A letter from the U.S. pharmaceutical association (PhRMA) to the TTIP chief negotiator for the United States, Douglas Bell, states: "The disclosure of confidential data from clinical and pre-clinical study files and patient data puts at risk the health system and the well-being of patients." Why more transparency should harm the health systems, the lobby group doesn't explain, but it makes clear to the negotiator how he should conduct the negotiations with the EU: the publication of commercially-sensitive data from a market authorization, the PhRMA letter said threateningly, is not only contrary to the rules of the American FDA, but also to the internationally-accepted intellectual property rights of the World Trade Organization, the so-called TRIPS Agreement. "PhRMA and its members call on the U.S. government to influence the EU at all levels in order to eliminate this problem."
What's worrying is that there's already been one attempt to water down these requirements. Der Tagesspiegel suggests this may have been as a result of pressure from the European Commission, concerned about US reaction to them. It will be interesting to see how the Commission reconciles any US demands during the TAFTA/TTIP negotiations to remove the requirement to publish drug safety information with the new EU regulation that requires it.
Last fall, we noted that the FDA had come down hard on 23andme for offering its inexpensive and easy to use genetic testing without first getting detailed FDA approval. As we noted at the time, this seemed to be a typical FDA overreaction. People aren't using 23andme as the final word on something, but rather as a useful indicator to explore more deeply with medical professionals if they needed to be aware of something, change lifestyles, etc. Furthermore, we noted how stopping 23andme and similar offerings would only delay important innovations that the medical world really needs today.
And, now it appears that all the FDA has really succeeded in doing is driving that innovation overseas, as 23andme focuses on expanding in various countries abroad, rather than the US.
While it awaits the agency's approval, a process that could take years, 23andMe aims to offer partial or full genetic-testing services in one or more countries outside of the United States by the end of the year, with likely contenders including Canada, Australia and the United Kingdom, the source said.
A big part of the problem is that the FDA is simply not designed to actually deal with innovative healthcare products. It was built to handle one thing and one thing only: approving pharmaceuticals. And it has a very hammer-and-nail approach to everything it does. Nearly a decade ago, we wrote about Andy Kessler's book The End of Medicine. While that book is now a little outdated, one thing that was quite clear in that book is how ill-prepared (and ill-interested in ever becoming prepared) the FDA is for technological innovations in the healthcare space. The FDA understands clinical testing for drugs, and has trouble understanding anything that doesn't fit into that paradigm.
Providing more useful information to people about their own genes and makeup is a very useful tool. Yes, there can be false positives, but is it better to keep people totally ignorant, or to better inform them across the board? Sure, perhaps it makes sense to do thorough testing of drugs to make sure they're safe (though, even with that there are plenty of compelling arguments for why the FDA does that wrong too), but when it comes to a service that is about providing more information to people, allowing them to be better informed and do more research to be healthier, you'd hope that the FDA would learn how to enable more innovation, rather than shutting it down... and sending the innovation overseas.
Information stored electronically does not constitute property which someone can exercise possession of, judges in the UK have ruled.
The Court of Appeal rejected arguments to the contrary and refused to interpret existing laws in a manner which would, it admitted, "have the beneficial effect of extending the protection of property rights in a way that would take account of recent technological developments".
The judges said that whilst it is possible to exert control over electronic information it is not possible to gain possession of it. The distinction was drawn in a case concerning a dispute between a publisher and an IT supplier.
The details of that case can be read in the useful post on Out-law.com quoted above. The basic facts are as follows. The publisher Datateam Business Media Limited wanted to outsource the management of its subscriber database. The company Your Response Ltd took on the job, but the publisher became dissatisfied with its services, and sought to terminate the contract. In the following dispute over the payment of fees, Your Response Ltd claimed possession of the database -- hence the court case. The analysis of one of the judges is interesting:
"An electronic database consists of structured information," Lord Justice Floyd said. "Although information may give rise to intellectual property rights, such as database right and copyright, the law has been reluctant to treat information itself as property. When information is created and recorded there are sharp distinctions between the information itself, the physical medium on which the information is recorded and the rights to which the information gives rise. Whilst the physical medium and the rights are treated as property, the information itself has never been."
