a framework to guide assessment of the clinical risk … · a framework to guide assessment of the...
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A framework to guide
assessment of the clinical
risk of health apps
Michelle van Velthoven
Postdoctoral researcher in Digital Health, University of Oxford
4 April 2017
Associate editor, DIGITAL HEALTH & Honorary Research Fellow, Imperial College London
Co-authors: John Powell & Jeremy Wyatt
How important do you consider risk assessment of health apps?
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1 Not at all important 0%
2 Slightly important 0%
3 Moderately important 3%
4 Very important 27%
5 Extremely important 70%
Risk: more questions than answers…
1. What risks can health apps can pose?
2. How can we determine which health apps are the riskiest?
3. What assessment criteria can be used to assess risks of different types of apps?
1. What risks can health apps pose?
NHS health apps library (2013 - 16/10/2015)
Suspended
Smartphone apps for calculating insulin dose: a systematic assessment
46 calculators for carbohydrate intake and blood glucose:
• 59% (n = 27) allowed calculation when values were missing;
• 67% (n = 31) provided a recommendation that violated basic clinical assumptions;
• Only one app was issue-free.
Huckvale et al. BMC Medicine (2015) 13:106
2. How can we determine which health apps are the riskiest?
Risk: • Likelihood harm occurs • Severity of harm
functionality, user and context
Lewis TL and Wyatt JC. J Med Internet Res 2014;16(9):e210
Vallespin B, Cornet J, Kotzeva A. Stud Health Technol Inform. 2016;222:248-61
3. What assessment criteria can be used to guide risk assessment for different types of
health apps? (1)
Innovation Regulation
3. What assessment criteria can be used to guide risk assessment for different types of
health apps? (2)
Our work:
• Comprehensive review of literature;
• Wide consultation of different stakeholders;
• Sense-checking successive versions of the framework;
• Participation in multiagency policy discussion.
A framework to guide clinical risk assessment
1. ‘Ideal’ app model with criteria for a ‘good’ app (so that you know what a safe app should look like)
2. Linking ‘good app criteria’ to questions for risk assessment (so that you can assess whether a health app poses a potential risk)
3. Linking function(s) of a health app to ‘good app criteria’ (so that you don’t have to answer all questions for all health apps but only the most relevant questions)
A lot more work is needed…
1. Reporting of harm caused by health apps;
2. Specifying the likelihood and severity of risk;
3. Testing and validating risk assessment criteria.
Innovation Regulation
How important do you consider risk assessment of health apps? (2)
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0.0%
2 Slightly important
0.0%
3 Moderately important
7.9%
4 Very important
7.9%
5 Extremely important
84.2%
Authors participated in discussions part of the UK National Information Board Workstream 1.2.
This work is supported by the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust.
Thank you!
