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> Through a secure cloud connection, the Ellume COVID-19 Home Test provides real time reporting of test results and critical data to health authorities, employe

> Through a secure cloud connection, the Ellume COVID-19 Home Test provides real time reporting of test results and critical data to health authorities, employers and educators, for efficient COVID-19 mapping. [1] > Real-time reporting through secure, HIPAA compliant cloud connection [1] My understanding is that a major hurdle was the FDA requiring test results be reported back to health authorities. Or at least there has been a lot of disagreement on the issue [2]. It's a bit unclear if the reporting via the app is 100% mandatory but I would bet on it sending at least something indicating positive/negative by default. I'd expect the majority of the per unit cost to be the digital test reader and Bluetooth capability. I'm skeptical if this is anything more than a fancy camera + Bluetooth like digital pregnancy tests. [3] I'm glad we are finally getting an at home test but I can not help but think that having cheaper and simpler antigen test strips available months ago would have been a better solution. [1] https://www.ellumehealth.com/products/consumer-products/covid-home-test https://www.ellumehealth.com/products/consumer-products/covi... [2] https://www.nytimes.com/2020/09/06/health/coronavirus-rapid-test.html https://www.nytimes.com/2020/09/06/health/coronavirus-rapid-... [3] https://hackaday.com/2020/09/09/digital-pregnancy-tests-use-leds-to-read-between-the-lines/ https://hackaday.com/2020/09/09/digital-pregnancy-tests-use-...

nitrogen 6y ago
My understanding is that a major hurdle was the FDA requiring test results be reported back to health authorities. Or at least there has been a lot of disagreement on the issue [2]. It's a bit unclear if the reporting via the app is 100% mandatory but I would bet on it sending at least something indicating positive/negative by default. This would be a dealbreaker for me. If I'm buying a test kit it's because I want to know, not because I want the world to know.
- save_ferris 6y ago
  > I want to know, not because I want the world to know. I understand this attitude, but just to be clear, the FDA != "the world". Their job is to protect the health of the pubic and work to mitigate the spread of a highly-contagious virus that will likely hit 2M global deaths in fairly short order. It's your choice not to take the test, but the reality is that if you've received medical care in the last 10 years, several parties probably already have access to that data. If your medical provider's EMR system uses cloud servers, then at least one of the big firms has access to it. And that's not even considering the possibility that your (anonymized) medical records haven't been sold to third parties for research purposes. Last year, outlets reported that Ascension Health, one of the largest healthcare providers in the US, was sharing medical data on millions of Americans with Google[0] without disclosure. At least in this case, you're being informed before agreeing to service how your data is going to be used. We're largely losing that right in this world. 0: https://www.engadget.com/2019-11-11-google-ascension-patient-records-project-nightingale.html https://www.engadget.com/2019-11-11-google-ascension-patient...
  - KorematsuFred 6y ago
    "Their job is to protect the health of the pubic and work to mitigate the spread of a highly-contagious virus that will likely hit 2M global deaths in fairly short order. " This is a good example of how heavy handed approach beats reasonable regulation. Somehow I should consent for cookies (which I don't even know what they do) on websites I explicitly visit but my consent not needed for collecting health data ? Having a cheap and simple covid test will greatly help arrest the spread of COVID whether or not FDA gets that data. Having said that there might be some marginal benefit for FDA to have some data for which the FDA should incentivize users by asking them to give consent, offer discounts and promise anonymisation. A lot of people will call me a Libertarian sshole for pointing this out, but remember a rogue admin like Trump weaponized various terrorism related programs to target large groups of immigrants. Later Miller used covid as a weapon against lot of immigrants effectively bringing entire immigration system to halt. Such collection of data will BE used against some undesirable groups in future and this is something people should fight against.
