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Why The FDA Ban On Providing Health Reports Based On Personal Genomes Won't Work

van TechDirt - 5 uur 50 min geleden

When the first human genome was sequenced -- that is, when most of the 3 billion base-pairs that go to make up our DNA were elucidated -- as part of the Human Genome Project, around $3 billion was spent. Today, the cost of sequencing is falling even faster than Moore's Law, which means everyone could have their genome sequenced soon, if they wished (and maybe even if they don't....). By analyzing the DNA, and looking at the gene variants found there, it is possible to spot predispositions to certain diseases or medical conditions, potentially allowing lifestyle changes or treatment that reduce the risk. The well-known personal genomics company 23andMe was offering this kind of service, at least on a small scale. But that stopped at the end of last year, as the company explains: We no longer offer our health-related genetic reports to new customers to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process.

At this time, we do not know the timeline as to which health reports might be available in the future or when they might be available.
According to an article in MIT Technology Review, here's what had happened: in November 2013, the Food and Drug Administration had cracked down on 23andMe. The direct-to-consumer gene testing company's popular DNA health reports and slick TV ads were illegal, it said, since they'd never been cleared by the agency. But as that same article goes on to explain in detail, users of 23andMe are having no difficulty in getting around that ban on obtaining health-related analyses of their genomes, using third-party sites like Promethease: Promethease was created by a tiny, two-man company run as a side project by Greg Lennon, a geneticist based in Maryland, and Mike Cariaso, a computer programmer. It works by comparing a person's DNA data with entries in SNPedia, a sprawling public wiki on human genetics that the pair created eight years ago and run with the help of a few dozen volunteer editors. Lennon says Promethease is being used to build as many as 500 gene reports a day. That kind of analysis is possible because, once sequenced, DNA is essentially just digital data: very easy to upload and compare against biomedical databases storing information as digital files. Even though they are not currently allowed to analyze it, companies like 23andMe still provide customers with access to the raw genomic data, which can then be sent to services like Promethease for a basic report drawing on its DNA database.

This raises an interesting question: given that the information on SNPedia is drawn from public databases, can the FDA stop people using it to circumvent the ban on 23andMe? According to MIT Technology Review, the FDA believes the answers is "yes", but that just won't work in practice. Even if the FDA manages to shut down all the services like Promethease, it would be easy to write a program that searches the main public biomedical databases for exactly the same kind of information about particular gene variants found in somebody's genome. The software could be shared freely as open source, making it impossible to prevent people from obtaining the program and carrying out such searches independently on their own computers.

It's true that there are good reasons why the FDA might be concerned about members of the public being given medical analyses of their genome in inappropriate ways. For a start, the results are generally probabilistic, rather than definite predictions; that makes them hard for non-experts to interpret. And when it isn't about probabilities -- if it is certain that you will develop a disease, possibly a devastating one -- there's a strong argument that counselling needs to be made available when that information is given to the person affected.

Still, regardless of the extent to which the FDA's actions are understandable, trying to stop people comparing their DNA with publicly-available information is futile. As the copyright industry has learned the hard way, once data is digital, it is essentially uncontrollable. The best thing to do is to accept that fact and move on. In this case, that means the FDA should encourage companies offering analysis to do a good job, not block them completely.

Follow me @glynmoody on Twitter or identi.ca, and +glynmoody on Google+



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Categorieën: Technieuws

City Of London Police Fail And Censor Their Way To A Lot More UK Taxpayer Money

van TechDirt - 8 uur 53 min geleden
We've written plenty about the City of London Police and its Police Intellectual Property Crime Unit (PIPCU), which despite an official jurisdiction covering a square mile of London, has made it clear that it considers itself Hollywood's private police force worldwide when it comes to stopping copyright infringement online. PIPCU has basically been a bumbling, censoring mess from the beginning. A year ago, it started ordering domain registrars to kill off websites with no court order and no legal basis -- demands that actually violated ICANN's policies. For registrars that ignored those baseless, bogus censorship demands, PIPCU started sending ridiculous threats claiming that they were engaged in criminal behavior. Of course, PIPCU's understanding of both the internet and "criminal" laws is suspect. The head of the unit, Adrian Leppard, claims that "the Tor" is "90% of the internet" and "is a risk to society." Another top officer, Andy Fyfe, somehow believes that if PIPCU isn't running around censoring sites there would be anarchy online.