That's an important statement that touches on many aspects of the online world, not least digital copyright. It confirms that the property of "intellectual property" is of monopoly rights, not of the information in the creative work. And since that information cannot be possessed, it therefore cannot be stolen, despite what copyright maximalists would have us believe.
Of course, in between point A and point B, you have to imagine someone at the NSA rushed down to the FISA court seeking a Section 215 bulk "business records" order from every American car company for "mere metadata" on every driver in America, right? Just joking. Maybe.
Of course, even if Farley wasn't accurate in his initial statement, it's close enough to true anyway, since so many people carry mobile phones in their pockets, and those are easily tracked as well. In many cases, people are willing to get the benefits of location information, but we don't have nearly enough transparency or knowledge about what's being done with that information, or given the right to control or limit how that information is shared or used.
In an age where so much information is shared with companies, those companies need to move to solutions that involve much greater transparency and controls. Companies making use of your information need to start being upfront about the type of data they collect and how it's being used. The problem with the idea of Ford keeping track of which one of you has a lead foot isn't in that this is possible. Everyone knew it was already possible. It was just been the assumption that no one would actually do it. And that's the kind of thing that needs to change. Companies want to make use of our data, and sometimes it's for very useful purposes -- things that we're happy to get in exchange for the data. The problem is that too often, how the data is being used is hidden from us, and the "benefits" are not clearly laid out. Furthermore, once the data is gone... it's gone, and there are little to no controls about how it's used and shared.
Whether or not Ford in particular is tracking how fast you drive is barely the point. These days, someone is tracking how fast you drive, and as a driver, you should know who it is, and be able to limit how that information is used.
The Washington Post is out with the latest revelations from the Snowden leaks and it shows that the NSA relies on foreign telcos and "allied" intelligence agencies to scoop up data on email contact lists and instant messaging buddy lists to help build its giant database of connections. Remember a few weeks ago how it was reported that the NSA was basically building a secret shadow social network? It seems like this might be one of the ways it's able to tell who your friends are.
There are a variety of important points here. First off, this information is not coming directly from the tech companies (which, again, suggests that earlier claims that the NSA had direct access to all their servers was mistaken). Rather they're picking this information up off the backbone connections in foreign countries. It also explains why they get so much data from Yahoo -- because, for no good reason at all, Yahoo hasn't forced encryption on its webmail users until... the news of this started to come out.
And here's the big problem: because all of this information is collected overseas, rather than at home, it's not subject to "oversight" (and I use that term loosely) by the FISA court or Congress. Those two only cover oversight for domestic intelligence. The fact that the NSA can scoop up all this data overseas is just a bonus.
Also, while the program is ostensibly targeted at "metadata" concerning connections between individuals, the fact that it collects "inboxes" and "buddy lists" appears to reveal content at times. With buddy lists, it can often collect content that was sent while one participant was offline (where a server holds the message until the recipient is back online), and with inboxes, they often display the beginning of messages, which the NSA collects.
Separately, because this is allowing them to gather so much data, it apparently overwhelmed the NSA's datacenters. At times, this is because they get inundated with... spam. For example, one of the documents revealed show that a target they had been following in Iran had his Yahoo email address hacked for spamming, and that presented a problem:
In fall 2011, according to an NSA presentation, the Yahoo account of an Iranian target was “hacked by an unknown actor,” who used it to send spam. The Iranian had “a number of Yahoo groups in his/her contact list, some with many hundreds or thousands of members.”
The cascading effects of repeated spam messages, compounded by the automatic addition of the Iranian’s contacts to other people’s address books, led to a massive spike in the volume of traffic collected by the Australian intelligence service on the NSA’s behalf.
