What is the primary objective of **LGPD**?

**The primary objective of LGPD is to protect the fundamental rights of privacy and freedom of natural persons through comprehensive regulation of personal data processing.** Enacted as Law No. 13.709/2018 on August 14, 2018, LGPD unifies Brazil's data protection framework, mandating 10 core principles under Article 6—including purpose limitation, necessity, transparency, security, prevention, non-discrimination, and accountability—to govern controllers and processors handling identified or identifiable personal data (Article 5, I), with heightened rules for sensitive data like health or biometrics (Article 5, II).

Who is legally or professionally required to comply with **LGPD**?

**All controllers and operators processing personal data in Brazil, targeting Brazilian residents, or collected therein must comply with LGPD, regardless of organization size or location.** Article 3 establishes extraterritorial scope for any entity offering goods/services to or monitoring Brazilians; no employee/revenue thresholds apply, encompassing public/private sectors, multinationals in e-commerce, fintech, healthcare, and cloud services. Controllers decide purposes/means (Article 5, VI) and bear primary liability; operators execute instructions (Article 5, VII).

Does **LGPD** require an external audit or third-party certification?

**LGPD does not mandate external audits or third-party certification.** The Autoridade Nacional de Proteção de Dados (ANPD) conducts audits under Articles 55-56, but organizations must maintain internal records of processing activities (Article 37), perform Data Protection Impact Assessments (DPIAs) for high-risk activities (Article 38), and demonstrate compliance via governance programs; voluntary certifications like ISO 27701 may support accountability.

How often should an assessment for **LGPD** be performed?

**LGPD assessments, including Records of Processing Activities and DPIAs, must be maintained continuously and updated for changes, with no fixed frequency specified.** ANPD regulations like CD/ANPD No. 02/2022 require simplified records for small entities; high-risk processing demands ongoing DPIAs (Article 38), quarterly internal reviews via governance programs, and annual audits recommended for sustained compliance amid evolving ANPD guidance.

What are the consequences of non-compliance with **LGPD**?

**Non-compliance with LGPD incurs graduated administrative sanctions by ANPD, including fines up to 2% of Brazilian revenue (capped at R$50 million per infraction), data processing suspension up to 6 months, and publicity of violations.** Article 52 outlines 9 sanctions considering gravity, cooperation, and recidivism; civil liabilities for damages (Article 42) and operational disruptions apply to B2B/employee data processing.

Can **LGPD** be mapped to other international frameworks?

**Yes, LGPD can be mapped to other international frameworks due to shared principles like purpose limitation, transparency, and data subject rights.** Its 10 principles (Article 6) and rights (Article 18) align closely with global regimes, facilitating hybrid programs; cross-border transfers use mechanisms like ANPD-approved Standard Contractual Clauses (Resolution CD/ANPD No. 19/2024, mandatory by August 23, 2025) or Binding Corporate Rules.

What is the first step to begin implementing **LGPD**?

**The first step to implement LGPD is appointing a Data Protection Officer (DPO) and conducting data mapping to create a Record of Processing Activities (RoPA).** Article 41 requires controllers to designate a DPO for ANPD liaison and rights fulfillment; Phase 1 gap analysis inventories data flows, purposes, legal bases (Article 7), and risks, prioritizing high-risk/sensitive processing per ANPD guidance.

What is the primary objective of **HIPAA**?

**HIPAA establishes national standards to protect individuals’ protected health information (PHI) while enabling necessary information flows for care, payment, and operations.** The Privacy Rule governs uses and disclosures of PHI with the minimum necessary principle; the Security Rule mandates administrative, physical, and technical safeguards for electronic PHI (ePHI); and the Breach Notification Rule requires timely reporting of breaches of unsecured PHI.

Who is legally or professionally required to comply with **HIPAA**?

**HIPAA applies to covered entities—health plans, health care clearinghouses, and health care providers transmitting health information in electronic form for standard transactions—and their business associates.** Business associates include vendors creating, receiving, maintaining, or transmitting PHI or ePHI, with direct liability under HITECH for Security Rule provisions, minimum necessary, and breach notification, extended via Business Associate Agreements (BAAs) to subcontractors.

