Introduction: Why a Requirements Checklist Matters

Healthcare founders don’t struggle to imagine features—they struggle to sequence them while staying compliant, safe, and cost-aware. The right Minimum Viable Product (MVP) should prove value with minimal scope, protect patient data, and be built on a foundation that won’t collapse when you add your second customer or pursue an enterprise pilot.

This checklist is a pragmatic guide for healthcare Software as a Service (SaaS) teams that want a Health Insurance Portability and Accountability Act (HIPAA)-ready MVP on Amazon Web Services (AWS) or Microsoft Azure, with guardrails for security, integrations, and operations. Use it end-to-end or cherry-pick sections to fit your phase.

1) Problem, Users, and Outcomes

Your goal in the MVP isn’t “all features”—it’s a thin, high-value slice that proves a real outcome for a very specific user.

Decide and document:

• The one primary job-to-be-done (e.g., “cut referral triage time by 30%”).

• The first 50 users (role, organization type, device mix, clinical/non-clinical).

• The critical workflow (happy path) and where data originates (manual entry, import, Electronic Health Record [EHR]).

• Non-goals for version 1 (features you will not ship).

• A 90-day success metric (activation rate, time-to-value, reduction in task time, error rate).

Healthcare note: Confirm if Protected Health Information (PHI) is involved in version 1. If yes, plan Health Insurance Portability and Accountability Act (HIPAA) controls and Business Associate Agreements (BAAs) now—not later.

2) Stakeholders and Clinical Reality

Healthcare has many actors and constraints. Your MVP must fit how people actually work.

Map the human system:

• Primary user, reviewers/approvers, administrators, and patients (if applicable).

• Clinical time constraints (short sessions, multi-tasking, session timeouts).

• Offline or low-connectivity points in the workflow.

• Devices and environments (shared terminals, tablets on carts, Bring Your Own Device [BYOD]).

• Accessibility needs (keyboard navigation, color contrast, readable error messages).

Tip: Shadow two real users doing the target task. Record steps, delays, and workarounds. Design to remove the biggest friction first.

3) Regulatory Baseline and Vendor Agreements

Regulations aren’t a later add-on. Treat them as design inputs.

Set your baseline:

• Health Insurance Portability and Accountability Act (HIPAA) scope: PHI in version 1? If yes, list all places PHI is collected, processed, stored, and displayed.

• Business Associate Agreements (BAAs): Cloud provider, data ingress tools, analytics, error tracking, and any vendor that can touch PHI.

• System and Organization Controls 2 (SOC 2): Decide if you’ll adopt key controls now or plan a phased path (common buyer requirement).

• General Data Protection Regulation (GDPR) / California Consumer Privacy Act (CCPA) (if applicable): lawful basis, data subject rights, Data Processing Agreement (DPA) with vendors.

• Policies you’ll actually follow: access control, incident response, vendor risk, data retention/deletion.

Deliverables: a one-page Regulatory Scope document, a Vendor BAA / Data Processing Agreement (DPA) matrix, and a Data Retention policy.

4) Architecture and Tenancy

Choose simplicity first; plan a path for scale.

Core choices

• Monolith first, with clear modular boundaries. Defer microservices.

• Application Programming Interface (API) versioning (/v1/*), idempotent writes, pagination by default.

• Multi-tenancy: pick one—

• Database-per-tenant (easier isolation, higher cost)

• Schema-per-tenant (middle ground)

• Shared schema with strict row-level isolation and per-tenant keys

• Feature flags for risky or regulated modules.

• Background jobs with retries and dead-letter queues.

Networking

• Private subnets for data stores; public only for load balancers.

• Web Application Firewall (WAF) and Content Delivery Network (CDN) in front (e.g., AWS CloudFront or Azure Front Door).

• Private connectivity (e.g., AWS PrivateLink or Azure Private Link, and Service Endpoints) to keep traffic on the cloud backbone.

5) Interoperability and Electronic Health Record (EHR) Strategy

Don’t start with the hardest integration. Prove value, then go deeper.

Phased integration plan

• Phase 1: Comma-Separated Values (CSV)/flat-file exchange to prove workflow value.

• Phase 2: Fast Healthcare Interoperability Resources (FHIR) sandbox (Substitutable Medical Applications and Reusable Technologies [SMART] on FHIR / OAuth 2.0).

• Phase 3: Production EHR APIs or integration engines as needed.

Interface hygiene

• Clear mapping docs (source → target), versioning, idempotency keys.

