The payload might be agnostic to the OS, but what about the dropper? I would imagine that would have to be custom-tailored to each OS. Unless the manufacturers are letting NSA drop the payload in before it gets to the consumer.
That's why FDA issued this guidance. Because they were being forced to heavily regulate simple things unnecessarily. Up until now, if you wanted a doctor to use your app, you had to get it FDA approved. Now, assuming your app meets one of the exemptions, doctors can use your app more easily without potential liability (doctors tend to be paranoid about what they'll use on patients).
I kinda sorta work in this industry, so I already knew about this guidance. In fact, I kinda sorta knew it was going to happen before it was official. So I didn't really have to read the article.:)
It seems that literally nobody can be bothered to actually understand what happened ("nanny state" "snuffing" "innovation" with "unnecessary regulations"). The FDA's guidance, released this past Monday, is RELAXING regulations - it is EXEMPTING whole categories of applications from regulation.
FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"
FDA has ALREADY been regulating medical apps. For a long time. The problem is, even if all your app does is draw pretty graphs, you still needed to go through e.g. 510K certification for your application. This guidance by FDA is aimed at reducing the barriers to entry for non-critical medical applications.
Except this is not preemptive. FDA has already been regulating medical applications on mobile platforms (quote, FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"). This guidance is saying that certain medical applications are now exempt from regulation.
While I use My Days to track my wife's cycle, you can have improved accuracy using an LH strip. It's a "pee in a cup, stick strip into pee for three seconds, let dry for five minutes" test.
I've also read (Amazon reviews, so take with appropriate amounts of salt) that if a woman has polycystic ovarian syndrome, she may not ovulate, even if she menstruates. The LH surge can tell her when she actually ovulates.
Using the LH strip in combination with My Days, you can reliably avoid or become pregnant. After a few cycles, you can tell whether My Days is correctly predicting ovulation (my wife is usually right on or a day late). Since sperm lasts up to five days, and there's some natural variations in the cycle, we generally avoid 8 days before and four days after ovulation is supposed to start. No condoms, no pill, no spermicide, and still no babies, four years running.
This new guidance *relaxes* the regulations, meaning that the barrier to entry for releasing a medical app has been lowered. Before Monday, if you wanted to sell a medical app on a mobile platform, you needed FDA approval. As of Monday, large swaths of medical apps are no longer required to comply with Federal Drug and Cosmetic Act.
The headline is misleading. It implies that this is about *beginning* to regulate medical apps. In reality, medical apps have ALWAYS been regulated. The new guidelines issued by FDA *relax* the regulations, meaning that some medical apps no longer require FDA 510K approval. I have a feeling that OP's "read, parse, and analyze data" app will fit into that category, as of Monday.
This is actually a big deal to people who already have 510K. It used to be that you could say, "yeah I'm 510K" and you were one of only a few fish in a small pond. FDA just made that pond a LOT bigger, so now saying "yeah I'm 510K" isn't all that useful.
That's great, if you live in an area where it's possible to pull off to the side of the road. In many places where I live, there IS no side of the road, especially when that road runs along a ravine, or the road has trees all along both sides. It's great if you want to avoid speed traps, since there's no where for a cop to park - but terrible if you need to pull over for an emergency.
Or the side of the road is a sidewalk with pedestrians. Or you're on the highway - do you really think it's a good idea to pull over on the highway?
I'm not trying to defend people who text and drive (although "sitting at a red light" != "driving", IMO) - personally I make my wife handle all phone/GPS details while I'm driving - but I think pulling over to text is more dangerous than texting at a red light. At least in my locale.
The big difference between being drunk at a stoplight and texting at a stoplight is that when you put the phone down and start moving, you're no longer texting. But if you were drunk and you start moving...you're still drunk.
But for that matter, I don't know why anyone types on text messages anymore. Verbal transcription in the latest mobile OS platforms is so good that I haven't typed a message in at least a year.
A driver trying to steer out of the way of a pedestrian engaged in reckless behavior (like walking out in front of traffic) might very well end up killing someone, and it WOULD be the pedestrian's fault.
