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 MoreOn January 6, 2016, in a dramatic national press conference, President Obama announced several actions by his administration to address gun violence in the US. One of these actions is a long-planned modification to the Health Insurance Portability and Accountability Act (HIPAA). The same day, the Department of Health and Human Services (HHS) published a Final Rule adding a permitted disclosure to the HIPAA Privacy Rule, which expressly permits a limited number of Covered Entities to disclose protected health information (PHI) of certain individuals to the National Instant Criminal Background Check System (NICS). The modification is aimed at removing one barrier to expanding the quality of the information in NICS, which is used by firearms vendors to disqualify potential purchasers who are federally barred from owning firearms.
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