When terrorists used the stolen serial number of the U.S. Vice President’s pacemaker to wirelessly access the device and deliver a fatal jolt of electricity in an episode of the TV series Homeland last year, to many it seemed like science fiction. But not to the real U.S. Federal Government.
Life may be starting to imitate art. Any implant that depends on computer and wireless technologies to function is vulnerable to cyber-hacking and computer-sewn viruses, a fact that shouldn’t be lost on any of us.
First brought to the fore in 2008 by researchers at the University of Washington and the University of Massachusetts, the vulnerabilities of implantable medical devices to cyber attacks has been receiving more attention recently. This past fall, the Government Accountability Office (GOA) issued a report on the subject and in response, the FDA is now asking device manufacturers to address cyber-security concerns in all applications for new product approvals.
It’s critically important to ensure that future implantable medical devices have protections against cyber attacks and hacking, as is protecting those patients who currently have an implantable medical device. It’s a tall order, but I think there’s a role that everyone involved in implantable medical devices. Take my shop, for instance. My colleagues and I at Access MediQuip have developed systems and processes to address the issue from our vantage point as deeply involved in the end-to-end surgical process. For instance:
1. Through our Level III patient implant registry, the only one in the country, we track implants throughout the life of the patient and measure outcomes for better quality of care.
2. Patients and their doctors can be notified immediately whenever a defect or known cyber-hacking attempt occurs through our Recall Management System (RMS).
3. Our National Physicians Board of Advisors is at the clinical forefront of any changes in risks and we proactively reach out to global healthcare technology leaders, like Health Information Management Systems Society (HIMSS) to stay current on the evolving use of technology in health care.
The proliferation of technology — in the implantable medical devices we rely on, the hospitals, ambulatory care centers and doctors’ offices where care is provided and everywhere else — requires us to be ever more vigilant and attentive to securing the equipment, practices and protocols we use every day. And, like any quality improvement in the healthcare industry, cyber-security is a continuous process requiring continuous improvement. Art and real life are merging, and we all have a role to play to protect our patients.