Comments on: Now For Sale at Fire Sale Prices: Thousands of People’s Genomes http://blogs.discovermagazine.com/80beats/2009/11/18/now-for-sale-at-firehouse-prices-thousands-of-peoples-genomes/ 80beats is DISCOVER's news aggregator, weaving together the choicest tidbits from the best articles covering the day's most compelling topics. Tue, 14 Feb 2012 16:42:50 +0000 hourly 1 http://wordpress.org/?v=3.2.1 By: Edward Farmer http://blogs.discovermagazine.com/80beats/2009/11/18/now-for-sale-at-firehouse-prices-thousands-of-peoples-genomes/comment-page-1/#comment-70325 Edward Farmer Fri, 20 Nov 2009 11:09:21 +0000 http://blogs.discovermagazine.com/80beats/?p=6061#comment-70325 A quick but fundamental clarification to your piece on deCODE genetics' bankruptcy filing: the Iceland-based subsidiary that performs all of deCODE's human genetics work - manages its population resources, conducts its research and services, offers and processes its tests and genome scans, and whose scientists and laboratories are licensed to undertake this work - is not in bankruptcy. It continues all its operations without interruption. This subsidiary (Islensk Erfdagreining, or IE) does so under the same data and privacy protections as ever, rooted in the Icelandic community and within a tried and tested regulatory environment. The long and the short of it is that under the Chapter 11 process, IE, currently owned by deCODE genetics, will likely be sold to another group of investors as a going concern. Such a change in ownership of the operating company will have no bearing on the terms under which the Icelandic subsidiary manages and analyzes samples and data. Indeed, given the tone of your story it seems important to emphasize that the Icelandic subsidiary does not own these samples or data. They are owned by the individuals who provide them and are only utilized for the specific purpose, whether research or testing, agreed upon with those individuals and under the regulatory protections under which we work. Thus these resources cannot be sold and are not for sale, and IE's genetics operation cannot be put in a box and taken somewhere else. Yours sincerely, Kari Stefansson CEO, deCODE genetics A quick but fundamental clarification to your piece on deCODE genetics’ bankruptcy filing: the Iceland-based subsidiary that performs all of deCODE’s human genetics work – manages its population resources, conducts its research and services, offers and processes its tests and genome scans, and whose scientists and laboratories are licensed to undertake this work – is not in bankruptcy. It continues all its operations without interruption. This subsidiary (Islensk Erfdagreining, or IE) does so under the same data and privacy protections as ever, rooted in the Icelandic community and within a tried and tested regulatory environment.

The long and the short of it is that under the Chapter 11 process, IE, currently owned by deCODE genetics, will likely be sold to another group of investors as a going concern. Such a change in ownership of the operating company will have no bearing on the terms under which the Icelandic
subsidiary manages and analyzes samples and data. Indeed, given the tone of your story it seems important to emphasize that the Icelandic subsidiary does not own these samples or data. They are owned by the individuals who provide them and are only utilized for the specific purpose, whether
research or testing, agreed upon with those individuals and under the regulatory protections under which we work. Thus these resources cannot be sold and are not for sale, and IE’s genetics operation cannot be put in a box and taken somewhere else.
Yours sincerely,
Kari Stefansson
CEO, deCODE genetics

]]> By: Deborah C. Peel, MD http://blogs.discovermagazine.com/80beats/2009/11/18/now-for-sale-at-firehouse-prices-thousands-of-peoples-genomes/comment-page-1/#comment-69876 Deborah C. Peel, MD Thu, 19 Nov 2009 00:04:46 +0000 http://blogs.discovermagazine.com/80beats/?p=6061#comment-69876 Congress passed a ban on the sale of protected health information in the stimulus bill. The idea was to prevent sales of Americans' sensitive health information by corporations, UNLESS they get our consent. The Coalition for Patient Privacy pushed for this consumer protection. So DeCode can still sell Icelanders' genomic data, but not Americans' genomic data. See: the letter from the bipartisan Coalition for Patient Privacy, representing 10 million Americans, that pressed Congress for this and other new consumer protections to stop the worst abuses of patient privacy in electronic health systems. URL: http://www.patientprivacyrights.org/site/DocServer/CoalitionPatPriv_Final01.14.09.pdf?docID=4701 * American Recovery & Reinvestment Act, H.R. 1 (stimulus bill) 2/17/09: On February 17, 2009 President Barack Obama signed the stimulus bill, the American Recovery & Reinvestment Act into law. Over $19 Billion is included in this bill to promote health IT, and overall, it is a positive step forward. The privacy protections Congress passed are the first major step towards safeguarding our basic, fundamental rights to keep our health matters private in federal law. This new law: * Prohibits the sale of our medical records without consent. There are exceptions for research, public health and treatment. * Limits marketing. * Requires any entity using an EHR (covered entities and business associates) to keep an audit trail of all people and organizations with whom they share your information. * Requires the policy committee to consider setting standards for technology systems to segment sensitive information so we can easily keep an x-ray tech from seeing our pap smear results. * Requires the policy committee to consider setting standards for encryption of data. * Increases monetary penalties for violations, grants Attorneys General authority to file suit on behalf of a state’s citizens, requires monitoring of contracts and reporting on compliance. * Grants funds for non-profits to participate in the regulatory process. * Requires breach notification. Congress passed a ban on the sale of protected health information in the stimulus bill. The idea was to prevent sales of Americans’ sensitive health information by corporations, UNLESS they get our consent. The Coalition for Patient Privacy pushed for this consumer protection.

So DeCode can still sell Icelanders’ genomic data, but not Americans’ genomic data.

See: the letter from the bipartisan Coalition for Patient Privacy, representing 10 million Americans, that pressed Congress for this and other new consumer protections to stop the worst abuses of patient privacy in electronic health systems. URL: http://www.patientprivacyrights.org/site/DocServer/CoalitionPatPriv_Final01.14.09.pdf?docID=4701

* American Recovery & Reinvestment Act, H.R. 1 (stimulus bill)

2/17/09: On February 17, 2009 President Barack Obama signed the stimulus bill, the American Recovery & Reinvestment Act into law. Over $19 Billion is included in this bill to promote health IT, and overall, it is a positive step forward. The privacy protections Congress passed are the first major step towards safeguarding our basic, fundamental rights to keep our health matters private in federal law. This new law:

* Prohibits the sale of our medical records without consent. There are exceptions for research, public health and treatment.
* Limits marketing.
* Requires any entity using an EHR (covered entities and business associates) to keep an audit trail of all people and organizations with whom they share your information.
* Requires the policy committee to consider setting standards for technology systems to segment sensitive information so we can easily keep an x-ray tech from seeing our pap smear results.
* Requires the policy committee to consider setting standards for encryption of data.
* Increases monetary penalties for violations, grants Attorneys General authority to file suit on behalf of a state’s citizens, requires monitoring of contracts and reporting on compliance.
* Grants funds for non-profits to participate in the regulatory process.
* Requires breach notification.

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