Episode 332 -- Deep Dive into SEC’s Internal Controls and Cybersecurity Settlement with R&R Donnelly
Mitigating Political-Law Risk
The Preferred Return Podcast | AIFMD II – Implementation Begins
Why ESG Matters?
Meeting the Proposed SEC Climate Disclosure Requirements
California Regulation of Charitable Fundraising Platforms Part 2 - Reporting Due Diligence, Recordkeeping, and Disclosure Rules
ESG Masterclass — ESG and Impact Investing
The Justice Insiders Podcast - Human Beings: Cybersecurity's Most Fragile Attack Surface
JONES DAY TALKS®: Court Grants Stay on SEC’s Climate Disclosure Rule, but Companies Should Continue Preparations
ESG Masterclass — ESG and Politics
Ad Law Tool Kit Show – Episode 5 – Surviving an FTC Investigation
SEC’s New Cyber Rules for Publicly Traded Companies — The Consumer Finance Podcast
PLI's inSecurities Podcast - Commissioner Uyeda on “the Perils of Regulation by Theory and Hypothesis”
PLI's inSecurities Podcast - Addressing the “Netflix Problem” in Securities Regulation
What Nonprofit Leaders Need To Know About the Corporate Transparency Act
December 1st Deadline to Adopt Executive Compensation Clawback Policies — The Consumer Finance Podcast
How to Fix the Cyber Incident Reporting Mess--DHS Weighs In
ESG Essentials: What You Need To Know Now - Episode 16 - ESG Backlash
Regulatory Phishing Podcast - The Impact of Cybersecurity Compliance on Corporate Transactions
The Justice Insiders Podcast: Incidents in the Material World: SEC Adopts New Cybersecurity Rules
The U.S. Food and Drug Administration (FDA) is facing pressure from Congress and the medical community to enhance its oversight of online prescription drug advertising. The pressure comes amidst growing concerns about social...more
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more
Employer group health plans must make an annual disclosure of the plan's prescription drug and healthcare spending to the Centers for Medicare & Medicaid Services (CMS). The disclosure, called the Prescription Drug Data...more
Artificial intelligence (AI) and machine learning (ML) are ushering in a new era in drug discovery. The AlphaFold2 system developed by Google’s Deepmind was able to predict the 3D structures of over 200 million proteins -...more
History of 401(k) Plan Excessive Fee Cases. Once the Department of Labor’s participant fee disclosure rules for retirement plans became effective in 2012, the plaintiffs’ bar latched onto recordkeeping and investment fees...more
The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more
Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June,...more
Well, it was good while it lasted. On September 27th, the Departments issued new FAQs regarding implementation of provisions of The Transparency in Coverage Final Rules (TiC Final Rules). ...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
New Jersey has passed a landmark law limiting the power of pharmacy benefit managers (PBMs). On Monday, July 10, 2023, Governor Phil Murphy signed the law, requiring PBMs to disclose their negotiated reimbursement rates for...more
The Federal Trade Commission (FTC) announced its Health Products Compliance Guidance on December 20, 2022. The 2022 guidance updates and replaces the FTC’s 1998 guidance, Dietary Supplements: An Advertising Guide for...more
On December 20th, 2022, the Federal Trade Commission published new guidance regarding claims about the benefits and safety of health-related products: Health Products Compliance Guidance. This guidance replaces the...more
To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians. Beginning on January 1,...more
FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more
States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...more
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) requires employers that offer prescription drug coverage to update the Centers for Medicare & Medicaid Services (CMS) regarding the creditable...more
Most employers who offer plans that include prescription drug coverage are acutely aware of the requirement to notify individuals as to the creditable status of that coverage before October 15 each year. However, many are...more
Group health plan sponsors soon will face daunting new disclosure and transparency requirements under multiple laws including the Affordable Care Act (ACA), the No Surprises Act (the Act) and the Consolidated Appropriations...more
Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more
Lawsuit advertisements—specifically ones that target prescription drugs and medical devices—can be dangerous. Nationwide, dramatized and exaggerated legal ads have flooded both televisions and the internet, often masquerading...more
Similar to the laws of several other states, the North Dakota law contains three main disclosure requirements that apply to “drug manufacturers” - The Governor of North Dakota signed House Bill 1032 into law on April 27,...more
The Consolidated Appropriations Act (CAA), 2021, which was signed into law December 27, 2020, includes provisions designed to increase transparency in employee health benefit plans in four key areas. Removal of Gag Clauses...more
Telehealth expanded dramatically in response to the COVID pandemic. Now that providers, patients, payers and public officials have seen the benefits, it is almost certain that telehealth will continue to play an increasingly...more