INSIDE COMPLIANCE

Conversations about the privacy and security of health information systems and patient data are ongoing, and frequently front-page news. But what about healthcare’s “internet of things”? More specifically, the web of wearable or implantable medical devices, and the applications that go along with them, which collect and transmit health information? The Food and Drug Administration (FDA) is charged with approving medical devices for patient use in a clinical setting, such as pacemakers. These devices require FDA approval and cannot be altered after receiving that approval. Additionally, an upgrade to an approved device could result in the need for an entirely new FDA approval, making device’s security essentially obsolete soon after its deployment. The inability to upgrade device security poses a unique cybersecurity risk. And this risk is one that Congress seems poised to take on.