ISO 27001 for healthcare companies: Benefits and implementation steps

ISO 27001 is a widely used standard for protecting the security of organizations across sectors and their data through comprehensive controls. While it’s beneficial for virtually any industry, organizations in the healthcare sector often find it especially valuable.

‍

This is because they’re often subject to extensive but vaguely defined regulations, and ISO 27001 provides the structured approach to compliance they need.

In this guide, you’ll learn:

• How ISO 27001 helps healthcare organizations achieve compliance with the necessary regulations
• The key implementation steps to understand before pursuing certification

‍

ISO 27001 at a glance

ISO 27001 is an international standard for developing a comprehensive information security management system (ISMS). Organizations in any sector can implement it, and it’s often combined with mandatory regulations (such as HIPAA for healthcare organizations) to enhance an organization’s security posture.

‍

The standard has over 90 clear, prescriptive controls split into four categories:

1. Organizational (Annex A.5)
2. People (Annex A.6)
3. Physical (Annex A.7)
4. Technological (Annex A.8)

‍

It also outlines seven notable Clauses (4–10), some of which are particularly relevant for healthcare organizations and will be covered later in this guide. 

‍

Benefits of ISO 27001 for healthcare organizations

The main benefit of adopting ISO 27001 for healthcare organizations is that it is a demonstrable step toward meeting HIPAA’s Security Rule. About 40 percent of ISO 27001 controls overlap with HIPAA, meaning that implementing the standard gives organizations that aim to be HIPAA-compliant a notable head start.

‍

Other reasons why healthcare organizations should adopt ISO 27001 include:

• Clarifying regulatory requirements: ISO 27001 helps clarify the often vague requirements of HIPAA, reducing the risk of costly violations and eliminating confusion that could drain time and resources
• Increasing patient trust and transparency: A well-developed ISMS contributes to the security of protected health information (PHI), making your organization more trustworthy in the eyes of patients and other stakeholders
• Maturing your organization’s security program: Implementing ISO 27001 helps establish governance, technical, and procedural safeguards that improve the overall maturity of your security program
• Increasing cyber resilience: The standard’s strong emphasis on cybersecurity helps improve your overall posture and resilience against both internal and external threats
• Adopting privacy-focused standards: ISO 27001 certification is a prerequisite for implementing privacy-oriented standards like ISO 27701 and ISO 27018, which protect personal information in cloud environments

‍

{{cta_withimage2="/cta-blocks"}} 

‍

Mapping ISO 27001 controls to healthcare regulations

HIPAA’s interpretive nature calls for a more systematic approach to compliance, which is provided by specific Clauses and Annex controls of ISO 27001. The following table outlines some of the most notable ones:

‍

‍

ISO 27001 Annexes prescribe the actual controls that healthcare organizations can implement, while Clauses outline the requirements they must meet to get certified. Healthcare organizations can also add specific risks or controls to their ISO 27001 program.

‍

“

Organizations should look at any unique program requirements that could include physical safeguards, access controls, and incident response. They should drive program objectives and metrics that support risks identified from their risk assessment.”

Jill Henriques

GRC Subject Matter Expert, GTM, Vanta

|

LinkedIn

‍

How healthcare organizations can achieve ISO 27001 compliance

You can take the following steps to obtain an ISO 27001 certificate:

1. Scope your ISMS
2. Choose the applicable controls
3. Identify a qualified and independent ISO 27001 auditor
4. Establish the audit criteria
5. Perform an internal audit and share the findings
6. Remediate non-conformities
7. Undergo the external audit and get ISO 27001-certified
8. Maintain your ISO 27001 certificate

‍

We’ll cover each step in more detail below.

‍

Step 1: Scope your ISMS

Before undergoing an ISO 27001 audit, you must scope all the elements of your IT infrastructure that will be included in the ISMS. When doing so, you should prioritize hardware, software, and network devices that store, process, or transmit PHI.

‍

To ensure comprehensive insights into your ISMS, build an asset inventory that lists all the key components and maps the flow of sensitive data. Ideally, you’ll do this through a dedicated compliance solution rather than manually using outdated techniques like spreadsheets. The right software can help you maintain and update your inventory as needed, which is crucial to ongoing compliance.

‍

Besides information assets, you need to consider employees and physical locations that your ISMS should encompass. This allows you to implement the Annex A.6 controls that ensure your staff follows the necessary security practices.

‍

Step 2: Choose the applicable controls

Your organization doesn’t need to implement all ISO 27001 controls to get certified—you can choose those applicable to your organization. You’ll include those in your Statement of Applicability, which the auditor will review to understand the assessment scope.

‍

The two main criteria for selecting the right ISO 27001 controls are your regulatory obligations and risk appetite. For example, organizations pursuing HIPAA compliance will focus on the controls aligned with the Security Rule.

‍

Use the regulations and standards you wish to implement as a reference point when choosing ISO 27001 controls. Through careful mapping, you can connect the controls to various regulations to streamline your compliance process.

