This document discusses issues related to assuring the safe operation of health IT systems. It notes that while IT systems can increase efficiency and safety, they also introduce new risks if not implemented properly. A key risk is that health IT systems, consisting of large, complex interoperable components from different vendors, can lead to problems like duplicate records, wrong dosages, treatment delays and assigning the wrong patients. The document cites the example of the London Ambulance Service which faced chaos after a new computer dispatch system was deployed before being fully tested. It emphasizes that operators need evidence like testing results and standards compliance to justify how a health IT system can be considered safe. Overall challenges include increasing awareness of IT-related risks, managing procurement,

1. An Introduction to Issues in Assuring
the Safe Operation of Health IT Systems
Eur Ing Dr George Despotou, PhD

2. The problem

3. Safety is about risk
• Risk
– Likelihood of a ‘bad’ event
– Severity of a bad event
• Consensus on benefits of IT
– Efficiency
– Safety (e.g. reduction of prescription errors with e-prescription)
• This risk reduction process can itself add some risk
• E.g. IT systems may add risk
– We need to remove any unnecessary risks !!!
• We need to analyse it, understand it, accept it, or reduce it to acceptable
levels

4. Risks
•Many large systems
• Data representations, storage, interfaces, functions
• Different vendors, different technologies
• Risks: Duplicate records (information splitting), wrong dosage, delays in
treatment, missing patients, wrong patients etc.

5. Health IT Risk: The London Ambulance
Case
• One of the most known examples: London Ambulance Service
– Computer Assisted Dispatch
– Contract given to the lowest offer !!!!
– A number of problems
• Exceptions, many delays, operators did not know what to do, back up system not fully tested
• Hours after deployment
– The entire system descended into chaos,
• ambulance found the patient dead and taken away by undertakers
• ambulance answered a ‘stroke’ call after 11 hours
– 5 hours after the patient had made their own way to hospital
• In hindsight
– They should never have had assurance in the operation of LAS
• How could they have known?

6. Safety
impact of
Health IT
events study
(ECRI PSO
Deep Dive)

7. Health IT System type (PSO Deep Dive)

8. More risks (example)

9. Example: A&E Admissions
X
Name Surname Time Dr Assign. Examined Criticality
John Adams 8:20 p.m. Yes No Medium
Mark Richards 9:15 p.m. No No Low
Tom Smith 9:17 p.m. Yes Yes High
Edmund Black 8: 55 p.m. No Yes Urgent
B. Higgins 9:21 p.m. Yes No Low
Tim Smith 9: 25 p.m. No No Low
S. Bold 8: 57 p.m. No No Urgent

10. Example: A&E Admissions
X
Name Surname Time Dr Assign. Examined Criticality
John Adams 8:20 p.m. Yes No Medium
Mark Richards 9:15 p.m. No No Low
Tom Smith 9:17 p.m. Yes Yes High
Edmund Black 8: 55 p.m. No Yes Urgent
B. Higgins 9:21 p.m. Yes No Low
Tim Smith 9: 25 p.m. No No Low
S. Bold 8: 57 p.m. No No Urgent

11. Example: A&E Admissions
X
Name Surname Time Dr Assign. Examined Criticality
John Adams 8:20 p.m. Yes No Medium
Mark Richards 9:15 p.m. No No Low
Tom Smith 9:17 p.m. Yes Yes High
Edmund Black 8: 55 p.m. No Yes Urgent
B. Higgins 9:21 p.m. Yes No Low
Tim Smith 9: 25 p.m. No No Low
S. Bold 8: 57 p.m. No No Urgent

12. Regulation & practice

13. Motivation, regulation & practice
• Legal issues: duty of care
• Ethical issues
• There is a lot of momentum towards safety of systems in healthcare
– Medical devices – ISO standards, CE mark
– Interconnected devices – ISO standards
• Safety of health IT
• ISB 0129, 0160
– All NHS trusts implementing e-Health/Health IT must comply

14. Health IT Safety Explanation
• UK NHS ISB 0160 (operator) and ISB 0129 (manufacturer) ask for an explicit
explanation
• Argue how based on the available evidence we can confidently claim that the
system will be safe
– Evidence
• Testing results, code reviews, expert opinion, independent audit, standards compliance
• Inevitable referencing of manufacturer’s data
• It’s information that a good manufacturer is expected to produce anyway
• A.k.a.
– Safety justification, assurance case, safety case
• Two standards
– The manufacturer complying with the standard does not discharge the responsibility of
the operator
– Ultimately, the operator delivers healthcare services

15. Why should I believe that your system is
safe?
a) It cost a lot of money
b) I analysed the risks to the service/pathway
c) I know what I am doing
d) I comply to ISO 9000 (CE etc)
e) I have introduced safety controls/functions
f) Uuuuuhhhhmmmm…..
g) I have testing results
h) You mean I’m unsafe? I’m offended

16. Challenges for health IT safety
• Appreciation of the IT related risk (awareness)
• Management
• Procurement of IT systems
• Explanation of testing results (and other evidence)
• Use of tacit knowledge
• Need for commonality of practice

17. Let us know about your interest
• Interested in your experiences, anecdotes, examples,
problems
• LinkedIn group: safety of connected health
• Follow up talks on ISB by NHS HSCIC