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8:00 am Registration & Morning Refreshments

8:45 am Chair’s Opening Remarks

  • Greg Garcia Executive Director for Cyber Security, Health Sector Coordinating Council

Understanding the Security Requirements for Emerging Medical Devices

9:00 am The Effectiveness of Static Firmware Code Analysis in Medical Device Security Assessment

  • Avi Rubin Professor,
    Computer Science and Technical Director of the Information Security Institute, John Hopkins University

Synopsis

• Insight into benefits of static code analysis on the process of testing and device debugging
• Advantages and cost benefits for updating embedded devices
• Recognising the importance of static analysis over additional software testing techniques

9:30 am Solving the “Last Mile” Problem

  • Jeffrey Tully Resident Anesthesiologist, UC Davis Medical Center

Synopsis

• Outlining how independent security researchers have increased awareness of the importance of secure-by-design medical devices
• Insight to overcome the challenge of lack of resources facing health care delivery organizations
• Expertise behind the epidemiology on the actual risk of insecure medical devices and lacking infrastructure

10:00 am Panel Discussion: HDO & Device Manufacturers – Building Upon the Key Relationship

  • Ken Zalevsky Director, Informatics, Bayer
  • Greg Garcia Executive Director for Cyber Security, Health Sector Coordinating Council
  • Avi Rubin Professor,
    Computer Science and Technical Director of the Information Security Institute, John Hopkins University

Synopsis

• Moving forward with the particular challenges behind legacy devices
• Establishing a common framework for assessing appropriate levels of risk
• The advantages and challenges of setting up minimum medical device cybersecurity requirements across the product life cycle

10:30 am Speed Networking

Synopsis

Your opportunity to meet and engage with 60+ experts across the Medtech Landscape

11:00 am Morning Refreshments

11:30 am FDA Premarket Guidance Impact on Medical Device Manufacturers

Synopsis

• Outlining the advantages of securing devices by design
• An overview of product security assessments for device manufacturers
• The advantages and transparency in presenting a Cybersecurity Bill of Materials (CBOM)

12:00 pm Lunch

Strategies to Overcome Post-Market Device Vulnerability

1:00 pm UL LLC Panel Session

Synopsis

Expertise insight behind the benefits of UL Cybersecurity Assurance Program (UL CAP) for Network Connectable Components of Healthcare and Wellness Systems

1:30 pm Information Sharing: How Software Bill of Materials help HDOs Manage Risk

  • Jim Jacobson Chief Product and Solution Security Officer, Siemens Healthineers

Synopsis

• Use cases for medical device Software Bill of Materials (SBOM)
• SBOM Healthcare Proof of Concept and next steps in SBOM for medical devices

2:00 pm Interactive Q/A Session

Synopsis

Opening the floor to our audience to debate to discuss with speakers the latest medtech industry challenges

2:30 pm Afternoon Refreshments

3:15 pm Being Cyber Compliant – From Evolving Regulatory Frameworks to Software & Data Privacy of Your Connected Medical Devices

Synopsis

This is an interactive session with practical takeaways for participants. We have invited leading cybersecurity law firm Moses & Singer LLP to share their expert insights on the following subjects:

1) Evaluating compliance risks of your connected medical device – and the liabilities as a device manufacturer, HDO and pharmaceutical company

2) Why you should embed a “total lifecycle product” approach to address common challenges between HDO and device manufacturers

3) Regulatory requirements and variation from country to country on: software as a medical device, data privacy and patient privacy

4) What if? Prepare for the worst case scenario: during a cyber attack, what should you do?

4:00 pm Feedback from Roundtable Discussion

4:30 pm Chair’s Closing Remarks

  • Greg Garcia Executive Director for Cyber Security, Health Sector Coordinating Council