Securing Trust: The Essential Role of Cybersecurity in MedTech

Digital solutions play a vital role in driving efficiency and innovation within the healthcare industry. These digital solutions are becoming more interconnected to further streamline processes and alleviate burden on medical staff. However, to fully leverage their potential, robust cybersecurity assessments and implementation of defined measures are imperative for medical technologies.

Trust in medical software is a key factor in driving adoption for digital medical technology, and this trust also relies on the software's ability to protect sensitive data and ensure uninterrupted functionality. Without robust cybersecurity measures, data breaches and system vulnerabilities can compromise the potential benefits of digital healthcare and harm patients in the worst case. Therefore, cybersecurity is not only important but also crucial for unlocking the full potential of digital transformation in healthcare.

Creating and maintaining secure medical technology solutions presents numerous interrelated challenges.

• Technical challenges include integrating modern cybersecurity measures with legacy systems, ensuring compatibility and interoperability among a variety of devices.
• Regulatory challenges involve adhering to constantly changing standards and regulations, achieving certification, and staying up-to-date with evolving cybersecurity requirements.
• Organizational challenges encompass budget constraints, resource allocation, available expertise, staff training, fostering a culture of security, and ensuring robust incident response plans.
• User-related challenges include implementing user-friendly security measures, providing adequate training, mitigating human error risks, and managing access control effectively.

Overcoming these challenges requires a coordinated effort and a comprehensive cybersecurity strategy that balances security, usability, and compliance to safeguard medical technologies and patient data.

To ensure the security of your medical software, it is crucial to follow best practices and take proactive measures. Some key measures are:

• Integrating Security as a Standard Practice in Software Development Processes:
  Implementing software development processes that prioritize cybersecurity and comply with regulatory requirements (e.g. IEC 62304 “Medical device software – Software life cycle processes” and ISO 14971 “Medical devices – Application of risk management to medical devices”) is essential. This involves incorporating security measures throughout the development lifecycle and regularly monitoring, updating and patching software to address any known vulnerabilities.
• Applying Secure-by-Design Methodology:
  Adopting proactive practices such as threat modeling during software development helps to identify potential security risks and allows for their mitigation before they can be exploited.
• Executing Vulnerability Testing before Penetration Testing:
  Even before conducting penetration testing, it is important to verify that your software is free of common vulnerabilities. This can be achieved through rigorous testing and code review, ensuring that any identified risks are promptly addressed and resolved. By following these practices, you can significantly enhance the security of your medical software and protect it from potential threats.

Depending on your specific competencies, we provide several services, including consulting, assessments, testing, and implementation of measures, specifically designed to assist both start ups and established medical device manufacturers in developing secure medical solutions. Supporting you with your cybersecurity from design to operations:

1. Health Check for your Medical Software Development Process: We will review your current security practices in a joint interactive workshop and help you refine a secure development methodology for medical device software based on established standards and best practices.
2. Threat and Risk Assessment for your Medical Device Software: We will assess the security risk of your product's architecture and code and provide you with specific directions on how to mitigate identified security risks and how to comply with respective regulatory standards. We can also assist with respective implementation of countermeasures. We provide security checks for solutions that are currently in development or for existing solutions and offer an interactive workshop to discuss results.
   
3. Security Verification and Vulnerability Handling for your Medical Device Software: We will create and perform suitable security tests for your medical device and/or software. With our experience, we will help you integrating triage and mitigation continuously and efficiently into your software development procedures.
   
4. Secure Medical Cloud Operations: We analyze the status quo of your cloud environment hosting medical technology to assess the risk posture of your infrastructure. We provide step-by-step support to your DevOps teams to manage your cloud security posture, mitigating threats and attack vectors proactively. Alternatively, we assist in defining workflows and concepts to ensure your medical technology is operated securely and efficiently in the cloud.
   

Whether you need assistance leveraging one or all of these services, we're here to help.

• Dedicated security experts specialized in medical software
• Experienced test and software engineering teams skilled in applying security methodologies like threat modeling
• Active contributor in ClusterforFuture Initiative: Secure Medical Microsystems and Communications SEMECO, accelerating secure medical technology innovations
   

Our mission is to create digital solutions today that will improve people's health tomorrow. We are a member of the ZEISS Group and your specialized partner for custom health software development and quality assurance.

We speak health & digital: Together, we accelerate your digital health innovations. We look forward to meeting you and discussing how we can help you implement your digital roadmap!