What It Is

HIPAA, the Health Insurance Portability and Accountability Act of 1996, is a U.S. federal regulation creating national standards to protect protected health information (PHI). It includes the Privacy Rule (uses/disclosures), Security Rule (ePHI safeguards), and Breach Notification Rule, using a flexible, risk-based approach scalable to entity size and risks.

Key Components

• Core pillars: scope/applicability, privacy controls, security safeguards (administrative/physical/technical), breach notification, patient rights, business associates, enforcement.
• Required/addressable specifications; no fixed controls count.
• Principles: confidentiality, integrity, availability; minimum necessary standard.
• Compliance via HHS OCR audits, no formal certification.

Why Organizations Use It

• Mandatory for covered entities/business associates to avoid penalties.
• Reduces breach risks, enables secure care/payment/operations.
• Builds patient trust, supports vendor ecosystems.
• Provides cyber resilience, market differentiation.

Implementation Overview

• Phased: assess risks, build policies/training/safeguards, operate/monitor, assure via audits.
• Applies to U.S. healthcare providers/plans/clearinghouses/vendors.
• Ongoing program with 6-year documentation retention.

What It Is

The BRCGS Global Standard for Food Safety (Issue 9) is a GFSI-benchmarked third-party certification framework for food manufacturers, processors, and packers. It assures product safety, legality, authenticity, and quality through a structured management system combining senior management commitment, Codex HACCP-based food safety plans, and robust prerequisite programs like GMP/GHP to control contamination, fraud, and operational risks.

Key Components

Core elements include seven sections: senior management, food safety plan, FSQMS, site standards, product control, process control, and personnel. Fundamental requirements (e.g., HACCP, internal audits, traceability, allergen management) are non-negotiable. Certification involves grading (AA/A/B/C/D), announced/unannounced audits, and root cause analysis for non-conformities.

Why Organizations Use It

Provides retailer-mandated market access, reduces recalls from allergens/pathogens/labelling errors, demonstrates due diligence, and builds supply-chain trust. Enhances resilience against incidents and aligns with regulations like FSMA.

Implementation Overview

Phased approach: gap analysis, documentation/training, internal audits, mock audits, certification by accredited bodies. Suited for global food manufacturers; requires annual audits and continuous improvement.