[ ] Which issues are likely to come up in the code base or in the community?
[ ] How does the community handle complaints or issues that may come up with the apps?
any examples?
who looks at the data?
what data is collected?
how often do people look at the data?
[ ] Which data is accessible to who?
How does the process work? How is it that hundreds or thousands of people can achieve these results?
What about it is predictable vs unpredictable? Which parts of it can be measured? What are the risks? What are the claims being made?
FDA has following questions:
How does the process work? How is it that hundreds or thousands of people can achieve these results? What about it is predictable vs unpredictable? Which parts of it can be measured? What are the risks? What are the claims being made?
See https://github.com/nightscout/process-controls/issues/2 for more details.