After nine days of data-bombing, the Iranian’s contact book and contact books for several people within it were “emergency detasked.”
Because of this mess, the NSA has tried to stop collecting certain types of information, doing "emergency detasks" of certain collections. This, yet again, shows how ridiculous Keith Alexander's "collect it all" mantra is. When you collect it all, you get inundated with a ton of bogus data, and the information presented here seems to support that.
This one is fairly incredible. Bloomberg LP's main business is selling ridiculously expensive terminals to Wall Street/financial folks for tracking market information. While I understood why they were able to succeed early on, I've been shocked that the internet hasn't seriously disrupted their business over the past decade or so. However, the company also has a pretty big journalism business as well (even owning Business Week, which it bought for pennies a few years ago). Now it's coming out that the journalists at Bloomberg had all sorts of access to how customers use the terminals.
Until recently, all Bloomberg employees could access information about when and how terminals were used by any customer. But after complaints by Goldman Sachs and JP Morgan, Bloomberg says its 2,000 or so journalists no longer have access to that information, though other staff still do. Bloomberg has more than 15,000 employees.
Incredibly, the reporters also had access to "help" transcripts of any customer and could call them at will, which apparently some of them did for fun.
Several former Bloomberg employees say colleagues would look up chat transcripts of famous customers, like Alan Greenspan, for amusement on slow workdays. The transcripts were typically mundane and hardly incriminating, but who wouldn’t enjoy watching a former US Treasury secretary struggle to use a computer? And, in theory, the substance of someone’s query to customer service could reveal specific information that he’s interested in, tipping off a reporter to a story.
These are the kinds of things that small companies sometimes screw up with poor controls over information. But a massive company like Bloomberg -- especially when it deals with critical financial information -- you would think would have much tighter controls on information. I'd be curious if this violates whatever privacy policies Bloomberg has with its customers. At the very least, it should make Bloomberg customers pretty damn skeptical of continuing to use their terminals. Seems like a huge opportunity for competitors with better controls to step in.
The European Medicines Agency (EMA) has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutical companies, AbbVie and InterMune. The companies are challenging the Agency's decisions to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications in accordance with its 2010 access-to-documents policy.
As the EMA notes, it's not as if the release of this data is unprecedented:
Since November 2010, the Agency has released over 1.9 million pages in response to such requests. This is the first time that the policy has been legally challenged.
That obviously raises the question of why AbbVie and InterMune have problems with drug safety data being released when other companies don't. Fortunately, there is very broad support for the EMA's attempt to make this important information available for other researchers to check and analyze:
Since the two pharmaceutical companies filed these legal actions, the EMA has received more than 30 statements of support from various stakeholders, including the European Ombudsman, national competent authorities, members of the Agency's Management Board, Members of the European Parliament, academic institutions, non-governmental organisations, citizens' initiatives and scientific journals, some of whom have also applied to formally intervene in defence of the EMA at the Court.
There's a crucially important principle here, that public safety must outweigh any claims of commercial confidentiality. Let's hope that the General Court of the European Union recognizes that in its final judgment, which will have a major impact on health and safety not just in Europe but, as a knock-on effect, around the world too.
One of the many complaints about the "six strikes" Copyright Alert System (CAS) in the US is the fact that while it doesn't directly lead to litigation, there is nothing in the agreement that prevents copyright holders from seeking out and using information from the six strikes system in copyright infringement lawsuits. And, surprise surprise, it appears that at least one copyright trolling operation has jumped to the front of the line in testing this out. Malibu Media, who was already building up quite the reputation as a copyright troll (not quite Prenda-like, but still up there), is trying to get Verizon to cough up a ton of information, including details from its six strikes system.
As TorrentFreak notes, the list of information demanded via subpoena has been culled down to the following:
DMCA notices and if applicable six strike notices sent to the applicable subscribers.
Defendants’ bandwidth usage.
Information about the (reliability of the) correlation of the IP-Address to the subscriber for purposes of use at trial.
