Comparison of HIPAA compliance and ISO 27001 certification

Update 2022-04-25.

All over the world, organizations in the healthcare industry are becoming more and more interested in protecting their patients’ information; but, in the United States, this need goes back to 1996, with the enforcement of HIPAA (Health Insurance Portability and Accountability Act), which regulates the use and disclosure of U.S. citizens’ protected health information.

This article will compare HIPAA compliance vs. ISO 27001, and present how organizations that need to ensure HIPAA compliance can take advantage of ISO 27001, the leading ISO standard for information security management, to fulfill the requirements.

HIPAA is a legislation for sensitive health/patient data protection and is applicable only in the United States, for health organizations. ISO 27001 is a standard for information security management and is applicable internationally, in any industry.

What are the security requirements in HIPAA?

Broadly speaking, HIPAA requirements are defined by two main rules: the Privacy rule and the Security rule. These rules must be followed by any U.S. healthcare provider who transmits health information in electronic form (generally called “covered entities”).

The Privacy rule establishes standards for the use and disclosure of personal health information (called Protected Health Information, or PHI) – information about the present or future physical or mental health or condition of an individual. Examples of established standards are limitation of use and disclosure to the minimum necessary, notification of privacy practices, and adoption of administrative practices (e.g., privacy policies and procedures, definition of responsibilities, training, documentation, records and retention, etc.).

The Security rule establishes standards for the protection of confidentiality, integrity, and availability of PHI that is held or transferred in electronic form (i.e., electronic Protected Health Information, or e-PHI), by means of administrative, physical, and technical safeguards. Examples of addressed safeguards are risk analysis and management, information access management, workforce training management, facilities access and control, workstation and device security, audit controls, and transmission security.

It is also important to note that HIPPA does not require any specific set of technology or software, so organizations are free to adopt the solutions that best fit their needs to ensure compliance with HIPAA.

How is ISO 27001 applicable for health organizations?

ISO 27001 is a standard for information security management designed to be applicable to organizations of any size and industry. It consists of 10 clauses and 114 security controls grouped into 14 sections (Annex A).

ISO 27001 has at least 47 controls that can be used to comply with HIPAA requirements. For example:

HIPAA requirements vs. ISO 27001 controls

HIPAA general requirement ISO 27001 requirement / control Additional information
Assigned Security Responsibility (164.308(a)(2)) A.6.1.1 – Information security roles and responsibilities How to document roles and responsibilities according to ISO 27001
Security Awareness and Training (164.308(a)(5)) A.7.2.2 – Information security awareness, education and training How to perform training & awareness for ISO 27001 and ISO 22301
Workstation Use (164.310(b)) A.8.1.3 – Acceptable use of assets IT Security Policy
Information Access Management (164.308(a)(4))


A.9.1 – Business requirements of access control (2 controls)

A.9.2 – User access management (6 controls)


How to handle access control according to ISO 27001

Template Access Control Policy

Access Control (to information systems) (164.312(a)(1)) A.9.4 – System and application access control (5 controls) How to handle access control according to ISO 27001

Template Access Control Policy

Workstation Security (164.310(c)) A.11.2 – Equipment (9 controls) How to implement equipment physical protection according to ISO 27001 A.11.2 – Part 1

How to implement equipment physical protection according to ISO 27001 A.11.2 – Part 2

Audit Controls (164.312(b)) A.12.7.1 – Information systems audit controls How to integrate ISO 27001 A.14 controls into the system/software development life cycle (SDLC) (this article is about including security features in software development and maintenance)
Transmission Security (164.312(e)(1)) A.13 – Communications security (7 controls) How to manage the security of network services according to ISO 27001 A.13.1.2
Security Incident Procedures (164.308(a)(6)) A.16 – Information security incident management (7 controls) How to handle incidents according to ISO 27001 A.16
Privacy Rule Obligations for Business Associates (general provision) A.15.1.2 – Addressing security within supplier agreements Which security clauses to use for supplier agreements?
Contingency Plan (164.308(a)(7)) A.17 – Information security aspects of business continuity management (4 controls) How to use ISO 22301 for the implementation of business continuity in ISO 27001
Evaluation (164.308(a)(8)) A.18.2.2 – Compliance with security policies and standards

A.18.2.3 – Technical compliance review

How to make an Internal Audit checklist for ISO 27001 / ISO 22301

However, one of the main contributions of ISO 27001 is the management system approach, defined in the requirements from clauses 4 through 10, which allows an organization to continuously adapt and improve its security to keep it aligned with the organization’s desired objectives and outcomes.

For more information, read these articles: What do the ISO 27001 requirements and structure look like? and An overview of ISO 27001:2013 Annex A.

Does ISO 27001 mean HIPAA compliance?

Although well aligned, ISO 27001 compliance does not mean HIPAA compliance, because ISO 27001 does not have some of the controls necessary to handle specific HIPAA requirements, like privacy-related controls. To fill the gaps within HIPAA compliance vs. ISO 27001, you should consider using ISO 27799, the ISO standard for the protection of personal health information, as a supporting guidance.

HIPAA Compliance vs. ISO 27001 | Which standard is best for you?

For more information about ISO 27799, read this article: How ISO 27001 and ISO 27799 complement each other in health organizations.

HIPAA compliance vs. ISO 27001: Which one should you go for?

In short, it is not a question of HIPAA vs. ISO 27001, because HIPAA is a law, while ISO 27001 is a standard to establish an Information Security Management System. In terms of ISO 27001, HIPAA can be viewed as one of the many requirements that can be fulfilled by an ISO 27001 ISMS implementation.

The proper way to see the relationship between these two is this: ISO 27001 can provide a sound basis for driving and optimizing an organization’s resources to implement HIPAA security, and any other information security requirement the organization may have, thereby reducing compliance efforts.

For a better understanding of how to comply with ISO 27001, sign up for a free 14-day trial of Conformio, the leading ISO 27001 compliance software.

Advisera Rhand Leal
Rhand Leal

Rhand Leal has more than 15 years of experience in information security, and for six years he continuously maintained а certified Information Security Management System based on ISO 27001.

Rhand holds an MBA in Business Management from Fundação Getúlio Vargas. Among his certifications are ISO 27001 Lead Auditor, ISO 9001 Lead Auditor, Certified Information Security Manager (CISM), Certified Information Systems Security Professional (CISSP), and others. He is a member of the ISACA Brasília Chapter.