Achieving ISO 27001:2022 Certification in Healthcare: A Practitioner’s Guide

Updated on April 8, 2024
Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice

As the head of information security and compliance at Luma Health, a healthcare SaaS platform, I recently led our organization through successful ISO 27001:2022 certification. This internationally recognized standard offers significant security and operational benefits for healthcare providers. I’d like to share essential steps and insights from my experience to support your organization’s journey towards certification.

1. Secure Executive Buy-In

This is the first and arguably most important step — no organization is going to be successful without leadership being on board. Depending on how mature your information security program is, there may be significant changes on how your business operates once you start applying ISO controls to your regular day-to-day workflow. Strong leadership support lays the foundation for successful ISO 27001:2022 implementation, so it’s important to clearly articulate the key benefits for healthcare organizations:

  • Enhanced security culture: ISO 27001:2022 compliance cultivates a security-conscious mindset across the organization, mitigating risks associated with sensitive patient data.
  • Customer and partner trust: Certification demonstrates a commitment to robust data protection, a critical factor in the healthcare sector.
  • Competitive advantage: Many healthcare customers increasingly require compliance with recognized security standards like ISO 27001:2022 from their vendors, so your explicit actions to safeguard their data sets your organization apart from those whose approach is not as rigorous.
  • HIPAA support: The ISO 27001:2022 framework, particularly its focus on risk management and data security, aligns with HIPAA’s Privacy and Security Rules. This is essential for any company operating in the US healthcare sector.

Once executive buy-in is secured, your organization’s leadership can champion the initiative and drive company-wide acceptance and promotion of this important certification.

2. Define Scope and Establish Clear Objectives

Precisely outline the scope of your certification effort and set measurable objectives for your Information Security Management System (ISMS):

  • Targeted vs. organizational scope: Consider whether your goal is to certify a specific healthcare product or service or pursue certification for your entire organization. A well-defined scope streamlines the process and optimizes resource allocation.
  • Specific objectives: In collaboration with your executive team, define achievable ISMS objectives. These could include initial certification, continuous security posture improvement, or addressing specific HIPAA-related goals.

3. Understand the ISO 27001:2022 Standard and Develop Your SOA

Before you begin, a thorough understanding of ISO 27001:2022 requirements is essential.

  • Obtain the standard: Purchase a copy from ISO to gain a comprehensive understanding of mandatory and optional controls.
  • Statement of Applicability (SOA): This crucial document outlines all ISO 27001:2022 controls. For each control, justify its inclusion, modification, or exclusion based on your healthcare organization’s specific context and risk profile. The SOA guides implementation efforts.

4. Select a Qualified Audit Partner

Once the groundwork has been laid and you are confident about moving forward, you’ll need to select a partner that can guide you through the audit process through to certification. Choose an audit partner that aligns with your organization’s needs and possesses the following attributes:

  • Accreditation: Ensure the partner is accredited by an acknowledged certification body to ensure your certification holds global recognition and value.
  • Scope expertise: A qualified partner will collaborate with you to meticulously define the scope of your certification, ensuring efficiency and avoiding unnecessary scope creep.
  • Healthcare experience: Ideally, select a partner with a proven track record of success in the healthcare sector. They will understand the unique regulatory and security challenges you face.

5. Additional Considerations for Healthcare Providers

  • HIPAA cross-mapping: Develop a cross-reference table demonstrating how specific ISO 27001:2022 controls support compliance with various HIPAA requirements. This can simplify audits and streamline your security program.
  • Vendor due diligence: ISO 27001:2022 principles can be applied when evaluating your healthcare supply chain and partner relationships. Consider requiring ISO 27001:2022 certification or equivalent security standards from third-party vendors who handle sensitive patient information.
  • Focus on continuous improvement: View ISO 27001:2022 certification as an ongoing process, not a one-time goal. Regularly review your ISMS, adapt to evolving healthcare cybersecurity threats, and prioritize continuous improvement for optimal data protection.


While ISO 27001:2022 certification in healthcare demands effort and resources, the rewards are substantial. Careful planning, strategic partnerships, and a commitment to long-term security excellence will position your healthcare organization for both success and enhanced patient trust.

Luma Health Nick Lees
Nick Lees
Head of Information Security and Compliance at Luma Health

Nick Lees is the head of information security and compliance at Luma Health. Nick has more than twenty years of experience in Security, Compliance, and Infrastructure Engineering working for organizations across the globe such as Luma Health, Red Canary, Thomson Reuters, and IBM. Connect with Nick on LinkedIn.