PCI vs. HIPAA: A Beginner’s Guide to What Each Covers, Key Differences, and How to Stay Compliant

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PCI vs. HIPAA: A Beginner’s Guide to What Each Covers, Key Differences, and How to Stay Compliant

Kevin Henry

HIPAA

April 10, 2025

6 minutes read
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PCI vs. HIPAA: A Beginner’s Guide to What Each Covers, Key Differences, and How to Stay Compliant

Scope and Applicability

PCI DSS: Who and what it covers

The Payment Card Industry Data Security Standard (PCI DSS) applies to any entity that stores, processes, or transmits cardholder data or sensitive authentication data. That includes merchants of all sizes, service providers, gateways, processors, and issuers.

Scope is defined by your cardholder data environment (CDE)—the systems, people, and processes that touch the primary account number (PAN). Network segmentation can reduce scope, but third-party systems that can impact the CDE are in scope too.

HIPAA: Who and what it covers

HIPAA is a U.S. federal law that applies to covered entities (health plans, health care clearinghouses, and most health care providers) and their business associates. It protects Protected Health Information (PHI) in any form, while the Security Rule focuses on electronic PHI (ePHI).

Vendors that create, receive, maintain, or transmit PHI for a covered entity must have Business Associate Agreements and demonstrate Business Associate Compliance.

Regulatory Authority

PCI DSS

The Payment Card Industry Security Standards Council develops and maintains PCI DSS and related standards. Enforcement is contractual, driven by the card brands (e.g., Visa, Mastercard) and acquiring banks through merchant agreements rather than by statute.

HIPAA

HIPAA is regulated and enforced by the U.S. Department of Health and Human Services’ Office for Civil Rights (HHS OCR). OCR investigates complaints and breaches, audits organizations, and issues guidance and settlement agreements.

Focus and Objectives

PCI DSS objectives

PCI DSS is designed to prevent payment card fraud by protecting cardholder data and sensitive authentication data. Its objectives center on securing networks, hardening systems, encrypting data, managing vulnerabilities, and monitoring access to the CDE.

HIPAA objectives

HIPAA seeks to safeguard the confidentiality, integrity, and availability of PHI while enabling appropriate care delivery and data sharing. The Security Rule emphasizes risk management across Administrative Safeguards, Physical Safeguards, and Technical Safeguards.

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Specificity of Requirements

PCI DSS: Prescriptive controls

PCI DSS sets prescriptive, testable requirements (for example, strong cryptography for PAN, multi-factor authentication for administrative access, quarterly vulnerability scans by an Approved Scanning Vendor, and periodic penetration testing). It expects written policies, detailed logging, and continuous monitoring across the 12 control domains.

HIPAA: Risk-based flexibility

HIPAA’s Security Rule is principles-based. It requires an enterprise-wide risk analysis and risk management plan, with “required” and “addressable” implementation specifications. You choose reasonable and appropriate controls based on size, complexity, and risk—then document your decisions.

Penalties for Non-Compliance

PCI DSS consequences

Non-compliance can lead to brand and acquirer-imposed fines, higher processing fees, mandatory forensic investigations, liability for fraud and card reissuance costs, and even termination of card acceptance. These are contractual consequences rather than statutory Civil Penalties.

HIPAA consequences

HIPAA violations can trigger OCR investigations, corrective action plans, and tiered civil monetary penalties based on culpability and harm. Certain wrongful disclosures or misuse of PHI can also lead to criminal penalties.

Compliance Requirements

Building a PCI DSS program

  • Map card data flows, minimize storage, and tokenize or encrypt PAN wherever possible. Never store sensitive authentication data after authorization.
  • Define and segment the CDE; enforce strong access control and multi-factor authentication for administrative and remote access.
  • Implement secure configuration, patching, anti-malware, change control, and centralized logging with daily reviews.
  • Complete the appropriate Self-Assessment Questionnaire (SAQ) or a Report on Compliance (ROC) with a Qualified Security Assessor; perform quarterly ASV scans and periodic penetration tests.
  • Manage third parties; require documented PCI compliance from service providers and maintain incident response procedures.

Building a HIPAA program

  • Conduct an enterprise-wide risk analysis; implement risk management with Administrative Safeguards (policies, workforce training, sanctions), Physical Safeguards (facility and device controls), and Technical Safeguards (access control, audit controls, integrity, authentication, and transmission security).
  • Adopt privacy policies (e.g., minimum necessary), role-based access, and continuous auditing. Encrypt ePHI in transit and at rest where feasible.
  • Execute Business Associate Agreements and oversee Business Associate Compliance with documented due diligence and monitoring.
  • Prepare incident response and contingency plans, including backups and disaster recovery; maintain documentation and conduct periodic evaluations.

Breach Notification

PCI DSS expectations

PCI DSS itself does not create statutory Data Breach Notification duties, but contracts require immediate action. If a compromise is suspected, notify your acquirer, contain the incident, preserve evidence, and engage a PCI Forensic Investigator as directed. Coordinate any legal notifications required under applicable laws.

HIPAA requirements

Under HIPAA’s Breach Notification Rule, you must notify affected individuals without unreasonable delay and no later than 60 days after discovery. For breaches involving 500 or more individuals, notify HHS within 60 days and the media in the affected jurisdiction; for fewer than 500, report to HHS within 60 days after the end of the calendar year. Business associates must notify the covered entity without unreasonable delay and within 60 days.

Conclusion

In PCI vs. HIPAA, PCI DSS is an industry standard aimed at card data security, while HIPAA is federal law safeguarding PHI. PCI is prescriptive and contractually enforced; HIPAA is risk-based with statutory Civil Penalties. Treat both as continuous programs: know your data, reduce exposure, implement layered controls, verify third parties, test regularly, and be ready to respond.

FAQs

What types of data do PCI and HIPAA protect?

PCI protects cardholder data and sensitive authentication data associated with payment cards, focusing on the PAN and related elements. HIPAA protects Protected Health Information about an individual’s health, care, or payment for care, with the Security Rule centered on ePHI.

How do penalties differ between PCI and HIPAA violations?

PCI non-compliance leads to contractual consequences from card brands and acquirers—fines, higher fees, mandated investigations, and possible loss of card acceptance. HIPAA violations can result in OCR investigations, corrective action plans, tiered civil monetary penalties, and, for egregious misconduct, criminal penalties.

Who must comply with PCI DSS versus HIPAA?

Any organization that stores, processes, or transmits payment card data must comply with PCI DSS. HIPAA applies to covered entities (plans, clearinghouses, most providers) and to business associates that handle PHI on their behalf.

What are the breach notification requirements under each standard?

For PCI, contractual obligations require immediate coordination with the acquirer and card brands; statutory Data Breach Notification duties come from applicable laws, not PCI itself. HIPAA mandates notice to affected individuals within 60 days, timely reporting to HHS, and, for large breaches, media notification; business associates must notify covered entities without unreasonable delay.

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