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 MoreIf you’re building a digital health company, it is especially important to develop a multi-faceted intellectual property protection strategy. Here’s why: a strategy that includes multiple pathways for IP protection allows you to protect both tangible assets, like proprietary hardware, software, and documentation, as well as intangible assets, like branding, customer-facing website designs, pricing strategies, business models and projections.
Read More
