Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter,...more
FedRAMP Director Pete Waterman recently unveiled the “FedRAMP 20x” plan – a proposal designed to reimagine and reformulate the FedRAMP authorization process for federal government use of cloud-based products and services....more
The incoming Trump administration has sent many signals that it intends to ramp up the Department of Defense’s use of nontraditional acquisition pathways to bridge the “Valley of Death” and bring innovative technologies to...more
2/17/2025
/ Acquisitions ,
Biomedical Advanced Research and Development Authority (BARDA) ,
Contract Terms ,
Defense Sector ,
Department of Defense (DOD) ,
Department of Homeland Security (DHS) ,
Federal Contractors ,
Government Agencies ,
Intellectual Property Protection ,
NASA ,
National Institute of Health (NIH) ,
National Security ,
Procurement Guidelines ,
Risk Management ,
Trump Administration ,
TSA
A flurry of presidential directives, agency communications, and court orders has left federal contract and grant recipients with operational disruptions and in a state of confusion. As we write, it has been difficult to...more
2/3/2025
/ Compliance ,
Executive Orders ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Funding ,
Government Agencies ,
Grants ,
OMB ,
Regulatory Freeze ,
Suspensions & Debarments ,
Termination for Convenience ,
Trump Administration
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
1/28/2025
/ Anti-Kickback Statute ,
Appointments Clause ,
Article II ,
Books & Records ,
CVS ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Genetic Testing ,
Healthcare Fraud ,
Medicare ,
OIG ,
Patient Referrals ,
Qui Tam ,
State and Local Government ,
State Attorneys General ,
Walgreens ,
Whistleblowers
The Federal Acquisition Regulation (FAR) Council issued its long awaited proposed rule on Controlled Unclassified Information (CUI) on January 15, 2025. The proposed rule establishes a common form to be used by all federal...more
1/24/2025
/ Controlled Unclassified Information (CUI) ,
Cybersecurity ,
Defense Contracts ,
Department of Defense (DOD) ,
DFARS ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Government Agencies ,
NIST ,
Proposed Rules ,
Reporting Requirements ,
Risk Management ,
Subcontractors ,
Subcontracts
Citing the threats posed by foreign adversaries and criminal organizations, and seeking enhanced accountability for companies that provide software and cloud services to the federal government, the Biden administration has...more
1/20/2025
/ Artificial Intelligence ,
Biden Administration ,
Cloud Computing ,
Cloud Service Providers (CSPs) ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Data Security ,
Department of Defense (DOD) ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
FedRAMP ,
Foreign Adversaries ,
NIST ,
OMB ,
Pay Equity Laws ,
Privacy Laws ,
Regulatory Reform ,
Risk Management ,
Software ,
Supply Chain ,
Trump Administration
The Biden Administration withdrew a proposed climate change-inspired amendment to the Federal Acquisition Regulation (FAR) one week before former President Donald Trump’s return to the White House. According to a notice...more
1/17/2025
/ Biden Administration ,
Carbon Emissions ,
Climate Change ,
Disclosure Requirements ,
Environmental Policies ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Greenhouse Gas Emissions ,
Proposed Rules ,
Regulatory Agenda ,
Reporting Requirements ,
Rulemaking Process ,
Sustainability ,
Trump Administration
On December 23, 2024, President Biden signed the Source Code Harmonization and Reuse in Information Technology Act (“SHARE IT Act” or “the Act”), which provides a formal mechanism for federal agencies to store and share...more
1/14/2025
/ Biden Administration ,
Compliance ,
Contract Terms ,
Data Security ,
Department of Defense (DOD) ,
DFARS ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Funding ,
Intellectual Property Protection ,
New Legislation ,
Regulatory Requirements ,
Software ,
Source Code
On December 4, 2024, the House passed the Strengthening Agency Management and Oversight of Software Assets (SAMOSA) Act, a bipartisan bill that is now before the Senate. Under the SAMOSA Act, federal agencies are directed to...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
10/31/2024
/ Cybersecurity ,
Defense Contracts ,
Denial of Certiorari ,
Department of Justice (DOJ) ,
E-Rates ,
False Claims Act (FCA) ,
FCC ,
Federal Contractors ,
Fraud ,
Healthcare Fraud ,
Overpayment ,
Qui Tam ,
Reimbursements ,
Retaliation ,
SCOTUS
On September 4, 2024, the U.S. Department of Defense (DoD) issued a proposed rule to update its longstanding but little-known regulations for prototype other transactions (OTs), including new sections that authorize follow-on...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
7/25/2024
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Lenders ,
Lockheed Martin ,
National Institute of Health (NIH) ,
