What It Is

General Data Protection Regulation (GDPR), or Regulation (EU) 2016/679, is a binding EU regulation replacing the 1995 Data Protection Directive. It protects personal data of EU individuals with global extraterritorial scope, using an accountability-based, risk-oriented approach to ensure lawful processing.

Key Components

• Seven core principles: lawfulness, fairness, purpose limitation, minimization, accuracy, storage limitation, integrity/confidentiality, and accountability.
• Expanded data subject rights: access, rectification, erasure ("right to be forgotten"), portability, objection.
• Key obligations include Data Protection Officers (DPOs), Data Protection Impact Assessments (DPIAs), Records of Processing Activities (ROPAs), and 72-hour breach notifications.
• Enforced via supervisory authorities (DPAs) with fines up to €20M or 4% global turnover; no formal certification but demonstrable compliance required.

Why Organizations Use It

Mandatory for any processing EU data, it mitigates severe penalties, legal risks, and reputational damage. Builds stakeholder trust, enables secure global operations, and sets "gold standard" compliance influencing worldwide laws.

Implementation Overview

Requires gap analysis, governance restructuring, training, tech upgrades like pseudonymization. Applies universally to organizations handling EU data regardless of size/location; ongoing via audits, DPO oversight, and EDPB guidance. (178 words)

What It Is

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 is a US federal regulation that sets national standards to protect individuals' protected health information (PHI). Its primary purpose is safeguarding privacy and security of health data while enabling electronic transactions, using a risk-based, flexible, scalable approach applicable to covered entities and business associates.

Key Components

• **Privacy RuleGoverns PHI uses, disclosures, minimum necessary principle, and patient rights.
• **Security RuleAdministrative, physical, technical safeguards for ePHI.
• **Breach Notification RulePresumption-of-breach reporting requirements. No fixed controls count; enforced through OCR audits and tiered penalties.

Why Organizations Use It

• Mandatory for healthcare providers, plans, clearinghouses, vendors handling PHI.
• Avoids multimillion-dollar fines, criminal liability.
• Enhances cyber resilience, patient trust, secure data flows.
• Provides competitive edge via compliance maturity.

Implementation Overview

Phased: gap analysis, risk assessment, safeguard deployment, continuous monitoring. Targets US healthcare sector; requires documentation, training, BAAs, no formal certification but audit readiness essential. (178 words)