I'd rather people talk on the phone while driving, than text or GPS while driving, or even talking to a passenger in the same car.
You see, when talking on the phone, your eyes are still on the road. If texting or GPS, your eyes are on the gadget. If talking to a passenger, you will inevitably look away from the road in order to observe nonverbal cues from your companion.
this information comes from revelation of secret court documents, not a PR statement itself.
I believe I read that this declassified opinion from FISC was written *after* the Snowden documents were leaked. So we cannot actually be too sure that this opinion was not written as a matter of PR.
A widow in PA lost her $280,000 home over $6.30 in unpaid property taxes. Well, after interest and penalties, the $6.30 became $235 - still less than 0.1% of her home value.
The NYT link does not back up your side of the story. In fact, it explicitly debunks the other two links.
Moreover, their claim depends on careful selection of the starting and ending points. The starting point is almost always 1998, a particularly warm year because of a strong El Niño weather pattern.
Somebody who wanted to sell you gold coins as an investment could make the same kind of argument about the futility of putting your retirement funds into the stock market. If he picked the start date and the end date carefully enough, the gold salesman could make it look like the stock market did not go up for a decade or longer.
Emphasis mine. Every time someone says "global temperatures are not going up" - literally, every single time - it is because they use 1998 as the starting point. 1998 sets off all kinds of alarm bells, because it's a cherry-picked date.
Worse, it's not even proper statistics. These people are using high-school-level point-slope form; (Y2-Y1) = m(X2-X1). That's the only way you can get "flat". If you do a proper undergraduate-level Least Squared Linear Regression, even using 1998 as your starting point isn't enough to claim "flat". If you don't feel capable of performing undergraduate statistics, you can always use Excel, or any number of free online spreadsheets, to do the Linear Regression for you.
It is not a matter of "how do you know that that's not supposed to be [the] temperature?"
It's not like we have real "equilibriums", i.e. a global minima/maxima. It's more like we have a lot of local minimas/maximas. Enough forcings can push us out of our current local min/max and into a new min/max - like a flip flop that went metastable, sure it's not "supposed" to be at half-voltage, but it's a local minima that is relatively stable until something forces it toward the global minima. In all cases, the earth is at temperatures it's "supposed" to be at, otherwise we'd be violating laws of physics.
The question is, can humanity deal with the new local min/max as well as humanity dealt with the old min/max? That is why arguments about what temperature the earth was back in prehistory are red herrings. We didn't have massive civilizations with skyscrapers and monoculture farms feeding billions of people back in prehistory.
So it's not true that the 1979 revolution in Iran was in part fueled by anti-American animosity for our role in installing and supporting the Shah as ruler of Iran?
I mean, sure, in 1953, they might not have been opposed to what was happening (if they even knew what was happening at the time). But then again, in 2003, the US and most of the world thought Iraq had WMD and planned on using it. Funny how time has a habit of changing how an action is perceived. Just because someone isn't against it at the time it happened doesn't mean that it isn't viewed as a "disagreement" after-the-fact.
Bad analogy. You're choosing an evil target and a sympathetic target - that is not the case in Syria. On one side, you have Assad. On the other side, you have a coalition of rebels, a significant portion of whom align themselves with al-Qaeda (they are referred to as "al-Nusra" in media reports)
Better analogy: you have two neighbors, Assad and al-Nusra. You hate them both, they're both deadbeats, they leave garbage all over their lawn, beat their wife and kids, etc. You see Assad and al-Nusra get into a fight with each other.
Doing nothing in this case is prudent because you don't want either of them to win the fight. They're both bad guys.
Keep in mind that the gas attack happened in a suburb of Damascus.
Damascus is the capital of Syria. Assad's palace is like, what, 10 miles from where the gas attack happened?
Do you REALLY think that he would launch a gas attack when a change in the wind could bring that gas directly to him? That reminds me of the people who think Iran would blow up Israel, not realizing that the land Israel sits on is holy land for Iran, too; the epitome of cutting off your nose to spite your face.
