The session will focus on the risks and potential liability associated with securing (or failing to secure) medical devices, the systems that interact with devices, and the data they generate – including the potential liability when hacking causes patient harm or the threat of harm. We plan to cover the following topics: Identification of US privacy and security laws applicable to medical devices (and other connected healthcare devices); Potential threats to medical devices and the systems that connect them (e.g., bioterrorism, ransomware, etc); Types of potential civil and criminal liability if a medical device is compromised or misused (particularly if used to harm patients); Suggestions to help manage cyber risk and liability (including the FDA’s perspective).
Elliot Golding, Partner, Squire Patton Boggs LLP
Seth Carmody, Ph.D., Cybersecurity Program Manager, Food and Drug Administration
Teri Campbell, Global Privacy Officer, Permobil