What It Is

Health Insurance Portability and Accountability Act (HIPAA) is a U.S. federal regulation establishing national standards for protecting individuals' health information. It comprises the Privacy Rule, Security Rule, and Breach Notification Rule, applying a risk-based approach to safeguard protected health information (PHI) and electronic PHI (ePHI) for covered entities and business associates.

Key Components

• **Privacy RuleControls PHI uses/disclosures, minimum necessary principle, patient rights.
• **Security RuleAdministrative, physical, technical safeguards; risk analysis required.
• **Breach Notification RuleTimely notifications post-unsecured PHI breaches. Built on flexible, scalable framework with ~20 standards/specifications; enforced via OCR audits, no formal certification but compliance mandatory.

Why Organizations Use It

Mandated for healthcare entities to avoid penalties up to $2M+ annually; reduces breach risks, builds patient trust, enables secure data flows for care/operations. Enhances cyber resilience, vendor oversight via BAAs.

Implementation Overview

Phased: assess risks/gaps, deploy safeguards/training/BAAs, monitor/audit continuously. Applies to providers, plans, clearinghouses nationwide; involves documentation retention (6 years), no certification but OCR enforcement.

What It Is

ISO 37001 is the international certifiable standard for Anti-Bribery Management Systems (ABMS). It provides requirements and guidance to prevent, detect, and respond to bribery risks. The risk-based approach follows the ISO Harmonized Structure (HS) and PDCA cycle, applicable to all organization sizes, sectors, and bribery forms (direct/indirect, public/private).

Key Components

• Clauses 4-10 cover context, leadership, planning, support, operation, evaluation, improvement.
• Core controls: policy, compliance function, risk assessment, due diligence, training, financial/non-financial controls, reporting, audits.
• Built on proportionality and continual improvement; optional third-party certification with audits.

Why Organizations Use It

• Mitigates legal risks (e.g., FCPA, UK Bribery Act) via evidentiary due diligence.
• Builds stakeholder trust, reduces compliance costs (up to 15%), enhances reputation.
• Enables market access, ESG alignment, operational efficiencies.

Implementation Overview

• Phased: gap analysis, risk assessment, control design, training, audits.
• Scalable for SMEs to multinationals; 6-12 months typical; certification optional but recommended.