A draft list of the set of documentation needed for HAs. To compare with what we actually have, to identify work to be done. This has been written with PathCheck GPS in mind. An equivalent list for PathCheck BT would probably have some overlap, but also some differences.
This documentation is an important input for Testing, as it clarifies the context in which the product will be deployed.
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Acceptance by Path Check
Organization: Conditions an organization must meet to be a Path Check Health Authority
TBD - what is our definition of a “Health Authority”?
Deployment: Conditions a deployment must meet for Path Check to move ahead
(TBD whether we enforce all these, or whether there would be some flexibility in moving forward with an HA that did not align on all of these).
Use of App must be voluntary
Any incentives used must be governed by clear Ethical principles.
Independent oversight committee
Clear published privacy policy (with some defined standards this must meet)
All data to be deleted within 30 days
Clear conditions for termination of program
Program not to be used for other healthcare purposes (e.g. seasonal flu)
No data to be shared with any organization that is not directly involved with public health.
Systematic monitoring for effectiveness, benefits, harms, and fair distribution of benefits and harms.
Deployment
Technical Infrastructure
Database
Back-end server
HTTPS server for published data
HTTPS Certificates
User Authentication System
“pre-production” instance of all the above
Sparing/Redundancy
Security
Tech for Contact Tracers
Web Browser for Contact Tracers
Phone system for outbound calls
Case tracking IT system
Phone system for incoming calls
Digital Assets
HA Name (as it is to appear in Path Check GPS)
Info Website
Reference Website
Privacy Policy
News Website
Sensitivity settings for Exposure Notifications
Guidelines on what to do in the event of an exposure notification
(is there any other per-HA customization of the app?)
Translated versions of above assets for all offered languages.
Human Resources procedures
Training procedures
Onboarding procedures
Offboarding procedures
Pre-Pilot Testing
Test Plan
Maintenance
Upgrade procedure (including pre-production, test & roll-out to production)
Failure procedures (e.g. hardware failure)
Clinical capabilities
PCR Tests available
Predictable elapsed time to receive test results
Known PCR testing capacity
Support mechanisms
Support for community members who may be exposed to follow protocols
Support needed may be financial, practical, emotional.
Procedures / protocols
Contact Tracing Interview procedure
Principles for redaction
Principles for adding data points.
Data Publishing procedure
Exposure Notification protocol
Measurement & Efficacy
Definition of success
Metrics used for that definition of success
How those metrics will be gathered
“control” of the experiment
Statistical analysis of the data (assess significance, p-values etc.)
Capture information on any resulting harms
Measure community distribution of harms & benefits.
Equitability
What measures can be taken if benefits or harms are unevenly distributed?
E.g. On benefits: increase level of non-digital contact tracing for those communities not benefitting
E.g. On harms: compensation for, or mitigation of, harms resulting from the program.
Optimization
Plan for tuning of parameters / protocols
Efficacy Model - e.g. to assess the overall impact of changes to parameters / protocols.
A/B testing capability
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