Wednesday, August 17, 2011

Meata Culpa:
Methods for Well Done Experiments with Medical Devices and RF


This posting is a mea culpa of sorts to correct a research trend of using ground beef and bacon for in vitro experimentation with implanted medical devices in the context of computer communication and trustworthy computing. We have seen several research papers repeating our methods in a variety of computer science venues. While the methods consistently elicit laughter during presentations, our recommendation is that researchers should instead use a less amusing but more carefully calibrated saline bath or synthetic torso.

In 2008, members of the Medical Device Security Center published Pacemakers and Implantable Cardiac Defibrillators: Software Radio Attacks and Zero-power Defenses. The paper describes our security analysis of an Implantable Cardioverter Defibrillator (ICD). We found no mechanisms that prevented unauthorized reprogramming of an implant. For example, we demonstrated how to issue a command shock that is designed to induce ventricular fibrillation (a deadly heart rhythm). A number of privacy vulnerabilities were also identified. In concert with our analysis, we developed prototype zero-power defenses intended to mitigate the vulnerabilities that we uncovered. To validate our zero-power defenses, we needed to complete in vitro testing in a somewhat realistic environment. Crunched for time, but with a desire to do better than simple open air testing, we implanted our defensive prototype in a plastic bag full of ground beef and bacon. Kevin was walking through Whole Foods near Amherst in late 2007, and after a quick call with a cardiologist decided to buy some high-fat bacon and ground chuck beef. The cashier gave Kevin some strange looks when he asked if the meat would be a good stand-in for human tissue.




The bag of ground beef and bacon that we used to prototype
our defenses. The video on the bottom shows a batteryless, computational RFID called the WISP. We wirelessly powered the piezoelement (which is audible).


Providing further evidence of the importance of reversing this trend, Jeff Mogul from HP Labs composed this haiku poetry that reflects on our research presented at ACM SIGCOMM.
They can hear your heart beats
Through several layers of
Bacon and beef
Unfortunately, meat remains the state of the art testing methodology for computer scientists working with implantable medical devices (IMDs). We made our original decision to use a bag of meat based on time constraints, and our methodology lacked the scientific rigor for meaningfully reproducible results. As a practicing cardiologist told us, "Dead meat don't beat… a pig heart from the grocery store will be no more electrically active than a cold hot dog - the physiological processes that govern the propagation of electrical impulses through the heart require metabolically active, i.e. 'alive' cells."

We have recently begun to explore the question of how we should conduct in vitro testing in order to have greater confidence in our results. We would like to share what we have found. A scientist from the FDA Center for Devices and Radiological Health pointed us to a methodology that has been used by the FDA to test wireless interference with implantable devices caused by, e.g., RFID readers. This methodology is described in sufficient detail to reproduce in a paper titled, Electromagnetic compatibility of pacemakers and implantable cardiac defibrillators exposed to RFID readers. We have reproduced this experimental setup using ~$30 worth of parts from a hardware store and a handful of other items (see picture below). While this human analogue has the virtue of being a de facto standard used by the FDA, it is still not perfect. It does not conform to any fully specified standard that we are aware of and working with a tub full of water can be an experimental hazard. The next experimental setup that we intend to build conforms to the Association for the Advancement of Medical Instrumentation (AAMI) standard number PC69 and consists completely of discrete analog components. We will be sure to share the details of our experiences once we have completed this next step.




Our FDA-inspired prototype required only: a plastic tub,
steel plates, bolts, nuts, silicone caulk, a refactometer,
distilled water, and table salt.

We encourage any researchers interested in working with IMDs to carefully consider what in vitro testing methodology to use. If computer scientists and other security researchers wish to have an impact that reaches outside of our own community, we will need to adopt credible standards that are used by biomedical engineers and other domain experts. Moreover, experiments must be meaningfully reproducible.

In summary, please avoid beef and bacon in experiments to show that your prototype implantable medical device works effectively. Instead, use a calibrated saline bath or synthetic torso according to AAMI standard PC69. No in vitro apparatus will perfectly model the behavior of a device in vivo, but these methods will lead to more reproducible experiments of stronger scientific rigor. Meata culpa. And may your research now be more well done.

Monday, April 5, 2010

Security Standards for Implantable Medical Devices

Following an attack that contaminated bottles of Tylenol and killed 7 people in 1982, the medical community -- including doctors, regulators, legislators, and manufacturers -- forever changed the way medicines are handled to secure the medical supply chain. Out of this process, we got the child-proof (and sometimes, adult-proof!) lids and tamper-resistant seals that those taking medicine deal with on a daily basis.

The state of implantable medical device computer security (and privacy) today parallels that of the 1980's drug supply, and needs similar protection and regulation innovation. A new paper from the MDSC explains the risks and offers some steps forwards towards "develop[ing] a security paradigm for medical devices that welcomes important technological advances while ensuring the well-being of millions of medical-device recipients."

Sunday, March 7, 2010

Assistant/Associate Professor Position in Health IT and/or Security

The MDSC received the following post regarding an open faculty position in Health IT/security.

Computing and Information Sciences
Kansas State University
Assistant/Associate Professor Position in Health IT and/or Security
The department of Computing and Information Sciences at Kansas State University invites applications for a tenure track position beginning in Fall 2010 at the level of assistant or associate professor from candidates working in the areas of health information technology and/or security. For the area of health care, we seek candidates working on designing improved health care systems which ensure patient safety, preserve privacy of data, establish high-assurance information infrastructure, and provide automated decision support capabilities. Preference will be given to candidates who will compliment the existing areas of strengths of the department which include enterprise system security, medical data privacy, language-based security, high assurance systems, medical device plug-n-play interoperability, medical device integration frameworks, and health information management. Applicants must be committed to both teaching and research. Applicants should have a PhD degree in computer science or related discipline; salary will be commensurate with qualifications. Applications must include descriptions of teaching and research interests along with copies of representative publications.

Kansas State University is committed to the growth and excellence of the CIS department. The department offers a stimulating environment for research and teaching, and has several ongoing collaborative projects involving researchers in different areas of computer science as well as other engineering and science departments. The department has a faculty of nineteen, more than 100 graduate students, and 250 undergraduate students and offers BS, MS, MSE, and PhD degrees. Computing facilities include a large network of servers, workstations and PCs with more than 300 machines and a Beowulf cluster with 1000+ processors. The department building has a wireless network and state-of-the-art media-equipped classrooms. The department hosts several laboratories for embedded systems, software analysis, robotics, computational engineering and science, and data-mining. Details of the CIS Department can be found at the URL http://www.cis.ksu.edu/.

Kansas State University is an Equal Opportunity Employer and actively seeks diversity among its employees. Paid for by Kansas State University. Background check required.