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ActiveInternational Standardupdate Last Updated: December 2024

HIPAA

Health Insurance Portability and Accountability Act — US Public Law 104-191

apartmentPublishing Organization:U.S. Department of Health and Human Services (HHS)

Standard Introduction

The Health Insurance Portability and Accountability Act (HIPAA) is a foundational US federal law enacted in August 1996 to protect sensitive patient health information from being disclosed without patient consent or knowledge. HIPAA establishes national standards for the protection of Protected Health Information (PHI), ensuring that healthcare providers, health plans, healthcare clearinghouses, and their business associates implement appropriate safeguards. The law comprises multiple rules including the Privacy Rule (effective April 2003), Security Rule (effective April 2005), and Breach Notification Rule (enforceable September 2009). HIPAA applies to 'covered entities' - healthcare providers conducting electronic transactions, health plans, and healthcare clearinghouses - as well as 'business associates' who handle PHI on behalf of covered entities.

HIPAA compliance requires implementing three categories of safeguards: Administrative (policies, procedures, training), Physical (facility access controls, workstation security), and Technical (access controls, encryption, audit controls). The Privacy Rule governs the use and disclosure of PHI, granting patients rights to access their records, request corrections, and receive an accounting of disclosures. The Security Rule specifically addresses electronic PHI (ePHI) protection through required and addressable implementation specifications. Recent updates include the 2024 Reproductive Health Privacy Rule and proposed 2025 cybersecurity enhancements addressing ransomware and hacking threats. The HHS Office for Civil Rights (OCR) enforces HIPAA through audits and investigations, with penalties ranging from $100 to $50,000 per violation, up to $1.5 million per year for each violation category. The 2024-2025 HIPAA audit program focuses on Security Rule compliance related to cybersecurity threats.

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Scope

Applicable to organizations of all sizes and industries, covering the protection of confidentiality, integrity, and availability.

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Structure

Follows the High Level Structure (HLS), ensuring seamless integration with other ISO management standards like ISO 9001.

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Certification

Organizations can achieve accredited certification after successfully completing an external audit of their ISMS.

list_alt Core Requirements (Clauses 4-10)

  • Context of the organization
  • Leadership & Commitment
  • Planning & Risk Assessment
  • Support & Awareness
  • Operation
  • Performance evaluation
  • Continual Improvement

Official Documentation

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Implementation Timeline

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Aug 1996
HIPAA enacted by President Clinton - Public Law 104-191 signed into law to protect patient health information
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Dec 2000
Privacy Rule published - HHS issued final Privacy Rule establishing national standards for PHI protection
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Apr 2003
Privacy Rule effective date - Healthcare providers, health plans, and clearinghouses required to comply
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Feb 2003
Security Rule published - HHS issued final Security Rule for electronic PHI (ePHI) protection
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Apr 2005
Security Rule effective date - Covered entities required to implement administrative, physical, and technical safeguards
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Sept 2009
Breach Notification Rule enforceable - HITECH Act requirement to notify individuals of PHI breaches became enforceable
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March 2013
Omnibus Final Rule enforceable - Strengthened privacy and security protections, extended to business associates
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June 2024
Reproductive Health Privacy Rule effective - New protections for reproductive healthcare information privacy
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Jan 2025
Security Rule cybersecurity update proposed - NPRM published with enhanced cybersecurity standards addressing ransomware

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