Planning a new product
HIPAA-compliant SaaS development, web platforms, HIPAA-compliant mobile app development, HIPAA-compliant telehealth software, and remote patient monitoring software.
Start with:risk analysis and architecture.
What Is HIPAA-Compliant Software Development?
It is software designed, built, and operated to protect electronic protected health information (ePHI) under the HIPAA rules that apply to you. It combines a documented risk analysis, technical safeguards, and agreements with every vendor that handles PHI.
Does HIPAA Apply to Your Software? A 30-Second Check
0 / 2 answered
1. Does your software create, receive, maintain, or transmit health information?
2. Is it used by, or on behalf of, a healthcare provider, health plan, clearinghouse, or their business associate?
Answer both questions, then share your details to reveal your result.
HIPAA-Compliant Software Development Services: Choose Your Starting Point
Third-party AI safeguards
Before integrating external AI providers with PHI, we assess their contractual terms, data-use policies, retention practices, and applicable security safeguards. PHI is only routed through services approved for the intended use and contractual arrangement.
Related:healthcare software development↗generative AI development services↗data engineering services↗custom software development↗
HIPAA Technical Safeguards at Every Stop: Follow the Patient Record
Every patient record travels. We protect each stop, and each control maps to a Security Rule safeguard.
- 1CaptureWhat we build
Strong authentication, validated inputs
Security Rule safeguardPerson or entity authentication
- 2TransitWhat we build
TLS encryption, secure APIs
Security Rule safeguardTransmission security
- 3StoreWhat we build
Encryption at rest with managed keys, aligned with HIPAA encryption requirements
Security Rule safeguardEncryption and integrity
- 4AccessWhat we build
Role-based access, least privilege, unique user IDs, automatic logoff
Security Rule safeguardAccess control
- 5ShareWhat we build
EHR connections over HL7 FHIR, restricted and logged
Security Rule safeguardTransmission security
- 6AuditWhat we build
HIPAA audit logging in tamper-evident logs, with review workflows
Security Rule safeguardAudit controls
- 7RecoverWhat we build
Backups, recovery testing, availability planning
Security Rule safeguardContingency planning
Built for What Comes Next
HHS has proposed updates to the HIPAA Security Rule. The proposal is not yet final, and the current rule remains in effect. We design security controls with evolving requirements in mind.
STATUS · PROPOSED RULE
Secure Healthcare Architecture and BAAs
- 1
Select suitable cloud servicesWe evaluate cloud services against your application's requirements, data flows, and security needs.
- 2
Protect PHI across the data lifecycleWe design appropriate access controls, encryption, secure data storage and transmission, and data-retention practices based on the application's risk profile and requirements.
- 3
Establish clear security responsibilitiesWe work with your team to define and implement the controls required across infrastructure, applications, identities, logging, and operations.
- 4
Build auditability into the architectureWe design appropriate audit logging, monitoring, and security documentation to support investigation, risk management, and your organization's compliance processes.
Moving an existing application to Cloud? Explore our cloud computing services.
Engagement Models
Fixed scope
Clearly defined projects and MVPs.
Time and material
Products whose requirements evolve.
Dedicated team
An extension of your own team.
Deciding between custom and ready-made tools? Read custom software vs off-the-shelf.
Frequently Asked Questions (FAQ): Get the Answers You Need
What is HIPAA-compliant software development?
Software designed, built, and operated to protect ePHI under the HIPAA rules that apply to your organization, with a documented risk analysis, technical safeguards, and vendor agreements.
Is there a HIPAA certification for software?
HIPAA compliance is demonstrated through documented risk analysis, safeguards, and ongoing management rather than a certificate. We build the controls and documentation your team and customers can review.
Do you sign a Business Associate Agreement?
We work with clients to determine applicable business associate agreement requirements and agree on appropriate contractual safeguards before handling PHI.
Can you make an existing application HIPAA compliant?
Yes. We start with a gap assessment against the Security Rule safeguards, then remediate in priority order.
Does hosting on AWS make my software HIPAA compliant?
No. Hosting on AWS alone does not make an application HIPAA-compliant. AWS provides HIPAA-eligible services and offers a Business Associate Addendum (BAA). The application must also be appropriately designed, configured, and operated, with suitable access controls, data protection, audit logging, risk management, and other required safeguards. Responsibilities depend on the architecture and the agreement between the parties.
Can we use AI with PHI?
Yes, subject to the use case, architecture, and applicable safeguards. We assess the AI service and features involved, how PHI flows through the system, access controls, logging, data retention, and contractual requirements before implementation. Where PHI is handled by a cloud provider on your behalf, the required business associate agreement must be in place. We also evaluate whether the proposed AI workflow meets your organization's HIPAA obligations and risk-management requirements.
What does HIPAA-compliant software development cost?
Cost depends on user roles, integrations, security and testing depth, hosting, and maintenance. We scope after a short discovery so the estimate reflects your actual PHI workflows.
Will the proposed Security Rule update change what you build?
It is still a proposal as of October 2026. We already design for its direction, which reduces rework if a final rule follows.
Does this cover substance use disorder records?
Those records can fall under 42 CFR Part 2 in addition to HIPAA, and its civil enforcement program began on February 16, 2026. We include Part 2 in the regulatory review when a project handles them.