Real-world notes for founders navigating the messy road from idea to launched product.
Is your health app a medical device? FDA SaMD decision framework for founders. Real criteria, enforcement patterns, and strategic implications for health tech startups.
What it actually takes to use GPT and AI chatbots in healthcare while maintaining HIPAA compliance. Technical architecture, BAA requirements, and risk mitigation strategies.
Mental health apps and regulatory gray zones - when wellness becomes medical. FDA classification, HIPAA requirements, and crisis intervention obligations for behavioral health startups.
The 5 compliance questions healthcare investors ask in every pitch. How to answer HIPAA, FDA, BAA, security, and regulatory strategy questions that determine funding decisions.
Remote patient monitoring MVP feature priorities when budget limits IoT ambitions. What to build, what to defer, and what to partner for in RPM startups.
Real-world timeline for integrating with Epic and Cerner EHR systems. Budget expectations, technical requirements, and critical milestones for healthcare startups.