‍

Step 3: Identify a qualified and independent ISO 27001 auditor

After completing an internal ISO 27001 audit, you’ll need a third-party auditor to carry out the external one. The auditor will provide a plan for the external audit, which you can review to allocate your resources accordingly.

‍

Make sure your auditor has experience working with healthcare organizations. Assess their qualifications and ensure they can provide support throughout the audit process to help you get certified efficiently.

‍

{{cta_withimage39="/cta-blocks"}} 

‍

Step 4: Establish the audit criteria

Before performing the internal audit, you need to define how it will be conducted. The audit must encompass your entire ISMS, so you need to consider:

• Risk assessment criteria
• Information security controls
• ISMS documentation
• Awareness and training
• Management review processes

‍

Plan all these activities and map them to the necessary time and resources. If you’ve performed compliance audits before, use historical data to estimate the time frame.

‍

You should also assign task owners to ensure everyone understands their responsibilities. You’ll likely need to include various departments, so establish the necessary collaboration channels. Additionally, make sure the appropriate ISMS documentation approvals have been completed and made available as needed to support the audit process.

‍

Step 5: Perform an internal audit and share the findings

After defining the audit criteria, perform a thorough assessment to identify compliance gaps. The specific activities you’ll need to complete include:

• Policy and process reviews
• Security reviews
• Risk assessment and scoring

‍

Share the results of these activities with upper management and the key stakeholders to develop a gap remediation plan. Depending on your current compliance and security posture, closing these gaps may take significant time and effort, so plan the related activities carefully.

‍

Step 6: Remediate non-conformities

Managing non-comformity remediation plans is the final step before you undergo the external ISO 27001 audit. To avoid unnecessary delays or back-and-forth during the audit, ensure your controls are fully aligned with the ISO requirements.

‍

Manage non-conformities by starting with Majors (e.g., clause related). Don’t overhaul your processes at once—this can cause operational disruptions and lead to haphazard control implementation, the consequences of which might not become apparent until the external audit.

‍

As you remediate non-conformities, document your processes and collect evidence of ISO 27001 compliance. Your auditor will review the evidence during their assessment, so prepare all the necessary documents to streamline the process.

‍

Step 7: Undergo the external audit and get ISO 27001-certified

An external ISO 27001 audit happens in two stages:

1. Documentation and readiness review: The auditor examines your ISMS program documentation to verify alignment with Clauses 4 through 10 of the ISO 27001 standard. This stage assesses whether your governance structure, risk management approach, and documented policies are in place and sufficient to proceed to Stage 2.
2. Certification audit: During this stage, the auditor conducts an in-depth evaluation of your ISMS in practice by reviewing Clause 4–10 evidence along with Annex supporting evidence.

‍

During the certification audit, the auditor will examine your policies, procedures, and controls to ensure alignment with the selected ISO 27001 controls. They’ll do so by reviewing a sample of your assets to assess the operational effectiveness of these controls and interviewing ISMS in-scope personnel.

‍

If the audit is successful, you’ll obtain the ISO 27001 certificate, which is valid for three years. Still, you’ll need to take additional steps to ensure ongoing compliance and continual improvement.

‍

{{cta_withimage2="/cta-blocks"}}

‍

Step 8: Maintain your ISO 27001 certificate

ISO 27001 follows a three-year certification cycle. After the initial certification audit, you’ll undergo two additional audits to maintain certification:

1. Surveillance audit: An annual audit conducted after years one and two to ensure the ongoing effectiveness of your controls and alignment with the ISO 27001 requirements
2. Recertification audit: A comprehensive audit of your ISMS carried out before the three-year certification period ends

‍

To pass these audits efficiently, make sure to centralize your ISO 27001 compliance documentation. You should also keep up with the standard’s updates and ensure continuous ISMS program improvements through regular reviews and upgrades.

‍

Finally, stay on the lookout for any ISMS changes that might stem from updated legal, regulatory, and contractual compliance requirements or changes in your security posture. This way, you can prevent unidentified threats or compliance lapses.

‍

Achieve and maintain ISO 27001 compliance efficiently with Vanta

Vanta is a trust management platform that automates up to 80% of the ISO 27001 compliance processes. It helps your team achieve and maintain compliance so you can focus your efforts on strengthening your security posture.

‍

The platform does this through a dedicated ISO 27001 solution, which offers useful features such as:

• ISMS scoping templates and checklists
• Effective risk assessment and management features built around ISO 27005 guidelines
• Streamlined access review features
• Centralized documentation and automated evidence collection supported by over 375 integrations
• Built-in resources (templates, tests, etc.)

‍

Vanta also offers an extensive partner network to help you find an ISO 27001 auditor who will help you achieve compliance with less friction. 

‍

To help you manage compliance with other frameworks, Vanta comes with pre-built workflows for other standards and regulations, including HIPAA. You can leverage numerous automation features and expert support throughout the compliance process.

‍

To see Vanta’s ISO 27001 product in action, schedule a custom demo.

‍

{{cta_simple2="/cta-blocks"}}