MASSDEVICE ON CALL — The FDA announced that it will hold a public meeting in October to discuss cybersecurity in medical devices.

Co-hosted with the Dept. of Homeland Security, the 2-day summit will bring together a variety of healthcare stakeholders to discuss areas of vulnerability and best approaches to shoring up the digital defenses of medical systems.

The FDA has been homing in on medtech cybersecurity issues over many years as ethical or "white hat" hackers have made headlines by hacking vital devices and implants. The Government Accountability Office issued a report in 2012 urging the FDA to take a stronger hand in mandating and evaluating cybersecurity systems and the FDA in 2013 issued draft guidance identifying issues and recommending that manufacturers take time to ensure their devices are secure.

The upcoming meeting, accessible in-person or via webcast, will take place October 21-22 at the National Intellectual Property Rights Coordination Center in Arlington, Va.

The FDA identified the primary themes as follows:

1. Envisioning a collaborative environment for information sharing and developing a shared risk-assessment framework using a common lexicon; overcoming barriers (perceived and real) to create a community of "shared ownership and shared responsibility" within the HPH Sector to increase medical device cybersecurity;
2. Gaining situational awareness of the current cyber threats to the HPH Sector including those that impact medical devices;
3. Identifying cybersecurity gaps and challenges, especially end-of-life support for legacy devices and interconnectivity of medical devices;
4. Adapting and implementing the "Framework for Improving Critical Infrastructure Cybersecurity" to support management of cybersecurity risks involving medical devices;
5. Developing tools and standards to build a comprehensive cybersecurity program to meet the unique needs of the sector’s critical infrastructure including medical devices;
6. How to leverage the technical subject matter expertise of the cybersecurity researcher community working with HPH stakeholders to identify, assess, and mitigate vulnerabilities; and
7. Building potential solutions: Exploring collaborative models to gather diverse experts and establish medical device security benchmarks which are continuously validated.

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