AAMI TIR57: Medical Device Risk Management

What Is AAMI TIR57 for Medical Device Cybersecurity?

AAMI TIR57, formally titled “Principles for medical device security—Risk management,” is a guidance document that explains how to perform medical device cybersecurity risk management in a structured, standards-based way. In simple terms, AAMI TIR57 guides how to manage cybersecurity risk for medical devices, using the same rigor as you already apply to safety and effectiveness.

Rather than treating cybersecurity as a separate IT issue, AAMI TIR57 demonstrates to manufacturers how to integrate medical device cybersecurity risk management with frameworks such as ISO 14971 and IEC 80001-1. This makes it a key reference for companies building or maintaining an FDA-ready medical device cybersecurity program.

What does “TIR” mean?

TIR stands for Technical Information Report. A Technical Information Report is a type of publication that provides practical guidance, best practices, and technical recommendations in a focused area. It is more flexible and advisory than a formal standard, which makes TIRs especially useful in fast-moving fields like medical device cybersecurity, where manufacturers need detailed, actionable direction before full standards are finalized.

Where to get AAMI TIR57

You can obtain AAMI TIR57: “Principles for medical device security—Risk management” directly from the AAMI webstore as a downloadable PDF. Pricing typically differs for AAMI members and non-members, and you’ll need to purchase it to access the full text and annexes.

Who is AAMI?

AAMI (the Association for the Advancement of Medical Instrumentation) is a nonprofit organization that develops and maintains many of the standards and technical reports used across medical devices and health technology. AAMI works with regulators, manufacturers, clinicians, IT and HTM professionals, and other stakeholders to improve the safety, quality, and effectiveness of medical devices and related systems. AAMI TIR57 is part of this broader portfolio, focused explicitly on medical device cybersecurity risk management.

Key concepts in AAMI TIR57

AAMI TIR57 is centered on medical device security risk management. Some of its core ideas include:

Risk management approach

It promotes a structured, proactive approach to identifying, analyzing, and mitigating cybersecurity risks that could impact device safety, performance, or patient data, rather than treating cybersecurity as a separate or informal assessment.

Lifecycle integration

It emphasizes integrating cybersecurity across the entire device lifecycle—concept, design, development, verification, production, deployment, and postmarket surveillance—so cyber risk is considered whenever the device or its environment changes.

Stakeholder collaboration

It encourages cross-functional participation from engineering, IT and security, quality and regulatory, clinical users, and sometimes even patients. This helps ensure that cyber risks, threat scenarios, and controls are realistic and clinically grounded.

Adaptive and continuous monitoring

It recognizes that cyber threats evolve and recommends ongoing monitoring, vulnerability assessments, and updates to security controls, documentation, and processes over time, rather than just a one-time assessment before launch.

Alignment with other standards

It is designed to complement standards such as ISO 14971 (risk management for medical devices), IEC 62304 (medical device software lifecycle), and IEC 80001-1 (IT-networked medical devices), supporting a holistic, compliant approach to medical device cybersecurity risk management.

When used together with IEC 62304, ISO 14971, IEC 81001-5-1, and an FDA-aligned Secure Product Development Framework (SPDF), AAMI TIR57 becomes a cornerstone reference for medical device cybersecurity risk management and a powerful tool for demonstrating maturity to regulators, auditors, and hospital security teams.

The Relationship with Medical Devices

The relationship between AAMI TIR57 and medical devices is crucial in healthcare technology. This technical report ensures that medical devices fulfill their health-related functions and maintain robust defenses against cybersecurity threats.

• Enhanced Patient Safety: By implementing the principles of AAMI TIR57, medical devices are safeguarded against cyber threats that could potentially harm patients. For instance, a secured pacemaker is less likely to suffer from malicious interference, ensuring its reliability and effectiveness.
• Compliance and Trust: AAMI TIR57 helps manufacturers and healthcare providers comply with regulatory standards, fostering trust among users, patients, and regulatory bodies. Compliance with these guidelines demonstrates a commitment to patient safety and data security.
• Adaptability to Technological Advancements: As medical devices increasingly integrate advanced technologies like IoT and AI, AAMI TIR57 provides a framework for ensuring that these innovations are securely incorporated, addressing new challenges that arise from technological evolution.
• Holistic Approach to Device Lifecycle: AAMI TIR57 emphasizes security throughout a medical device’s entire lifecycle — from design and development to disposal or decommissioning. This comprehensive approach ensures that security is a core component at every stage of a device’s life.
• Interoperability and Connectivity: With the rise of interconnected medical devices, AAMI TIR57’s guidelines ensure these connections are secure, protecting the integrity of networks and the data shared across them.

How to Conduct a Medical Device Cybersecurity Risk Assessment Using AAMI TIR57

Here’s a step-by-step guide on how to conduct a cybersecurity risk assessment for medical devices in accordance with AAMI TIR57 guidelines:

1. Identify Potential Threats and Vulnerabilities

Start by systematically identifying cybersecurity threats and system vulnerabilities that could compromise the confidentiality, integrity, or availability of your medical device or its data. This includes evaluating internal threats (such as misconfigurations or insider misuse) and external threats (like malware, ransomware, and remote access attacks). Consider the device’s environment, intended use, connectivity features, and threat actor profiles.

2. Analyze Cybersecurity Risks

Use a risk matrix or scoring system to assess the likelihood and impact of each identified threat. Focus on how a cybersecurity event could affect patient safety, device functionality, or regulatory compliance. This step should consider the severity of harm, exposure levels, exploitability, and existing controls.

3. Develop Cyber Risk Mitigation Strategies

Define risk control measures tailored to the device’s architecture and threat model based on your risk analysis. These may include:

• Security patch management
• Data encryption protocols
• User authentication enhancements
• Access controls and audit trails
• Secure software development practices

Additionally, consider human factors, such as staff training or adjustments to operational workflows, that could reduce exposure.

4. Implement Security Controls

Roll out your mitigation strategies by integrating them into the device lifecycle’s design, manufacturing, and operational phases. Coordinate across product development, IT security, quality assurance, and regulatory affairs teams. This multidisciplinary effort ensures that both technical and procedural safeguards are enforced consistently.

5. Monitor and Review Cybersecurity Effectiveness

Continuous monitoring is critical. Regularly test and reassess your security controls to ensure they are effective against emerging threats. Update your threat models and risk register in response to vulnerability disclosures, postmarket surveillance, or real-world incidents.

6. Document Everything for Regulatory Compliance

Maintain detailed records of your risk assessment process, including:

• Threat identification and rationale
• Risk scoring and acceptance criteria
• Mitigation strategies and implementation timelines
• Ongoing reviews and outcomes

This documentation is essential for FDA premarket submissions, internal audits, and compliance with standards like AAMI TIR57, ISO 14971, and FDA guidance.

Conclusion

In wrapping up, remember, AAMI TIR57 isn’t just a set of guidelines; it’s a vital instrument in the symphony of medical device security. By adhering to its principles, we ensure that medical devices meet their health objectives and stand firm against cyber threats. As we continue our digital adventures, let’s keep the insights from AAMI TIR57 close to our hearts, ensuring a safer and more secure future in healthcare technology. Stay curious, stay informed, and let’s meet again soon for another chapter in our cybersecurity journey with Blue Goat Cyber!

Explore our FDA Compliance package for assistance with securing your medical devices.