1) Competition is good, right? Well, if these health exchanges that PPACA sets up provide more competition to provide insurers, isn't that a good thing? I mean, if the private insurance is so much better than the public health exchanges, everyone will just buy private insurance.
2) Congress isn't exempting anyone. Congress pays for some of the staffers' insurance. This little "exemption" thing (lol) is about how the payments will be handled under PPACA.
3) Tort reform isn't going to fix the incentives. Patients don't have enough knowledge to make intelligent decisions, and their decisions are frequently made under duress. Doctors have huge debt burdens that need to be taken away. Insurance companies have shareholders that they need to pay off. Hospitals make money on every service, so their incentive is to provide as many services as possible, even if they aren't necessary.
IMO, the true potential for reform involves two things.
a) Increase the supply of medical professionals. Supply goes up, price goes down. To make this easier, medical school needs to be less expensive. We need more GPs, fewer specialists, and you don't need to be top-tier to help people with checkups, or general medical treatments for colds, flus, etc.
b) Smaller patient care centers. Imagine a doctor's office, but instead of doctors, it's staffed almost entirely by nurses. They form a triage, identifying people who don't actually need to see a full-fledged M.D. They would take walk-ins, no appointment necessary, so that people are more willing to go see the nurse about their problem, instead of waiting for it to become so bad that they need to go to the hospital. This would take care of the bulk of medical appointments, reducing the burden on doctors so that they can spend more than five or ten minutes with each patient.
Unfortunately, neither of my two suggestions do anything to fix most of the incentives. I'm afraid to say it, but the only thing that can provide industry with proper incentives in this regard is government regulation.
I have seen the death panels, and thy name is "grievance review board". Allow me to elaborate...
My mother was in severe need of back surgery. Honestly, given the excruciating pain she was in, I'm surprised she didn't try to take her own life. She had an MRI that showed a massive slipped disc that was crushing her spinal card (the technical term for this is "spondylolisthesis with spinal stenosis")
Anyway, the doctor recommended surgery. But he said, "the insurance company won't pay for the surgery until you get these epidural steroid shots". You know, those shots from compounding pharmacies that gave a lot of people a fungal infection? Lucky for her, she got her shots about six months before those tainted shipments left Massachusetts. But I digress.
So she gets the shots. They're quite embarrassing; since the shots go right into the bottom of the spine, you pretty much have to be naked from the waist down. They're also very painful. And they aren't cheap, either; they need to use an X-ray machine to guide the needle in.
The result? Shots didn't do shit. Surgeon even said, "these shots will probably have minimal effectiveness due to the physical nature of your condition" - the shots are incapable of making the slipped disc stop crushing her spinal cord. So the surgeon schedules her surgery.
Then we get a call back. Surgery has been denied because "it is not medically necessary". Because literally the day before the surgeon scheduled her surgery, the insurer changed their guidelines as to what defines "medically necessary", such that in addition to the ineffective, painful, and embarrassing steroid shots, you also need physical therapy, regardless of whether PT will have any impact on the patient's condition (the exercises actually made her condition worse, partially because the therapist was unaware of what therapies are effective for spinal stenosis...and partially because exercises aren't going to make the slipped disc stop crushing her spinal cord).
So I start learning as much as I can about the spine. I start reading scholarly articles. I collect a ton of evidence and write a detailed report to her insurer's death panel - I mean, "grievance review board". After receiving my report, we were told we would have an opportunity to meet the death panel - I mean, "grievance review board" - in person. About one week before the meeting, I get a phone call that they finally approved her surgery.
What would my mother had done, if she didn't have a college educated son who was capable of reading highly technical academic research papers and collating the information together in such a manner that could convince the death panel - I mean, "grievance review board" - that surgery was medically necessary for her?
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The payload might be agnostic to the OS, but what about the dropper? I would imagine that would have to be custom-tailored to each OS. Unless the manufacturers are letting NSA drop the payload in before it gets to the consumer.
