Agent skill · product strategy · borghei
healthtech-advisor
Strategic advisory for digital health founders on HIPAA scope, FDA SaMD classification, EHR integration, and payor/provider GTM. Use when scoping a healthtech idea, classifying PHI, or mentioning HIPAA, FDA SaMD, EHR, or telehealth.
Why this skill is useful
Provides strategic frameworks and a PHI scope checker script that help healthtech founders navigate HIPAA and FDA regulations effectively.
What it needs
Requires python installed locally. About 4k tokens when loaded. Last updated 2026-07-21. 462 stars on the source repository.
What this skill does
Healthtech Advisor Strategic frameworks for digital health and healthtech founders, operators, and product leaders. Complements (does not replace) the RA/QM compliance domain. RA/QM covers regulatory and quality management for medical devices; this skill covers business-side strategy for health software companies. Disclaimer: Frameworks and orientation only. Not legal, regulatory, clinical, or compliance advice. Healthtech businesses need licensed counsel (HIPAA, FDA, fraud-and-abuse), clinical advisors, and qualified RA/QM specialists. Use this skill to organize strategy; engage specialists for binding decisions. --- Table of Contents Keywords Quick Start Core Workflows Tools Reference Guides Templates Best Practices --- Keywords healthtech, digital health, HIPAA, PHI, BAA, business associate, covered entity, FDA SaMD, software as medical device, EHR, EMR, FHIR, HL7, telehealth, digital therapeutics, DTx, payor, provider, value-based care, fee-for-service, RPM, remote patient monitoring --- Quick Start 10-Minute Scope Check 1. Write a 1-paragraph description of what your product does and what data it touches 2. Run python scripts/phiscopechecker.py description.txt 3. Use the output to scope HIPAA exposure and identify whether you're a Business Associate, Covered Entity, neither, or both Pick a GTM 1. Read references/gtmpatterns.md 2. Identify your buyer: payor, provider, employer, individual, pharma, government 3. Each GTM has a different sales motion, contract length, and economics — pick before committing engineering --- Core Workflows Workflow 1: HIPAA Scope and BAA Strategy Goal: Determine whether HIPAA applies, in what capacity (Covered Entity, Business Associate, neither), and what BAAs you need with whom. Steps: 1. Run PHI scope checker on your product description 2. Identify: do you handle PHI on behalf of a Covered Entity (you're a BA), are you a CE yourself, or are you handling consumer-generated health data outside HIPAA? 3. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills borghei/healthtech-advisor