Content viewed by Defendants to the extent the content is the same show or movie that Plaintiff learned from third-party BitTorrent scanning companies that Defendants also used BitTorrent to download and distribute.
So far, Verizon (who has been one of the better companies in resisting copyright trolls) is objecting to handing over the information and has so far refused to do so, arguing that it does not wish to help "shakedown tactics" by copyright trolls. Malibu is now trying to have the court compel Verizon to cough up the info. Given that we'll likely see more of this, how the court responds should be worth following.
My goodness. Yesterday we posted about Rep. Louis Gohmert's incredible, head-shakingly ignorant exchange with lawyer Orin Kerr during a Congressional hearing concerning "hacking" and the CFAA. In that discussion, Gohmert spoke out in favor of being able to "hack back" and destroy the computers of hackers -- and grew indignant at the mere suggestion that this might have unintended consequences or lead people to attack the wrong targets. Gohmert thought that such talk was just Kerr trying to protect hackers.
I thought perhaps Rep. Gohmert was just having a bad day. Maybe he's having a bad month. In a different hearing, held yesterday concerning ECPA reform, Gohmert opened his mouth again, and it was even worse. Much, much worse. Cringe-inducingly clueless. Yell at your screen clueless. Watch for yourself, but be prepared to want to yell.
The short version of this is that he seems to think that when Google has advertisements on Gmail, that's the same thing as selling all of the information in your email to advertisers. And no matter how many times Google's lawyer politely tries to explain the difference, Gohmert doesn't get it. He thinks he's making a point -- smirking the whole time -- that what Google does is somehow the equivalent of government snooping, in that he keeps asking if Google can just "sell" access to everyone's email to the government. I'm going to post a transcript below, and because I simply cannot not interject how ridiculously uninformed Gohmert's line of questioning is, I'm going to interject in the transcript as appropriate.
Rep. Gohmert: I was curious. Doesn't Google sell information acquired from emails to different vendors so that they can target certain individuals with their promotions?
Google lawyer whose name I didn't catch: Uh, no, we don't sell email content. We do have a system -- similar to the system we have for scanning for spam and malware -- that can identify what type of ads are most relevant to serve on email messages. It's an automated process. There's no human interaction. Certainly, the email is not sold to anybody or disclosed.
Gohmert: So how do these other vendors get our emails and think that we may be interested in the products they're selling.
Okay, already we're off to a great start in monumental ignorance. The initial question was based on a complete falsehood -- that Google sells such information -- and after the lawyer told him that this is not true, Gohmert completely ignores that and still asks how they get the emails. It never seems to occur to him that they don't get the emails.
Google lawyer: They don't actually get your email. What they're able to do is through our advertising business be able to identify keywords that they would like to trigger the display of one of their ads, but they don't get information about who the user is or any...
Gohmert: Well that brings me back. So they get information about keywords in our emails that they use to decide who to send promotions to, albeit automatically done. Correct?
NO. Not correct. In fact, that's the exact opposite of what the lawyer just said. Gohmert can't seem to comprehend that Google placing targeted ads next to emails has NOTHING to do with sending any information back to the advertiser. I wonder, when Rep. Gohmert turns on his television to watch the evening news, does he think that the TV station is sending his name, address, channel watching info, etc. back to advertisers? That's not how it works. At all. The advertisers state where they want their ads to appear, and Google's system figures out where to place the ads. At no point does any information from email accounts go back to anyone. And yet Gohmert keeps asking.
And not understanding the rather basic answers. Unfortunately, the lawyer tries to actually explain reality to Gohmert in a professional and detailed manner, when it seems clear that the proper way to answer his questions is in shorter, simpler sentences such as: "No, that's 100% incorrect."
Lawyer: The email context is used to identify what ads are most relevant to the user...
Gohmert: And do they pay for the right or the contractual ability to target those individuals who use those keywords?