Of course, it's not just crazy statements and bogus threats. PIPCU is actually causing real damage. It has built a secret pirate blacklist over which there is no transparency, no due process and no appeal. On some of those sites, it is injecting advertisements that are mockably ridiculous (though the injections are potentially illegal in their own right). Much more troubling is that PIPCU has been completely shutting down websites and privacy services with no legal basis at all. And, when they did actually arrest someone -- claiming "industrial scale" infringement -- the eventual details were so weak that the case was completely dropped in a matter of weeks.

Given the Keystone e-Cops nature of the City of London Police's PIPCU, you'd think that, maybe, just maybe, it would be time to disband PIPCU and let the City of London Police get back to protecting London's banks (its other main pasttime). Instead, the UK government has just given PIPCU a raise, dumping £3 million of UK taxpayer money into the group to continue its bumbling, censoring, technologically clueless ways. While I'm sure this makes some increasingly obsolete gatekeepers happy, it's hard to see how this helps content creators or the public in any way at all.

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Categorieën: Technieuws

Cameron slapped with new €2bn EU bill

van EU Observer - 9 uur 10 min geleden
The EU has told the UK it must pay a new €2.1 billion bill by 1 December, in grist for the mill of Cameron's eurosceptic adversaries at home.


Categorieën: Europees nieuws

Cyprus seeks harsh EU statement on Turkey

van EU Observer - 9 uur 28 min geleden
Nicosia persuaded EU leaders at the summit in Brussels on Thursday to criticise Turkey for violating its economic zone and sovereignty.


Categorieën: Europees nieuws

Renzi stirs up EU row ahead of eurozone meeting

van EU Observer - 9 uur 31 min geleden
Eurozone leaders are meeting Friday on public deficits and debt, amid an escalating dispute between Italian PM Renzi and outgoing commission chief Barroso.


Categorieën: Europees nieuws

[Ticker] Ice-cold relations inside the ECB: report

van EU Observer - 9 uur 57 min geleden
Relations between European Central Bank president Mario Draghi and German Bundesbank President Jens Weidmann have almost broken down, according to a Reuters Insight report. Weidmann's predecessor Axel Weber and ECB board member Juergen Stark both resigned in 2011 in protest against bond-buying policies of the European Central Bank.


Categorieën: Europees nieuws

[Ticker] Soros: EU has lost its way

van EU Observer - 9 uur 57 min geleden
"Europe is facing a challenge from Russia to its very existence," philanthropist George Soros warns in an article, entitled “Wake Up, Europe”, in the New York Review of Books. The EU in general, and the eurozone in particular, have lost their way after the financial crisis, he writes.


Categorieën: Europees nieuws

[Ticker] European bank stress tests to reveal small problems: report

van EU Observer - 9 uur 59 min geleden
The European Central Bank's stress test of 130 eurozone banks and 20 non-eurozone banks is to be published Sunday. The banks need about €10 billion in total, which would be easy for the sector to absorb, analysts told the Wall Street Journal. A few banks will technically fail the test.


Categorieën: Europees nieuws

[Ticker] Beer and wine fuelled EU climate deal

van EU Observer - 10 uur 1 min geleden
EU commission president Barroso joked Friday that beer and wine helped clinch the climate deal. "Dinner started with ... the best beer in the world, so from Belgium ... afterwards we had wine ... from Alentejo in Portugal", he said, noting it might have helped create "stimulating and inspiring conclusions".


Categorieën: Europees nieuws

Court Ruling: The NFL Isn't Violating Player's Publicity Rights By Selling Videos Of Historical Game Footage

van TechDirt - 12 uur 57 min geleden

While the NFL isn't necessarily great at preserving its own historical footage in sum total, the fact is that the league makes a great deal of money by selling copies of game footage and interviews from seasons since past. Recently, three former players opted out of a settlement the league had agreed to in a class action case and decided to pursue their own rewards for the NFL's use of old game footage and interviews. Their theory is that the league violated their publicity rights. Their theory is wrong. Now, thanks to the First Amendment and two other reasons, U.S. District Judge Paul Magnuson has ruled that the claims can't survive. In coming to the decision, Judge Magnuson looks at various productions like NFL Films' “1973 Houston Oilers Season Highlights" and "Cliffhangers, Comebacks & Character: The 1981 San Diego Chargers.” These productions weren't about Dryer, Bethea or White per se. The players were nevertheless shown on field, sometimes mentioned by name, and in some instances, interviewed about their playing days.

