Navigating the Evolving FDA Cybersecurity Landscape: What It Means for Health Systems and Patient Safety

Health systems face growing cyber threats that jeopardize patient data, clinical workflows, and hospital operations.

With ransomware and data breaches on the rise, hospitals need medical devices that go beyond regulatory standards to actively protect networks and patient safety.

As cyber threats evolve, so must safeguards for medical devices, especially Software as a Medical Device (SaMD) solutions like EndoTool.

At Monarch Medical Technologies, we see cybersecurity as a patient safety imperative, not just a regulatory requirement.

The Evolution of FDA’s Cybersecurity Guidance

The FDA’s cybersecurity approach has transformed in response to increasing threats. The 2023 guidance expanded prior recommendations, setting clearer expectations for manufacturers across the product lifecycle.

Organizations developing software-driven medical devices must now take a proactive, risk-based approach to cybersecurity.

In March 2024, the FDA released draft guidance updating premarket cybersecurity expectations, providing additional clarity on compliance with Section 524B of the Federal Food, Drug, and Cosmetic Act.

These updates reinforce the FDA’s commitment to strengthening cybersecurity standards and keeping manufacturers ahead of emerging risks.

Pre-Market Cybersecurity Requirements

The FDA now requires manufacturers to demonstrate:

• Threat Modeling & Risk Assessments: Identifying vulnerabilities early.
• Secure Design & Architecture: Implementing authentication, encryption, and access controls.
• Security Testing & Validation: Conducting penetration testing and software analysis.
• Software Bill of Materials (SBOM): Providing transparency into third-party software components.

These measures ensure security-by-design principles, reducing risks before devices reach healthcare settings.

Post-Market Cybersecurity Expectations

Cybersecurity extends beyond launch. The FDA outlines post-market responsibilities, including:

• Continuous Monitoring: Identifying threats in real time.
• Incident Response & Remediation: Ensuring security updates maintain device performance and patient safety.

For SaMD products like EndoTool, ongoing vigilance is key to both security and clinical effectiveness, helping hospitals prevent disruptions and safeguard patient data without overburdening IT teams.

How EndoTool Helps Hospitals Stay Ahead of Cyber Threats

Monarch Medical Technologies ensures cybersecurity is simple, seamless, and effective by:

• Minimizing Cyber Risks – Integrating threat modeling and risk assessments into EndoTool’s design.
• Providing Full Transparency – Offering SBOM for visibility into third-party components.
• Ensuring Continuous Protection – Real-time monitoring and rapid response without disrupting care.
• Reducing IT Burden – Meeting FDA cybersecurity requirements, so hospital IT teams can focus on other priorities.

Looking Ahead

The FDA’s evolving cybersecurity expectations highlight security’s critical role in patient safety. With the 2024 updates, regulations will continue adapting to emerging threats. Monarch Medical Technologies remains committed to exceeding these standards, ensuring EndoTool stays secure and compliant.

Healthcare IT leaders and clinical teams have enough on their plates without having to worry about whether their medical software is secure.

By proactively identifying and mitigating cybersecurity risks, EndoTool supports hospital IT teams in preventing disruptions, minimizing downtime, and safeguarding patient data—all while seamlessly integrating into existing workflows for hospital staff.

About EndoTool

Made by Monarch Medical Technologies, EndoTool is the only patient-specific insulin dosing system which simplifies the complex task of glycemic management in hospital environments. The recommended dosing is different for each patient based on multiple clinical characteristics. The FDA-cleared platform is utilized in hundreds of hospitals across the United States and is fully integrated with all major electronic medical records. To see how EndoTool can support your health system, get in touch today.