Government Contracting Science, Computers & Technology

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Opportunities for Increased Drug Sales to the VA

Pharmaceutical manufacturers that produce drugs in non-designated countries under the Trade Agreements Act (TAA) may now have an opportunity to increase their sales to the United States government. The Department of Veterans...more

A New Cybersecurity Regime and a New Regulation to Mandate Secure Information Systems for Government Contractors

Congress has enacted a recent wave of legislation to address ongoing cybersecurity threats; the Executive Branch, on May 12, 2016, adopted new cybersecurity regulations; and other Federal initiatives are underway and will...more

FAR Information System Security Standards Rules Finalized

The U.S. federal government announced on May 16, 2016, new Federal Acquisition Regulation (FAR) rules that set high-level standards for the basic safeguarding of contractor information systems that process, store or transmit...more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

A lighter touch — Final FAR rule issued on safeguarding contractor information systems

On Monday, May 16, 2016, the FAR Council is expected to issue its long- awaited final FAR rule ("the Final Rule") on safeguarding contractor information systems. This rule, effective immediately, creates a new contract...more

False Claims Act Trends: Technical Data, Software And IP

Government contracting has never been easy. But occasionally it is exciting, at least at the outset: Figuring out how to prepare the most competitive proposal and landing a significant contract are memorable achievements...more

Final Government Contractor Basic Data Security Rule Issued

On May 16, 2016, the Federal Acquisition Regulations (“FAR”) Council published the final FAR rule on Basic Safeguarding of Contractor Information Systems. The rule is intended to prescribe “the most basic level” of...more

Guest Post - Implied Certification: An Eradicated Pest or Here to Stay?

Today’s guest post is courtesy of Reed Smith’s Lindsey Harteis. She’s been following the big-deal UHS v. Escobar False Claims Act that the Supreme Court could decide any day now (or could wait until the end of June), which...more

It’s Arrived! FAR Final Rule Addressing “Basic Safeguarding of Contractor Information Systems”

After nearly four years of planning and comments, DoD, GSA, and NASA issued a final rule today amending the Federal Acquisition Regulations (“FAR”) with a new Subpart 4-19 and a new contract clause 52.204-21 addressing the...more

Coordinating your reimbursement and regulatory strategies for a successful product launch

Ensuring appropriate third-party reimbursement for a new pharmaceutical or medical product involves an intricate interplay of considerations. There is no doubt that government and private payers have been under increasing...more

Q&A: Robert Metzger – Cybersecurity, DOD and Regulation

In this Q&A, CREATe CEO Pamela Passman asks questions of Robert Metzger about the latest trends and challenges in protecting sensitive Department of Defense information. Metzger recently reviewed and commented on CREATe’s...more

Expansion of HIPAA audit program now underway

As detailed in our latest webinar, “Daunting but doable: Preparing for the next round of HIPAA audits,” the Office for Civil Rights (OCR) has begun implementing the first full-phase HIPAA audit program. The 2009 HITECH Act,...more

Getting Started with E-Rate

Public schools and libraries in the U.S. can save a lot of money on Internet service by applying for the Schools and Libraries Program, a federal subsidy better known as E-Rate. E-Rate funding, capped yearly at $3.9...more

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more

Senator Tom Carper Questions Office Of Management And Budget Regarding Emerging Cybersecurity Technologies

On April 8, 2016, U.S. Senator Tom Carper, the ranking Democratic member of the Senate Homeland Security and Governmental Affairs Committee, sent a letter to Shaun Donovan, Director of the Office of Management and Budget...more

DoD Proposes Cost Allowability Rule for Correcting Counterfeit Electronic Parts

The Department of Defense (“DoD”) recently proposed to make specified costs allowable that are associated with discovering and correcting counterfeit or suspect counterfeit electronic parts. DoD’s proposed rule would amend...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

Health Care E-Note - April 2016

Patient care is not confined to a single office or exam room, or a single physician or other provider. Caring for patients these days now includes complex coordination among physicians, nurses, technicians, staff, management,...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

Abbott Laboratories Prevails in False Claims Act Case

On April 7, 2016, following a three-week trial and after only three hours of deliberations, a federal jury in Dallas, Texas found that Abbott Laboratories had not violated the False Claims Act (FCA) when it marketed bile duct...more

Appeals Court Confirms that HITECH Violations Do Not Violate FCA

In an important recent decision, the Sixth Circuit Court of Appeals confirmed that a qui tam relator's claim that her former husband improperly accessed electronic protected health information (e-PHI) of her and her relatives...more

Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of...more

340B Proposed Pricing Rule Reopened for Comment: Penny Pricing, New Drug Pricing and Definition of “Knowing and Intentional” Back...

On Monday, April 18, the Health Resources and Services Administration (“HRSA”) published a Notice reopening comment on its June 17, 2015 Proposed Rule regarding 340B pricing and manufacturer civil monetary penalties....more

Data Rights Under Federal Government Contracts: What Are Data rights?

Data rights under federal government contracts create confusion from both the government and the contractor perspectives. There is substantial misunderstanding as to the purpose of the data rights regulations and the limits...more

Sixth Circuit Affirms Dismissal of FCA Claim Based on Health Data Breaches

The U.S. Court of Appeals for the Sixth Circuit recently affirmed the dismissal of a False Claims Act (FCA) case premised on protected health data breaches. In United States ex rel. Sheldon v. Kettering Health Network, the...more

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