If you have an implanted medical device , have been hooked up to a machine in a hospital, or have accessed your electronic medical records, you might assume the infrastructure and data are secure and protected against hackers. Connected medical devices and systems are vulnerable to cyberattacks, which could reveal sensitive data, delay critical care, and physically harm patients. The U. Food and Drug Administration , which oversees the safety and effectiveness of medical equipment sold in the country, has recalled medical devices in the past few years due to cybersecurity concerns.
They include pacemakers , DNA sequencing instruments , and insulin pumps. Released in September, IEEE covers ways to secure electronic health records, electronic medical records, and in-hospital and wearable devices that communicate with each other and with other health care systems.
More than people from 32 countries helped develop the IEEE standard. The working group included representatives from health care—related organizations including Draeger Medical Systems , Indiana University Health , Medtronic , and Thermo Fisher Scientific.
The FDA and other regulatory agencies participated as well. She says the standard is intended for the entire health care industry, including medical device manufacturers; hardware, software, and firmware developers; patients; care providers; and regulatory agencies. Hudson says that security in the design of hardware, firmware, and software needs to be the first step in the development process. TIPPSS includes technical recommendations such as multifactor authentication; encryption at the hardware, software, and firmware levels; and encryption of data when at rest or in motion, Hudson says.
Included in the standard are four scenarios that outline the steps users of the standard would take to ensure that the medical equipment they interact with is trustworthy in multiple environments. The use cases include a continuous glucose monitor CGM , an automated insulin delivery AID system, and hospital-at-home and home-to-hospital scenarios.
