7 · Compliance tracks (SOC 2 · HIPAA)

TL;DR

Non-blocking — reference only

This step is not a launch gate. Most CodeCanyon SaaS launches skip SOC 2 and HIPAA entirely; read it when a customer contract or regulated data triggers either track.

Objective — know when (if ever) SOC 2 and HIPAA become real so you don’t start an expensive track an MVP doesn’t need: run the applicability tests, weigh cost + timeline, and recognize the platforms that automate evidence collection. Most CodeCanyon SaaS launches skip both.

User part + done-when

👤 User part — this is a decision page: run the applicability test, decide whether either track applies, and (if so) sign BAAs and select a compliance platform. Nothing here is terminal-runnable.

Done when the HIPAA applicability test is run and the answer recorded, any contractual SOC 2 requirement is confirmed or deferred, and the decision (skip + reopening trigger, or start + platform/policies underway) is documented.  ·  ⏱ ~30 min read  ·  👤 user decision.

Background

This page is reference only — most CodeCanyon SaaS launches need neither framework. Don’t start either track for an MVP or a consumer app. Know the triggers so you recognize the moment one becomes real, and what you’re signing up for when it does.

GDPR ≠ SOC 2 ≠ HIPAA

GDPR is a legal requirement the moment you touch EU/UK personal data — do it now. SOC 2 and HIPAA below are conditional and expensive; they enter only on specific triggers.

Steps

1. Determine which (if any) applies

Walk the decision tree, then record the answer. Most apps land on “neither — GDPR only.”

Who does this

👤 User runs the applicability test and records the decision — it’s a business/legal judgment about PHI and enterprise contracts, not a command an agent can run.

1. Walk the applicability tree.

   flowchart TD
     Start["Compliance check"] --> PHI{Store health data +<br/>a HIPAA identifier?}
     PHI -->|yes| HIPAA["HIPAA applies — required by law"]
     PHI -->|no| B2B{Enterprise B2B clients<br/>requesting an audit?}
     B2B -->|yes| SOC2["SOC 2 — start the track"]
     B2B -->|no| None["Neither — GDPR only.<br/>Revisit when a trigger fires"]

   	SOC 2	HIPAA
   Trigger	Enterprise B2B clients demand it	App handles Protected Health Information (PHI)
   Nature	Voluntary, sales-driven	Legally mandated when applicable
   Cost	$15K–50K audit + $8K–15K/yr platform	$32K–85K consulting + implementation
   Timeline	3–12 months	4–8 weeks
   Certification?	Yes — Type I or Type II report	No official cert; validated by audits + BAAs

   • ✅ The applicability outcome (HIPAA / SOC 2 / neither) is recorded.

2. SOC 2 — when enterprise asks

SOC 2 is a security audit you pursue because customers require it before they’ll sign. Skip it for MVP or consumer SaaS.

1. Confirm the trigger and scope before committing. Start when an enterprise client requests it, you’re competing against SOC 2-certified vendors, or you handle sensitive client data at scale. Scope: Security (mandatory) plus optionally Availability and Confidentiality.

   • Type I — a point-in-time snapshot that controls exist.

   • Type II — controls operate effectively over 3–12 months. This is the gold standard enterprises expect.

   • ✅ The trigger is genuine and the Type I vs Type II target is chosen (or SOC 2 is deferred).

2. Stand up the required artifacts — six policy documents (Information Security, Access Control, Incident Response, Business Continuity, Change Management, Acceptable Use), an evidence-collection system, vendor SOC 2 reports, and a documented risk assessment.

   • ✅ Policy docs + an evidence-collection system are in place (if the track is live).

A compliance platform automates the evidence grind

These integrate with your stack to continuously collect evidence, cutting months of manual work: Sprinto ($8K/yr), Vanta ($10K/yr), Drata ($12K/yr), Secureframe ($15K/yr).

Much of the SOC 2 control set is already in place from earlier in this phase — access control, change management via the deploy pipeline, activity logging, backups, and observability. The audit largely formalizes and documents what you’ve built.

3. HIPAA — only with PHI

HIPAA applies only when the app touches health data combined with an identifier. Run the test before assuming you’re in scope.

1. Run the applicability test — does the app store, process, or transmit any of the 18 HIPAA identifiers combined with health data? If no — stop here. (A generic AI content tool or typical SaaS does not.)

   • ✅ The PHI test result is recorded — and if it’s “no,” HIPAA is out of scope.

2. Stand up the safeguards if it applies — Business Associate Agreements (BAAs) with every vendor that touches PHI (host, database, email, error tracking; no BAA, no compliance — and not every vendor will sign one), a designated Security Officer and Privacy Officer, PHI access logging, a 15-minute session timeout, encryption everywhere (TLS 1.2+ in transit, AES-256 at rest), a risk assessment, workforce training, and a breach-notification plan.

   • ✅ BAAs, officers, access logging, timeouts, and encryption are in place (only if HIPAA applies).

There is no “HIPAA certified” badge

Unlike SOC 2, HIPAA has no official certification. Compliance is validated through audits, signed BAAs, and documented safeguards. HITRUST is the closest third-party certification framework.

Checklist

Do not mark this step done until every box below is checked.

• 👤 HIPAA test run — applicability test done; confirmed HIPAA does not apply (or flagged that it does).
• 👤 SOC 2 decided — confirmed whether any client contractually requires SOC 2; if not, deferred.
• 🔀 Track in motion (if live) — platform selected, policy docs drafted, BAAs/evidence collection underway.
• 👤 Decision documented — otherwise: the decision to skip and the trigger that would reopen it is written down.

→Next step

Phase 8 · Configure the app