HIPAA Compliance

HIPAA Compliance Built Around How Your Product Actually Works

HIPAA's Security Rule is technology-neutral - but implementing it in a modern cloud-native health tech product requires expertise in both regulations and architecture. We bridge that gap with hands-on assessments and practical remediation guidance.

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HIPAA Compliance

Why HIPAA Compliance Matters

The stakes in health tech are higher than in most other industries

Protect ePHI and Your Patients

A HIPAA breach causes real harm - to patients whose data is exposed and to the organisation that failed to protect it. Proper safeguards reduce breach likelihood and limit impact when incidents do occur.

Avoid OCR Penalties

HIPAA enforcement actions can result in fines from $100 to $50,000 per violation - with annual caps up to $1.9M per violation category. A serious breach without documented safeguards can be existential for a health tech startup.

Enable Healthcare Partnerships

Covered entities - hospitals, health systems, insurers - require their business associates to maintain documented HIPAA compliance. A thorough risk analysis and safeguards documentation is what opens these partnership opportunities.

What's Included

Comprehensive coverage of all HIPAA Security Rule requirements

Risk Analysis & Risk Management

HIPAA requires a formal risk analysis as its foundation. We identify all ePHI flows across your environment, assess the likelihood and impact of threats to that data, and produce a risk management plan that satisfies OCR audit requirements.

Administrative Safeguards Review

We assess your security officer designation, workforce training programme, access management procedures, incident response plan, and contingency planning against the HIPAA Administrative Safeguards requirements.

Physical Safeguards Assessment

Coverage of facility access controls, workstation use policies, and device and media controls - assessed against HIPAA Physical Safeguards requirements and real-world cloud-first implementations.

Technical Safeguards Audit

We review your access controls, audit logging, data integrity controls, and transmission security against the HIPAA Technical Safeguards - including encryption in transit and at rest across all systems that touch ePHI.

Business Associate Agreement Review

We review your BAAs with all downstream subservice organisations to ensure they contain the required provisions, are appropriately scoped, and that your BAA management process is audit-ready.

Breach Notification Readiness

We assess your breach detection, investigation, and notification processes against the HIPAA Breach Notification Rule - including the 60-day notification timeline, documentation standards, and media notification requirements.

Our Methodology

Three phases from initial ePHI discovery to ongoing compliance maintenance

ePHI Discovery & Risk Analysis

We map every system, service, and workflow that touches protected health information, assess threats to each, and produce a risk analysis that satisfies the HIPAA Security Rule's foundational requirement.

Safeguards Assessment & Gap Remediation

We assess all three safeguard domains, identify gaps, and help you implement the controls needed - along with the policies, procedures, and workforce training that HIPAA requires.

Documentation & Ongoing Compliance

We produce audit-ready documentation across all required areas and help you put in place the ongoing review cycle that HIPAA requires - including annual risk analysis updates and policy reviews.

Health Tech Compliance

Who This Is For

Health Tech Companies Handling ePHI

If your SaaS product stores, processes, or transmits protected health information, HIPAA applies. We help you understand your obligations and implement controls that satisfy them.

Business Associates of Covered Entities

If you provide services to hospitals, health systems, or insurers and handle ePHI in doing so, you're a business associate with direct HIPAA obligations - regardless of whether you're in the healthcare industry yourself.

Healthcare Organisations Modernising Systems

Legacy healthcare infrastructure often lacks the technical safeguards HIPAA requires. We assess where you stand and help you implement cloud-native controls that satisfy the Security Rule.

Frequently Asked Questions

Common questions about HIPAA compliance for technology companies

If your software stores, processes, or transmits protected health information on behalf of a covered entity (a hospital, health system, insurer, or healthcare clearinghouse), you are a Business Associate and HIPAA applies to you. You are required to sign a Business Associate Agreement with each covered entity you work with and to implement the HIPAA Security Rule safeguards. We can help you determine whether HIPAA applies and what your obligations are.

The HIPAA Security Rule (45 CFR § 164.308(a)(1)) requires covered entities and business associates to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of all ePHI they hold. This risk analysis must be documented and must be reviewed and updated periodically. It's not optional - OCR enforcement actions frequently cite inadequate or missing risk analyses as findings.

No. Cloud providers can sign a Business Associate Agreement and offer HIPAA-eligible services, but using those services does not make your application HIPAA compliant. Compliance depends on how you configure and use those services - encryption settings, access controls, audit logging, backup configurations, and dozens of other implementation decisions are your responsibility, not your cloud provider's.

For a typical health tech startup or mid-size company, our HIPAA assessment takes 4-6 weeks from kickoff to final report. This includes ePHI discovery, all three safeguard assessments, BAA review, and breach notification readiness review. Remediation support (implementing missing controls and documentation) typically takes an additional 6-12 weeks depending on the number and complexity of gaps identified.

Ready to Address Your HIPAA Obligations?

Risk analysis, safeguards assessment, BAA review - we cover it all, with practical guidance that fits how your product actually works.

Start Your HIPAA Assessment