17 - 20 February, 2020 | Mercure Hotel MOA Berlin, Berlin, Germany
Cybersecurity Focus Day
9:15 am - 9:55 am Early Insight into the European Cyber Security Guideline for Medical Devices
· Uncover how the new guideline compares and contrasts to the EU Medical Device Regulation
· Explore how the European Cyber Security Guideline integrates with risk management for safety
· Ask the question: ‘Will hacking attacks for medical devices be considered ‘foreseeable’ now?
9:55 am - 10:35 am Fire-side Q&A: Operationally Implementing the European Cyber Security Guideline for Medical Devices in Your Company
· Troubleshoot your foreseen challenges with this new regulatory guidance
· Follow on Q&A session to presentation above
11:05 am - 11:35 am Developing a Cybersecurity Model for Medical Devices in Line with International Regulatory Requirements
• Learn how medical device manufacturers navigate evolving international regulatory requirements, no matter
where they are located or which markets they serve
• Familiarize yourself with an approach that matches the need for safe and secure devices with engineering
requirements and security-capable device architectures
• Understand how device manufacturers can be ready to meet market demands and face the cyber threats of
the future
11:35 am - 12:15 pm A Patient (and Hacker) Perspective on Medical Device Security
•Hear my journey in hacking my own medical device
•Highlight how connected medical devices impact patient safety
•Deep dive into strategies medical device designers can use to ensure patient safety
12:15 pm - 12:55 pm Securing a Cloud-Connected Medical Device for Smartphones
· Review the regulatory requirements, standards, guidance and best practices for the cybersecurity of connected devices
· Understand the cybersecurity threat/security model and risk mitigations to ensure integrity, privacy, confidentiality and availability of the data in medical device, app and cloud
· Apply the risk management strategies (IEC 80001-1, 80001-2-2, 80001-2-8) and analyse the risks according to the classification of the Mobile App and sensitivity of the data (GDPR/HIPAA compliance)
1:55 pm - 2:35 pm Interactive Discussion Groups
Collaborate with your peers and discuss the key cybersecurity challenges for medical devices. Pick a topic and join an interactive discussion group of your choice to get stuck into the debate!
- Preparing for Future Security Challenges
- Navigating the New FDA Regulatory Updates
- GDPR and Patient Privacy in the Context of Commercial Apps for Clinical Trials
- Factoring the MDR into Security Considerations
- Software ISO 14791 Risk Management
3:05 pm - 3:35 pm IT Security Applied to Medical Devices...What Is So Special About It?
· Discuss the medical device cybersecurity evolution
· Ask the question: What is special about medical device cybersecurity?
· Consider the customer view on medical device cybersecurity
3:45 pm - 4:25 pm Cybersecurity MedTech Challenges
· Explore the authentication of MedTech users: Challenges of usability of user authentication and its effectiveness
· Perfect your patching of unconnected (over internet) medical devices: culture, cost, and (de)motivation of patching a medical device.
· Discuss the lack of common cyber security certification standards such as PCI DSS in MedTech
