HIPAA Compliance Software
HIPAA Compliance Software That Keeps You Audit-Ready
Qireon maps the HIPAA Security Rule to your live controls, tracks Business Associate Agreements, runs your required risk analysis, and collects evidence automatically — so protecting PHI and proving compliance stop being a manual burden.
HIPAA readiness
LiveThe challenge
Why HIPAA compliance is challenging
Selling to US healthcare means HIPAA — but HIPAA isn’t a one-time certificate you earn and forget. It’s an ongoing regulatory obligation to protect PHI, and demonstrating it the manual way is relentless.
No single “pass” to aim for
HIPAA is a regulation, not a certification. Compliance is continuous — safeguards, risk analysis, and documentation must be kept current, not produced once.
Mapping the safeguards
The Security Rule’s administrative, physical, and technical safeguards have to be translated into the controls you actually run — hard to get right without healthcare experience.
Tracking Business Associate Agreements
Every vendor that touches PHI needs a signed BAA. Managing that across a growing vendor list in spreadsheets is a compliance gap waiting to happen.
The required risk analysis
The Security Rule mandates a documented risk analysis and risk management process. Many teams either skip it or can’t evidence it when OCR asks.
Breach readiness
The Breach Notification Rule sets strict timelines. Without incident response and BC/DR documented and tested, a breach becomes a crisis.
Evidence of safeguards
Proving encryption, access controls, audit logging, and workforce training are actually operating means collecting evidence continuously — not screenshotting before a review.
Meet Qireon
Protect PHI and prove it — from one platform
Qireon is the AI-powered compliance platform that manages your entire HIPAA program in one place — mapping the Privacy, Security, and Breach Notification Rules to live controls, and keeping the evidence current automatically.
Track Business Associate Agreements in a vendor register, run your required risk analysis with an AI-assisted risk register, generate HIPAA policies from expert templates, and let Qireon collect proof of your safeguards from the tools you already use. Incident response and BC/DR live in the same system of record, so you’re ready if OCR ever asks.
The result is continuous HIPAA compliance with far less manual work — and the confidence to sell into healthcare and pass any customer security review.
What you get
Everything you need for HIPAA — in one platform.
Automated Evidence Collection
Connect your stack once and Qireon continuously gathers audit-ready evidence — no screenshots, no spreadsheets.
AI-Guided Gap Assessment
Know exactly where you stand against every requirement, with a prioritized roadmap to close gaps fast.
Policy Management
Generate, approve, and version expert-written policies mapped to the controls they support.
Risk Register
Identify, score, and treat risks with AI-assisted assessments before they become audit findings.
Internal Audit
Run internal audits and track corrective actions so you are ready before the external audit begins.
Continuous Compliance
Stay audit-ready year-round with monitoring and alerts that catch control drift the moment it happens.
Trust Center
Publish a live, shareable Trust Center to answer security questionnaires and shorten your sales cycle.
Auditor Collaboration
Give your auditor a signed, read-only workspace instead of a folder of PDFs — always current.
How it works
Achieve HIPAA in six simple steps.
Create your workspace
Set up your organization, scope, and team in minutes.
Gap assessment
AI shows where you stand and what to fix first.
Risk management
Build a risk register and treat what matters most.
Policy implementation
Generate and approve policies from expert templates.
Evidence collection
Connect your cloud and collect evidence automatically.
Audit & certification
Invite your auditor to a live workspace and finish the audit.
Framework requirements
What HIPAA actually requires
HIPAA — the US Health Insurance Portability and Accountability Act — protects individuals’ health information. Compliance is defined by a set of rules enforced by the HHS Office for Civil Rights (OCR), not by a single certificate.
The HIPAA Rules
HIPAA compliance is built on three core rules that work together to protect health information:
- Privacy Rule — how PHI may be used and disclosed
- Security Rule — how ePHI must be safeguarded
- Breach Notification Rule — what to do if PHI is exposed
Who must comply, and what is PHI
HIPAA applies to Covered Entities (healthcare providers, health plans, clearinghouses) and to Business Associates — any vendor that creates, receives, maintains, or transmits Protected Health Information (PHI) on their behalf. Most software companies selling into healthcare are Business Associates.
PHI is individually identifiable health information; ePHI is PHI in electronic form. The Security Rule specifically governs how ePHI is protected.
The Security Rule safeguards
The Security Rule organizes its requirements into three categories of safeguards. Qireon maps each to concrete, evidenced controls:
- Administrative safeguards — risk analysis, workforce access management, training
- Physical safeguards — facility access, device & media controls
- Technical safeguards — access control, audit logging, encryption of ePHI
- Organizational requirements — Business Associate Agreements
- Policies, procedures & documentation
Risk analysis & management
The Security Rule explicitly requires a documented risk analysis and an ongoing risk management process. This is one of the most commonly cited gaps in OCR investigations.
Qireon’s AI-assisted risk register helps you identify risks to ePHI, score them by impact and likelihood, and document treatment — with an audit trail that stands up to scrutiny.
