There is a perfect storm of consumer electronics, mobile communications and customer need - the need to help people manage chronic disease like Parkinson, diabetes and MSA and sustain life with pacemakers and ICDs
Mob Sec Mobile Security Conference 4/11/2010 Herzliya
Danny Lieberman – Software Associates.
Mobile medical is hot
A threat model framework for secure code
Mobile consumer electronics creates
potential for life-saving applications
that are cheaper and more
accessible than any other
The FDA is not there yet.
Neither is traditional IT security.
Who: Patients, care-givers, doctors
What: Data acquisition
Why: Controlling symptoms of chronic
illness requires tracking data over long
periods of time.
• Heart rate
• Blood pressure
• Dosage (insulin, dopamine …)
Platforms : Smart-phones, data &
What: Implanted devices for cardiac
pacing, defibrillation, drug delivery…
Why: Sustain life
Platforms : Embedded devices with
mobile connectivity for remote
monitoring & programming.
Chronic heart disease
“…the latest technology in a full complement of patient-focused CRM products”
An attacker may exploit
vulnerabilities to cause damage to
Security countermeasures mitigate
vulnerabilities and reduce risk.
Patient with ICD
Threat T1 – A malicious attacker may exploit a clear text
protocol and instruct an ICD to deliver a shock that would
cause sudden cardiac death.
Vulnerability V1 – Clear text communications protocol
Countermeasure C1 – Encrypt network link
Countermeasure C2 – Validate messages using secure
In 2008, approximately 350,000
pacemakers and 140,000 ICDs were
implanted in the US.
Forecasted to $48BN in 2014.
Proof of concept attack:
• Reverse-engineered commands
• Intercepted vital signs, history
• Reprogrammed therapy settings
• DoS to deplete battery
• Directed the ICD to deliver 137V
shocks that would induce
ventricular fibrillation in a patient.
2008 ICD vulnerability study
Threat T2 – An internal short circuit is undetected by the
device control software and may be fatal.
Vulnerability V2 – Software doesn’t monitor hardware
Countermeasure C3 – Notify customer service when
hardware issue identified.
Countermeasure C4 – Implement fail-safe function
The FDA issued 23 recalls of
defective devices in H1/2010.
All were “Class 1” :
“reasonable probability that use of
these products will cause serious
adverse health consequences or
At least 6 recalls were
probably caused by
Weak or well-
Threat T3 – Malicious code may be used in order to exploit
multiple vulnerabilities and obtain patient information
Vulnerability V3 – USB, and/or Internet access enabled
Countermeasure C4 – Hardware toggle USB
Countermeasure C5 – Network isolation
Countermeasure C6 – Software security assessment
Mobile imaging analysis devices
used by hospital radiologists had
unplanned Internet access.
Over 300 devices infected by
Conficker and taken out of service.
Regulatory requirements mandated
that the impacted hospitals would
have to wait 90 days before the
systems could be modified to remove
the infections and vulnerabilities.
The FDA has refocused regulation
from patient safety to auditing
manufacturers’ compliance with
their own standards.
If the FDA has approved a medical
device, consumers cannot sue.
“Riegel v. Medtronic “, 2008
Product management has 1
dollar in their pocket:
Countermeasure C1 –
Encrypt network link to ICD
Countermeasure C21 –
Validate POST requests
with secure tokens.
Countermeasure C3 –
Wearable “cloaker” to ensure
that only authorized
programmers can interact
with the device.
Transparency means more eyeballs
can look at issues.
More eyeballs reduces cost.
More eyeballs means safer devices.
Safer devices means more revenue.
Riegel v. Medtronic, Inc.
Pacemakers and implantable cardiac defibrillators: Software radio
attacks and zero-power defenses.
Daniel Halperin et al.
Proceedings of the 29th Annual IEEE Symposium on Security and
Privacy, May 2008.
Software transparency in imbedded medical devices
Prof. Nir Giladi,Tel Aviv Souraski Hospital Neurology Department,
personal communication on data tracking for MSA patients
Biotronik – cellular pacemaker, http://www.biotronik.com/en/us/19412