News & Analysis as of

Software Cybersecurity Risk Assessment

Pillsbury Winthrop Shaw Pittman LLP

The EU’s Cyber Resilience Act: New Cybersecurity Requirements for Connected Products and Software

The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more

Sheppard Mullin Richter & Hampton LLP

FedRAMP 20x – Major Overhaul Announced to Streamline the Security Authorization Process for Government Cloud Offerings

On March 24, 2025, the Federal Risk and Authorization Management Program (“FedRAMP”) announced a major overhaul of the program, which is being called “FedRAMP 20x.” The FedRAMP 20x announcement stated there are no immediate...more

Accelerynt, Inc.

How Over-engineered Security Stacks Are Killing Agility—And What to Do About It

Accelerynt, Inc. on

Tool sprawl is paralyzing enterprise security teams. Learn how to shift from fragile, over-engineered stacks to agile security architectures that accelerate progress....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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

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On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Proskauer - California Employment Law

California Takes Steps to Regulate the Use of AI for Significant Employment Decisions

On November 8, 2024, the California Privacy Protection Agency (CPPA) voted 4-1 to proceed with formal rulemaking regarding automated decision-making technology (“ADMT”), which the draft regulations define as “any technology...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Supply Chain Attacks in the UK: Reducing Risk and Preparing for Upcoming Legal Changes

Effective information security is no longer just dependent on an organisation’s own internal cybersecurity controls. The UK Information Commissioner’s Office (ICO) highlights that third-party service providers are processing...more

NAVEX

Don't Be the Weakest Link – Your Team's Crucial Role in Cybersecurity

NAVEX on

Cybersecurity success depends on more than just technology. As we’ve seen in part one and part two of this series on cybersecurity risk, the costs of a cyber attack are high – and bad actors always look for the easiest entry...more

NAVEX

Immediate vs. Slow Burn Risks: A Balanced Cybersecurity Strategy

NAVEX on

The consequences of a cyberattack can be catastrophic, as we saw in the previous blog of this series. Cybersecurity is a business-wide responsibility that demands a proactive strategy extending far beyond technical solutions...more

Woods Rogers

DoD Unveils Cybersecurity Strategy for Defense Industrial Base: What You Need to Know

Woods Rogers on

The United States Department of Defense (“DoD”) recently published its Defense Industrial Base Cybersecurity Strategy 2024. For context, the DIB is comprised of more than 100,000 domestic and foreign companies or...more

NAVEX

Compliance & Cybersecurity – Working and Worrying Together About the Intersection of People and Technology

NAVEX on

I’m not a cyber expert, but as a compliance professional with accountability for internal investigations of employee and third-party misconduct I’ve had a front row seat to the evolution of risk that has mirrored the mass...more

Mitratech Holdings, Inc

5 Reasons to Invest in Enterprise Risk Management Software

From financial uncertainties to cybersecurity threats, regulatory changes, and everything in between, just how imperative is Enterprise Risk Management (ERM) technology in today’s business environment? According to a...more

Jones Day

California Privacy: A Deeper Dive Into the New Regulations Expected in 2024

Jones Day on

The Background: The California Privacy Protection Agency board ("CPPA" or "Board") is in the process of issuing new regulations as authorized under the California Privacy Rights Act. These three sets of proposed regulations...more

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more

Accelerynt, Inc.

Best Patch Management Strategy for Remote Workers

Accelerynt, Inc. on

Like it or not, the remote workforce is here to stay. Statistics show that employees say they are more productive working from home, and even before the global pandemic, there had been a 44% growth in the remote workforce...more

McDermott Will & Emery

The EU Medical Device Regulation: What’s Next?

The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more

Akin Gump Strauss Hauer & Feld LLP

Six Recent Government Supply Chain Risk and Cybersecurity Initiatives

• DoD and other government agencies will scrutinize contractors’ supply chain security plans and programs from proposal submission to contract closeout. • The 2019 NDAA as approved by Congress and DHS initiatives highlight...more

Hogan Lovells

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

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