Lawyer: I might phrase that slightly differently, but the gist is correct, that advertisers are able to bid for the placement of advertisements to users, where our system has detected might be interested in the advertisement.
Gohmert: Okay, so what would prevent the federal government from making a deal with Google, so they could also "Scroogle" people, and say "I want to know everyone who has ever used the term 'Benghazi'" or "I want everyone who's ever used... a certain term." Would you discriminate against the government, or would you allow the government to know about all emails that included those words?
Okay, try not to hit your head on your desk after that exchange. First, he (perhaps accidentally) gets a statement more or less correct, that advertisers pay to have their ads show up, but immediately follows that up with something completely unrelated to that. First, he tosses in "Scroogled" -- a term that Microsoft uses in its advertising against Gmail and in favor of Outlook.com -- suggesting exactly where this "line" of questioning may have originated. Tip to Microsoft lobbyists, by the way: if you want to put Google on the hot seat, it might help to try a line of questioning that actually makes sense.
Then, the second part, you just have to say huh? The lawyer already explained, repeatedly, that Google doesn't send any information back to the advertiser, and yet he's trying to suggest that the government snooping through your email is the same thing... and Google somehow not giving the government that info is Google "discriminating" against the government? What? Really?
Lawyer [confounded look] Uh... sir, I think those are apples and oranges. I think the disclosure of the identity...
Gohmert: I'm not asking for a fruit comparison. I'm just asking would you be willing to make that deal with the government? The same one you do with private advertisers, so that the government would know which emails are using which words.
Seriously? I recognize that there are no requirements on intelligence to get elected to Congress, but is there anyone who honestly could not comprehend what he meant by saying it's "apples and oranges"? But, clearly he does not understand that because not only does he mock the analogy, he then repeats the same question in which he insists -- despite the multiple explanations that state the exact opposite -- that advertisers get access to emails and information about email users, and that the government should be able to do the same thing.
Lawyer: Thank you, sir. I meant by that, that it isn't the same deal that's being suggested there.
Gohmert: But I'm asking specifically if the same type of deal could be made by the federal government? [some pointless rant about US government videos aired overseas that is completely irrelevant and which it wasn't worth transcribing] But if that same government will spend tens of thousands to do a commercial, they might, under some hare-brained idea like to do a deal to get all the email addresses that use certain words. Couldn't they make that same kind of deal that private advertisers do?
Holy crap. Gohmert, for the fourth time already, nobody gets email addresses. No private business gets the email addresses. No private business gets to see inside of anyone's email. Seeing inside someone's email has nothing to do with buying ads in email. If the government wants to "do the same deal as private advertisers" then yes it can advertise on Gmail... and it still won't get the email addresses or any other information about emailers, because at no point does Google advertising work that way.
Lawyer: We would not honor a request from the government for such a...
Gohmert: So you would discriminate against the government if they tried to do what your private advertisers do?
No. No. No. No. No. The lawyer already told you half a dozen times, no. The government can do exactly what private advertisers do, which is buy ads. And, just like private advertisers, they would get back no email addresses or any such information.
Lawyer: I don't think that describes what private advertisers...
Gohmert: Okay, does anybody here have any -- obviously, you're doing a good job protecting your employer -- but does anybody have any proposed legislation that would assist us in what we're doing?
What are we doing, here? Because it certainly seems like you're making one of the most ignorant arguments ever to come out of an elected officials' mouth, and that's saying quite a bit. You keep saying "private advertisers get A" when the reality is that private advertisers get nothing of the sort -- and then you ignore that (over and over and over and over again) and then say "well if private advertisers get A, why can't the government get A." The answer is because neither of them get A and never have.
Gohmert: I would be very interested in any phrase, any clauses, any items that we might add to legislation, or take from existing legislation, to help us deal with this problem. Because I am very interested and very concerned about our privacy and our email.
