Yes, there are risks from doctors as well, which is why doctors are required to go through a fairly extensive certification process. I think home genomic testing is a great idea provided the tests can demonstrate a reasonable level of accuracy. But from the FDA's letter, it seems that 23andMe has repeatedly failed to offer any credible studies to support its assertions.
Yes, but the concern (at least from my reading of the letter) is primarily over people reacting to inaccurate results. Like the example they give immediately after that statement:
For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect.
The FDA is also concerned that 23andMe has not submitted anything validating that it's test is effective or accurate, which is a larger part of the issue. Not to mention the fact that the list of things they purport to test for has grown significantly since initially filing for FDA approval.
From the FDA's letter:
However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.
They're also not banning home genomics testing. They're saying that if you want to market something as a medical diagnostic test, you need to submit verifiable and credible evidence that the test is accurate. You know, ensuring that "medical" offerings aren't snake oil or fearmongering. Part of what the FDA exists for.
So, maybe this is a silly question, but if he was running away, as they claim, how did he get shot in the face. Now, my knowledge of anatomy is a little rusty, but the face is usually oriented in the direction of movement, ie. away from the cops.
I'm picturing the discussion going something like this:
Judge: Tech industry, the government has said some terrible things about you. How do you respond? Tech Lawyers: Well, what did they say? Judge: Terrrrrrible things. Things I can't even bring myself to repeat. Tech Lawyers: Well, how are we supposed to respond if we don't know what we're responding to? Judge: Terrrrrrrrrrrrrrrrrible things.
You were absolutely given that information. Buried in this giant haystack of possibly tangentially related material. If you had a proper method to search through that haystack, and the inclination to do so, you would have the capabilities to know whatever you wanted.
This viewpoint seems oddly appropriate coming out of the NSA.
Which is fine if you live somewhere those things are available. For a large number of people living outside major metropolitan areas, that's really not an option. I know that my first few jobs were all 7-20 miles from my home, which isn't that significant in a car, moving at highway speeds, but is a much different story on foot or by bike. Doubly so when you consider that, at a northern climate, a large part of the year there was heavy snow. As a rural area, there was no real public transportation, and while I could theoretically have taken a cab, the cost was prohibitive.
Duplicating the functionality is not a violation of copyright. He admits he's created similar functionality, that's not illegal. If you come at a problem in a different language, the methodology (and therefor the code) you use to recreate that functionality will be different.
Nor is duplicating functionality (with different code) inherently going to expose vulnerabilities in the original. They're written differently and will have different vulnerabilities.