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Medical Device Cybersecurity Audit Checklist

A comprehensive checklist for auditing cybersecurity processes in medical device development and maintenance, ensuring compliance with ISO 13485 and relevant cybersecurity standards, and improving overall device security and patient data protection.

Medical Device Cybersecurity Audit Checklist

by: audit-now
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About This Checklist

The Medical Device Cybersecurity Audit Checklist is a crucial tool for healthcare organizations to ensure compliance with ISO 13485 and relevant cybersecurity standards in the development and maintenance of connected medical devices. This comprehensive checklist addresses critical aspects of cybersecurity risk management, threat modeling, secure software development, and ongoing security monitoring for medical devices. By implementing robust cybersecurity practices, manufacturers can protect patient data, maintain device integrity, and safeguard against potential cyber threats. This checklist aids in systematically evaluating security controls, vulnerability management, incident response procedures, and secure communication protocols, ultimately contributing to the development of more resilient and trustworthy medical devices in the increasingly connected healthcare ecosystem.

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Industry

Healthcare

Standard

Medical Device Standards and Cybersecurity

Workspaces

Medical Device Manufacturing Facilities

Occupations

Cybersecurity Specialist
Software Engineer
Network Security Expert
Quality Assurance Manager
Regulatory Affairs Specialist
1
Is the medical device software compliant with ISO 13485 and IEC 80001 standards?

Select the compliance status.

To ensure adherence to industry standards for medical device cybersecurity.
2
What is the date of the last vulnerability assessment conducted?

Enter the date of the last assessment.

To track the frequency of vulnerability assessments.
3
How many vulnerabilities were identified in the latest assessment?

Enter the number of identified vulnerabilities.

To quantify the security posture of the medical device software.
Min: 0
Target: 0
Max: 100
4
Is the patch management process for the device up-to-date?

Select the status of the patch management process.

To evaluate the effectiveness of the patch management process.
5
Please provide insights or findings from the latest threat modeling exercise.

Enter findings from the threat modeling exercise.

To gather qualitative data on potential threats and mitigations.
6
Is the data protection strategy compliant with NIST Cybersecurity Framework?

Select the compliance status.

To ensure data protection measures meet established cybersecurity standards.
7
Is there an incident response plan in place for the medical device software?

Select the availability status of the incident response plan.

To verify that there is a defined process for responding to cybersecurity incidents.
8
When was the last review of any cybersecurity incidents conducted?

Enter the date of the last incident review.

To ensure timely reviews of incidents to improve response strategies.
9
How often is incident response training conducted for staff?

Enter the frequency of training sessions per year.

To assess the organization's commitment to training personnel in incident response.
Min: 0
Target: 1
Max: 12
10
Was a post-incident analysis completed for the last recorded incident?

Select the status of the post-incident analysis.

To ensure that lessons learned from incidents are documented and used for future improvements.
11
What improvements have been identified for incident handling processes?

Provide details on identified improvements.

To document any identified areas for improvement in incident management.
12
Is the incident reporting process compliant with regulatory requirements?

Select the compliance status of the reporting process.

To ensure that incident reporting meets legal and regulatory obligations.
13
How often is a comprehensive risk assessment performed on medical device software?

Select the frequency of risk assessments.

To ensure that risks are regularly evaluated to maintain cybersecurity posture.
14
When was the last risk assessment conducted?

Enter the date of the last risk assessment.

To track the recency of risk assessments for effective risk management.
15
How many high-risk vulnerabilities were identified in the latest risk assessment?

Enter the number of high-risk vulnerabilities identified.

To evaluate the severity of risks associated with the medical device software.
Min: 0
Target: 0
Max: 50
16
Is there an active risk mitigation plan for identified cybersecurity risks?

Select the status of the risk mitigation plan.

To ensure that there are strategies in place to address identified risks.
17
What improvements have been identified for the risk management process?

Provide details on identified improvements.

To capture feedback on the effectiveness of current risk management strategies.
18
Is the risk management process compliant with relevant cybersecurity standards?

Select the compliance status of the risk management process.

To ensure that risk management practices align with established cybersecurity frameworks.
19
Is there a cybersecurity training program available for all medical device software personnel?

Select the availability status of the training program.

To ensure that all relevant staff receive necessary training in cybersecurity practices.
20
When was the last cybersecurity training session conducted?

Enter the date of the last training session.

To monitor the frequency of training sessions and ensure staff are up to date.
21
What percentage of personnel have completed the cybersecurity training?

Enter the percentage of completed training.

To assess the effectiveness and reach of the training program.
Min: 0
Target: 100
Max: 100
22
What were the results of the last phishing simulation exercise conducted?

Select the results of the phishing simulation.

To evaluate staff awareness and responses to phishing threats.
23
What feedback have participants provided about the cybersecurity training program?

Provide participant feedback.

To gather insights on the effectiveness and areas for improvement in the training.
24
Is the training program compliant with industry regulations and standards?

Select the compliance status of the training program.

To ensure that the training program meets required cybersecurity standards.
25
Is there a formal mechanism for reporting cybersecurity incidents?

Select the status of the incident reporting mechanism.

To ensure that incidents are reported in a timely and organized manner.
26
When was the last cybersecurity incident reported?

Enter the date of the last incident report.

To track the frequency of reported incidents and ensure accountability.
27
What is the average response time to cybersecurity incidents?

Enter the average response time in minutes.

To evaluate the efficiency of the incident management process.
Min: 0
Target: 30
Max: 120
28
What is the resolution status of the most recent cybersecurity incident?

Select the resolution status of the last incident.

To assess the effectiveness of the incident management process.
29
What lessons were learned from the last cybersecurity incident?

Provide details on lessons learned.

To improve future incident response strategies based on previous experiences.
30
Is the incident management process compliant with internal policies and external regulations?

Select the compliance status of the incident management process.

To ensure adherence to established policies and regulatory requirements.

FAQs

The checklist covers areas such as threat modeling, secure software development practices, encryption implementation, access control mechanisms, network security, vulnerability management, security testing, incident response planning, and ongoing security monitoring and updates.

It includes specific items to verify that potential cybersecurity risks are identified and mitigated throughout the device lifecycle, from design and development to post-market support and updates.

The audit should involve cybersecurity specialists, software engineers, network security experts, quality assurance personnel, and regulatory affairs professionals to ensure a comprehensive evaluation of security aspects.

Cybersecurity audits should be performed at key stages of product development, before major software updates, and at least annually for marketed devices to ensure ongoing protection against evolving cyber threats.

Inadequate cybersecurity can lead to data breaches, compromised device functionality, patient harm, loss of trust, regulatory non-compliance, and significant financial and reputational damage for the manufacturer.

Benefits of Medical Device Cybersecurity Audit Checklist

Ensures compliance with ISO 13485 and cybersecurity standards for medical devices

Reduces the risk of cyber attacks and unauthorized access to medical devices

Enhances patient data protection and privacy

Improves overall device reliability and trustworthiness

Facilitates regulatory approvals by demonstrating comprehensive cybersecurity measures