If you were either interested or concerned then you would know that no such information goes back to advertisers before you stepped into the room (hell, before you got elected, really). But, even if you were ignorant of that fact before the hearing, the fact that the lawyer tried half a dozen times, in a half a dozen different ways to tell you that the information is not shared should have educated you on that fact. So I'm "very interested" in what sort of "language" Gohmert is going to try to add to legislation that deals with a non-existent problem that he insists is real.
Gohmert: And just so the simpletons that sometimes write for the Huffington Post understand, I don't want the government to have all that information.
Rep. Sensenbrenner: For the point of personal privilege, my son writes for the Huffington Post.
Gohmert: Well then maybe he's not one of the simpletons I was referring to.
Sensenbrenner: He does have a Phd.
Gohmert: Well, you can still be a PHUL.
Har, har, har... wait, what? So much insanity to unpack. First of all, Gohmert seems to think that people will be making fun of him for suggesting that the government should "buy" access to your email on Google. And, yes, we will make fun of that, but not for the reasons that he thinks they will. No one thinks that Gohmert seriously wants the government to buy access to information on Google. What everyone's laughing (or cringing) at is the idea that anyone could buy that info, because you can't. No private advertiser. No government. It's just not possible.
But, I guess we're all just "simpletons."
Seriously, however, we as citizens deserve better politicians. No one expects politicians to necessarily understand every aspect of technology, but there are some simple concepts that you should at least be able to grasp when explained to you repeatedly by experts. When a politician repeatedly demonstrates no ability to comprehend a rather basic concept -- and to then granstand on their own ignorance -- it's time to find better politicians. Quickly.
One of the initiatives gaining momentum around the world is open data -- the idea that, for example, non-personal data affecting the public should be made freely available. That's partly to improve transparency, so that citizens are more informed about what is happening, and partly to stimulate new kinds of business that build products and services based on that data.
An important category of open data that boosts transparency concerns basic drug safety information. Last month, Techdirt wrote about the AllTrials initiative that seeks to have key information about clinical trials placed in the public domain. As part of a wider move towards greater openness, the European Medicines Agency, the main body that licenses drugs in Europe, is starting to make available information that has hitherto been withheld.
AbbVie, a pharmaceutical company has sought an injunction to block Europe's medicines regulator from releasing "confidential" and "commercially-sensitive" information on its blockbuster rheumatoid arthritis drug, a spokeswoman for the U.S. drugmaker confirmed on Sunday.
The Chicago-based company had taken legal action against the European Medicines Agency to stop it from releasing data on the effects in individual patients in clinical trials for its drug Humira, the Financial Times reported earlier on Sunday.
Except, of course, this isn't "confidential" and "commercially-sensitive" information: it's just basic data about its safety and efficacy. Doctors and patients surely have a right to know this before using products that could potentially have serious, even fatal, side-effects.
The project is part of EFSA's continuing commitment to openness and addresses recommendations made by an independent evaluation report of the Authority's performance to further enhance transparency in its decision-making processes. EFSA's Science Strategy also highlights the importance of the Authority playing a leading role in making relevant scientific data more accessible to all interested parties.
Here's one particular set of data that it has now released:
Given the level of public interest, EFSA will make all data on genetically modified (GM) maize NK603 publicly available on its website today (14 January).
Once more, that seems reasonable, since the public ought to be able to find about what is going into the food chain whose end-products it will consume. But some disagree: according to a story on Bakeryandsnacks.com, Monsanto is threatening to sue the EFSA over the release of this data.
What makes this a little confusing is that the company is quoted in that article as saying that it "firmly supports transparency" -- and yet here it is fighting tooth and nail against precisely that. Apparently, Monsanto also wants the regulatory environment in Europe to be "science-based". Modern science requires experimental data to be made available so that anyone can check the validity of the conclusions that have been drawn from it. If it can't be scrutinized, the conclusions can't be confirmed, and it's not science. So, given its call for "science-based" regulation, why does the company want to keep that data hidden? A cynic might almost suspect that Monsanto and AbbVie have something to hide.