The judge finds that these productions weren't commercial speech. The plaintiffs brought forward a theory that the productions were advertising because they served to enhance the NFL's brand, but the judge says that "brand enhancement alone is not sufficient to render a production advertising as a matter of law." Because the speech was deemed to not be advertising in nature, it falls under the protection of the First Amendment. That would be enough for the publicity rights claim to fall apart. Add to that the judge's finding that the former players were well-aware that game footage and interviews would be used in future broadcasts or publications before participating in the games or the interviews and you have a slam dunk dismissal. Even so, Judge Magnuson wasn't done. Further, and not insignificantly, the judge finds a third reason why the lawsuit must fail. The judge writes that the NFL has the right to exploit "copyrighted game footage in expressive works such as the NFL Films productions at issue here. The NFL’s valid copyright in the game footage forecloses Plaintiffs’ publicity claims." While I'm no fan of the current state of copyright in this country, seeing one form of intellectual property cannibalize another, more horrible form of IP is admittedly entertaining. Now, the NFL wins this case, but as the article points out, the NCAA may be the most interested observer in the metaphorical courtroom. The college sports megalith is in the middle of appealing the O'bannon case that is currently preventing me from playing NCAA Football '15 and could theoretically bring the association to its knees, all while giving way to an era in which college athletes get paid for their service. The NCAA's entire argument in that case rested on First Amendment grounds, which would appear to be bolstered by this NFL win.

DV.load("//www.documentcloud.org/documents/1341908-242844379-dryer-sj.js", { width: 560, height: 550, sidebar: false, text: false, container: "#DV-viewer-1341908-242844379-dryer-sj" }); 242844379 Dryer SJ (PDF)
242844379 Dryer SJ (Text)

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Categorieën: Technieuws

EU leaders reach 2030 deal on climate and energy

van EU Observer - 14 uur 59 min geleden
EU leaders have agreed to cut greenhouse emissions by 40 percent by 2030, but poorer states won concessions, while green NGOs voiced dismay.


Categorieën: Europees nieuws

Merkel criticises Putin for broken promise on Ukraine

van EU Observer - 14 uur 59 min geleden
Most EU leaders on Thursday criticised Russia’s non-compliance with peace accords in Ukraine, but Italy called for re-engagement with Moscow.


Categorieën: Europees nieuws

[Ticker] No comment from Barroso on extra €2 billion from UK

van EU Observer - 15 uur 26 min geleden
When asked about a one-off €2 billion top-up the United Kingdom is to make to the EU budget, as reported by the FT on Thursday evening, European Commission president Barroso gave no comment. "It's the first time I've heard about that", he said at a press conference early Friday.


Categorieën: Europees nieuws

DailyDirt: DIY Space Exploration

van TechDirt - 16 uur 58 min geleden
The cost of getting an object into space is getting cheaper with time, so it's not too surprising that amateurs are starting to mess around with small satellites and vehicles that reach the edge of the Earth's atmosphere. Amateurs haven't achieved low Earth orbit without the help of actual aerospace companies, but citizen scientists could be getting closer to doing real space science on shoestring budgets. Here are just a few space exploration projects that didn't cost billions of taxpayer dollars. If you'd like to read more awesome and interesting stuff, check out this unrelated (but not entirely random!) Techdirt post via StumbleUpon.

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Categorieën: Technieuws

[Ticker] Van Rompuy: EU deal reached on climate targets

van EU Observer - 17 uur 50 min geleden
EU leaders have reached a deal on climate targets, Council president Van Rompuy announced via Twitter. "Deal! At least 40% emissions cut by 2030", he wrote. "Also agreement on at least 27% renewables, at least 27% energy efficiency & boost to interconnections".


