Fielding, Ops and Maintenance

Raj RajkumarHarvey RubinFelix Alfonso

Scott L. BartowAndrew Casertano

Karl HammermeisterRon HenselStacy PowellVictoria Rich

Douglas Rosendale

Topics

• Assurance

• Deployment

• Upgrade

• Systems administration, configuration and policy

• Spring meeting

Questions

• Will an x-ray kill the patient if a sensor is embedded in the brain?

• How does the health care provider even know that there is a sensor in the brain?

• Will devices work under extreme conditions?

Assurance Issues• Human Factors• Deployment in a wide range of conditions: each

set of conditions can have a different failure mode• Certifiable for home use?

– OTC vs prescription drugs?• Human comfort level varies• Meeting standards for development and

deployment• Simple feedback to user (green light for ok, red for

not ok)• Pacemakers introduced 40 years ago

– Automatic defibrillators save lives– Willing to accept certain levels of imperfection

• In the long term, patient care must be better

Assurance Issues (contd.)

• Stratification: Multiple levels of assurance for the patient, health care provider and the manufacturer

• Perfection is impossible to achieve• Information systems:

– Legacy to modern systems– Certain mandatory testing is required; – Acceptance test at health care facility

• Extent based on resources

• Impact of failure can be different• If 1% of the time, heartbeats are irregular, one

cannot afford to keep the patient in the hospital until that 1% happens

Assurance (contd.)

• Mission vs. safety– Regulation of civilian vs fighter aircraft

• FDA does not have an “IT” group: the device is treated as a system and the requirements imposed depend on the device

• Different network security requirements– Can certify only a fixed set of configurations

Patching/Upgrade

• Could break tested configurations• Could introduce latent errors leading

to mission failure• Single check layer vs multiple checks• Most catastrophic failures known

happened due to a sequence of failures (each failure by itself may look innocent)

Accountability

• Harvard Business Review (Oct. issue): price discounts vs working with the vendor to improve their products

• Legal implications of problems in software?– Accountability and traceability

• Certification of proprietary vs open-source software

Spring meeting

• Microsoft?• FAA and avionics• Automotive systems• NASA Challenger lead investigator• Executives vs techies• Certification of software engineers?• Biomedical engineers?• Critical care information vendors:

Siemens, GE, Philips, • Electronic health records vendors …