    - deleted 6y ago
      [deleted]
    - gsk22 6y ago
      How will one data point (did this person test positive?) be used against minority groups? I'm as skeptical of govt data collection as the next HNer, but I fail to see how this particular piece of information could be weaponized.
      - mulmen 6y ago
        Off the top of my head: Micro: A positive test is reported to the FDA. DHS gets this information. It is determined the individual "exposed others to Coronavirus". A "common sense" remedy is applied like, say, prohibiting the individual from boarding airplanes. Individual is now on a possibly secret "no fly list" with terrorist connotations. Macro: Minority groups are skeptical of the government because of historic abuse. They tend to take fewer tests. Majority groups trust the government because of being treated well historically. They tend to take more tests. More cases are found in majority groups per capita because they took more tests per capita. Data shows more cases in majority areas. More resources are sent to majority areas. Minority areas are neglected and do not receive the resources they need. This perpetuates the experience of mistreatment and discourages future cooperation. The chilling effect is real, and concern is reasonable on the part of individuals. Who wants to defend a group of bioterrorists anyway?
- stjohnswarts 6y ago
  Exactly. This can only be used against you by your insurance company to raise your premiums.
- mehrdadn 6y ago
  Normally I care more about privacy than other people, and for a lot of illnesses I'd find this more than understandable, but for this pandemic, I don't understand your sentiment. Not only has it already infected over 74M people and killed 1.5M of them (and counting...) from all walks of society (hardly making you unique!), but by sharing 1 bit of information about yourself, you can help others avoid that fate. What exactly is so scary about the FDA knowing if you had COVID that terrifies you and trumps (no pun intended) everything else?
  - tboyd47 6y ago
    It seems to me that the point of mandatory reporting is to impose quarantining by force on people who wouldn't otherwise have done it. But if the test itself is not mandatory, then it defeats the purpose. i.e. If I have the choice between taking the test or not, and I know the test is going to report me if my result is positive, leading to consequences I see as negative, then I can just choose not to take the test. If I see the consequences of a positive test (quarantine, isolation, etc.) as necessary then I would just do it voluntarily and the government wouldn't need to step in.
  - TheAceOfHearts 6y ago
    If it was consensual I wouldn't have an issue with it. The fact that I'm not being given a choice means I'll just avoid taking the test. Consent matters.
    - mehrdadn 6y ago
      I mean... you understand why it's not consensual here, right? It's not because they're trying to use your data for marketing purposes, it's because they need it to address public health. When you send your kids to school (if you have any, or hypothetically) and they ask for the immunization records, do you refuse to tell them and decide to home-school instead, because you don't like mandatory things? Does the context not matter at all?
prepend 6y ago
There’s requirements that labs must report race,ethnicity,age,sex [0] so I assume the app is how the lab meets this requirement. [0] https://www.hhs.gov/about/news/2020/06/04/hhs-announces-new-laboratory-data-reporting-guidance-for-covid-19-testing.html https://www.hhs.gov/about/news/2020/06/04/hhs-announces-new-...
- prepend 6y ago
  Yep, here’s the language from the FDA’s approval letter [0]: “ Test results from your product will be automatically reported to relevant public health authorities, via your product’s software application (app), in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the “Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests” provided by the Centers for Disease Control and Prevention (CDC).” [0] https://www.fda.gov/media/144457/download https://www.fda.gov/media/144457/download
denimnerd42 6y ago
cheap at home tests and limitless N95. there would be zero spread at retail stores.
- easytiger 6y ago
  How much spread is there at retail stores?
  - denimnerd42 6y ago
    in the US no one knows anything about where spread is happening.

