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White House Announces Vulnerabilities Equities Policy and Process

by Balch & Bingham LLP on

On November 15, 2017, the Trump administration released the Vulnerabilities Equities Policy and Process. This documents describes the process by which U.S. agencies and departments determine whether to disclose or restrict...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

Third Circuit Weighs in on Materiality for First Time Since Escobar

by Pepper Hamilton LLP on

A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more

Top unmanned aircraft systems developments in 2017 for ADG companies

by Hogan Lovells on

Aerospace, defense, and government services (ADG) companies are not new to game-changing technology innovations. It is therefore no surprise that a number of ADG companies are early investors in unmanned aircraft systems...more

CMS's Payment Suspensions Wreak Havoc: Understanding the Risks

by Baker Ober Health Law on

CMS payment suspensions can cripple any provider's or supplier's operations. Yet, CMS has the authority to impose a payment suspension upon the mere existence of "reliable information" that an overpayment or fraud may exist....more

GAO Tackles Cybersecurity

In two recent decisions, GAO denied protest grounds challenging the ability of contract awardees to satisfy government requirements related to cybersecurity. This posting analyzes those decisions and their implications for...more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

MoFo New York Tax Insights - Volume 6, Issue 11

by Morrison & Foerster LLP on

Resident Is Not Subject to Use Tax on Yacht Briefly Docked in the State - In Matter of Michael Pellino, DTA No. 825869 (N.Y.S. Div. of Tax App., Oct. 1, 2015), a New York State Administrative Law Judge concluded that...more

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

OPM data breach update–$133 million contract awarded to vendor

The Office of Personnel Management (OPM) and the Defense Department announced this week that a Portland, OR based vendor has been selected to assist with breach notification and credit assistance for the almost 22 million...more

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

Two Laboratories Settle Claims Regarding Specimen Processing Fees

by Baker Ober Health Law on

Continuing the scrutiny of laboratory arrangements with referring physician practices, the United States Department of Justice (DOJ) recently announced the settlement of False Claims Act allegations against two cardiovascular...more

Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers

On March 19, 2015, the U.S. Department of Justice and the U.S. Department of Health and Human Services issued their joint annual report on health care fraud and abuse control. The annual report states that during fiscal year...more

2014 Intelligence Authorization Act Imposes Cyber Breach Reporting Requirement on Intelligence Community Contractors - Many...

by Holland & Knight LLP on

The federal government must publish new procedures 90 days after the 2014 Intelligence Authorization Act is signed. These procedures will become effective upon publication. Intelligence community contractors will be...more

California Bill Would Create Cyber Security Commission

by Davis Wright Tremaine LLP on

In recognition of the increasing threat that cyber-attacks pose to the state's infrastructure and the considerable costs that government and private sectors are estimated to spend on cyber security (more than $70 billion...more

OMB Revises and Consolidates Rules Governing Most Federal Grants

by Morrison & Foerster LLP on

In the final days of 2013, the White House Office of Management and Budget (OMB) released for publication long-awaited final guidance on administrative requirements, cost principles and audit requirements pertaining to...more

Chinese MOH Announced Centralized Procurement of High Value Medical Consumables

by Ropes & Gray LLP on

On December 17, 2012, the Ministry of Health (“MOH”) issued the Tentative Guidelines for Centralized Procurement of High Value Medical Consumables (the “Guidelines”) with immediate effect, with an aim to control health care...more

CMS Seeks Comments on Hospital Readiness for EHR Hospital Inpatient Quality Data Reporting

by King & Spalding on

CMS is seeking comments from hospitals, electronic health record (EHR) vendors, and other interested parties regarding whether hospitals could be ready as early as January 1, 2014, to electronically report patient-level...more

Audits, Audits And More Audits: Life In The Healthcare Industry

by Michael Volkov on

Healthcare suppliers and service providers live in a regulated world. They are constantly under audit scrutiny. Sometimes federal agencies (i.e private contractors) conduct the audits; other times state agencies conduct the...more

Cybersecurity Provisions Enacted under 2013 National Defense Authorization Act

by King & Spalding on

On January 2, 2013, President Obama signed the 2013 National Defense Authorization Act for 2013 (NDAA) into law. Each year Congress passes the NDAA to authorize funding levels for Department of Defense (DoD) programs and...more

Conflict of Interest in Research Regulations: Is Your Institution Compliant with the New Rules?

by Baker Donelson on

Although the Department of Health and Human Services (HHS) issued the final conflict of interest rule last year, many entities conducting research that is funded under Public Health Service (PHS) grants, cooperative...more

District Court Rejects Fraud-on-the-FDA Theory of False Claims Act Liability

by Ropes & Gray LLP on

In an opinion that continues a welcome trend in False Claims Act cases, Judge Saylor of the United States District Court for the District of Massachusetts has dismissed a relator’s FCA complaint for failing to plead facts...more

Ownership of Inventions Funded with Federal Research Grants

by Smith Anderson on

The FY-2012 National Defense Authorization Act reauthorized the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs through 2017. Administered by the U.S. Small Business...more

U.S. Supreme Court Asked to Review Federal Funding of Human Embryonic Stem Cell Research

by Foley & Lardner LLP on

On October 10, 2012, two pro-life groups petitioned the U.S. Supreme Court to review and reverse the U.S. Court of Appeals for the District of Columbia Circuit Court’s decision allowing the continued federal funding of...more

Access to Confidential Information in Failed Bid Not Allowed

by Dentons on

A recent Order (MO-2786) of a Senior Adjudicator of the Office of the Ontario Information and Privacy Commissioner provides a useful guide for organizations wishing to protect confidential and financial information submitted...more

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Cybersecurity

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