That's why FDA issued this guidance. Because they were being forced to heavily regulate simple things unnecessarily. Up until now, if you wanted a doctor to use your app, you had to get it FDA approved. Now, assuming your app meets one of the exemptions, doctors can use your app more easily without potential liability (doctors tend to be paranoid about what they'll use on patients).
I kinda sorta work in this industry, so I already knew about this guidance. In fact, I kinda sorta knew it was going to happen before it was official. So I didn't really have to read the article. :)
It seems that literally nobody can be bothered to actually understand what happened ("nanny state" "snuffing" "innovation" with "unnecessary regulations"). The FDA's guidance, released this past Monday, is RELAXING regulations - it is EXEMPTING whole categories of applications from regulation.
FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"
FDA has ALREADY been regulating medical apps. For a long time. The problem is, even if all your app does is draw pretty graphs, you still needed to go through e.g. 510K certification for your application. This guidance by FDA is aimed at reducing the barriers to entry for non-critical medical applications.
Except this is not preemptive. FDA has already been regulating medical applications on mobile platforms (quote, FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"). This guidance is saying that certain medical applications are now exempt from regulation.
Yeah...it's almost as if the FDA is doing a good job.
While I use My Days to track my wife's cycle, you can have improved accuracy using an LH strip. It's a "pee in a cup, stick strip into pee for three seconds, let dry for five minutes" test.
The beautiful thing is that the LH surge happens very reliably, 24-48 hours before ovulation. (see the third chart in this link and note how narrow the blue peak is compared to the other charts: http://upload.wikimedia.org/wikipedia/commons/c/c8/Hormones_estradiol%2C_progesterone%2C_LH_and_FSH_during_menstrual_cycle.svg )
I've also read (Amazon reviews, so take with appropriate amounts of salt) that if a woman has polycystic ovarian syndrome, she may not ovulate, even if she menstruates. The LH surge can tell her when she actually ovulates.
Using the LH strip in combination with My Days, you can reliably avoid or become pregnant. After a few cycles, you can tell whether My Days is correctly predicting ovulation (my wife is usually right on or a day late). Since sperm lasts up to five days, and there's some natural variations in the cycle, we generally avoid 8 days before and four days after ovulation is supposed to start. No condoms, no pill, no spermicide, and still no babies, four years running.
This new guidance *relaxes* the regulations, meaning that the barrier to entry for releasing a medical app has been lowered. Before Monday, if you wanted to sell a medical app on a mobile platform, you needed FDA approval. As of Monday, large swaths of medical apps are no longer required to comply with Federal Drug and Cosmetic Act.
The headline is misleading. It implies that this is about *beginning* to regulate medical apps. In reality, medical apps have ALWAYS been regulated. The new guidelines issued by FDA *relax* the regulations, meaning that some medical apps no longer require FDA 510K approval. I have a feeling that OP's "read, parse, and analyze data" app will fit into that category, as of Monday.
This is actually a big deal to people who already have 510K. It used to be that you could say, "yeah I'm 510K" and you were one of only a few fish in a small pond. FDA just made that pond a LOT bigger, so now saying "yeah I'm 510K" isn't all that useful.
That's great, if you live in an area where it's possible to pull off to the side of the road. In many places where I live, there IS no side of the road, especially when that road runs along a ravine, or the road has trees all along both sides. It's great if you want to avoid speed traps, since there's no where for a cop to park - but terrible if you need to pull over for an emergency.
Or the side of the road is a sidewalk with pedestrians. Or you're on the highway - do you really think it's a good idea to pull over on the highway?
I'm not trying to defend people who text and drive (although "sitting at a red light" != "driving", IMO) - personally I make my wife handle all phone/GPS details while I'm driving - but I think pulling over to text is more dangerous than texting at a red light. At least in my locale.
The big difference between being drunk at a stoplight and texting at a stoplight is that when you put the phone down and start moving, you're no longer texting. But if you were drunk and you start moving...you're still drunk.
But for that matter, I don't know why anyone types on text messages anymore. Verbal transcription in the latest mobile OS platforms is so good that I haven't typed a message in at least a year.
