4 ms·

Couldn't the same argument be applied to WebMD's symptom checker ?

by ig1 13y ago

metaphorm 13y ago
no. the symptom checker is just a document. it is a not a device or an ingested substance.
- Dylan16807 13y ago
  23AM's offering is in two parts. First, they do some genetic mapping. Second, they do an analysis on the markers found. The objections are based on the second part (and the marketing for it), which seems by itself to be very equivalent to WebMD. I don't think there's any suggestion that abstract-genetic-marker-finding is the problem here.
  - smackfu 13y ago
    Any lab test is going to have those two parts, a lab procedure and an analysis. I would expect both parts to be governed by the FDA to ensure reliable results.
    - Dylan16807 13y ago
      There is a difference between mechanical analysis and medical analysis. Obviously they need to analyze the raw signals coming out of the machine to figure out what markers are present. But they could stop there, saying "with four nines certainty you have genes ABJ2, CBI8, LOC9, JOLO, ZZT". The FDA is objecting to doing a medical correlation/explanation beyond that point, doing the things WebMD does.
      - smackfu 13y ago
        To be honest, I think they have to do both things to get regulated under the FDA. The FDA is involved because they consider it a "device" that is "intended for use in the diagnosis of disease or other conditions." If they just did the analysis based on provided data, I don't think that would count as a device.
  - jes5199 13y ago
    It seems to me that it's the link between those two parts that is problematic! If someone sold genetic tests that just output a list of markers, and the clients consulted publicly available literature to discern the meaning of those results, then no one would have taken the responsibility of giving advice to a client. By packaging a specific, curated set of information with the test results, 23andme has crossed over from offering tools to offering expertise - and has therefor taken on responsibilities.
jrochkind1 13y ago
I wonder if it _does_ apply. I am not certain if it doesn't. In general, products sold to diagnose diseases -- including software products -- may be subject to regulation. See this article (on WebMD cause I found it when googling to answer the original question, heheh) http://www.webmd.com/news/20130923/fda-sets-rules-for-smartphone-medical-apps http://www.webmd.com/news/20130923/fda-sets-rules-for-smartp... > The U.S. Food and Drug Administration on Monday drew a line between which smartphone medical apps it will regulate and which ones it will not, saying it will focus only on those that turn the phone into an actual diagnostic tool. > In essence, those applications include software that enables the phone to read a patient's heart rhythm, take a blood pressure reading or measure a person's health in some other way. > For example, an ECG machine that diagnoses heart rhythms is "still an ECG machine whether it is the size of a breadbox or the size of a smartphone," Shuren said. "It's not about the platform, it's about the functionality. An ECG is an ECG. Ah, it sounds like it probably wouldn't apply to the 'symptom checker', they've decided their regulatory regime only applies to devices that... actually directly take medical readings themselves, it sounds like? That doesn't seem unreasonable. And, yeah, a service/process/system that takes your saliva as input seems in that category.
- HeyLaughingBoy 13y ago
  My gut feeling is that it's an issue of manpower: they're choosing their battles. I've been in the Medical Device industry for over 10 years as a software engineer. Soon after I started, during one of our mandatory Quality Systems training sessions, it was pointed out that there are many software-only companies whose products were Medical Devices under the FDA definition, but the FDA simply didn't have the manpower to police all of them. In many cases, the companies themselves probably didn't know they fell under FDA regulation.

Couldn't the same argument be applied to WebMD's symptom checker ?

by ig1 13y ago

Couldn't the same argument be applied to WebMD's symptom checker ?

metaphorm 13y ago

no. the symptom checker is just a document. it is a not a device or an ingested substance.

Dylan16807 13y ago
23AM's offering is in two parts. First, they do some genetic mapping. Second, they do an analysis on the markers found. The objections are based on the second part (and the marketing for it), which seems by itself to be very equivalent to WebMD. I don't think there's any suggestion that abstract-genetic-marker-finding is the problem here.
- smackfu 13y ago
  Any lab test is going to have those two parts, a lab procedure and an analysis. I would expect both parts to be governed by the FDA to ensure reliable results.
  - Dylan16807 13y ago
    There is a difference between mechanical analysis and medical analysis. Obviously they need to analyze the raw signals coming out of the machine to figure out what markers are present. But they could stop there, saying "with four nines certainty you have genes ABJ2, CBI8, LOC9, JOLO, ZZT". The FDA is objecting to doing a medical correlation/explanation beyond that point, doing the things WebMD does.
    - smackfu 13y ago
      To be honest, I think they have to do both things to get regulated under the FDA. The FDA is involved because they consider it a "device" that is "intended for use in the diagnosis of disease or other conditions." If they just did the analysis based on provided data, I don't think that would count as a device.
- jes5199 13y ago
  It seems to me that it's the link between those two parts that is problematic! If someone sold genetic tests that just output a list of markers, and the clients consulted publicly available literature to discern the meaning of those results, then no one would have taken the responsibility of giving advice to a client. By packaging a specific, curated set of information with the test results, 23andme has crossed over from offering tools to offering expertise - and has therefor taken on responsibilities.

jrochkind1 13y ago

I wonder if it _does_ apply. I am not certain if it doesn't. In general, products sold to diagnose diseases -- including software products -- may be subject to regulation. See this article (on WebMD cause I found it when googling to answer the original question, heheh) http://www.webmd.com/news/20130923/fda-sets-rules-for-smartphone-medical-apps http://www.webmd.com/news/20130923/fda-sets-rules-for-smartp... > The U.S. Food and Drug Administration on Monday drew a line between which smartphone medical apps it will regulate and which ones it will not, saying it will focus only on those that turn the phone into an actual diagnostic tool. > In essence, those applications include software that enables the phone to read a patient's heart rhythm, take a blood pressure reading or measure a person's health in some other way. > For example, an ECG machine that diagnoses heart rhythms is "still an ECG machine whether it is the size of a breadbox or the size of a smartphone," Shuren said. "It's not about the platform, it's about the functionality. An ECG is an ECG. Ah, it sounds like it probably wouldn't apply to the 'symptom checker', they've decided their regulatory regime only applies to devices that... actually directly take medical readings themselves, it sounds like? That doesn't seem unreasonable. And, yeah, a service/process/system that takes your saliva as input seems in that category.

HeyLaughingBoy 13y ago
My gut feeling is that it's an issue of manpower: they're choosing their battles. I've been in the Medical Device industry for over 10 years as a software engineer. Soon after I started, during one of our mandatory Quality Systems training sessions, it was pointed out that there are many software-only companies whose products were Medical Devices under the FDA definition, but the FDA simply didn't have the manpower to police all of them. In many cases, the companies themselves probably didn't know they fell under FDA regulation.