Can the FDA secure medical devices?

Electronic medical devices could provide a route for hackers to gain access to individuals' health data and even interfere with aspects of care delivery. Therefore, a key challenge for device makers and regulators is how to balance functionality with security, according to panelists at a Feb. 24 Atlantic Council event on the cybersecurity of medical devices.

"No one wants to be in a reactive mode," said Dr. Suzanne Schwartz, associate director for science and strategic partnerships at the Food and Drug Administration. "We want to be able to encourage and incentivize manufacturers and also health care facilities to take cybersecurity and the safety of devices much more seriously."

There is some debate over how to do that, but the overall mood seems to support medical standards rather than one-size-fits-all regulations.

"In the corporate IT world, you want to lock somebody out of the system if they fail to get the password right three times," said Beau Woods, deputy director of the Atlantic Council's Cyber Statecraft Initiative. "If that device is in an emergency room and you have a matter of seconds before a patient has irreparable harm, you don't want to have any barrier between a physician and life-giving therapies."

Schwartz said regulatory incentives could be a way to address safety vulnerabilities because "we know vulnerabilities with medical devices are not only ubiquitous, but thousands and thousands of them will continue to emerge."

However, addressing those vulnerabilities, especially if they exist on otherwise effective systems, might not be easily accomplished.

Vulnerability coordination and disclosure "takes a lot of work," said Mara Tam, director of government affairs at HackerOne. "It takes resources...to develop and put to work for an organization. But the payoff is huge. If you are in the business of national security and you are not paying attention to what is going on here, you really ought to start."