ECRI 2015 Patient Safety Concerns

ECRI has released their top 10 Patient Safety Concerns for 2015. Second on the list is “Data Integrity: Incorrect or missing data in EHRs and other HealthIT systems”. While we are not surprised to see this area of patient safety risk on the list, SoftwareCPR believes that many of these data integrity hazards could easily be eliminated or risk reduced through simple to implement active risk controls designed into the software during development. Simply arguing that Design Controls and risk management requirements will “slow down” the development of HealthIT, is a poor excuse for not adding simple data integrity checks and defensive coding practices. IEC/TR 80001-2 (or AAMI TIR32) is an excellent resource to help your team identify these hazards and provides common risk control methods. SoftwareCPR experts can perform data integrity assessments or help you define effective data integrity risk control control measures as part of your design and risk management.

A PDF with the Top 10 Patient Safety Concerns for Healthcare Organizations can be found at: 2015_Patient_Safety_Top10

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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