A driver trying to steer out of the way of a pedestrian engaged in reckless behavior (like walking out in front of traffic) might very well end up killing someone, and it WOULD be the pedestrian's fault.
I'd rather people talk on the phone while driving, than text or GPS while driving, or even talking to a passenger in the same car.
You see, when talking on the phone, your eyes are still on the road. If texting or GPS, your eyes are on the gadget. If talking to a passenger, you will inevitably look away from the road in order to observe nonverbal cues from your companion.
Why is it that the natural reaction of attraction to a beautiful woman implies that she is an object?
this information comes from revelation of secret court documents, not a PR statement itself.
I believe I read that this declassified opinion from FISC was written *after* the Snowden documents were leaked. So we cannot actually be too sure that this opinion was not written as a matter of PR.
You will appreciate this.
A widow in PA lost her $280,000 home over $6.30 in unpaid property taxes. Well, after interest and penalties, the $6.30 became $235 - still less than 0.1% of her home value.
http://www.cnbc.com/id/100975448
Fortunately, a Judge has decided she has a chance to appeal the loss of her home. But it has already been auctioned off.
The NYT link does not back up your side of the story. In fact, it explicitly debunks the other two links.
Emphasis mine. Every time someone says "global temperatures are not going up" - literally, every single time - it is because they use 1998 as the starting point. 1998 sets off all kinds of alarm bells, because it's a cherry-picked date.
Worse, it's not even proper statistics. These people are using high-school-level point-slope form; (Y2-Y1) = m(X2-X1). That's the only way you can get "flat". If you do a proper undergraduate-level Least Squared Linear Regression, even using 1998 as your starting point isn't enough to claim "flat". If you don't feel capable of performing undergraduate statistics, you can always use Excel, or any number of free online spreadsheets, to do the Linear Regression for you.
It is not a matter of "how do you know that that's not supposed to be [the] temperature?"
It's not like we have real "equilibriums", i.e. a global minima/maxima. It's more like we have a lot of local minimas/maximas. Enough forcings can push us out of our current local min/max and into a new min/max - like a flip flop that went metastable, sure it's not "supposed" to be at half-voltage, but it's a local minima that is relatively stable until something forces it toward the global minima. In all cases, the earth is at temperatures it's "supposed" to be at, otherwise we'd be violating laws of physics.
The question is, can humanity deal with the new local min/max as well as humanity dealt with the old min/max? That is why arguments about what temperature the earth was back in prehistory are red herrings. We didn't have massive civilizations with skyscrapers and monoculture farms feeding billions of people back in prehistory.
No?
So it's not true that the 1979 revolution in Iran was in part fueled by anti-American animosity for our role in installing and supporting the Shah as ruler of Iran?
I mean, sure, in 1953, they might not have been opposed to what was happening (if they even knew what was happening at the time). But then again, in 2003, the US and most of the world thought Iraq had WMD and planned on using it. Funny how time has a habit of changing how an action is perceived. Just because someone isn't against it at the time it happened doesn't mean that it isn't viewed as a "disagreement" after-the-fact.
Bad analogy. You're choosing an evil target and a sympathetic target - that is not the case in Syria. On one side, you have Assad. On the other side, you have a coalition of rebels, a significant portion of whom align themselves with al-Qaeda (they are referred to as "al-Nusra" in media reports)
Better analogy: you have two neighbors, Assad and al-Nusra. You hate them both, they're both deadbeats, they leave garbage all over their lawn, beat their wife and kids, etc. You see Assad and al-Nusra get into a fight with each other.
Doing nothing in this case is prudent because you don't want either of them to win the fight. They're both bad guys.
Damascus is not a remote village full of civilians. It is the capital of Syria.
This would be not unlike Obama gassing a suburb of DC because he's in a disagreement with Republicans.
Keep in mind that the gas attack happened in a suburb of Damascus.
Damascus is the capital of Syria. Assad's palace is like, what, 10 miles from where the gas attack happened?
