Solutions | Healthcare

FDA guidance focusing on cybersecurity for medical devices throughout their lifecycle.

Core Requirements:
- Premarket submissions
- A cybersecurity risk management plan
- Software Bill of Materials
- A postmarket cybersecurity plan
- Quality management systems
- Accurate & informative labeling to ensure safe usage
An extension of FDA guidance that focuses on the pre- and post-market cybersecurity of medical devices.

Core Requirements for Premarket Submissions:
- Software Bill of Materials
- A plan to monitor, identify, and address postmarket cybersecurity vulnerabilities and exploits
- The implementation of processes and procedures that provide reasonable assurance that the device (and related systems) are cybersecure
- A plan to make available postmarket updates and patches on a regular cycle (or as soon as possible for out-of-cycle updates)
A risk-based approach designed to improve the security and resilience of critical infrastructure, including healthcare.

Core Requirements:
- Safeguards to limit or contain the impact of potential security incidents
- Processes to identify cybersecurity events promptly
- Response plans to contain and mitigate the impact of cybersecurity incidents
- Plans to restore any capabilities or services impaired by a cybersecurity event
A prioritized set of cybersecurity best practices that can be applied to medical devices and the healthcare industry.

Core Requirements:
- Basic Controls: An inventory and control of hardware/software assets, continuous vulnerability management, and secure configuration of systems.
- Foundational Controls: The implementation of email/web browser protections, malware defenses, and limiting user access.
- Organizational Controls: Incident response planning, penetration testing, and ongoing staff cybersecurity awareness training.
Specifies the software lifecycle processes for medical devices.

Core Requirements:
- Software risk management
- Processes for the development, maintenance, and decommissioning of medical device software
- Safety classification to meet testing and validation criteria
A framework for risk management in medical devices that focuses on patient safety.

Core Requirements:
- A documented process to manage risks that includes a definition of scope and risk management policy
- Risk analysis & evaluation
- Risk control measures
- Post-market surveillance and risk monitoring

Software Bill of Materials

A detailed list of all software components within a medical device must be maintained, including any open-source and third-party components.

Continuous Monitoring

Medical devices must be monitored in real-time to detect potential security threats, anomalies, or vulnerabilities before they can be exploited.

Ongoing Risk Assessments

Medical device manufacturers must conduct regular assessments to identify, evaluate, and prioritize risks in healthcare systems to stay ahead of evolving threats and meet post-market security requirements.