A bipartisan coalition of 23 state attorney generals led by Virginia AG Jason Miyares recently went up in arms about a products liability ruling they believe will threaten state consumer protection laws. On May 30, the...more
6/16/2023
/ Life Sciences ,
Merck ,
Pharmaceutical Industry ,
Preemption ,
Prescription Drugs ,
Product Defects ,
Regulatory Agenda ,
Regulatory Oversight ,
State Attorneys General ,
State Sovereignty ,
Unfair or Deceptive Trade Practices
AI continues to capture the headlines. One recent headline noted that ChatGPT passed the medical boards. In this third episode, Stephen Piepgrass and colleagues Michael Yaghi and Barry Boise discuss the potential risks health...more
Over the last decade, observers have noted that states have begun to play a greater role as regulatory enforcers — a trend that increased with the federal regulatory rollback that began with the advent of the Trump...more
Why It Matters -
Businesses should begin to address these issues now so that when COVID-19 vaccines are ready for distribution, they will be too....more
12/16/2020
/ Americans with Disabilities Act (ADA) ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Employer Liability Issues ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
OSHA ,
Popular ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Title VII ,
Vaccinations
Over the last decade, observers have noted that states have begun to play a greater role as regulatory enforcers – a trend that increased with the federal regulatory roll-back that began with the advent of the Trump...more
10/1/2020
/ Corporate Counsel ,
Department of Justice (DOJ) ,
Enforcement Authority ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Healthcare Fraud ,
Insurance Fraud ,
Medicaid ,
Medicare ,
Opioid ,
Regulatory Authority ,
Relators ,
State and Local Government ,
State Attorneys General ,
Unfair or Deceptive Trade Practices
On March 23, New Jersey Gov. Phil Murphy issued Executive Order 109 — the state’s latest directive relating to COVID-19. ...more
3/24/2020
/ Coronavirus/COVID-19 ,
Elective Surgical Procedures ,
Executive Orders ,
Goods or Services ,
Life Sciences ,
Medical Devices ,
Medical Supplies ,
Pharmaceutical Industry ,
Relief Measures ,
State and Local Government ,
Supply Chain
1. Product Safety -
1.1 Legal Framework -
The main laws and regulations governing product safety in the United States include:
The Consumer Product Safety Act of 1972, 15 U.S.C. § 2051 et seq, created the Consumer...more
A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients.
Originally published in Update magazine - August/September 2018....more
8/22/2018
/ Big Data ,
Electronic Medical Records ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Innovation ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
Patent protection can be critical for health care products, including medical devices, prescription drugs, dietary supplements and software as a medical device (SaMD).
Originally published in Law360 - September 8, 2017....more
Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more
10/6/2017
/ Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Big Data ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medical Devices ,
Off-Label Promotion ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Standards ,
Value-Based Payments
The Food and Drug Administration and the Federal Trade Commission have jointly requested that consumers report dietary supplements that “didn’t work as promised” or that are marketed with “unbelievable” claims. Consumers may...more
There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more
7/13/2017
/ Attorney General ,
Consumer Protection Laws ,
Data Breach ,
Data Protection ,
Digital Health ,
Electronic Medical Records ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
mHealth ,
Mobile Apps ,
Popular
Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more
As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated.
As mobile health applications...more
4/14/2016
/ App Developers ,
Covered Entities ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Mobile Apps ,
Mobile Health Apps ,
OCR ,
PHI ,
Popular
By advancing their argument, plaintiffs exposed what parties have long known — that the ‘bellwether’ process has lost its meaning…. This process results either in resolutions dictated by aberrant cases or, more likely, a...more
State and local governments will increasingly use consumer protection law to regulate long-term care facilities, with private plaintiffs’ counsel advocating for a role in government actions.
Under GGNSC Clarion LP v....more