On Jan. 14, 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly released the “Guiding Principles of Good AI Practice in Drug Development,” a set of 10 high-level principles intended to steer the safe and responsible use of AI across the product lifecycle. While not formal industry guidance, the
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NYDFS Issues Guidance on Third-Party Cybersecurity Risk Management: What Regulated Entities Need to Know
Overview
On October 21, 2025, the New York State Department of Financial Services (NYDFS) released comprehensive guidance for registrants regarding management of cybersecurity risks associated with third-party service providers (TPSPs) including cloud computing, file transfer system, AI and fintech solutions.[1] As reliance on external vendors for critical technology services grows, so too do the…
Halloween Reminder – Don’t Get Haunted by Hacks
With Halloween lurking around the corner and as National Cybersecurity Awareness Month comes to a close, the McGuireWoods Data Privacy & Cybersecurity Practice Group reminds you to not wait to be spooked by a cybersecurity incident or haunted by the task of maintaining your cybersecurity program.
Today’s threat landscape is rapidly changing and accelerated evermore…
New CCPA Rules Are Here: Is Your Business Ready for What’s Next?
In a significant step toward strengthening consumer privacy protections, the California Privacy Protection Agency (CPPA) board has officially adopted a comprehensive set of updates to the California Consumer Privacy Act (CCPA) regulations. These long-anticipated regulations—covering cybersecurity audits, risk assessments, and automated decision-making technology (ADMT)—mark a pivotal shift in the state’s data privacy enforcement landscape.…
The New Frontier: Data Centers, AI & Insurance Implications
Amazon’s recent announcement to invest at least $20 billion in cloud computing and AI data center campuses across Pennsylvania — a record‑breaking private investment in the state — marks a turning point in digital infrastructure build-out. Spanning sites in Luzerne and Bucks counties, the project promises 1,250 full‑time roles and thousands more in construction, while pairing…
DOJ Targets Remote Patient Monitoring Company in $1.29M FCA Settlement
Remote patient monitoring (“RPM”) continues to see increased growth and evolution. With that industry growth, the government has begun to examine whether certain RPM models may have fraud and abuse concerns when others will not. To that end, on June 26, 2025, the Department of Justice (“DOJ”) announced that Health Wealth Safe, Inc. (“Health Wealth…
Healthcare & Life Sciences Private Equity Deal Tracker: New Mountain Invests in SmarterDx
New Mountain Capital has completed a strategic investment in SmarterDx, according to a news release.
SmarterDx, founded in 2020 and based in New York, develops clinical artificial intelligence focused on revenue integrity and care quality.
New Mountain, based in New York, is a growth-oriented investment firm. Founded in 1999, the firm manages private…
HHS Proposed Rule May Enhance HIPAA Security but Leaves AI Questions Open
In response to increased cybersecurity threats and significant regulatory enforcement actions, on Dec. 27, 2024, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking seeking to enhance cybersecurity protections under the Security Rule implemented pursuant to the Health Insurance Portability and Accountability Act of 1996. While the proposed rule is…
Healthcare & Life Sciences Private Equity Deal Tracker: WindRose Invests in CIVIE
WindRose Health Investors has announced a strategic investment in CIVIE.
CIVIE, founded in 2018 and based in Plano, Texas, is an artificial intelligence-powered ecosystem of radiology solutions.
WindRose, founded in 2000 and based in New York, pursues equity investments in healthcare companies. The firm invests in a broad range of industry segments, including…
Healthcare & Life Sciences Private Equity Deal Tracker: New Mountain to Acquire Machinify
New Mountain Capital has announced it will acquire Machinify.
Machinify, founded in 2016 and based in Palo Alto, California, is a provider of artificial intelligence (AI)-powered software focused on healthcare claims and payments.
New Mountain, based in New York, is a growth-oriented investment firm. Founded in 1999, the firm manages private equity, credit and…