OIG ,
Self-Disclosure Requirements
Earlier this month, the Federal Acquisition Regulatory Council (“FAR Council”) issued an advanced notice of proposed rulemaking (ANPR) to implement parts of Section 5949 of the National Defense Authorization Act (NDAA) for...more
5/17/2024
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Bid Solicitation ,
Contractors ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
National Security ,
NDAA ,
Safe Harbors ,
Semiconductors ,
Subcontractors ,
Supply Chain
On May 2, 2024, the U.S. Department of Defense (DoD) issued an important class deviation that provides necessary relief for contractors endeavoring to comply with ever-changing cybersecurity requirements. The deviation...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
4/12/2024
/ Anti-Kickback Statute ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Federal Employees ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Nursing Homes ,
Popular
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
1/4/2024
/ Anti-Kickback Statute ,
Compliance ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Health Care Providers ,
Healthcare Fraud ,
Internal Investigations ,
Patient Referrals ,
Pharmaceutical Industry ,
Popular
On December 22, 2023, President Biden signed the National Defense Authorization Act for Fiscal Year 2024 into law after bipartisan congressional majorities approved the bill earlier in the month. The annual bill authorizes...more
1/3/2024
/ Antitrust Provisions ,
Department of Defense (DOD) ,
Economic Sanctions ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Goods or Services ,
Inflation Adjustments ,
NDAA ,
Popular ,
SDVOSB ,
Small Business ,
Supply Chain
The U.S. Department of Defense released a special holiday treat for government contractors and subcontractors last week in the form of long-promised proposed regulations for its Cybersecurity Maturity Model Certification...more
1/3/2024
/ Chief Information Officers (CIO) ,
Controlled Unclassified Information (CUI) ,
Cybersecurity ,
Cybersecurity Maturity Model Certification (CMMC) ,
Department of Defense (DOD) ,
DFARS ,
Federal Contractors ,
Internet of Things ,
NIST ,
Popular ,
Risk Assessment ,
Risk Management ,
Subcontractors
Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more
12/19/2023
/ Bayh-Dole Act ,
Biden Administration ,
Drug Pricing ,
Executive Orders ,
Federal Funding ,
March-in-Rights ,
National Institute of Health (NIH) ,
NIST ,
Pharmaceutical Industry ,
Prescription Drugs ,
Research and Development
The Biden administration issued a widely anticipated executive order on artificial intelligence (“AI”) earlier this week. The Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence...more
11/6/2023
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Department of Homeland Security (DHS) ,
Executive Orders ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
IaaS ,
National Security ,
NIST ,
Office of Science ,
OMB ,
Risk Management ,
Secretary of Commerce ,
Semiconductors ,
Technology ,
Technology Sector ,
Transparency
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
10/11/2023
/ Anti-Kickback Statute ,
Causation ,
Cybersecurity ,
Denial of Certiorari ,
Department of Justice (DOJ) ,
DFARS ,
Failure To Disclose ,
Failure to Monitor ,
False Billing ,
False Claims Act (FCA) ,
Foreign Subsidies ,
General Services Administration (GSA) ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
NIST ,
Pharmaceutical Industry ,
Popular ,
Remuneration ,
Risk Management ,
SCOTUS ,
State Grants ,
TRICARE ,
Whistleblowers
In what can best be described as a tsunami of cybersecurity regulation, the Federal Acquisition Regulation (FAR) Council—consisting of the Department of Defense (DoD), General Services Administration (GSA), and National...more
10/9/2023
/ Cloud Storage ,
Cyber Incident Reporting ,
Cyber Threats ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Department of Defense (DOD) ,
Department of Homeland Security (DHS) ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
General Services Administration (GSA) ,
Information Technology ,
Internet of Things ,
NASA ,
National Security Agency (NSA) ,
NIST ,
OMB ,
Popular ,
Proposed Rules ,
Risk Management ,
Subcontractors
A new Biden administration Executive Order proposes to enforce more rigorously U.S. manufacturing requirements attendant to federally funded inventions. While the aim of the Executive Order is to support domestic...more
8/7/2023
/ Bayh-Dole Act ,
Biotechnology ,
Department of Energy (DOE) ,
Domestic Policy ,
Emerging Technology Companies ,
Executive Orders ,
Federal Contractors ,
Federal Funding ,
Inventions ,
Inventors ,
Joe Biden ,
Manufacturers ,
NASA ,
NIST ,
Research and Development
In the extensive chatter since the Federal Acquisition Regulatory Council (“FAR Council”) published an interim rule on the new Federal Acquisition Regulation (FAR) 52.204-27, “Prohibition on a ByteDance Covered Application,”...more