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.
Read MoreScaling 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.
Read MoreThe 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.
Read MoreNew 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.
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