Categorieën: Europees nieuws

[Ticker] Poorer EU states to get pollution permits until 2030

van EU Observer - 17 uur 58 min geleden
The latest draft of summit conclusions, distributed at the leaders' dinner Thursday, says poorer EU states should get free carbon permits until 2030, but the figure from 2020 onward should be no more than 40% of the bulk of available allowances. Previous drafts spoke of no free permits after 2025.


Categorieën: Europees nieuws

[Ticker] EU money to pay for Baltic, Iberian electricity connectors

van EU Observer - 18 uur 5 min geleden
A third draft of summit conclusions, presented to EU leaders at dinner Thursday, tasks the European Commission with proposing "possibilities of the EU financing" electricity interconnectors between the Baltic states, Portugal, Spain, and the rest of Europe. Connectors are to cover 10% of installed capacity "no later than 2020".


Categorieën: Europees nieuws

Judge: The Supreme Court Has Said Aereo Must Die, So Go Die

van TechDirt - 18 uur 10 min geleden
This isn't a huge surprise, given Judge Alison Nathan's recent comments during the Aereo hearing, but Judge Nathan has now basically granted the networks what they want -- a pretty broad injunction (pdf) against Aereo.

Judge Nathan doesn't buy the "okay, the Supreme Court said we looked like a duck, so now we'll pay like a duck" argument. To begin with, Aereo's argument suffers from the fallacy that simply because an entity performs copyrighted works in a way similar to cable systems it must then be deemed a cable system for all other purposes of the Copyright Act. The Supreme Court's opinion in Aereo III avoided any such holding.

[....]

the Supreme Court in Aereo III did not imply, much less hold, that simply because an entity performs publicly in much the same way as a CA TV system, it is necessarily a cable system entitled to a § 111 compulsory license.... Stated simply, while all cable systems may perform publicly, not all entities that perform publicly are necessarily cable systems, and nothing in the Supreme Court's opinion indicates otherwise.
The court also makes quick work of Aereo's DMCA defense, noting that Aereo never even bothered to make a complete showing for how it could possibly be eligible for the DMCA's safe harbors. The judge doesn't fully grant the networks' request, but comes pretty close. Therefore, while Plaintiffs may have a viable argument that even Aereo's fully time-shifted retransmission of Plaintiffs' copyrighted works violates Plaintiffs' public performance right, the Court will not reach the issue at this preliminary stage of the litigation. Plaintiffs will be held to their earlier decision, strategic or otherwise, to seek a preliminary injunction limited in scope to enjoining retransmission of their copyrighted works while the works are still being broadcast.

Likewise, Aereo cannot limit the scope of the preliminary injunction to anything short of the complete airing of the broadcast despite its contention at oral argument that the Supreme Court intended "near-live retransmission" to mean something less than a ten-minute delay. See, e.g., 10/15/14 Tr. 27 :22-24 ("So that nothing is transmitted within ten minutes of the beginning of the program, for example. That would be one way theoretically to handle it."). The preliminary injunction that was before the Supreme Court contemplated enjoining retransmission of Plaintiffs' copyrighted works while the works are still being broadcast and that is the injunction that will issue now. The questions involving the scope of the permanent injunction that Plaintiffs seek in this litigation can be addressed quickly, and finally, by this Court in short order following the close of discovery. As a matter of sound case management, the Court declines to address the broader scope question now, before the factual record is closed, and without the benefit of fuller briefing on the matter.
In short, it's what was said at the hearing last week: the Supreme Court made it pretty clear that Aereo should die, so the judge is going to help make that happen.

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Categorieën: Technieuws

South Stream driving wedge between EU and Balkan hopefuls

van EU Observer - 18 uur 20 min geleden
Macedonia has become the latest Balkan country to receive a stark warning on the implications of building South Stream for its EU future.


Categorieën: Europees nieuws

[Ticker] UK has to add €2 billion to EU budget

van EU Observer - 18 uur 28 min geleden
The United Kingdom has to contribute a one-off €2.1 billion top-up to the EU budget, now that the method for calculating gross national income has changed, the FT reported on Thursday. The Netherlands has to pay €642 million, while France will receive a €1 billion refund.


Categorieën: Europees nieuws

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