For Health Tech — Promise Legal Insights

Insights for Health Tech

Digital health, women-led healthcare, and AI in clinical workflows.

Digital health and women-led healthcare founders work at the most heavily-regulated edge of consumer technology. HIPAA is just the start: telehealth licensure across state lines, FDA classification for digital therapeutics, BAAs with every vendor that touches PHI, and the rapidly-emerging AI-in-clinical-workflow rules add layers traditional tech-startup counsel rarely navigates.

This hub is for digital health founders, women-led healthcare ventures, and the operators building clinical AI. Pre-seed through Series A, with cap tables that have to absorb compliance cost the way other startups absorb engineering hires.

Questions This Hub Answers

  • When am I a HIPAA Covered Entity vs. a Business Associate, and what changes?
  • How do I structure BAAs with AI vendors that train on data?
  • What does practicing telehealth across state lines actually require?
  • When does my product cross into FDA digital-therapeutic territory?
  • How do I price compliance into my cap table and option pool?
  • What does AI clinical-workflow compliance look like under HIPAA + state law?

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