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
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 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
Artificial intelligence (AI) is expanding into more industries (often in surprising ways) and has inevitably caught the attention of federal and state regulators. Our Privacy, Cyber & Data Strategy Team summarizes the...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
• 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
Recently, the Health Care Industry Cybersecurity Task Force (the “Task Force”) issued its Report on Improving Cybersecurity in the Health Care Industry (the “Report”). The Task Force, which was created by Congress as part of...more
Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry’s cybersecurity challenges. That Task Force–a combination of public and private...more
The National Institute of Standards and Technology (NIST) announced this week that it has issued draft cybersecurity guidance for hospitals to consider when using infusion pumps, particularly since infusion pumps are no...more
The Food and Drug Administration (FDA) recently issued nonbinding guidance focusing on the software vulnerabilities of networked medical devices that are already on the market. The guidance focuses on the importance of...more
New York’s Cybersecurity Requirements for DFS Licensees: A New Item at the Top of the To Do List - With a compliance date a few months away, licensees of the New York Department of Financial Services (DFS) must start...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more
The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more
Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers...more
Medical devices increasingly contain software or connect to networks that may leave the devices vulnerable to cyber-attacks. The U.S. Food and Drug Administration (“FDA”) has recognized the potential risks that these...more
On January 15, 2016, the U.S. Food and Drug Administration (FDA) announced in a Press Release that it would issue draft guidance on January 22 outlining “steps medical device manufacturers should take to continually address...more
Friday (January 22, 2016), the Food and Drug Administration (FDA) published draft guidance for medical device makers on the importance of including cybersecurity measures in approved products. Further, the guidance highlights...more
In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more