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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

      • (see: Ethical Compliance Assessment for COVID Safe Paths )

      • (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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