Some 67 percent of medical device manufacturers and 56 percent of healthcare delivery organizations (HDOs) believe an attack on a medical device built or in use by their organizations is likely to occur over the next 12 months, according to new research from San Jose, Calif.-based electronic design automation company Synopsys.
The survey also found that roughly one-third of device makers and HDOs are aware of potential adverse effects to patients due to an insecure medical device, but despite the risk, only 17 percent of device makers and 15 percent of HDOs are taking significant steps to prevent such attacks.
Also alarmingly, only 9 percent of manufacturers and 5 percent of HDOs say they test medical devices at least once a year, while 53 percent of HDOs and 43 percent of manufacturers do not test devices at all.
Focused on the North America market, the study surveyed approximately 550 individuals from manufacturers and HDOs, whose roles involve the security of medical devices, including implantable devices, radiation equipment, diagnostic and monitoring equipment, robots, as well as networking equipment designed specifically for medical devices and mobile medical apps. The Synopsys study, "Medical Device Security: An Industry Under Attack and Unprepared to Defend,” was conducted by the Ponemon Institute, an IT security research organization, and was aimed at identifying whether device makers and HDOs are in alignment about the need to address cybersecurity risks.
Other key findings from the study highlight:
- Building secure devices is challenging. Eighty percent of device makers and HDOs report that medical devices are very difficult to secure. The top reasons cited for why devices remain vulnerable include accidental coding errors, lack of knowledge/training on secure coding practices and pressure on development teams to meet product deadlines.
- Lack of accountability. While 41 percent of HDOs believe they are primarily responsible for the security of medical devices, almost one-third of both device makers and HDOs say no one person or function in their organizations is primarily responsible.
- FDA guidance is not enough. Only 51 percent of device makers and 44 percent of HDOs follow current FDA guidance to mitigate or reduce inherent security risks in medical devices.
"The security of medical devices is truly a life or death issue for both device manufacturers and healthcare delivery organizations," Larry Ponemon, Ph.D., chairman and founder of the Ponemon Institute, said in statement. "According to the findings of the research, attacks on devices are likely and can put patients at risk. Consequently, it is urgent that the medical device industry makes the security of its devices a high priority."
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