Business Associate Agreements (BAAs)
Before sharing PHI with a vendor, HIPAA requires a signed Business Associate Agreement that binds them to protect it. Missing or expired BAAs are a serious liability.
Qireon tracks BAAs in your vendor register alongside each vendor’s risk review, so you always know which agreements are in place and current.
Breach notification & ongoing compliance
If unsecured PHI is breached, the Breach Notification Rule requires notifying affected individuals — and, depending on scale, HHS and the media — without unreasonable delay and no later than 60 days. Documented incident response and BC/DR are essential.
There is no official government HIPAA certification. Compliance is demonstrated through your safeguards, risk analysis, BAAs, and documentation — kept continuously current. Qireon keeps all of it audit-ready year-round, so you’re prepared for customer reviews and OCR alike.
Why Qireon
The traditional way vs. the Qireon way.
Integrations
Evidence lives in the tools you already use.
HIPAA evidence is scattered across your cloud, code, and identity providers. Qireon connects to them directly and collects proof automatically — so nothing is manual and nothing goes stale.
View all integrationsIndustries
Who needs HIPAA?
HIPAA applies to any organization that handles Protected Health Information — from healthtech and digital health platforms to the vendors and infrastructure providers that serve them.
HIPAA — frequently asked questions.
What is HIPAA?+
HIPAA (the Health Insurance Portability and Accountability Act) is a US law that protects individuals’ health information. Its Privacy, Security, and Breach Notification Rules define how Protected Health Information (PHI) must be used, safeguarded, and handled if exposed.
Who needs to be HIPAA compliant?+
Covered Entities (healthcare providers, health plans, and clearinghouses) and Business Associates — any vendor that creates, receives, maintains, or transmits PHI on their behalf. Most software companies selling into healthcare are Business Associates and must comply.
What is PHI and ePHI?+
PHI (Protected Health Information) is individually identifiable health information. ePHI is PHI in electronic form. The HIPAA Security Rule specifically governs how ePHI is protected through administrative, physical, and technical safeguards.
Is there an official HIPAA certification?+
No. Unlike ISO 27001, there is no official government HIPAA certification. Compliance is an ongoing obligation demonstrated through your safeguards, risk analysis, Business Associate Agreements, policies, and documentation. Qireon keeps all of that continuously audit-ready.
What are the HIPAA safeguards?+
The Security Rule requires administrative safeguards (risk analysis, access management, training), physical safeguards (facility and device controls), and technical safeguards (access control, audit logging, encryption of ePHI). Qireon maps each to evidenced controls.
What is a Business Associate Agreement (BAA)?+
A BAA is a contract HIPAA requires before you share PHI with a vendor. It binds that vendor to protect the information. Qireon tracks BAAs in your vendor register so none are missing or expired.
Is a HIPAA risk analysis required?+
Yes. The Security Rule explicitly requires a documented risk analysis and an ongoing risk management process — and it’s one of the most commonly cited gaps in OCR investigations. Qireon’s risk register makes it repeatable and evidenced.
What are the breach notification requirements?+
The Breach Notification Rule requires notifying affected individuals without unreasonable delay and no later than 60 days after discovery of a breach of unsecured PHI, with HHS (and sometimes the media) notified depending on scale. Documented incident response is essential.
How long does it take to become HIPAA compliant?+
Because HIPAA is ongoing rather than a one-time certification, the goal is getting your safeguards, risk analysis, BAAs, and documentation in place — then keeping them current. With Qireon, most teams reach a defensible, audit-ready state in weeks.
How much does HIPAA compliance cost?+
Cost depends on your platform, your team’s time, and any external assessment you choose. Qireon replaces manual work and consultant dependency, so most teams spend far less overall. Plans start at $299/month with onboarding included.
Does HIPAA require SOC 2 too?+
HIPAA doesn’t require SOC 2, but many healthcare buyers ask for both — HIPAA for regulatory obligations and SOC 2 as independent assurance of your controls. Qireon runs both off one evidence graph, so you don’t duplicate the work.
Does Qireon replace HIPAA consultants?+
For many teams, yes. Qireon provides the safeguard mapping, expert policy templates, risk analysis, and BAA tracking a consultant would — as software you own, not a one-time engagement.
Can Qireon track Business Associate Agreements?+
Yes. BAAs are tracked in Qireon’s vendor register alongside each vendor’s security review, so you always know which agreements are signed and current — a common HIPAA gap solved automatically.
Can Qireon handle HIPAA alongside SOC 2 or ISO 27001?+
Yes. Qireon runs HIPAA, SOC 2, ISO 27001, and GDPR off one evidence graph. Map a control once and satisfy it across every framework, so adding your next standard is a step, not a restart.
Start your HIPAA compliance journey today.
Whether you’re a Business Associate preparing for your first customer security review or scaling compliance across frameworks, Qireon gives your team everything needed to protect PHI and stay audit-ready.