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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.