An overview of software safety concepts and applicability to electronic medical records.

1. Principles of Software Safety Sanders, Ver 4 Copyright 2002 Guidelines For Clinical Information Systems And The Electronic Medical Record (EMR)

11. Contributing Factors to Safety Risks *-- From the FAA *

18. Creating a “Safe Software” Environment What would an auditor from the FAA look for at Boeing?

21. Applying This To Clinical Information Systems and EMR’s

23. Potential Categories of Patient Safety Risk Scenarios Type 1: Catastrophic Patient life is in grave danger. The probability for humans to recognize and intervene to mitigate this event is very low or non-existent. Intervention is required within seconds to prevent the loss of life. Type 2: Severe Patient health is in immediate danger. The probability for humans to recognize and intervene to mitigate this event is low, but possible. Intervention is required within minutes to prevent serious injury or degradation of patient health that could lead to the loss of life. Type 3: Moderate Patient health is at risk. However, the probability for humans to recognize and intervene to mitigate this event is probable. Intervention is required within hours or a few days to prevent a moderate degradation in patient health. Type 4: Minor Patient health is minimally at risk. The probability for humans to recognize and intervene to mitigate this event is high. Corrective action should occur within days or weeks to avoid any degradation in patient health.

26. Software Control vs. Safety Risk Does my software control any of these? If so, what is the probability that a defect could cause one of these scenarios? High Risk = Rigorous Design and Testing Catastrophic Severe Moderate Minor Computerized protocols and decision support tools Creating or updating data to the EMR Deleting data from the EMR Performance or availability of the overall EMR

27. Most to Least Safety Critical? GroupWise Transfusion Management HELP HELP2 Mysis Not necessarily the same as “Business Criticality”… For purposes of illustration… Increasing Safety Criticality and Software Engineering Rigor

28. For Illustration, Again… Software safety processes don’t apply Information System Business Criticality Data Sensitivity Safety Criticality Accudose 1 1 1 AGFA 1 1 1 Amicus 1 1 1 AS/400 Financial 1 1 4 Audit Log 2 4 4