Industry Struggles to Safeguard Medical Devices

November 30th, 2015

Industry Struggles to Safeguard Medical Devices

Earlier this year in July, the Food and Drug Administration (FDA) published an advisory opinion to strongly encourage hospitals to stop using a certain type of infusion pumps that were particularly vulnerable to remote hacking. Since then, the issue of cybersecurity vulnerabilities with medical devices has perplexed the pharmaceutical industry and its regulators.  As more medical devices connect to online networks, fears of hackers controlling these devices and stealing private patient information have risen.

Some industry professionals are taking matters into their own hands.  For example, a group comprised of practicing doctors and members from the National Institute of Standards and Technology, the Department of Homeland Security and FDA are currently developing a set of security standards for insulin pumps. The Mayo Clinic has also adopted a more rigorous set of security requirements for any companies providing them with medical devices.  Despite some efforts to institute to new protective standards, experts estimate that the overall medical device security as about a decade behind where it should be.