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.

Operating at Scale: Legal Considerations for Growth-Stage Health AI Companies

Scaling a healthcare AI company? Learn the top legal strategies for growth-stage digital health companies—from FDA SaMD analysis and HIPAA compliance to state AI laws and AI governance.

DEA Delays Implementation of Final Teleprescribing Rules—What’s Next for Telehealth Prescribing?

The DEA has delayed implementation of two major teleprescribing rules until December 31, 2025, citing stakeholder concerns about patient access and pharmacy burden. While current pandemic-era flexibilities remain in place, the future of telehealth prescribing, especially for opioid use disorder treatment, remains uncertain as regulators weigh next steps.

TelehealthCarrie NixonMay 5, 2025hipaa, privacy, privacy law, PHI, Telehealth, DEA, Telemedicine

State Health Privacy Laws Expand Beyond HIPAA: What Healthcare Businesses Need to Know About NYHIPA

New York is the latest state to introduce its own health privacy law, the NY Health Information Privacy Act (NYHIPA), signaling a growing trend of state-level regulations extending beyond HIPAA. If enacted, NYHIPA will impose strict requirements on how businesses—both inside and outside the healthcare industry—collect, process, and share consumer health data, making compliance a priority for many organizations.

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.