Does **HIPAA** require an external audit or third-party certification?

**No, HIPAA does not mandate external audits or third-party certification.** The Security Rule requires internal risk analysis, periodic evaluations of safeguards, and documentation retention for six years, but enforcement by HHS Office for Civil Rights (OCR) occurs via complaint investigations, compliance reviews, and targeted audits without prescribed certification.

How often should an assessment for **HIPAA** be performed?

**HIPAA requires an accurate and thorough risk analysis for ePHI as a foundational Security Rule standard, with periodic technical and non-technical evaluations and updates upon environmental changes.** Security Rule documentation must be reviewed regularly, with six-year retention; practice dictates annual reassessments or triggers like incidents, new technology, or mergers.

What are the consequences of non-compliance with **HIPAA**?

**Non-compliance with HIPAA triggers civil monetary penalties tiered by culpability, up to $50,200 per violation per affected individual (2024-adjusted), with annual caps to $2,134,831 for Tier 4 willful neglect.** OCR imposes settlements and corrective action plans; criminal penalties for knowing violations reach $250,000 and imprisonment; State Attorneys General enforce concurrently.

Can **HIPAA** be mapped to other international frameworks?

**Yes, HIPAA’s risk-based Security Rule safeguards and Privacy Rule controls map to frameworks like NIST SP 800-53, HITRUST, and ISO 27001.** Administrative, physical, and technical standards align with NIST CSF categories; organizations document mappings in risk analyses to demonstrate equivalent protections for integrated compliance.

What is the first step to begin implementing **HIPAA**?

**Conduct an accurate and thorough Security Risk Analysis identifying potential risks to ePHI confidentiality, integrity, and availability, per 45 CFR § 164.308(a)(1)(ii)(A).** Scope covered entities and business associates, inventory PHI/ePHI locations and flows, assess threats/vulnerabilities, evaluate controls, and prioritize via risk register to inform all safeguards.

LGPD vs HIPAA | GRADUM

Standards Comparison

LGPD

Mandatory

2020

Brazil's comprehensive regulation for personal data protection

HIPAA

Mandatory

1996

US federal regulation for health information privacy and security.

Quick Verdict

LGPD governs personal data for Brazilian residents across industries with ANPD fines up to 2% revenue, while HIPAA mandates health data safeguards for US providers with OCR penalties. Companies adopt both for legal compliance and trust in Brazil-US operations.

Data Privacy

LGPD

Lei Geral de Proteção de Dados Pessoais (Law No. 13.709/2018)

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Extraterritorial scope targets Brazilian residents' data worldwide
10 core principles expand GDPR with prevention, non-discrimination
Fines up to 2% Brazilian revenue capped at R$50 million
Mandatory DPO appointment for controllers with public disclosure
10 legal bases including credit protection exceed GDPR

Healthcare Data Privacy

HIPAA

Health Insurance Portability and Accountability Act of 1996

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Risk-based safeguards for electronic PHI
Minimum necessary principle for disclosures
Breach notification within 60 days
Business associate direct liability
Individual rights to PHI access

Detailed Analysis

A comprehensive look at the specific requirements, scope, and impact of each standard.

LGPD Details

What It Is

Lei Geral de Proteção de Dados Pessoais (LGPD), Law No. 13.709/2018, is Brazil's federal regulation establishing a comprehensive, risk-based framework for processing personal and sensitive data. It applies extraterritorially to any targeting Brazilian residents, mirroring GDPR but with local adaptations like 10 principles.

Key Components

**10 core principlespurpose limitation, necessity, transparency, security, prevention, accountability.
**10 legal basesconsent, contracts, legitimate interests, credit protection.
**Data subject rightsaccess, correction, deletion, portability, objection to automation.
ANPD enforcement via audits, graduated sanctions up to 2% Brazilian revenue (R$50M cap), mandatory DPO, DPIAs, 3-day breach notifications.

