Podcast - Cybersecurity Roundup: Analyzing New and Proposed Rules for Contractors
Cybersecurity Insights: Updates on CMMC Implementation and CUI Identification
Podcast - Third-Party Assessments and NIST SP 800-171
Third-Party Assessments and NIST SP 800-171
[Podcast] AI Risk Management: A Discussion with NIST’s Elham Tabassi on the NIST AI Risk Management Framework
Compliance into the Weeds - ChatGPT for the Compliance Professional
Nota Bene Episode 150: Building an AI Risk Management Framework with Siraj Husain
DoD Cyber: A Conversation with Melissa Vice, COO for DoD’s Vulnerability Disclosure Program
Cybersecurity and Data Privacy Year in Review: Major Breaches, Changes in the Law, and Upcoming Trends
The Government Contracts Cyber Café: Recent Developments Update
How to Respond to President Obama's Cybersecurity Executive Order
In our previous Mintz IRA Update, we covered the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the “Act”) to seize pharmaceutical patents if the administration...more
Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more
Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On February 22, 2024, the Federal Communications Commission (FCC or “Commission”) released a Public Draft of a Report and Order that, if adopted, would establish a voluntary labeling program for Internet of Things (IoT)...more
Artificial Intelligence, commonly known as AI, has been all over the news recently, from goofy uses (George Washington with a mullet) to apocalyptic fears (AI systems with the power to launch a missile attack without human...more
This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...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
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
Companies are developing, deploying, and interacting with artificial intelligence (AI) technologies more than ever. At Goodwin, we are keeping a close eye on any regulations that may affect companies operating in this...more
The US Department of Health and Human Services recently updated its guide to help the private and public healthcare sectors develop cybersecurity protocols that address NIST’s Framework for Improving Critical Infrastructure...more
The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more
Outlook for This Week in the Nation’s Capital - Congress. Congress is in recess to campaign for the upcoming midterms. Senate Majority Whip Dick Durbin (D-IL) on Wednesday said the Senate will focus on judicial nominations...more
Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...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
On May 12, President Biden signed an executive order on improving the nation’s cybersecurity (the “Executive Order”). The Executive Order identified six broad initiatives for the improvement of security within federal...more
Brexit Effects on Trademarks Beginning January 1 - Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana....more
UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Submits Comment on the Preliminary Draft for the NIST Privacy Framework - On October 24, 2019, the Federal Trade Commission ("FTC") announced that...more
UNITED STATES - Regulatory—Policy, Best Practices, and Standards - NIST Produces Roadmap for Improving Critical Infrastructure Cybersecurity Version 1.1 - On April 25, the National Institute of Standards and Technology...more
• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...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
President Donald Trump on February 12, 2018, submitted his budget request to Congress for Fiscal Year (FY) 2019. The President's full budget calls for approximately $4.4 trillion in total spending. Much of the budget seeks...more
UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Comments on Improvements to IoT Device Security - On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the...more