of interest, page-8

It's crude (apologies) but possibly apt: a quote from "Under Siege 2" (language warning):
Assumption is the mother...
In the brave new world that is digital health regulation maybe assumptions from innovating companies and muddy guidance from the FDA can't be avoided;  and should possibly be expected (and forgiven?- if you can stomach the SP fluctuations). When you read that even one of the most well- funded, private companies in digital health (Proteus) raised $170m in 2014 to help commercialise its ingestible sensor only to have the FDA reject their first proposal due to a lack of specific data it gives pause for thought. In that instance the FDA "requested additional information, including data regarding the performance of the product under the conditions in which it is likely to be used, and further human factors investigations."
Personally I hope there aren't too many more assumptions over the next six months that result in critical flaws blowing out the regulatory process timeline for RAP. A specific issue raised by the Proteus example may be if  Rap management have taken advice on " human factors testing". Will FDA deem data collected by trained staff in hospitals only valid for use by trained staff in hospitals? Or will they "assume" that because trained staff in hospitals can use the app effectively that end-users (the great unwashed masses) can use the device safely and effectively in their lounge room, given remote instruction via a telehealth platform, as well? If telehealth is the commercialisation goal perhaps testing should be done remotely as well - patient in a seperate room with the phone getting advice remotely from the clinician? Or perhaps the app is now idiot proof and more like the black box Tony first mentioned. Even if the data and results are outstanding FDA may ask for further human factor investigations before approving the app for telehealth? Maybe its overthinking things but it seems like muddy water to me.
As an aside Proteus had their second submission for the world's first digital pill approved by the FDA this month. Groundbreaking stuff. Let's hope that Rap follow suit (but nail it on the first try).
https://www.theverge.com/2017/11/14/16648166/fda-digital-pill-abilify-otsuka-proteus