Medical device development, as always, is shooting upwards – and it has just reached the clouds.
According to News Medical, Verizon just announced that it received 510(k) clearance for its Converged Health Management medical device (the first time Verizon has applied for and received FDA clearance). Converged is a remote patient-monitoring medical device based in the cloud and according to the press release should be available in late 2013.
Verizon claims that the new healthcare solution resides in its allegedly “HIPAA-ready cloud” and will provide easy access to nearly real-time patient data from connected medical devices. Theoretically, this will allow nearly constant medical monitoring – for example, you’re driving your car and you begin to display pre-stroke symptoms (which you can’t notice), if you’re hooked up to Verizon’s “HIPAA-ready cloud,” your primary care physician can call you to tell you to make your way to the nearest hospital.
The potential benefits of this technology could be very interesting (it doesn’t take much imagination to think of some). However, there are also potentially significant consequences. Clearance to fully wireless based devices was first granted in 2006. The FDA has recognized that, while it grants clearance to wireless and cloud-based medical devices, such wireless devices may present a significant security risk. On August 13, 2013 (a surprising 7 years after the first wireless based device clearance) the FDA issued “Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff,” a guide that attempts to offer “reasonable assurance of safety.” In recognition of the potential for cyber-attacks on wirelessly connected and internet-enabled medical devices (and the patients connected to them), the Center for Internet Security has publicized a new initiative attempting to better secure such systems from cyber-attacks.
All security systems have vulnerabilities which can be exploited – the question is how small they are and how smart a potential attacker must be to find them. Will Pelgrin, the president and CEO of the Center for Internet Security stated that:
[W]e wanted to be ahead of the curve. Instead of waiting for a major incident to happen, we wanted to provide guidance across the board. . . . As these devices become connected to the internet and networks, they become more than just clinical devices, they become IT systems. As we all know, the weakest node on a network can be your entry point for negative consequences that can affect those devices.
The EE Times points out that many medical devices (which can be connected to networks), such as sport watches, monitoring bracelets, heart rate monitors and pedometers, offer valuable information but would not harm the wearer upon malfunction. However, there are many medical devices which are life-sustaining, such as pacemakers, insulin pumps, defibrillators, and neural implants. If these medical devices were “hacked” through inherent weaknesses or through weaknesses in a node of the network to which they are connected, the consequences could obviously be fatal. According to the article, an insulin pump has already been hacked (by a diabetic white hat hacker demonstrating weaknesses in the system).
While most of the population, including those living with wireless medical devices, don’t realize the potential security risks, there are those that do. At the recent blackhat USA 2013 convention (not to be confused with black hat hackers) in Las Vegas, Nevada, a presentation on the roster was titled “Implantable Medical Devices: Hacking Humans” (or as it was being referred to “How to kill a man at 30 feet by hacking his pacemaker”). According to Forbes Magazine, the speaker was going to demonstrate how he could hack into someone’s pacemaker remotely. According to the speaker himself, doing so required only internal research software and a common bedside transmitter to scan for, and interrogate individual medical implants.
José Fernández Villaseñor, physician and electrical engineer, states that “The balance between privacy and security is critical, but the question remains of how much security is enough?” The quest for security is exactly like proving a positive – to get your answer you must test and prove every single instance (an impossibility). For now, we must hope that those designing security systems are smarter than those breaking security systems.