Regulatory vs. Business Compliance
Fintech Focus Podcast | Navigating IT and Security Risks in Fintechs in Light of Impending DORA Deadline
On-Demand Webinar: Bring Predictability to the Spiraling Cost of Cyber Incident Response Data Mining
Episode 347 -- LRN's Code of Conduct Survey
Workplace Investigation Protocols: One-on-One with Greg Keating
The Election's Impact on the FTC Will Bring Big Changes, But Being Vigilant Must Remain a Priority
Harnessing Generative AI: Innovations and Best Practices — The Good Bot Podcast
Innovation in Compliance: Navigating Risk Management in the Automotive Industry with Tom Kline
Effective Compliance Training
Compliance Tip of the Day: Board Questions and Metrics for 3rd Party Risk Management
AI Washing: Simple Guidance to Avoid Risk
Webinar ¦ Benefits of Using AI in Construction
The Future of AI Regulation and Legislation: 5 Key Takeaways
Episode 342 -- How to Conduct an Internal Compliance Site Visit and Review
Why Privacy is Your Secret Weapon Against Third-Party Risk
Due Diligence in AI: 3 things you need to survive AI scrutiny
Enhancing Compliance: The Power of Independent Monitorships in Consumer Protection — Regulatory Oversight Podcast
Investigations and Cognitive Interviews
Consumer Finance Monitor Podcast Episode: Regulators Escalate Focus on the Risks of Bank Relationships with Fintechs and Other Third Parties
Fraud Prevention Techniques for Nonprofit Organizations - Part 3
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...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 U.S. National Institute of Standards and Technology (NIST) is seeking comment on four draft publications meant to promote safe, secure, and trustworthy artificial intelligence (AI) systems. Two drafts provide guidance to...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
Welcome to this week's issue of AI: The Washington Report, a joint undertaking of Mintz and its government affairs affiliate, ML Strategies. The accelerating advances in artificial intelligence (“AI”) and the practical,...more
Seyfarth Synopsis: Following President Biden’s comprehensive Executive Order on AI, the White House announced the formation of the “US AI Safety Institute” within the Commerce Department’s technology arm, the NIST. The...more
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more
On February 19, 2020, the Information Commissioner’s Office (ICO), the data protection regulator in the United Kingdom, launched a consultation on its draft guidance on the artificial intelligence (AI) auditing framework. ...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
On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more
The United States Army Corps of Engineers (“Corps”) public noticed in the September 13th Federal Register the issuance of a revised document titled: Engineer Circular (EC) 1165-2-220, Policy and Procedural Guidance for...more
Seyfarth Synopsis: In compliance with the New York State Anti-Sexual Harassment legislation passed earlier this year, the Office of Governor Andrew M. Cuomo has released drafts of the model sexual harassment policy, training...more
The State of New York recently issued draft guidance for employers regarding the anti-sexual harassment legislation passed earlier this year....more
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this...more
In February 2018, the U.S. Army Corps of Engineers (“Corps”) issued a draft Engineering Circular (“EC”) outlining proposed policies and procedures regarding how it will address third-party requests to alter civil works...more
Happy New Year!!!!!! Yes, it is actually February, but it is a new year for this blog as we turn our attention to a world full of flood risk reduction actions in the second year of the Trump Administration. We are hearing...more
The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...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
On January 22, 2016, the US Food and Drug Administration ("FDA") issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks in order to improve patient safety and...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more
The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more
It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called...more