Nixon Law Group 6/26/24 Nixon Law Group 6/26/24

Food as Medicine Summit 2024: 4 Challenges FaM Innovators Face

At the most recent Food as Medicine (FaM) Summit, leading experts, policymakers, and healthcare innovators in FaM gathered to discuss one important goal: revolutionizing how we improve population health through food and nutritional guidance.

Here’s what we believe every healthcare and FaM innovator should know.

Nixon Law Group 6/24/24 Nixon Law Group 6/24/24

Digital Therapeutics Alliance Summit 2024: 5 Takeaways for DTx Innovators

The Digital Therapeutics Alliance Summit 2024, held in Washington, D.C., brought together over 500 industry leaders (including NLG’s own Carrie Nixon and Michael Schellhous), innovators, and key stakeholders to discuss the current state and future of digital therapeutics (DTx).

Nixon Law Group 6/10/24 Nixon Law Group 6/10/24

FTC Finalizes Changes to Health Breach Notification Rule: What Digital Health Companies and App Developers Need to Know

The Federal Trade Commission (FTC) finalized changes to the Health Breach Notification Rule (HBNR), clarifying its applicability to health apps and similar technologies, including those that are not subject to HIPAA. In 2023, FTC began enforcing the HBNR in earnest, with an expanded interpretation of their authority under the HBNR. In the 2024 Final Rule (the 2024 Final Rule), the agency conforms the HBNR to this expanded interpretation, clarifying its breadth for industry and the public.

Nixon Law Group 5/29/24 Nixon Law Group 5/29/24

FDA Enforcement Discretion: A Strategic Path to Market for Digital Health and Digital Therapeutics Companies

Healthcare delivery is changing, and digital health is revolutionizing healthcare, creating a burgeoning market opportunity for software-as-a-medical-device (SaMD) and digital therapeutic (DTx) products.

Nixon Law Group 5/21/24 Nixon Law Group 5/21/24

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.

Nixon Law Group 5/16/24 Nixon Law Group 5/16/24

ATA Nexus 2024: 4 Game-Changing Takeaways for Healthcare Innovators

The ATA Nexus 2024 Conference, one of the largest gatherings of virtual healthcare experts and thought leaders, just took place in Phoenix last week. If you weren’t able to attend…what did you miss?

Nixon Law Group 4/22/24 Nixon Law Group 4/22/24

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.