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

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

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

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

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

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

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

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?

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

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

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

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

Intelligence Committee Calls for Expansion of CFIUS Jurisdiction

On October 8, 2012, the House Intelligence Committee issued a damning bi-partisan report on what it perceived to be national security risks posed by two Chinese telecommunications companies: Huawei and ZTE. The committee...more

Access to Confidential Information in Failed Bid Not Allowed

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

Broad new data security rule proposed for federal contractors

A new rule proposed for federal government contractors will require that all federal contracts over $100,000 (including contracts for commercial items and those to small businesses) will have to include a clause requiring the...more

FISMA Extension: New Information Safeguarding Requirements Proposed for Government Contractors

Government contractors should take note of a newly proposed FAR rule that requires basic safeguards for government contractor information systems. Under the proposed rule, government contractor information systems that...more

Health Law Alert: Federal Research Grant Recipients Face False Claims Lawsuit

Many of the high-profile False Claims Act (FCA) cases against the health care industry have involved allegations that false claims for payment were submitted for items or services provided to Medicare or Medicaid...more

DoD Implements Broad Cybersecurity Information–Sharing Program

On May 11, 2012, the Department of Defense (DoD) published an interim final rule expanding its pilot program institutionalizing the sharing of cyber threat information between DoD and its contractors. Comments on the rule are...more

Outsourcing Company to Pay Record $500 Million Settlement in CityTime Investigation

Science Applications International Corp (SAIC) has agreed to pay more than $500 million in fines and penalties to settle federal charges alleging that the outsourcing company overcharged the city of New York for work and...more

Government Contractors Now Subject to Cybersecurity Regulations – And More are on the Way

Congress currently is considering various cybersecurity bills. While Congress debates cyber legislation, the executive agencies are adopting regulations governing how government contractors handle contract-related information...more

More Major Changes in DoD Rights in Technical Data and Computer Software for Government Contractors

On New Year's Eve, President Obama signed the National Defense Authorization Act for Fiscal Year 2012, which included Section 815 that addressed several revisions to the rights the Government obtains in technical data...more

SBIR Improvements -- Allowing Majority Investor Participation and More

On December 31, 2011, President Obama signed the National Defense Authorization Act for 2012, which included the SBIR/STTR Reauthorization Act of 2011 (the "Act"). H.R. 1540-526, Division E. Many changes, large and small,...more

Early Steps Toward a Streamlined Export Control System: Proposed Changes to the ITAR and EAR

On November 7, 2011, the U.S. State Department published a proposed rule amending the International Traffic in Arms Regulations (“ITAR”) by narrowing the categories of aircraft and related equipment controlled on the United...more

OFAC, BIS Double Up Flow Serve: What the Flowserve Settlement Says About Corporate Compliance Programs

In late September, Flowserve Corporation (“Flowserve”) and a number of its subsidiaries agreed to settle alleged export violations with the Department of Commerce, Bureau of Industry of Security (“BIS”) for $2.5 million, and...more

OIG Publishes Fiscal Year 2012 Work Plan

Last week, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published its work plan for the 2012 fiscal year in which it described its primary objectives for the year. We identify below, by...more

The Times They Are A Changin' - Independent Research and Development May Not Be So "Independent" Any More

Those familiar with Government contracting know at least a little bit about the elusive and fickle regulatory requirements for Independent Research and Development (“IR&D” or “IRAD”) costs. IR&D is a means by which the U.S....more

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