Unlocking the Potential of Digital Health Applications (DiGA): How ISO 27001 Can Accelerate Certification
Digital health applications (DiGA) are transforming healthcare by empowering patients to detect, manage, and monitor diseases more effectively. As CE-certified medical devices, they leverage cutting-edge technology to enhance patient care, improve health outcomes, and optimize healthcare processes.
However, before a DiGA can be officially approved, manufacturers must comply with strict security and quality requirements. A key component of this process is ISO 27001 certification, which not only ensures data protection but also significantly accelerates regulatory approval.
Why Is ISO 27001 Certification Essential for DiGA?
Certification according to ISO/IEC 27001 is a critical milestone for companies launching a digital health application. It guarantees the implementation of a robust Information Security Management System (ISMS)—a vital framework for protecting sensitive patient data and meeting regulatory requirements.
Key Security Measures for DiGA Manufacturers
1. Information Security Management System (ISMS) According to ISO 27001
An ISO 27001-compliant ISMS protects confidentiality, integrity, and availability of both patient and company data. It also signals to customers, partners, and regulatory bodies that data protection and cybersecurity are a top priority.
2. Penetration Testing for Maximum Security
Penetration tests (Pentests) simulate real-world cyberattacks to identify and mitigate system vulnerabilities. These tests are mandatory for DiGA and play a crucial role in maintaining a high level of security and compliance.
3. Additional Regulatory Requirements
Beyond ISO 27001, DiGA manufacturers must comply with various industry standards, including:
- Quality management (ISO 13485) for medical devices
- Data protection regulations (GDPR & BSI IT baseline protection) to ensure secure data processing
- The Digital Health Applications Ordinance (DiGAV), which defines the legal framework for DiGA approval
By combining these standards, manufacturers ensure that their digital health solutions meet the highest security and quality standards while streamlining the regulatory approval process.
Efficient Preparation for Certification
Achieving ISO 27001 certification is a complex process, but with the right approach and tools, it can be significantly accelerated. A well-structured ISMS is essential for meeting compliance requirements efficiently and adapting to evolving regulations.
How Kertos Accelerates the Certification Process
The Kertos platform simplifies and automates the development of an ISMS, helping companies:
- Reduce manual effort by over 50%
- Streamline risk management processes
- Automatically identify security vulnerabilities
- Ensure precise and well-documented security structures
By leveraging intelligent workflow automation, organizations can achieve certification faster and with greater accuracy, ensuring long-term compliance and security.
Are You Ready for Certification?
Successfully launching a DiGA requires navigating complex certification landscapes while ensuring robust information security measures. By proactively implementing ISO 27001 standards and utilizing automated security solutions, manufacturers can speed up the approval process, meet regulatory requirements, and build long-term trust with users, healthcare professionals, and stakeholders.
Discover how you can develop your ISMS in compliance with ISO 27001 using the Kertos platform and accelerate your DiGA certification process.