Why Organizations Use It

Mandatory for compliance avoiding multimillion fines, suspensions; drives trust, market access in $2T digital economy. Enhances security, enables innovation via anonymization, supports AI governance.

Implementation Overview

Phased: governance/DPO appointment, data mapping/RoPA, policies/contracts/SCCs, technical controls/training, monitoring/audits. Applies universally across sizes/industries processing Brazilian data; ANPD oversees without formal certification.

HIPAA Details

What It Is

HIPAA (Health Insurance Portability and Accountability Act of 1996) is a US federal regulation establishing national standards for protecting individuals' health information. It focuses on Privacy Rule, Security Rule, and Breach Notification Rule, using a risk-based, flexible approach for covered entities and business associates handling PHI and ePHI.

Key Components

Three core rules: Privacy (uses/disclosures), Security (safeguards), Breach Notification.
Administrative, physical, technical safeguards; minimum necessary principle.
No fixed control count; scalable to organization size.
Compliance via OCR enforcement, no formal certification.

Why Organizations Use It

Mandatory for healthcare providers, plans, clearinghouses.
Mitigates breach risks, penalties up to millions.
Builds patient trust, enables secure data flows for care.
Strategic cyber resilience, vendor management.

Implementation Overview

Phased: assess risks, build controls, monitor continuously.
Involves risk analysis, policies, training, BAAs.
Applies to US healthcare entities of all sizes.
Audits by OCR; documentation retained 6 years. (178 words)

Key Differences

Aspect	LGPD	HIPAA
Scope	Personal data processing, rights, transfers	Health information privacy, security, breaches
Industry	All sectors, Brazil residents, extraterritorial	Healthcare providers, plans, US-focused
Nature	Mandatory Brazilian regulation, ANPD enforcement	Mandatory US regulation, OCR enforcement
Testing	DPIAs for high-risk, ANPD audits	Risk analysis, periodic evaluations, OCR audits
Penalties	2% Brazilian revenue, max R$50M	Tiered fines up to $50K per violation

Scope

LGPD

Personal data processing, rights, transfers

HIPAA

Health information privacy, security, breaches

Industry

LGPD

All sectors, Brazil residents, extraterritorial

HIPAA

Healthcare providers, plans, US-focused

Nature

LGPD

Mandatory Brazilian regulation, ANPD enforcement

HIPAA

Mandatory US regulation, OCR enforcement

Testing

LGPD

DPIAs for high-risk, ANPD audits

HIPAA

Risk analysis, periodic evaluations, OCR audits

Penalties

LGPD

2% Brazilian revenue, max R$50M

HIPAA

Tiered fines up to $50K per violation

Frequently Asked Questions

Common questions about LGPD and HIPAA

LGPD FAQ

HIPAA FAQ

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LGPD

HIPAA

Quick Verdict

LGPD

Key Features

HIPAA

Key Features

Detailed Analysis

LGPD Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

HIPAA Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

LGPD FAQ

What is the primary objective of LGPD?

Who is legally or professionally required to comply with LGPD?

Does LGPD require an external audit or third-party certification?

How often should an assessment for LGPD be performed?

What are the consequences of non-compliance with LGPD?

Can LGPD be mapped to other international frameworks?

What is the first step to begin implementing LGPD?

HIPAA FAQ

What is the primary objective of HIPAA?

Who is legally or professionally required to comply with HIPAA?

Does HIPAA require an external audit or third-party certification?

How often should an assessment for HIPAA be performed?

What are the consequences of non-compliance with HIPAA?

Can HIPAA be mapped to other international frameworks?

What is the first step to begin implementing HIPAA?

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CIS Controls v8.1, Operationalized: Top 10 Reasons Compliance Monitoring Software Accelerates Real-World Implementation

Beyond Reactive: Transforming Compliance into Real-Time Threat Prevention

CIS Controls v8.1 Metrics That Matter: KPIs, KRIs, and Dashboards for Board-Ready Cyber Reporting

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

GMP vs ISO 27018

DORA vs ISA 95

CMMI vs ISO 27017