Updating Your Security Questionnaire for Third-Party Risk Assessment with the P.A.T.C.H. Act

As healthcare organizations increasingly rely on third-party vendors for medical devices and related services, ensuring these vendors comply with the latest cybersecurity regulations is vital. The Protecting and Transforming Cyber Health Care (P.A.T.C.H.) Act introduces specific requirements for medical device manufacturers, making it essential to update your security questionnaire to align with these guidelines. Below are key areas to focus on when revising your security questionnaire for third-party risk assessments under the P.A.T.C.H. Act.

1. Cybersecurity Plan and Vulnerability Management

Existing Question:

• Describe your overall cybersecurity strategy.

Updated Question:

• Do you have a documented cybersecurity plan that includes specific procedures for monitoring, identifying, and addressing vulnerabilities in your medical devices? Please provide details or a copy of this plan.

Reason for Change: The P.A.T.C.H. Act mandates that manufacturers must have a comprehensive cybersecurity plan. This question ensures that vendors have a structured approach to managing vulnerabilities, which is crucial for compliance.

2. Patch and Update Process

Existing Question:

• How do you handle software updates and patches for your devices?

Updated Question:

• What is your process for releasing and deploying patches and software updates for your medical devices? How often are these updates provided, and what mechanisms are in place to ensure timely application of these updates?

Reason for Change: The P.A.T.C.H. Act emphasizes the importance of timely updates to secure medical devices. The updated question seeks more specific information on the frequency and effectiveness of the vendor's patch management process.

3. Disclosure of Known Vulnerabilities

Existing Question:

• Do you report security vulnerabilities to your clients?

Updated Question:

• How do you handle the disclosure of known cybersecurity vulnerabilities? Do you report these vulnerabilities to the FDA, healthcare providers, and other relevant stakeholders? Please provide examples or documentation of your reporting process.

Reason for Change: Under the P.A.T.C.H. Act, manufacturers are required to disclose known vulnerabilities. This updated question ensures that vendors are transparent about their vulnerabilities and comply with the necessary reporting protocols.

4. Incident Response Plan

Existing Question:

• Do you have an incident response plan in place?

Updated Question:

• Does your incident response plan include specific procedures for addressing cybersecurity incidents related to medical devices? How do you communicate incidents to affected healthcare organizations, and what are your timelines for such notifications?

Reason for Change: The P.A.T.C.H. Act requires a robust incident response plan that addresses device-specific cybersecurity incidents. The revised question aims to assess the vendor's preparedness and communication protocols during an incident.

5. Regulatory Compliance and Certifications

Existing Question:

• Are your products compliant with relevant cybersecurity regulations?

Updated Question:

• Are your medical devices compliant with the P.A.T.C.H. Act's cybersecurity requirements? What certifications or assessments have you completed to demonstrate this compliance? Please provide supporting documentation.

Reason for Change: This question directly addresses the P.A.T.C.H. Act compliance, ensuring that vendors are not only aware of the regulations but have also taken steps to meet them.

6. Ongoing Monitoring and Risk Management

Existing Question:

• How do you monitor and manage security risks?

Updated Question:

• What ongoing monitoring processes do you have in place to identify new security vulnerabilities in your medical devices? How do you assess and mitigate these risks over the product lifecycle?

Reason for Change: The P.A.T.C.H. Act emphasizes continuous risk management. This question ensures that vendors have mechanisms for ongoing monitoring and risk mitigation, which is crucial for maintaining device security over time.

Conclusion

By updating your security questionnaire with these focused questions, you can better align your third-party risk assessment process with the P.A.T.C.H. Act requirements. This approach not only enhances your organization's compliance posture but also ensures that your vendors are actively managing the cybersecurity risks associated with medical devices. Regularly revising your questionnaire to reflect evolving regulations and industry best practices will keep your assessments robust and relevant.

• #Cybersecurity
• #HealthcareSecurity
• #MedicalDevices
• #PATCHAct
• #RiskAssessment
• #ThirdPartyRisk
• #Compliance
• #DataProtection
• #HealthcareCompliance
• #SecurityQuestionnaire
• #DigitalHealth
• #VendorManagement
• #CyberRiskManagement
• #DarkAnalytics