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

Read More
Corporate Healthcare LawRebecca Gwilt, Samuel Pinson, and Michael SchellhousFTC Breach Notification Rule, FTC, HBNR, Digital Health, developers, data breach
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.

Read More
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.

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