Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more
4/9/2025
/ Artificial Intelligence ,
Drug Pricing ,
Earn-Outs ,
Federal Funding ,
Foreign Aid ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Private Equity ,
Trump Administration ,
USPTO
State attorneys general ("AGs") have long had unique police powers over a variety of health care providers in their states. Recently, AGs in several states have used this authority to scrutinize consolidation and corporate...more
4/4/2025
/ Acquisition Agreements ,
Competition ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Merger Agreements ,
New Legislation ,
Private Equity ,
Quality of Care Standards ,
Regulatory Oversight ,
Regulatory Requirements ,
State Attorneys General
The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
4/8/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...more
4/1/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
DOJ, FTC, and HHS jointly announced the launching of a cross-government public inquiry into increasing private equity and corporate involvement in health care, the latest announcement in a string of public statements from the...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more
11/27/2023
/ Artificial Intelligence ,
California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Data Privacy ,
Data Security ,
DEA ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Popular ,
Public Health ,
Telehealth
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more
9/15/2023
/ Artificial Intelligence ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
End-Users ,
EULA ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
OIG ,
Popular ,
Software ,
Telehealth
Note From the Editors -
This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more
5/15/2023
/ Clinical Trials ,
Data Collection ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
OIG ,
Popular ,
Substance Abuse ,
Telehealth
Lawyer Spotlight:
Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health. This month, we highlight two lawyers who help clients...more
Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more
3/9/2022
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Digital Health ,
Enforcement Actions ,
Federal Taxes ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
HIPAA Breach Notification Rule ,
Income Taxes ,
Life Sciences ,
Pharmaceutical Patents ,
Popular ,
Proposed Legislation ,
Regulatory Agenda ,
State Taxes ,
Telecommuting ,
Telehealth ,
Telemedicine ,
USPTO
The Situation: The Supreme Court's ruling in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016), opened the door to more materiality defenses under the False Claims Act ("FCA"), but without making...more
3/4/2020
/ Defense Strategies ,
Deficit Reduction ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
False-Certification of Conformance ,
Materiality ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Relators ,
Summary Judgment ,
Universal Health Services Inc v United States ex rel Escobar
The Situation: In U.S. ex rel. Kasowitz Benson Torres LLP v. BASF Corporation, the relator alleged reverse false claims liability under the False Claims Act ("FCA") for the defendants' purported failure to comply with...more
The Situation: The total number of Corporate Integrity Agreements ("CIAs") between the Office of Inspector General ("OIG") and health care entities has been decreasing, and the OIG recently decided it would spotlight entities...more
12/19/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
GAO ,
Health Care Providers ,
Healthcare ,
OIG ,
Physicians ,
Settlement ,
Settlement Agreements
The civil settlement is one of the largest FCA settlements in recent years.
The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to...more
The Situation: In what may indicate a sea change in terms of who the Department of Justice ("DOJ") is willing to pursue in False Claims Act cases, a private equity firm has been named as a co-defendant in a False Claims Act...more
3/2/2018
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medical Monitoring ,
Pharmacies ,
Prescription Drugs ,
Private Equity Firms ,
Regulatory Requirements