Workshop | Do Validate!
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The document discusses the need for a risk-based validation framework for digital health tools. It identifies several components that could be used to assess the risk level of an e-health application, including the domain, users, aim, intervention depth, user health status, data handling, and integration of elements. A list of 10 potential components is presented. Feedback is sought to expand this list and further develop a framework that links risk analysis to the appropriate validation mechanisms in order to reduce unnecessary validation demands while still ensuring proper validation practices based on risk.
Workshop | Do Validate!
- 2. WHY ARE WE HERE WITH YOU? HKU
- 6. CORE PROBLEM: Current systems to assess modern digital (E-) health tools are often NOT sufficiantly tailored to cater for the specific qualities of these new digital developments, often leading to unnecessary heavy validation demands HKU
- 7. CORE PROBLEM: PULL THE HEAVY WEIGHT WHERE THE RISK IS HIGH MAKE IT LIGHTWEIGHT WHERE THE RISK IS LOW HKU
- 8. WHY IS THIS A PROBLEM? RCT validation takes a lot of time… … costs a lot of money … raises the threshold for small enterprises …. delays the critical time to market …prolongues the ‘valley of death’ HKU
- 9. FOR WHOM IS THIS A PROBLEM Transparency for patients, informal carers, health professionals, insurance companies, policy makers Developers and enterpreneurs HKU
- 10. WHAT WE WANT TO ADDRESS KEEP OUR FOCUS ON PROPER VALIDATION PRACTISES IMPROVE NATIONAL RISK ANALYSIS SCHEMES LINKING TO THE RIGHT VALIDATION MECHANISMS HKU
- 11. WHAT WE TRIED TO DO! TO IDENTIFY POSSIBLE (!) BUILDING BLOCKS OR COMPONENTS FOR A MORE ACCURATE RISK ANALYSIS FILTER HKU
- 12. WHAT WE DID NOT TRY TO SOLVE THIS COMPLEX ISSUE OR PRETEND WE CAN HKU
- 13. WHAT WE IDENTIFIED: In which domain is the application situated I pre care II community care III (low) complexity care, cure or training IV high complexity care, cure or training 1 HKU
- 14. Who is or who are the end users? Patient? Doctor? Combination? etc.. WHAT WE IDENTIFIED: 2 HKU
- 15. What is the intended aim of use? Examples: ‘empowerment’, ‘diagnostics’, ‘monitoring’, treatment WHAT WE IDENTIFIED: 3 HKU
- 16. What is the intervention ‘depth’ of the application? WHAT WE IDENTIFIED: 4 HKU
- 17. What is the user status? (with the health ‘consumer’ as end user) healthy (general life style intervention / advice / nudging) healthy with risk of falling ill (focussed lifestyle intervention, advice, nudging) temporary ill (recovery support, enhancement) chronically ill (lifestyle modification, continuous monitoring, acute intervention in escalation) WHAT WE IDENTIFIED: 5 HKU
- 18. medical professional as end-user 1. involved in part of the execution of treatment (monitoring, care support, signalling) 2. responsible for treatment (planning, communicating, follow up, monitoring) 3. responsible for coordination of various stakeholders in treatment (community care, home care, intramural multidisciplinary setting) 4. responsible for execution of complex medical interventions (doctors, surgeons, psychiatrists etc.) WHAT WE IDENTIFIED: 6 HKU
- 19. Actual data profile (risk) What type of data is actually transferred or stored? Locally, server side? Encrypted? WHAT WE IDENTIFIED: 7 HKU
- 20. Integration How to handle applications containing one or more elements from this collection? Will the most heavy define all? Differentiated validation? WHAT WE IDENTIFIED: 8 HKU
- 21. Specific game related 1. functionality, is the game playable (withou bugs or procedural errors) 2. validity of the game design, parametrisation WHAT WE IDENTIFIED: 9 HKU
- 22. Specific game related Effectivess of a game as intervention includes 1. Ease of use 2. the impact of the serious game on the end user within the set therapy, context or domain WHAT WE IDENTIFIED: 10 HKU
- 23. WHAT WE ASK YOU? CAN YOU HELP US EXPAND THIS LIST TO SET THE AGENDA FOR FURTHER DEVELOPMENT OF THIS KIND OF ARTICULATED FRAMEWORK IN ORDER TO AVOID… ? HKU
- 24. WHAT WE ASK YOU? CAN YOU HELP US EXPAND THIS LIST TO SET THE AGENDA FOR FURTHER DEVELOPMENT OF THIS KIND OF ARTICULATED FRAMEWORK IN ORDER TO AVOID… HKU
- 25. CREDITS HKU