12 Days of Regulatory Insights: Day 9 - Trends in the Tobacco Industry — Regulatory Oversight Podcast
12 Days of Regulatory Insights: Day 7 - New Rules in Advertising — Regulatory Oversight Podcast
Grupo Empresarial y Control … ¿a qué te cojo ratón?
Podcast - Decoding the Future of AI Regulation and Frontier Models
Emerging Trends in Consumer Protection: A Conversation With NAAG’s Kate Donoven - Regulatory Oversight Podcast
Podcast - 2024 Election Impacts on Food and Agriculture Policy
Navigating Regulatory Waters: Recent Enforcement Actions in BaaS — Payments Pros – The Payments Law Podcast
Ask a Certified Fraud Examiner Q&A - Part 4
Enhancing Compliance: The Power of Independent Monitorships in Consumer Protection — Regulatory Oversight Podcast
TortsCenter Podcast | Episode 5 | Higher Standards or Higher Stakes
El Salvador’s Bitcoin Nation: A Government Insider’s View
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
No Password Required: MITRE Engage Lead, Innovator in Cyber Deception, and Dance Community Builder
Georgia on My Mind: On the Frontlines of Federal Rulemaking With AG Carr — Regulatory Oversight Podcast
Podcast - Part 2: An FTC Official Speaks About the Regulation of AI Technology
Decoding Privacy Laws: Insights for Small to Mid-Sized Businesses — Regulatory Oversight Podcast
FCA Uncovered: Mitigating Risk in the Regulatory Spotlight — Regulatory Oversight Podcast
Proceso constituyente en Colombia Parte II
Navigating Facility Relocation: Legal and Practical Considerations — Regulatory Oversight Podcast
Leading With Purpose: Oregon AG Ellen Rosenblum Discusses Her Role at NAAG — Regulatory Oversight Podcast
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more
Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more
The Medical Board of California (“MBC”) began this project in 2013 when it required coroners to inform it of deaths resulting from opioids. The influx of coroners’ reports triggered an intense enforcement effort by the MBC...more
On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
In its final Calendar Year (CY) 2019 Outpatient Prospective Payment System (OPPS) Rule released November 2, 2018 (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to make payments for...more
On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...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
The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more
The state of Michigan has enacted a number of separate pieces of legislation to address the opioid epidemic. Most of these laws are directed at controlling the prescribing relationship between a physician and a patient....more
Generally, federal law requires practitioners to obtain a Drug Enforcement Agency (DEA) registration or a waiver from the DEA registration to use narcotics to treat opioid addiction. ...more
On March 30, 2017, Ohio Governor John Kasich issued a policy statement imposing new limits on prescribing opiates, which became effective August 31, 2017. ...more
At the close of the 2018 session, the Florida Legislature passed Senate Bill (SB) 675, which if allowed to become law by the Governor, will help hospitals and their facilities that are under common control manage their...more
In February, the Department of Justice (DOJ) intervened in a False Claims Act case alleging healthcare fraud, a common enough event. The case in question, originally began in 2015 as a whistleblower case brought by two...more
In a Draft Call Letter issued February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it is considering a number of new strategies to address opioid overutilization within the Medicare Part D...more
Prior to the Comprehensive Addiction and Recovery Act of 2016 (CARA) only “physicians” could dispense and prescribe narcotic drugs for maintenance and detoxification treatment. CARA expanded who may prescribe for maintenance...more
A recently finalized New Jersey rule imposes new limits on prescriber acceptance of gifts and compensation from pharmaceutical manufacturers and their agents, and will likely have a significant impact on many prescriber...more
The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the expected final rule is less...more
The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more