Conference Day 2
8:20 am Coffee & Networking
8:55 am Chair’s Opening Remarks
Navigating Barriers Around Interoperability to Consolidate Cybersecurity Across Medical Device Environments
9:00 am Navigating the Complexities Around Software as Medical Devices to Ensure Adequate Security Controls are Put in Place
Synopsis
- Strategies to develop and safeguard software as a medical device while maintaining cybersecurity standards
- Best practices for deploying comprehensive security controls to safeguard data integrity and protect against cyber threats
- Guidance on implementing effective risk management frameworks to mitigate security risks associated with integrated medical devices
9:30 am Generating Feedback Loop Systems in Cybersecurity Frameworks from Early Architecture Designs to Post-Market Monitoring to Accurately Assess Entire Life Cycle
Synopsis
- Embedding cybersecurity considerations into the initial architecture designs of systems and devices to establish a strong foundation for security.
- Establishing feedback loops between cybersecurity frameworks and operational practices to enhance security measures.
- Case-study based insights showcasing the processes behind this style of monitoring
10:00 am Navigating Challenges Under Combinations of Regulated Systems & Unregulated Systems Ensuring Security of Medical Devices in Different Systems
Synopsis
- Strategies for aligning security protocols across regulated and unregulated systems to ensure protection of medical devices
- Implementing risk assessment frameworks to mitigate security risks associated with interoperability between regulated and unregulated systems
- Ensuring cybersecurity best practices across diverse systems hosting medical devices
10:30 am Morning Break & Networking
11:30 am Improving Collaboration Between Software Developers & Cybersecurity Experts to Ensure Device Security From the Very Beginning
Synopsis
- Ensuring robust cybersecurity from the planning stages of the software verification and design development plans
- Embedding systems engineering perspectives in cybersecurity frameworks
- Implementing robust security measures throughout the device development lifecycle
12:00 pm Consolidating the Understanding Between the Differences in Safety Risk Analysis and Cyber Security Risk Analysis to Ensure Device Security & Patient Safety
Synopsis
- Differentiating between risks around physical and operational safety of medical devices, and risks around threats to data integrity and device functionality from cyber threats
- Developing an integrated risk management framework that harmonizes safety and cybersecurity risk assessments
- Implementing distinct methodologies for safety risk analysis versus cybersecurity risk analysis
12:30 pm Lunch Break & Networking
Consolidating Safety Risk Analysis & the Cybersecurity Risk Analysis to Establish Informed Guidance to Prevent Device Compromise
1:30 pm Establishing a Robust CIA (Confidentiality, Integrity, Availability) Triad to Serve as The Principal Foundation of Risk Analysis
Synopsis
- Strategies to balance the trade-off between product safety, security, and desirability
- Implementing robust encryption and access control measures to protect sensitive information from unauthorized access
- Securing update protocols to maintain the accuracy and consistency of data and establishing disaster recovery plans to ensure that medical devices remain operational in the face of cyber threats
2:00 pm Panel: Embedding the Cybersecurity Value System Upstream to Ensure Security Processes Are Implemented in the Early Architecture to Minimize Downstream Security Compliance Issues.
Synopsis
- Increasing the understanding behind cybersecurity literacy which does not require cybersecurity expertise
- Through this managerial committee ensuring smoother collaboration across wider members of the team
- Solutions to overcome challenges in implementing this internal shift in medical device companies
14:45 pm Afternoon Break & Networking
3:15 pm Navigating the Complexities of Vulnerability Management in Medical Device Cybersecurity to Manage Threats
Synopsis
- Addressing Legacy Systems and Ensuring Interoperability to Secure Diverse and Outdated Medical Devices
- Regulatory Compliance and Supply Chain Security: Overcoming Challenges in Meeting Standards and Protecting Components
- Real-Time Monitoring and Efficient Incident Response: Balancing Performance, Patient Safety, and Rapid Remediation
3:45 pm Roundtable: Strategizing a Plan of Action After Your Cybersecurity System Has Been Infiltrated
Synopsis
- Designing a robust plan of action to undertake as soon as an infiltration has taken place
- How will the users of the devices be kept informed, despite you as the manufacturer having limited insight into what has occurred
- Case-study based insights into potential action plans