US HIPAA Act

HIPAA Compliance

Health Insurance Portability and Accountability Act

Introduction

HIPAA is a US federal law establishing regulatory standards for the protection, privacy, and security of Protected Health Information (PHI). Healthcare organisations and their vendors must implement active measures to comply.

What is US HIPAA Act?

HIPAA compliance requires implementing administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of electronic PHI (ePHI), structured under the Security and Privacy Rules.

Benefits of US HIPAA Act Certification

  • Protects patient records and ePHI across all digital and physical systems
  • Enables business associate agreements (BAAs) with US hospitals and insurers
  • Reduces the risk of US Office for Civil Rights (OCR) enforcement and massive fines
  • Builds a documented, auditable log of how health data is accessed and shared
  • Demonstrates high security maturity to international healthcare partners

Who Needs US HIPAA Act Certification?

  • Telehealth and digital health platforms serving the US
  • IT companies and software vendors handling medical data
  • Medical billing and transcription service providers
  • Clinical research and analytics companies
  • US healthcare providers and insurers

US HIPAA Act Requirements

  • HIPAA Privacy Rule compliance — patient rights and consent
  • HIPAA Security Rule — administrative, physical, and technical safeguards
  • HIPAA Breach Notification Rule — process for reporting data breaches
  • HIPAA Omnibus Rule — subcontractor responsibility
  • Execution of Business Associate Agreements (BAAs) with partners

US HIPAA Act Certification Process

01

Initial Consultation

Discuss scope, objectives and current state.

02

Gap Analysis

Assess current practices against the standard’s requirements.

03

Documentation Development

Build the policies, procedures and records the standard calls for.

04

Implementation & Internal Audit

Roll out the system and test it with an internal audit.

05

Management Review

Leadership reviews performance and readiness for certification.

06

Certification Audit

An accredited certification body audits conformance.

07

Certification Awarded

The certification body issues the accredited certificate.

08

Surveillance Audits

Annual audits maintain certification status.

Documents Required

  • HIPAA Security Policies and Procedures
  • Risk assessment methodology and reports
  • Business Associate Agreements (BAAs)
  • Employee HIPAA training records
  • Disaster recovery and incident response procedures
  • Data encryption policies and logs

US HIPAA Act Certification Cost

We don’t publish a fixed price, because cost depends on organisation size, number of locations, scope, process complexity, audit duration, consulting requirements and certification body fees. Request a scoped estimate and we’ll walk you through each factor.

Certification Timeline

Timelines depend on organisational readiness, scope and the complexity of your processes. A well-prepared, single-site organisation typically moves faster than a multi-site or highly regulated one — we’ll give you a realistic timeline after the initial gap analysis.

HIPAA vs ISO 27001

ISO 27001 is a certifiable international standard for general security. HIPAA is a US federal law with specific rules (Privacy, Security, Breach Notification) protecting health data. They overlap, and ISO 27001 controls help satisfy HIPAA Security requirements.

Frequently Asked Questions

What is HIPAA compliance?

Adherence to US federal standards that protect the privacy, security, and integrity of patient health information.

What is a Business Associate?

Any third-party vendor (IT provider, hosting platform, billing service) that handles or has access to Protected Health Information (PHI) on behalf of a covered entity.

Is there an official HIPAA certification?

No. The US government does not issue or recognize any official HIPAA certification. Compliance is demonstrated through third-party audits and documentation.

Ready to start your US HIPAA Act certification?

Book a free initial consultation with an OMCS ISO consultant.

Talk to a HIPAA Consultant