA Data Security Settlement: Lessons Learned

On August 4, 2016, the Department of Health and Human Services, Office of Civil Rights (OCR) announced that Advocate Health Care Network, Illinois' largest hospital chain, agreed to pay $5.5 million to resolve multiple alleged violations of the Health Insurance Portability and Accountability Act (HIPAA). This settlement is the largest HIPAA-related settlement in OCR history, and comprises more than a quarter of the nearly $20 million that the government has collected in HIPAA-related enforcement actions in 2016 alone.

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False Claims Act Materiality After Escobar

Along with my Post & Schell colleagues, Matt Newcomer and Carolyn Kendall, I recently co-authored an article for Law360 that examined the U.S. Supreme Court's decision in Universal Health Services Inc. v. Escobar. We focused on the Court's rejection of a bright-line rule on the False Claims Act's materiality standard and adoption of a fact-specific standard that will need to be litigated on a case-by-case basis.

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DOJ's New FCPA Enforcement Plan and Crafting Due Diligence Programs

The June 2016 issue of Business Crimes Bulletin includes Part II of our examination of recent Foreign Corrupt Practices Act (FCPA) enforcement efforts related to the use of third-party intermediaries. Part II takes a detailed look at DOJ's April 2016 FCPA enforcement plan, which added ten prosecutors to DOJ's FCPA unit and initiated a pilot program through which companies may be able to avoid prosecution or achieve lower fines via voluntary disclosure to and cooperation with DOJ. The article also suggests seven keys to an effective FCPA due diligence system.

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Third Circuit Upholds Dismissal of FCA Suit Against Pottstown Memorial Medical Center

On June 10, 2016, the Third Circuit Court of Appeals upheld a 2015 decision that dismissed allegations of kickbacks in violation of the False Claims Act (FCA) against Pottstown Memorial Hospital (Pottstown). The decision, concerning physician “on call” contracts, provides important guidance about the drafting of hospital-physician contracts in a competitive environment.

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Plan Ahead, Stay On Top of Government and Tech Changes, and Be Ready to Call the FBI: Key Lessons from the PHI Protection Network Conference

Late last week, the health care data security community gathered in Philadelphia for the PHI Protection Network Conference. The diverse group of speakers included in-house data security officers, technology consultants, academics, attorneys, and a variety of influential federal government representatives. I was in the audience. A handful of key themes were reiterated in various ways throughout the two-day gathering.

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The Government Pushes The False Claims Act Envelope; Government Contractors Push Back

In recent weeks, corporations have pushed back against Departments of Justice (DOJ) and Health and Human Service (HHS) efforts to expand False Claims Act (FCA) remedies to conduct beyond the FCA's explicit reach. Yet a huge incentive exists for DOJ to push the FCA envelope: DOJ's recently released 2015 Civil Division fraud recoveries - totaling over $3.5 billion - establish a six-year trend of recoveries in excess of $3 billion annually.

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U.S. Sentencing Commission Engages on Conditions of Supervised Release and "Compassionate" Release

As an at large national appointee to the U.S. Sentencing Commission Practitioners Advisory Group (along with private bar defense counsel appointees from each federal circuit), I had a front row seat to Commission hearings last week concerning conditions of supervised release and probation and the criteria for a compassionate release or reduction in sentence from the Bureau of Prisons (BOP).

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The Enforceability of FDA's Off-Label Marketing Restrictions Following the Amarin Decision

Today, February 17, 2016, AHLA's Journal of Health & Life Sciences published as its “Featured Article” our analysis of the enforceability of FDA's off-label marketing restrictions in the aftermath of the August 2015 Amarin Pharma, Inc. v. United States FDA decision. The article, entitled, “To Promote or Not to Promote? The Enforceability of FDA's Off-Label Marketing Restrictions Following Amarin,” traces the recent string of judicial decisions challenging the government's restrictions on drug companies, truthful and non-misleading off-label speech as violating the First Amendment's free speech protections.

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Two Points and a Lesson from PrivacyCon, FTC's Digital-Privacy Conference

Last week, on January 14, 2016, the Federal Trade Commission (FTC) convened PrivacyCon, a first-of-its kind conference bringing together policymakers, academics, and technology researchers to discuss the challenges surrounding online privacy as we navigate between a fixed-internet world, a mobile one, and the growing “internet of things.” I was in the audience, and I came away with two major points and a lesson for white collar defense lawyers and their clients.

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