Great Women in Compliance: Creating Space to Speak Up: The Story Behind Psst.org
Hidden Fees in the Live-Event Ticketing and Short-Term Lodging Industries
Digital Planning Podcast Episode: Estate Planning and the Corporate Transparency Act
Episode 330 – Halyna Senyk on Anti-Corruption Progress in Ukraine
ESG Masterclass — ESG and Impact Investing
FCPA Compliance Report – Jonathan Wilson on The NSBU Decision
Áine Bryn of Mercer UK on Demonstrating the Strategic Credibility of the Marketing Function - Passle's CMO Series Podcast
Podcast - The CFPB's Proposal to Create a Public Registry
Breaking Mindsets with Sharon Sorkin from Ford on Being Reliably Transparent
Auditing and Monitoring in Healthcare
Exploring The ‘S’ In ESG & What To Expect In 2023
The Line Between Gift Giving and Bribery
The New Cold War: Risk, Sanctions, Compliance Episode 21: "Interview with Drago Kos of the OECD Working Group on Bribery"
ABA Sound Advice: Conducting Civil Rights Audits: Benefits and Best Practices
Early Advocates of Organic Food Products, Amy’s Kitchen Believes in the Benefits of a Fully Regenerative Ecosystem and Aims to Help Heal the Planet Through Its Business
AI, Analytics, and the Benefits of Transparency
Life With GDPR: Episode 50-The Experian Enforcement Notice Case
Scrutiny Increasing On Energy Private Equity Valuation
Compliance Perspectives: Supply Chain Compliance Challenges
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more
On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more
The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more
In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more
The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for...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
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more