The 2024 American Bar Association White Collar Crime conference delivered crucial insights from artificial intelligence’s tantalizing promise to its looming threats, a focus on individual accountability, repercussions for...more
In the latest edition of our False Claims Act Guide: 2023 and the road ahead, we analyze the key developments from 2023 and discuss how the most important cases and issues are shaping FCA enforcement now and in the year to...more
2/14/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Fraud ,
Health Care Providers ,
Medicaid ,
Popular ,
Private Equity Firms ,
Qui Tam
On April 18, 2023, the U.S. Supreme Court (SCOTUS) heard oral argument in the most significant False Claims Act (FCA) case to reach the Court in recent years. The Court is examining the scienter requirement in the FCA –...more
Because qui tam claims sound in fraud, under precedent and Rule 9(b) of the Federal Rules of Civil Procedure, relators are required to plead their claims with a heightened degree of specificity that many, having limited...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
The pace of False Claims Act (FCA) litigation remained furious over the past year. Companies (and individuals) in all sectors of the economy continue to face the ever-present threat of FCA enforcement whenever they do...more
1/22/2019
/ Department of Justice (DOJ) ,
Digital Realty Trust Inc v Somers ,
Enforcement Actions ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud ,
Health Information Technologies ,
Implied Certification ,
Materiality ,
Qui Tam ,
SCOTUS ,
Settlement Agreements ,
Universal Health Services Inc v United States ex rel Escobar ,
US Trade Policies ,
Whistleblowers
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum
Virtually all industries are being reshaped with the use of Artificial Intelligence and advanced machine-learning.
Everything from healthtech to self-driving vehicles, to education and smart homes, drones and space, social...more
4/4/2018
/ Antitrust Provisions ,
Artificial Intelligence ,
Asia Pacific ,
Connected Cars ,
Connected Items ,
Drones ,
Ethics ,
Export Controls ,
FinTech ,
Intellectual Property Protection ,
Life Sciences ,
Outer Space ,
Popular ,
Regulatory Oversight ,
Robotics ,
Satellites ,
Smart Devices ,
Unmanned Aircraft Systems
We are filing a lawsuit against Attorney General Sessions in the Eastern District of Pennsylvania on behalf of the City of Philadelphia. It asserts the U.S. Department of Justice (DOJ) new grant conditions imposed in July...more
Tuesday, the Fourth Circuit Court of Appeals ruled in the interlocutory appeal in United States ex rel. Michaels v. Agape Senior Community, Inc.. In an opinion considering two significant questions arising under the qui tam...more
2/16/2017
/ Appeals ,
Extrapolation ,
False Claims Act (FCA) ,
Federal Contractors ,
Healthcare Fraud ,
Hospice ,
Medicare ,
Nursing Homes ,
Qui Tam ,
Settlement ,
Statistical Sampling ,
Veto Rights