In the medtech industry, innovation and patient safety are paramount, but they hinge on the security of digital systems, devices, and the data they handle. As medical devices grow more connected and software-driven, cybersecurity challenges continue to evolve. Medtech companies need robust strategies that align cybersecurity with growth, compliance, and market demands across both the US and Canada. Here, we explore four critical cybersecurity focus areas essential to medtech today, along with key actions that DBH advises to ensure a secure foundation for innovation.

1. Regulatory Compliance and Cybersecurity Preparedness

DBH advises medtech companies to integrate cybersecurity directly into their compliance frameworks. For the US market, regulations such as HIPAA, the FDA’s cybersecurity guidelines, and ISO 13485 emphasize secure-by-design principles to ensure patient safety. In Canada, Health Canada’s Medical Device Regulations (MDR), in combination with the Personal Information Protection and Electronic Documents Act (PIPEDA), set similar yet unique standards, especially for personal data protection and device safety. To meet these requirements across both countries, DBH offers its vCISO (Virtual Chief Information Security Officer) services, providing tailored compliance roadmaps that guide companies through regulatory requirements step-by-step.

DBH recommends the following steps for medtech companies:

• Build a Comprehensive Regulatory Roadmap: Address HIPAA, FDA, and ISO 13485 requirements for the US, and MDR, PIPEDA, and ISO 13485 for Canada. Ensure cybersecurity is integrated into each step of product development and operation across both regions.
• Establish Audit-Readiness: Prepare documentation and policies that support regulatory audits for both US and Canadian requirements. DBH’s audit-readiness support ensures all necessary processes and records meet Health Canada’s standards for medical devices alongside FDA compliance.
• Continuous Monitoring: Stay up to date with both US and Canadian regulatory changes by regularly updating policies and implementing continuous monitoring. DBH’s compliance management services help companies remain compliant as regulations evolve in both countries.

2. Supply Chain Security: Mitigating Risks Beyond Your Organization

Given that many security vulnerabilities stem from third-party relationships, DBH advises medtech companies to implement comprehensive supply chain risk management that meets the standards of both the US and Canada. Medical devices often involve components from multiple vendors, each with unique security profiles, making the supply chain a critical risk area. DBH’s approach to supply chain security includes regular vendor assessments, dark web monitoring, and compliance with Health Canada’s import regulations.

Key recommendations for securing your supply chain include:

• Vendor Risk Assessments: Evaluate all vendors and suppliers to ensure they meet security standards, particularly those handling sensitive data or device components. DBH’s vendor risk assessments cover both US and Canadian compliance standards to identify weaknesses in your supply chain.
• Contractual Security Clauses: Enforce security requirements contractually, ensuring vendors adhere to standards aligned with Health Canada’s import regulations and FDA requirements. DBH can assist in drafting these requirements to ensure compliance on both sides of the border.
• Dark Web Monitoring for IP Protection: Monitor the dark web to catch any instances of leaked intellectual property or compromised credentials. DBH’s dark web monitoring services provide ongoing vigilance, helping medtech firms safeguard proprietary data from unauthorized exposure.

3. Incident Response and Recovery: Protecting Patient Trust and Minimizing Downtime

With cyberattacks increasingly targeting healthcare, DBH advises medtech companies to establish a robust incident response and recovery plan to minimize downtime and protect patient trust, with provisions that meet both US and Canadian breach reporting and data protection requirements. Effective incident response is not only about responding to a breach but also about preparing in advance to contain threats quickly and minimize damage.

DBH recommends these steps to enhance your incident response:

• Rapid Response and Containment: Have a dedicated team ready to respond to incidents immediately. DBH’s incident response service focuses on quick containment to protect operations and patient data in compliance with both HIPAA and PIPEDA.
• Root Cause Analysis and Prevention: Analyze incidents to understand their origins and prevent recurrence, including compliance with PIPEDA breach notification obligations for incidents involving Canadian patient data. DBH’s root cause analysis services help medtech companies strengthen defenses.
• Business Continuity Planning: Develop a business continuity plan that minimizes operational disruptions. DBH provides continuity planning services that ensure medtech companies can maintain essential functions, even in the face of a cyberattack. This includes adhering to US and Canadian expectations for operational resilience.

4. Device Security: End-to-End Protection Against Emerging Threats

As devices become more connected, from wearable health monitors to advanced diagnostic machines, DBH advises medtech companies to prioritize security at every stage of device development and deployment. With cyber threats increasingly targeting operational technology (OT) environments, DBH recommends comprehensive device testing and vulnerability assessments that align with regulatory requirements in both the US and Canada.

To secure medtech devices, DBH advises:

• Device Penetration Testing: Regularly test devices for vulnerabilities through simulated attacks. DBH’s penetration testing identifies weaknesses before devices reach patients, ensuring they are robust against threats in compliance with both FDA and Health Canada standards.
• Vulnerability Assessments Across IT and OT: Conduct thorough vulnerability assessments for both IT and OT systems. DBH provides end-to-end assessments to prevent breaches across all technology layers, meeting both FDA and Health Canada requirements.
• Prioritized Risk Management: Use the findings from penetration testing and assessments to prioritize the most critical security improvements. DBH’s detailed reports offer actionable recommendations, helping medtech companies focus on high-impact areas to comply with the strict regulatory environments of both countries.