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Pillsbury Winthrop Shaw Pittman LLP

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

Pillsbury Winthrop Shaw Pittman LLP on

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

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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions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On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

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

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Health Care Compliance Association (HCCA) on

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

McDermott Will & Emery

The EU Medical Device Regulation: What’s Next?

McDermott Will & Emery on

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

Akin Gump Strauss Hauer & Feld LLP on

• 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

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