Question 1

When should a telehealth startup build its own platform vs. use an existing solution?

Accepted Answer

Use an existing solution (Doxy, SimplePractice, Healthie) until you have: (a) a care model that the platform can't accommodate, or (b) patient volume and revenue that justifies the investment in custom infrastructure. Build custom when the platform constrains your care model, when integration requirements exceed what the platform's API can support, or when you need white-label for a B2B deployment.

Question 2

What does Series A technical due diligence look for in a digital health company?

Accepted Answer

DDs look at: HIPAA documentation (BAA chain, security policies, incident response plan), architecture quality (no obvious shortcuts that will create technical debt), scalability evidence (load testing, infrastructure-as-code), and compliance posture (SOC 2 progress, security assessments). We build with DD readiness in mind from day one.

Question 3

Is our clinical decision support software subject to FDA regulation?

Accepted Answer

Possibly. Software that is 'intended to treat, diagnose, cure, or prevent' a condition is a medical device under FDA's SaMD framework. The FDA's digital health guidance distinguishes between low-risk decision support (physician-directed, physician can independently review) and higher-risk clinical decision support (the software makes the decision, overrides physician judgment). Pre-Submission meetings with FDA are advisable early for any software making autonomous clinical recommendations.

Question 4

How do we handle multi-state prescribing compliance in our platform?

Accepted Answer

State-by-state prescribing rules are enforced at the platform layer: verify provider licensure in the patient's state at booking, restrict controlled substance telehealth workflows in states where DEA exceptions don't apply, and log each prescribing transaction with the applicable state compliance context. We build this as configurable rules in the scheduling and prescribing engine.

Question 5

How do we make our tech stack HIPAA-ready from day one?

Accepted Answer

HIPAA compliance is an architectural decision, not a retrofit. From day one: encrypted data storage and transmission, audit logging on all PHI access, role-based access controls, secure credential management, business associate agreements with vendors, and incident response planning. Building HIPAA-ready from the start costs less than retrofitting later.

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