HSCC Releases Medical Product Cyber Incident Playbook

In a world increasingly reliant on connected medical devices and automated systems, health systems face significant cyber risks impacting both operational integrity and patient safety. The Medical Product Manufacturer Cyber Incident Response Playbook (MPM CIRP), released by the Healthcare Sector Coordinating Council (HSCC) in collaboration with government and industry stakeholders, provides a structured approach to address these risks.

The guide is targeted to medical product manufacturers, especially those serving large health systems, to build cyber-resilience and ensure uninterrupted service and will shortly be available on the HSCC website

Understanding the Scope of the Cyber Incident Response Playbook

Medical product manufacturing spans a diverse range of technologies and product categories—from drug production and durable medical equipment to devices embedded with advanced software. As digital systems have become integral to manufacturing, so too have the vulnerabilities. The playbook offers an adaptable foundation for companies to respond effectively to cyber incidents, mitigating potential disruptions to healthcare services. Key aspects include preparedness, detection, containment, eradication, and recovery.

1. Building a Cyber Incident Response Team (CIRT)

A well-prepared response begins with assembling a capable Cyber Incident Response Team (CIRT). The playbook outlines the structure and roles within a CIRT to ensure that response actions are coordinated across an organization. Responsibilities range from technical responders to executive roles responsible for overseeing communication and compliance.

For large organizations, the CIRT may involve extensive personnel from various departments, including IT, legal, compliance, human resources, and external cybersecurity partners. Smaller organizations, however, may need to combine roles to accommodate resource constraints. Whether large or small, the team structure must support rapid decision-making, allowing individuals with appropriate authority to take critical actions, such as disconnecting compromised systems or authorizing external support, without delay.

2. Phases of Cyber Incident Response: From Detection to Recovery

The playbook delineates five key phases to systematically address and recover from cyber incidents:

Preparation

Preparation involves establishing response protocols, building a comprehensive contact list of personnel and third-party resources, and ensuring that teams receive regular training on incident response procedures. It also includes creating strategic communication channels and integrating legal considerations into the response strategy.

Detection, Investigation, and Analysis

Proactive threat monitoring is essential for early detection. Alerts can originate internally—via network monitoring tools, employee reports, or automated systems—or from external sources, such as threat intelligence feeds. The playbook encourages medical manufacturers to differentiate between potential incidents and actual compromises, ensuring accurate escalation through an initial response team capable of assessing severity and identifying response actions.

Containment

During containment, CIRT members act to prevent further spread of a cyber threat. This often includes isolating affected systems, capturing forensic data, and enacting legal communication protocols. Early containment can prevent data loss and operational downtime, but thorough documentation and forensic analysis are crucial to preserving evidence and facilitating potential law enforcement involvement.

Eradication

With containment achieved, the focus shifts to removing the threat and closing vulnerabilities. Depending on incident severity, this may require collaboration with third-party forensic analysts or cybersecurity experts to identify the root cause and implement a tailored response. This phase emphasizes effective communication across internal and external stakeholders to avoid further risk.

Recovery and Post-Incident Analysis

In the final phase, systems are restored to full functionality, with measures in place to prevent a recurrence. Recovery might include restoring from backups, strengthening monitoring systems, or enhancing employee cybersecurity training. Additionally, an after-action review captures lessons learned, informing future incident response strategies and updating policies where necessary.

The Role of External Resources and Partners in Incident Response

For health systems connected to complex supply chains and reliant on third-party support, collaboration with external resources can be crucial in handling cyber incidents. The playbook highlights the importance of pre-established relationships with agencies such as HHS, the FDA and CISA, all of which can assist in threat analysis and provide regulatory guidance during incidents.

Establishing these partnerships ahead of time ensures prompt support, expedites compliance processes, and provides a broader view of potential systemic threats, especially valuable in high-severity incidents.

Regulatory Compliance and Reporting Requirements

Medical product manufacturers are often subject to strict regulations due to their involvement in patient care and critical infrastructure. The playbook stresses the importance of compliance with both U.S.-based and international incident reporting standards, which often require notification within 24–72 hours of an incident. These requirements include the Cyber Incident Reporting for Critical Infrastructure Act of 2022 and FDA mandates under the Medical Device Reporting regulation.

Regulatory reporting not only helps maintain transparency but can also enhance the incident response by leveraging industry-wide threat intelligence. The playbook’s structured approach enables organizations to address these compliance needs quickly, coordinating communication through designated points of contact within the CIRT.

Training, Testing, and Evolving the Cyber Incident Response Plan

Effective response to cyber threats requires more than just a documented plan. The playbook advocates for regular training exercises and scenario testing to reinforce readiness and adaptability. Conducting annual or biannual drills simulates potential incidents, fostering interdepartmental collaboration and ensuring that all team members understand their roles in an actual cyber event.

After each real or simulated incident, a post-event review provides an opportunity to refine the response plan, addressing gaps and incorporating new insights.

Practical Implications for Health System IT Leaders

Leaders can leverage the playbook to:

• Assess and Allocate Resources: Understanding where to allocate personnel and funding for optimal incident response preparedness.
• Enhance Communication and Coordination: Ensuring that IT, legal, and executive teams are synchronized and capable of swift decision-making in crises.
• Engage in Cross-Industry Collaboration: Fostering relationships with government agencies, industry partners, and other health systems to bolster collective cybersecurity resilience.