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> Does anyone know if Google and Apple are working on this? It would probably illegal to create an app for contact tracing. E.g. it's legal for Apple to have a

> Does anyone know if Google and Apple are working on this? It would probably illegal to create an app for contact tracing. E.g. it's legal for Apple to have an iPhone app called Reminders, but if they were marketing it as a tool to help people to remember to take their medication then that would be illegal because it hasn't undergone testing to prove that it increases medication adherence or whatever. That's why the FDA banned doctors from using checklists to remind them to wash their hands before surgery.

graeme 7y ago
That’s the sort of regulation that needs to be relaxed in an emergency.
reaperducer 7y ago
if they were marketing it as a tool to help people to remember to take their medication then that would be illegal because it hasn't undergone testing to prove that it increases medication adherence or whatever I doubt those little plastic M-T-W-H-F-A-U pill organizers went through any FDA clearance. /Some days when I wake up, that's the only way I know what day it is.
closeparen 7y ago
Source for the checklist thing? Can’t find it.
rootusrootus 7y ago
> help people to remember to take their medication then that would be illegal Not sure about that. I've had just such an app installed on my iPhone.
ceejayoz 7y ago
The FDA did not ban doctors from using checklists. They shut down a specific study of checklists that didn't get informed consent. This article asserts that that was the wrong call, but your claim that the FDA has banned them is incorrect. https://www.nytimes.com/2007/12/30/opinion/30gawande.html https://www.nytimes.com/2007/12/30/opinion/30gawande.html
- Alex3917 7y ago
  OK fair, I misremembered exactly what happened. I'm still not convinced a contact tracing app would be legal though, given that it could lead people to seek medical attention who might not otherwise need or benefit from it. Didn't Apple talk about how they needed to work with the FDA to get their ECG functionality approved?
  - ceejayoz 7y ago
    An ECG is obviously a medical device. A contact tracing app is far less obviously in that category. It might be, but it might fall under various exemptions, with the right disclaimers. https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-mobile-apps-are-not-medical-devices https://www.fda.gov/medical-devices/device-software-function... https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications https://www.fda.gov/regulatory-information/search-fda-guidan... > Many software functions are not medical devices (meaning such software functions do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them as devices. Some software functions may meet the definition of a medical device, but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act).

graeme 7y ago

That’s the sort of regulation that needs to be relaxed in an emergency.

reaperducer 7y ago

if they were marketing it as a tool to help people to remember to take their medication then that would be illegal because it hasn't undergone testing to prove that it increases medication adherence or whatever I doubt those little plastic M-T-W-H-F-A-U pill organizers went through any FDA clearance. /Some days when I wake up, that's the only way I know what day it is.

closeparen 7y ago

Source for the checklist thing? Can’t find it.

rootusrootus 7y ago

> help people to remember to take their medication then that would be illegal Not sure about that. I've had just such an app installed on my iPhone.

ceejayoz 7y ago

The FDA did not ban doctors from using checklists. They shut down a specific study of checklists that didn't get informed consent. This article asserts that that was the wrong call, but your claim that the FDA has banned them is incorrect. https://www.nytimes.com/2007/12/30/opinion/30gawande.html https://www.nytimes.com/2007/12/30/opinion/30gawande.html

Alex3917 7y ago
OK fair, I misremembered exactly what happened. I'm still not convinced a contact tracing app would be legal though, given that it could lead people to seek medical attention who might not otherwise need or benefit from it. Didn't Apple talk about how they needed to work with the FDA to get their ECG functionality approved?
- ceejayoz 7y ago
  An ECG is obviously a medical device. A contact tracing app is far less obviously in that category. It might be, but it might fall under various exemptions, with the right disclaimers. https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-mobile-apps-are-not-medical-devices https://www.fda.gov/medical-devices/device-software-function... https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications https://www.fda.gov/regulatory-information/search-fda-guidan... > Many software functions are not medical devices (meaning such software functions do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them as devices. Some software functions may meet the definition of a medical device, but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act).