nitrogen 6y ago

My understanding is that a major hurdle was the FDA requiring test results be reported back to health authorities. Or at least there has been a lot of disagreement on the issue [2]. It's a bit unclear if the reporting via the app is 100% mandatory but I would bet on it sending at least something indicating positive/negative by default. This would be a dealbreaker for me. If I'm buying a test kit it's because I want to know, not because I want the world to know.

save_ferris 6y ago
> I want to know, not because I want the world to know. I understand this attitude, but just to be clear, the FDA != "the world". Their job is to protect the health of the pubic and work to mitigate the spread of a highly-contagious virus that will likely hit 2M global deaths in fairly short order. It's your choice not to take the test, but the reality is that if you've received medical care in the last 10 years, several parties probably already have access to that data. If your medical provider's EMR system uses cloud servers, then at least one of the big firms has access to it. And that's not even considering the possibility that your (anonymized) medical records haven't been sold to third parties for research purposes. Last year, outlets reported that Ascension Health, one of the largest healthcare providers in the US, was sharing medical data on millions of Americans with Google[0] without disclosure. At least in this case, you're being informed before agreeing to service how your data is going to be used. We're largely losing that right in this world. 0: https://www.engadget.com/2019-11-11-google-ascension-patient-records-project-nightingale.html https://www.engadget.com/2019-11-11-google-ascension-patient...
- KorematsuFred 6y ago
  "Their job is to protect the health of the pubic and work to mitigate the spread of a highly-contagious virus that will likely hit 2M global deaths in fairly short order. " This is a good example of how heavy handed approach beats reasonable regulation. Somehow I should consent for cookies (which I don't even know what they do) on websites I explicitly visit but my consent not needed for collecting health data ? Having a cheap and simple covid test will greatly help arrest the spread of COVID whether or not FDA gets that data. Having said that there might be some marginal benefit for FDA to have some data for which the FDA should incentivize users by asking them to give consent, offer discounts and promise anonymisation. A lot of people will call me a Libertarian sshole for pointing this out, but remember a rogue admin like Trump weaponized various terrorism related programs to target large groups of immigrants. Later Miller used covid as a weapon against lot of immigrants effectively bringing entire immigration system to halt. Such collection of data will BE used against some undesirable groups in future and this is something people should fight against.
  - deleted 6y ago
    [deleted]
  - gsk22 6y ago
    How will one data point (did this person test positive?) be used against minority groups? I'm as skeptical of govt data collection as the next HNer, but I fail to see how this particular piece of information could be weaponized.
    - mulmen 6y ago
      Off the top of my head: Micro: A positive test is reported to the FDA. DHS gets this information. It is determined the individual "exposed others to Coronavirus". A "common sense" remedy is applied like, say, prohibiting the individual from boarding airplanes. Individual is now on a possibly secret "no fly list" with terrorist connotations. Macro: Minority groups are skeptical of the government because of historic abuse. They tend to take fewer tests. Majority groups trust the government because of being treated well historically. They tend to take more tests. More cases are found in majority groups per capita because they took more tests per capita. Data shows more cases in majority areas. More resources are sent to majority areas. Minority areas are neglected and do not receive the resources they need. This perpetuates the experience of mistreatment and discourages future cooperation. The chilling effect is real, and concern is reasonable on the part of individuals. Who wants to defend a group of bioterrorists anyway?
stjohnswarts 6y ago
Exactly. This can only be used against you by your insurance company to raise your premiums.
mehrdadn 6y ago
Normally I care more about privacy than other people, and for a lot of illnesses I'd find this more than understandable, but for this pandemic, I don't understand your sentiment. Not only has it already infected over 74M people and killed 1.5M of them (and counting...) from all walks of society (hardly making you unique!), but by sharing 1 bit of information about yourself, you can help others avoid that fate. What exactly is so scary about the FDA knowing if you had COVID that terrifies you and trumps (no pun intended) everything else?
- tboyd47 6y ago
  It seems to me that the point of mandatory reporting is to impose quarantining by force on people who wouldn't otherwise have done it. But if the test itself is not mandatory, then it defeats the purpose. i.e. If I have the choice between taking the test or not, and I know the test is going to report me if my result is positive, leading to consequences I see as negative, then I can just choose not to take the test. If I see the consequences of a positive test (quarantine, isolation, etc.) as necessary then I would just do it voluntarily and the government wouldn't need to step in.
- TheAceOfHearts 6y ago
  If it was consensual I wouldn't have an issue with it. The fact that I'm not being given a choice means I'll just avoid taking the test. Consent matters.
  - mehrdadn 6y ago
    I mean... you understand why it's not consensual here, right? It's not because they're trying to use your data for marketing purposes, it's because they need it to address public health. When you send your kids to school (if you have any, or hypothetically) and they ask for the immunization records, do you refuse to tell them and decide to home-school instead, because you don't like mandatory things? Does the context not matter at all?

prepend 6y ago

There’s requirements that labs must report race,ethnicity,age,sex [0] so I assume the app is how the lab meets this requirement. [0] https://www.hhs.gov/about/news/2020/06/04/hhs-announces-new-laboratory-data-reporting-guidance-for-covid-19-testing.html https://www.hhs.gov/about/news/2020/06/04/hhs-announces-new-...

prepend 6y ago
Yep, here’s the language from the FDA’s approval letter [0]: “ Test results from your product will be automatically reported to relevant public health authorities, via your product’s software application (app), in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the “Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests” provided by the Centers for Disease Control and Prevention (CDC).” [0] https://www.fda.gov/media/144457/download https://www.fda.gov/media/144457/download

denimnerd42 6y ago

cheap at home tests and limitless N95. there would be zero spread at retail stores.

easytiger 6y ago
How much spread is there at retail stores?
- denimnerd42 6y ago
  in the US no one knows anything about where spread is happening.