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Enroll Today! Registered Listeners Welcome!

MW 10:30-12, Dow 1010. Winter 2013.

http://www.eecs.umich.edu/courses/eecs598-008/

Avoiding Software Sepsis

How do we improve the information security of increasingly

interconnected and wirelessly controlled medical devices? Learn the timeless concepts and cutting-edge skills in computer engineering, human factors, and regulatory policies that determine the safety and effectiveness of manufacturing software-controlled medical devices.

Dr. Ignaz Semmelweis

1818-1865

Dr. Charles Meigs

1792-1869

Medical devices

should be secure.

Doctors

are gentlemen and

therefore their

computers are always

secure.

MEDICAL DEVICE SECURITY

(2)

Avoiding Software Sepsis

How do we improve the information security of increasingly

interconnected and wirelessly controlled medical devices? Learn the timeless concepts and cutting-edge skills in computer engineering, human factors, and regulatory policies that determine the safety and effectiveness of manufacturing software-controlled medical devices.

St. Jude Medical, the

third major defibrillator

company, said it used

“proprietary techniques”

to protect the security of

its implants and had

not

heard of any

unauthorized or illegal

manipulation of them

.

[B. Feder, “A Heart Device Is Found Vulnerable to Hacker Attacks” NY Times, March 12, 2008]

Learn better ways to measure medical device security.

MEDICAL DEVICE SECURITY

EECS 598-008 with Prof. Kevin Fu

ht

tp

://t

obacco

.s

tanfo

rd

.ed

u

(3)

Enroll Today! Registered Listeners Welcome!

MW 10:30-12, Dow 1010. Winter 2013.

http://www.eecs.umich.edu/courses/eecs598-008/

Avoiding Software Sepsis

How do we improve the information security of increasingly

interconnected and wirelessly controlled medical devices? Learn the timeless concepts and cutting-edge skills in computer engineering, human factors, and regulatory policies that determine the safety and effectiveness of manufacturing software-controlled medical devices.

MEDICAL DEVICE SECURITY

(4)

Avoiding Software Sepsis

How do we improve the information security of increasingly

interconnected and wirelessly controlled medical devices? Learn the timeless concepts and cutting-edge skills in computer engineering, human factors, and regulatory policies that determine the safety and effectiveness of manufacturing software-controlled medical devices.

If you think buffer

overflows in your

EECS 280 homework

are bad, try infusion

pump software.

MEDICAL DEVICE SECURITY

(5)

Enroll Today! Registered Listeners Welcome!

MW 10:30-12, Dow 1010. Winter 2013.

http://www.eecs.umich.edu/courses/eecs598-008/

Avoiding Software Sepsis

How do we improve the information security of increasingly interconnected and wirelessly controlled medical devices? Learn the timeless concepts and cutting-edge skills in computer engineering, human factors, and regulatory policies that determine the safety and effectiveness of manufacturing software-controlled medical devices.

MEDICAL DEVICE SECURITY

EECS 598-008 with Prof. Kevin Fu

FDA Public Workshop on External Defibrillators, Dec 15, 2010

“We typically don't

experience the type of

viruses that are being

referred to, or any type of

viruses

, for that matter.”

-Peter Ohanian, VP of Quality & Regulatory Affairs, Philips

Healthcare

“We spend

considerable

efforts...so that we

can confirm that

nothing has been

compromised

.”

-Janine Hansen, Senior Director of Quality Assurance and Regulatory

Affairs, Cardiac Science

(6)

Avoiding Software Sepsis

How do we improve the information security of increasingly

interconnected and wirelessly controlled medical devices? Learn the timeless concepts and cutting-edge skills in computer engineering, human factors, and regulatory policies that determine the safety and effectiveness of manufacturing software-controlled medical devices.

MEDICAL DEVICE SECURITY

(7)

MEDICAL DEVICE SECURITY

EECS 598-008 with Prof. Kevin Fu

Enroll Today! Registered Listeners Welcome!

MW 10:30-12, Dow 1010. Winter 2013.

http://www.eecs.umich.edu/courses/eecs598-008/

Avoiding Software Sepsis

How do we improve the information security of increasingly

interconnected and wirelessly controlled medical devices? Learn the timeless concepts and cutting-edge skills in computer engineering, human factors, and regulatory policies that determine the safety and effectiveness of manufacturing software-controlled medical devices.

What’s wrong with this

user interface for a

wirelessly controlled,

implanted drug infusion

pump that led to a

patient death?

(8)

MEDICAL DEVICE SECURITY

EECS 598-008 with Prof. Kevin Fu

Avoiding Software Sepsis

How do we improve the information security of increasingly

interconnected and wirelessly controlled medical devices? Learn the timeless concepts and cutting-edge skills in computer engineering, human factors, and regulatory policies that determine the safety and effectiveness of manufacturing software-controlled medical devices.

The original UI did not label the

hours, minutes, seconds field for the

bolus duration. HCP mistakes

minutes for hours. 60x overdose.

Outcome: death.

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