Do you REALLY think that he would launch a gas attack when a change in the wind could bring that gas directly to him? That reminds me of the people who think Iran would blow up Israel, not realizing that the land Israel sits on is holy land for Iran, too; the epitome of cutting off your nose to spite your face.
Could that little disagreement have anything to do with another little disagreement the Iranians had with the US in 1953?
1) Competition is good, right? Well, if these health exchanges that PPACA sets up provide more competition to provide insurers, isn't that a good thing? I mean, if the private insurance is so much better than the public health exchanges, everyone will just buy private insurance.
2) Congress isn't exempting anyone. Congress pays for some of the staffers' insurance. This little "exemption" thing (lol) is about how the payments will be handled under PPACA.
3) Tort reform isn't going to fix the incentives. Patients don't have enough knowledge to make intelligent decisions, and their decisions are frequently made under duress. Doctors have huge debt burdens that need to be taken away. Insurance companies have shareholders that they need to pay off. Hospitals make money on every service, so their incentive is to provide as many services as possible, even if they aren't necessary.
IMO, the true potential for reform involves two things.
a) Increase the supply of medical professionals. Supply goes up, price goes down. To make this easier, medical school needs to be less expensive. We need more GPs, fewer specialists, and you don't need to be top-tier to help people with checkups, or general medical treatments for colds, flus, etc.
b) Smaller patient care centers. Imagine a doctor's office, but instead of doctors, it's staffed almost entirely by nurses. They form a triage, identifying people who don't actually need to see a full-fledged M.D. They would take walk-ins, no appointment necessary, so that people are more willing to go see the nurse about their problem, instead of waiting for it to become so bad that they need to go to the hospital. This would take care of the bulk of medical appointments, reducing the burden on doctors so that they can spend more than five or ten minutes with each patient.
Unfortunately, neither of my two suggestions do anything to fix most of the incentives. I'm afraid to say it, but the only thing that can provide industry with proper incentives in this regard is government regulation.
I have seen the death panels, and thy name is "grievance review board". Allow me to elaborate...
My mother was in severe need of back surgery. Honestly, given the excruciating pain she was in, I'm surprised she didn't try to take her own life. She had an MRI that showed a massive slipped disc that was crushing her spinal card (the technical term for this is "spondylolisthesis with spinal stenosis")
Anyway, the doctor recommended surgery. But he said, "the insurance company won't pay for the surgery until you get these epidural steroid shots". You know, those shots from compounding pharmacies that gave a lot of people a fungal infection? Lucky for her, she got her shots about six months before those tainted shipments left Massachusetts. But I digress.
So she gets the shots. They're quite embarrassing; since the shots go right into the bottom of the spine, you pretty much have to be naked from the waist down. They're also very painful. And they aren't cheap, either; they need to use an X-ray machine to guide the needle in.
The result? Shots didn't do shit. Surgeon even said, "these shots will probably have minimal effectiveness due to the physical nature of your condition" - the shots are incapable of making the slipped disc stop crushing her spinal cord. So the surgeon schedules her surgery.
Then we get a call back. Surgery has been denied because "it is not medically necessary". Because literally the day before the surgeon scheduled her surgery, the insurer changed their guidelines as to what defines "medically necessary", such that in addition to the ineffective, painful, and embarrassing steroid shots, you also need physical therapy, regardless of whether PT will have any impact on the patient's condition (the exercises actually made her condition worse, partially because the therapist was unaware of what therapies are effective for spinal stenosis...and partially because exercises aren't going to make the slipped disc stop crushing her spinal cord).
So I start learning as much as I can about the spine. I start reading scholarly articles. I collect a ton of evidence and write a detailed report to her insurer's death panel - I mean, "grievance review board". After receiving my report, we were told we would have an opportunity to meet the death panel - I mean, "grievance review board" - in person. About one week before the meeting, I get a phone call that they finally approved her surgery.
What would my mother had done, if she didn't have a college educated son who was capable of reading highly technical academic research papers and collating the information together in such a manner that could convince the death panel - I mean, "grievance review board" - that surgery was medically necessary for her?