HIPAA + IEC 62304

HIPAA-Compliant Software Development

The Costliest Healthcare Bug Is a Compliance Gap.

Most healthcare startups and clinics discover compliance gaps too late, leading to delayed launches and 3× more in remediation costs. We build HIPAA-ready apps in 12 weeks, with compliance engineered in from sprint one.

No Pitch Deck. Speak Directly to a Senior Developer.

100% Healthcare-only
US-fronted Team
Autism caregiver app — NavHealth home & Care Circle screens · HIPAA, live on the App Store
What we hear most

The Three Things That Keep Founders Up at Night

Three short fears we hear on every first call, and the proof behind each answer.

01
“What if we fail a HIPAA audit after launch?”
We add compliance from day one. Encryption, RBAC, audit logs, signed BAA, before the first line of product code.
02
“Our last build ran 3× over budget with no end in sight.”
Fixed scope, milestone billing. You approve each deliverable before the next phase starts. No open-ended retainers.
03
“How do I know an offshore team actually understands US healthcare?”
Every healthcare project is led by senior developers with 9+ years building HIPAA-compliant products, the same engineers behind the apps that are live and downloadable right now.
The Cost of Failing an Audit

One Failed Audit Can Cost You Millions

HIPAA fines are charged per violation, per category, per year, they add up fast.

$50K+Per-violation maximum
$1.5MAnnual cap, per category
3xCost of fixing it after launch
HIPAA Audit Readiness Checklist

The 6 Safeguards Auditors Look For

Tick every box. If you can't, you may have an audit gap. Check the ones your current build covers.

EncryptionAll ePHI encrypted at rest and in transit (AES-256, TLS 1.3).
Multi-Factor AuthenticationMFA enforced for all users accessing ePHI.
Role-Based AccessPatient data access restricted by role across UI, API, and database layers.
Audit LoggingEvery PHI access, edit, and disclosure logged and retained for 6 years.
Business Associate AgreementsSigned BAAs in place with every vendor handling ePHI.
Breach Response PlanTested process in place to meet HIPAA's 60-day notification requirement.
Your score: 0 / 6
Check the boxes you cover to see where you stand.
Get a Free HIPAA Readiness Check
Great Place To Work Certified 2026
Proof, Not Promises

Founders Who Trusted
Us to Build It Right

Real startup founders have used our process to move faster, launch smarter, and avoid costly missteps.

★★★★★

Their communication and care for the project were impressive. Tech Exactly has met 100% of our goals.

Dillon Partin
Dillon Partin COO, Life'sPilot
★★★★★

They understood the mission of my passion project and have always exceeded my expectations.

Amanda Pike
Amanda Pike Owner, Blossom Mindset Solutions
★★★★★

Their communication and deliverables are top-notch. Tech Exactly brought my long-held app idea to life.

Sandon Nixon
Sandon Nixon Founder, Music Remembers LLC
Our HIPAA Compliance Process

Engineered to Clear the Audit From Sprint One

Six compliance pillars, engineered from the first sprint, so there's nothing left to retrofit when the auditor arrives.

Encryption by design

AES-256 at rest, TLS 1.3 in transit, KMS key rotation, and field-level encryption on the most sensitive identifiers.

AES-256 · TLS 1.3

Authentication & access

MFA on all ePHI access and 3-layer RBAC at UI, API, and database, enforced to the minimum-necessary rule, not broad roles.

MFA · 3-layer RBAC

Audit & monitoring

Tamper-evident logging on every PHI access, 6-year retention, sanitised error handling, and real-time anomaly alerts.

6-year retention

Compliance & BAAs

BAAs executed with every cloud, AI, and analytics vendor, plus an ONC SRA risk assessment and HIPAA scanning before launch.

BAA · ONC SRA

Secure SDLC

AI-accelerated development with mandatory human review gates on every security-critical path, and penetration testing 6 weeks pre-launch.

Human-reviewed

Breach readiness

A documented, drill-tested breach-notification plan that meets HIPAA's 60-day window, ready before go-live, not after an incident.

60-day window
Who it's for

Two Types of Founders. Same Standard of Build.

Whether you're launching a product or modernizing a practice, the compliance bar doesn't move, and neither do we.

Building a health startup

You have a product idea and a compliance problem. You need a team that has already shipped a HIPAA app, not one that will learn on your budget.

We shipped the AI Autism Caregiver App in 4 months. It's live. You can install it.
Book a Startup Scoping Call

Running a clinic or practice

You need custom software that works with your existing systems and keeps patient data exactly where it should be, locked down, logged, auditable.

Our apps are HL7/FHIR-ready and integrate with Epic, Cerner, and Athena.
Book a Clinic Scoping Call
What we build

HIPAA-Compliant From the First Commit

A focused set of healthcare products, each shipped to medical-grade standards, not a generic service wall.

AI App for Autism CaregiversBuilt for families and care teams managing autism support. HIPAA-compliant, shipped in four months, live on app stores.
View case study
IEC 62304-Compliant Mobile AppRegulatory-grade software built for clinical diagnostic accuracy.
View case study
Surrogacy Journey Mobile AppComplex IVF journeys simplified through technology.
View case study
Therapy PlatformExpanded patient access to care while maintaining HIPAA compliance.
View case study
AI App for Autism Caregivers

Book a Scoping Call With a Senior Developer

We'll review your idea, flag the compliance gaps, and give you a grounded build estimate, no pitch deck, no obligation.

Book a Scoping Call
  • PHI data-flow review
  • BAA coverage check
  • Compliance gap estimate
  • Standard NDA signed

Not ready for a full build? Start with a two-week prototype →

Compliance Monitor — all HIPAA safeguards active
HIPAA Development FAQ

Questions Founders Ask Before They Build

Common questions founders ask before building a compliant app with us.

How long does a HIPAA-compliant build take? +

Typical healthcare apps take 3 to 6 months from discovery to launch. We shipped the autism caregiver app in four months — HIPAA-compliant, App Store approved, live. Timelines depend on scope, integrations, and regulatory complexity. We'll give you a grounded estimate after a scoping call, not before.

How much does HIPAA-compliant app development cost? +

Built compliance-first: roughly $45K–$70K for a simple app, $90K–$160K for a standard app, $160K–$300K for a complex platform. Built-then-fixed: add $90K–$180K in remediation on top. Compliance-first is consistently about 3× cheaper.

What is a BAA and do we need one for every vendor? +

A Business Associate Agreement legally requires any third party handling ePHI to maintain HIPAA safeguards. You need one with your cloud provider, any AI service processing health data, analytics tools, and any SaaS that touches PHI. One missing BAA makes you non-compliant.

Do you integrate with Epic, Cerner, or Athena? +

Yes. We build to HL7 and FHIR standards and have integration experience with major EHR platforms. We'll scope the integration requirements specifically in discovery — EHR integrations vary significantly in complexity depending on the system and the data you need.

How does an offshore team understand US healthcare regulations? +

Every TechExactly healthcare project is led by senior developers with 9+ years of experience building HIPAA-compliant products for the US market. They work with HIPAA, IEC 62304, security controls, audit requirements, and healthcare compliance from day one.

Who owns the code when the project is done? +

You do. Full code and IP ownership is transferred at project close. No licensing, no platform lock-in, no per-user fees. You can take the code and build with a different team tomorrow if you want.