The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous industries, including healthcare. 

ISO standards are voluntary, consensus-based documents that provide guidance on particular aspects of technology and operations. 

Companies can become ISO certified by going through an audit process and recently, that’s exactly what we did, with Alex Therapeutics becoming ISO 27001 certified - yay!

In this article we’ll break down what the ISO 27001 certification is and why it's important for digital health technology companies like ours to have it.

What is ISO 27001?

ISO 27001 is the international standard for information security and sets out the requirements for an effective information security management system. ISO 27001 helps organizations manage their information security and mitigate risks through policies and procedures related to people, processes and technology.

Why it’s important for digital health technology companies to be ISO 27001 certified

Enhanced Data Security

ISO 27001 certification demonstrates a commitment to robust information security management systems. It ensures that patient data, medical records, and other sensitive information are protected from breaches, ensuring data confidentiality, integrity, and availability.

Continuous Improvement

ISO 27001 is based on the Plan-Do-Check-Act (PDCA) model, which promotes a culture of continuous improvement in information security. Companies who regularly assess and refine their security measures can better adapt to evolving threats and vulnerabilities.

Reduced Risk and Cybersecurity

ISO 27001 helps companies identify and assess information security risks and implement controls to mitigate these risks. This proactive approach to risk management can prevent data breaches, cyberattacks, or other security incidents, reducing potential liabilities. 

In the context of medical devices, ISO 27001 simplifies the way in which a company can assess the safety and security risk of each medical device within the context of the larger system in which the device operates.

Legal and Regulatory Compliance

ISO 27001 helps ensure compliance with data protection regulations like Health Insurance Portability and Accountability Act (HIPAA) in the United States and the General Data Protection Regulation (GDPR) in Europe. Breaches of European GDPR regulations can be very costly so it’s also a form of insurance to know that the company you are working with is compliant.

Medical Device Regulatory Requirements

Medical device regulators, including the FDA, have started to pay increasing attention to cybersecurity, issuing guidelines and requiring risk assessments and other actions to be taken. The ISO 27001 certification simplifies the way in which companies can follow these guidelines and implement action.

Furthermore, for digital health companies interested in pursuing German reimbursement for a digital therapeutic via a DiGA, an information security certificate (ISO 27001 or other standard) is required. As Germany is leading the way in terms of European digital health technology regulation, it is quite likely that other countries will follow their lead and implement similar requirements.

Third-Party Vendors and Partnerships

Having the ISO 27001 certification builds trust among healthcare providers, patients, and partners. They can be confident that their data is handled securely, which is particularly crucial in digital health technology companies, where confidentiality and trust is paramount. If you want to work with partners and third-party vendors, ISO 27001 certification is something to look for when establishing these relationships, ensuring that the entire supply chain follows high security standards. 

Conclusion

In summary, ISO 27001 certification is essential for digital health technology companies because it helps protect patient data, ensures compliance with regulations, and strengthens overall information security practices. Furthermore, continuous process improvement is important to ensure that health technology companies and their partners adapt to the ever present and evolving threats of cybercrime.