AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast
Podcast - Who Owns Your DNA? Lessons Learned from 23andMe
AI Legislation: The Statewide Spotlight — The Consumer Finance Podcast
Business Better Podcast Episode: Bridging Campuses: Legal Insights on Education Industry Consolidation – Privacy and Data Security
The Next FCRA Frontier: Identity Theft and CFPB Updates — FCRA Focus Podcast
Episode 366 -- DOJ Issues Data Security Program Requirements
The Privacy Insider Podcast Episode 13: Preserving Privacy and Social Connection with Christine Rosen of the American Enterprise Institute
AI in Employment: Navigating the Legal Landscape with Lessons from I, Robot — The Good Bot Podcast
FCPA Compliance Report: AI, Data Compliance, and Ownership - A Conversation with Andrew Hopkins
Innovations in Compliance: Data Collection & Cybersecurity with ModeOne’s Matt Rasmussen and Ryan Frye
Fintech Focus Podcast | Responding to a Cyber Attack – Key Considerations for GCs and CISOs
A Blueprint for Efficient SRRs: Mastering Your Subject Rights Workflow
What is the CCF?
AI in Employment: Navigating the Legal Landscape with Lessons from I, Robot — Hiring to Firing Podcast
A Less is More Strategy for Data Risk Mitigation
Auditing Your Hotline and Case Management System
Compliance and AI: Ali Khan on Implementing AI Risk Management Systems
Weathering the 2025 Whirlwind: How to Keep Calm & Carry On
No Password Required Podcast: Chief Product Officer at ThreatLocker and Advocate of Buc-ee’s, Mascots, and Buc-ee Mascots
Compliance Tip of the Day: AI for Whistleblower Anonymity
The medical spa industry is rapidly growing, driven by technological advances and shifting consumer preferences for cosmetic and wellness services. While this growth offers many business opportunities for healthcare...more
Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more
The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more
On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more
Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more
Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business. ...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more
On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
The Patient Engagement Advisory Committee to the Food and Drug Association (FDA) met recently to discuss cybersecurity in medical devices. Medical devices are increasingly connected to the internet, hospital networks, and...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more