Posts tagged AI
FDA’s New Playbook for AI in Medical Devices: What Developers Need to Know
FDA’s New Playbook for AI in Medical Devices: What Developers Need to Know

AI is reshaping healthcare—but for innovators building AI/ML-enabled software as a medical device (SaMD), staying compliant with FDA regulations is just as critical as building great tech. The FDA’s evolving Total Product Lifecycle (TPLC) approach, new transparency principles, and guidance on Predetermined Change Control Plans (PCCPs) are reshaping the path to market.

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Artificial IntelligenceMichael SchellhousTelehealth, Telemedicine, AI, privacy law, SaMD, FDA, IP, Privacy laws, disclosure, compliance, FTC, hipaa, artificial intelligence, FDA Regulations, machine learning
Navigating the Future of AI in Healthcare: 3 State Law Trends to Watch
Navigating the Future of AI in Healthcare: 3 State Law Trends to Watch

Explore how state laws are shaping the future of AI in healthcare, focusing on transparency, consumer rights, and algorithmic fairness. As regulations evolve, healthcare AI innovators must adapt to ensure compliance and equitable outcomes in a multijurisdictional landscape.

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Artificial IntelligenceReema TanejaM&A, Digital Health, Venture Debt, health equity, interest rates, AI, value-based care, audits, FDA Regulations, interoperability
Trends and Opportunities for Digital Health Innovators in 2025
Trends and Opportunities for Digital Health Innovators in 2025

Discover the top trends and opportunities for digital health innovators in 2025, from AI adoption and value-based care to regulatory shifts and cybersecurity challenges. These insights from Nixon Law Group will help you navigate the year ahead.

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Firm News, Corporate Healthcare LawNixon Law GroupM&A, Digital Health, Venture Debt, health equity, interest rates, AI, value-based care, audits, FDA Regulations, interoperability
Point Solution Fatigue, Meet M&A: How Strategic Transactions Can Transform Digital Health
Point Solution Fatigue, Meet M&A: How Strategic Transactions Can Transform Digital Health

Explore how strategic mergers and acquisitions (M&A) can reduce or even eliminate point solution fatigue by creating more comprehensive and integrated platforms that will improve patient care and reduce administrative burden.

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Corporate Healthcare LawKevin Joyce, Carrie Nixon, Sam PinsonM&A, Digital Health, Remote Patient Monitoring, Remote Monitoring, AI, reimbursement, fee for service, privacy and security
Colorado’s New AI Law Sets “National Standard” for Healthcare AI: 5 Things Developers and Deployers Need to Know, Now
Colorado’s New AI Law Sets “National Standard” for Healthcare AI: 5 Things Developers and Deployers Need to Know, Now

Last Friday, Colorado’s governor signed into law the Colorado AI Act (“CAIA”). For digital health companies building with artificial intelligence, CAIA sets the first comprehensive national benchmark for minimum rights and protections for users of healthcare AI, effective February 1, 2026.

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Corporate Healthcare Law, Artificial IntelligenceGuest UserAI, Healthcare innovation, hipaa
How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?
How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

No centralized framework for the regulation of artificial intelligence in the United States currently exists. That said, the flurry of regulatory policymaking and legislation, congressional hearings and inquiries, and industry stakeholder organization around the development and deployment of healthcare AI portends major developments in the coming years. Experienced entrepreneurs and executives know that the ability to peer into the future can pay dividends, and we agree.

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Artificial IntelligenceRebecca Gwilt and Samuel Pinsonartificial intelligence, AI, Digital Health