The Presumption of Innocence Podcast: Episode 45 - The Grit, Grace and Gift of Second Chances
The Justice Insiders Podcast - The Ever-Expanding Net: Corporate Compliance in an Era of Increasing Trade Sanctions and Restrictions
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Episode 333 -- The Boeing Proposed Plea Agreement
DOJ’s New Self-Disclosure Policy and Corporate Whistleblower Awards Pilot Program
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
FCPA Survival Guide - Step 8 - Investing in Compliance
Exploring the AI and Crypto Intersection
The Justice Insiders Podcast: Jarkesy’s Implications for the Administrative State
The Presumption of Innocence Podcast: Episode 41 - The Dynamics of Decision-Making: Psychology and the Criminal Justice System
INTERPOL and Child Kidnapping Cases. What are INTERPOL’s Abilities and Limitations?
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
The Justice Insiders Podcast - AI-Washing: Everything Old Is New Again
The CFPB and State AGs Act Jointly Against Online Educational Company
Will the U.S. Have a GDPR? With Rachael Ormiston of Osano
Episode 328 -- Sanctions Enforcement Risks and Redlines
FCPA Survival Guide: Step 3 - Extensive Remediation
Episode 324 -- Third-Party Risks and Sanctions Compliance
Compliance Tip of the Day – Compliance Lessons from the Albemarle FCPA Enforcement Action
The Presumption of Innocence Podcast: Episode 38 - A Blueprint for Compliance: The Fraud Pentagon Theory
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more
A recently announced settlement with online alcohol addiction treatment service Monument Inc. demonstrates the Federal Trade Commission’s (FTC) continued focus on the use and disclosure of health data. The proposed settlement...more
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more
The Federal Trade Commission (FTC) has been aggressively pursuing enforcement actions that involve companies using applications that share consumer personal health information with third parties in violation of the Health...more
The FTC recently proposed amendments to the Health Breach Notification Rule (HBNR). This is on trend with its aggressive interest over the last couple of years in health data not covered by HIPAA....more
On May 18, the Federal Trade Commission (FTC) proposed changes to the Health Breach Notification Rule (the HBNR or the Rule), including clarifying the rule’s applicability to health apps and other similar technologies. These...more
The Federal Trade Commission (FTC) is on a roll in its efforts to signal to the digital health industry that data privacy must be a priority. The FTC announced a consent decree with BetterHelp on March 2, 2023, to settle...more
For the first time, the Federal Trade Commission has brought an enforcement action under its 2009 Health Breach Notification Rule (HBNR). The case was brought against a digital health company, GoodRx Holdings, Inc., for...more
Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...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
The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
Like many industries, the health care industry has become increasingly digitized and reliant on technology. Technology advancements also have had a major effect on enforcement. In his comments to the Federal Bar Association...more
Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more
Learning Objectives: - Hear from former state and federal prosecutors and regulators regarding the state of affairs for healthcare providers, operational, and compliance professionals - Learn about how the pandemic has...more
Many digital health app developers offering health and wellness solutions directly to consumers may find themselves in a space unregulated by the Health Insurance Portability and Accountability Act (“HIPAA”). While...more
Digital health is exciting, innovative and forward-looking. Investors have invested billions of dollars anticipating dividends from the next phase of the Big Data revolution: collecting and synthesizing millions of data...more
With 2020 officially behind us, what does 2021 have in store for telemedicine and digital health policy? A year ago, our team predicted 2020 would bring “notable expansions in Medicare and Medicaid coverage” and “the...more
Consumer-directed health apps are experiencing a boom thanks to COVID-19, as consumers seeking to avoid doctors’ office waiting rooms are increasingly relying on apps to measure and maintain their health. That trend is...more
The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...more
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more
Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more
In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many of these proposals are...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more