• Webhooks with retries/exponential backoff; dead-letter queues.

• Patient identity: Medical Record Number (MRN) / Enterprise Master Patient Index (EMPI) policies; matching and deduplication rules.

6) Testing and Validation Plan

Automated testing

• Unit tests for core logic; integration tests for hot paths.

• Contract tests for APIs/public webhooks.

• Smoke tests post-deploy.

Security testing

• Static Application Security Testing (SAST) / Dynamic Application Security Testing (DAST), dependency scans, container scans in Continuous Integration (CI).

• External penetration test before enterprise pilots with PHI.

• Regular access reviews.

Usability and clinical validation

• Task-based tests with target roles; measure time and errors.

• Document intended use, contraindications, and known limitations if clinical decisions are affected.

7) Artificial Intelligence (AI) Features (Only If They Change Outcomes)

AI can help, but it brings extra risk and cost. Use it only if it materially improves your outcome.

If you include AI:

• Clear use case and target metric (precision/recall, cost-per-resolution).

• Data governance: consent, lineage, retention, de-identification.

• Model lifecycle: versioning, evaluation sets, drift monitoring.

• Human-in-the-loop for high-risk recommendations.

• Vendor terms reviewed for data usage; BAAs if PHI could be exposed.

8) Metrics That Matter in the First 90 Days

• Activation: percentage of new accounts that complete the core task within 7 days.

• Time-to-value: minutes from first login to first successful outcome.

• Retention: 30-day return to complete the same task.

• Reliability: error rate <1%, 95th-percentile (P95) latency under your budgeted threshold.

• Support load: tickets per 100 users per week trending down.

• Adoption depth: number of active users per account; frequency of core task.

Set targets and track weekly. Share a single dashboard with the team.

9) Go-Live Readiness Checklist

• BAAs signed for any PHI-touching vendor (cloud, logging, analytics, error tracking).

• Role-Based Access Control (RBAC) live; Multi-Factor Authentication (MFA) enforced; Single Sign-On (SSO) tested; least-privilege Identity and Access Management (IAM).

• Transport Layer Security (TLS) everywhere; encryption at rest; keys in Key Management Service (KMS)/Azure Key Vault; rotation policy.

• Audit logs enabled, retained, and searchable; time sync verified.

• Rate limits, pagination, idempotent endpoints; HTTP 429 handling.

• Backups tested (restore proof); Disaster Recovery (DR) runbook with Recovery Point Objective (RPO)/Recovery Time Objective (RTO) targets.

• Separate Development/Staging/Production environments; PHI blocked from non-production.

• Security scans green in Continuous Integration (CI); penetration test issues triaged and fixed or risk-accepted.

• Observability: logs/metrics/tracing dashboards; on-call schedule; alert thresholds tuned.

• Terms of Service, Privacy Policy, and Security page published.

• In-app onboarding, quick-start video, tooltips for first-run.

• Release notes for version 1; feature flags ready to roll back risky modules.

10) Sample One-Page Requirement Template (You Can Reuse)

• Purpose: Describe the single job-to-be-done and the outcome metric.

• Users: Roles, devices, constraints.

• Scope: Must-haves (3–5 bullets), Non-goals (3–5 bullets).

• Data: Inputs, outputs, PHI yes/no, retention rules.

• Security: Role-Based Access Control (RBAC) roles, audit events, encryption needs, rate limits.

• Integrations: Inbound data, outbound data, mapping, error handling.

• User Experience (UX) Notes: Primary path, empty states, error copy, accessibility notes.

• Testing: Unit/integration criteria, usability target (time, error rate).

• Metrics: Activation definition, time-to-value target, reliability Service Level Objective (SLO).

• Rollout: Feature flag name, target cohort, fallback/rollback.

• Owner & Dates: Directly Responsible Individual (DRI), reviewers, acceptance date.

Paste this into your tracker for every significant feature.

Closing Thoughts

A healthcare Software as a Service (SaaS) MVP doesn’t need to be large; it needs to be clear, safe, and testable. Start with a sharp problem, design around real workflows, and bake compliance and security into the first commit. Keep your cloud footprint small, your metrics visible, and your release train frequent. When you do add scope, do it on a base that can carry the weight: strong identity, tenant isolation, audited access, and a pipeline you trust.

Want a fast budget sanity check? You can estimate ranges by feature set, stack, and integrations with a Healthcare MVP Cost Calculator—handy for conversations with buyers and investors.

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