A Conversation with Alexandra Johnson, CEO/Co-Founder of Rubber Ducky Labs, AI Recommender Systems Pioneer
The Future of AI Regulation and Legislation: 5 Key Takeaways
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 212: Fujifilm’s Investment in North Carolina with Christine Vannais and Laurie Braxton of Fujifilm
The Privacy Insider Podcast Ep. 8: Privacy Over Party: Peter Swire
Podcast - Robots, Rights and New Tech: Balancing Innovation and Data Privacy
DE Talk | How SMBs Can Use AI Hiring Tech in Inclusive Ways
The Briefing: New California Laws for Digital Replicas Both Live and Dead
Exploring AI's Potential in Financial Services With John Sun of SpringLabs — The Consumer Finance Podcast
Due Diligence in AI: Thinking like your biggest critic
Reel Shorts | Labor & Employment: Navigating AI Compliance Risks in Recruiting
AI Discrimination and Emerging Best Practices – Part 1 — The Good Bot Podcast
Due Diligence in AI: 3 things you need to survive AI scrutiny
How can founders navigate the explosion of state AI regulations?
Using Innovative Technology to Advance Trial Strategies | Episode 70
Dan Rudoy Examines the Impact of AI on IP Strategy
The Burr Broadcast: AI in the Workplace
Exploring the CFPB's Stance on AI in Financial Services — The Consumer Finance Podcast
Joe Green & Monica Rodriguez Kuniyoshi on Integrating Generative AI with Your Experts: Passle CMO Series Live Podcast
Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 2 — The Good Bot Podcast
When AI Meets PI: Assessing and Governing AI from a Privacy Perspective
On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more
At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more
...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more
Our downloadable report, Legal Insights for Manufacturing, explores how the business, legal, and regulatory framework is evolving—and will evolve—to address the large generational shifts taking place. This year, our report...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more
In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program....more
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) finalized new policies related to remote therapeutic monitoring (RTM) services reimbursed under the Medicare program. The changes, part of the...more
The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history...more
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more
The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more