AMHERST, Mass. Medical devices save countless lives, and increasingly functions such as data storage and wireless communication allow for individualized patient care and other advances. But after their recent study, an interdisciplinary team of medical researchers and computer scientists warn that federal regulators need to improve how they track security and privacy problems in medical devices.
Researchers from Beth Israel Deaconess Medical Center Harvard Medical School and the University of Massachusetts Amherst analyzed reports from decades of U.S. Food and Drug Administration's (FDA) databases and found that established mechanisms for evaluating device safety may not be suitable for security and privacy problems. The researchers, members of the Strategic Healthcare IT Advanced Research Projects on Security (SHARPS), report results in the current issue of the PLoS ONE journal.
Overall, they suggest a more effective reporting system for medical device cybersecurity should be established to catch security problems that otherwise could rapidly spread.
Computer scientist and medical device security expert Kevin Fu at UMass Amherst and electrophysiologist Daniel Kramer at Harvard recommend that federal surveillance strategies should "rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware," to improve detection of problems that could affect millions of patients who use such devices for treatment from heart disease to diabetes.
Fu says that increasingly, wireless communication and Internet connectivity are used to control devices and transmit patients' information. But little is known about the prevalence of risks. Kramer, Fu and their colleagues set out to evaluate product recalls and adverse event reports in three comprehensive, publicly available databases maintained by the FDA: its own weekly enfo
|Contact: Janet Lathrop|
University of Massachusetts at Amherst