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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +
Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now.   less -
Sheppard Mullin Richter & Hampton LLP

FedRAMP Releases New Draft Authorization Boundary Guidance

Sheppard Mullin Richter & Hampton LLP on

Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

Hogan Lovells on

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - December 2019

Skadden, Arps, Slate, Meagher & Flom LLP on

In this month's edition of our Privacy & Cybersecurity Update, we take a look at guidance on artificial intelligence released by the U.K. Information Commissioner's Office and the Turing Institute, as well as guidance...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - October 2019

Skadden, Arps, Slate, Meagher & Flom LLP on

In this month's edition of our Privacy & Cybersecurity Update, we examine the California attorney general's draft regulations on the California Consumer Privacy Act, the CJEU's clarified rulings on the use of cookies, the...more

Mintz

FDA Responds to Device Software Vulnerabilities by Releasing New Draft Cybersecurity Guidance

Mintz on

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

Pillsbury Winthrop Shaw Pittman LLP

New Proposed DoD Cyber Guidance May Fuel Bid Protest Docket

Pillsbury Winthrop Shaw Pittman LLP on

Newly published draft DoD Guidance for Reviewing System Security Plans (SSP) and the “NIST SP 800-171 Security Requirements Not Yet Implemented” answer some questions but may also result in an increased protest docket due to...more

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