Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest, Industry News

Privacy & Ownership of an Individual’s Personal Genetic Information

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Jennifer Sweeney, Knome, Inc.

As personal genetic information becomes increasingly accessible and affordable, the ownership and privacy of such data will emerge as a central issue in genomics. Is personal genetic information, stored within a centralized database where a third-party gatekeeper determines who has access, really still private? Who owns such data? Should the individual have control over how, when and where their information is used? In such cases, it certainly seems the individual may have forfeited ownership and rights to control access to their own data.
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Filed under Badges, What ELSI is New?

What Happens When Professors Have Valuable Inventions?

Bench to Market (article)

You are a faculty member at a research university and you have made a significant breakthrough. More specifically, you are on the verge of what might be loosely called an “invention.” It could be anything—a chemical formula, a gene, a medical test or therapy, an engineering advance, or even a method of financial analysis. But its defining elements are that it is new and that it has a potentially useful, real-world application.

So what do you do next? The answer is simple, unequivocal, and unavoidable: Read your university’s patent and invention policy. (It might also be called an intellectual property policy or a technology transfer policy.) In all probability, it became part of your terms and conditions of employment when you were hired.
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Filed under Badges, Bench to Market, Legal & Regulatory, Patents & IP

Finding The Proper Place for Genetics in Insurance

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Mark Henderson, Science Editor for The Times and author of 50 Genetics Ideas You Really Need to Know.

It is a mark of the quality of the science fiction movie Gattaca that, 12 years after its release, so many ethical issues surrounding genetics are still seen through its prism. In Andrew Niccol’s dystopian vision, DNA divides society into “valids” and “invalids”, some of whom are decidedly more equal than others.

Concerns about such genetic discrimination are relevant to many ELSI discussions, but rarely more so than when the subject is insurance. The great fear is that genetic data could create an uninsurable underclass, denied mortgages and life and health cover because of genomic flaws beyond their control.
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Filed under Badges, What ELSI is New?

Back to the Future: NIH to Revisit Genomic Data-Sharing Policy

Back to the Future Clock TowerAs first reported by GenomeWeb, last week the NIH issued a “Notice on Development of Data Sharing Policy for Sequence and Related Genomic Data.” Although the title doesn’t exactly trip off of the tongue, the NIH’s announcement provides an opportunity to review where we are and where we have already been when it comes to genomic data-sharing.

At the heart of the NIH’s announcement is a desire to increase the availability of genomic datasets. From last week’s notice:

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Consistent with the NIH mission to improve public health through research and the longstanding NIH policy to make data publicly available from the research activities that it funds, the NIH has concluded that the full value of sequence-based genomic data can best be realized by making the sequence, as well as other genomic and phenotype datasets derived from large-scale studies, available as broadly as possible to a wide range of scientific investigators.

For NIH-funded genomic researchers, this language should have a familiar ring. In 2007, the NIH published a policy covering data-sharing for genome-wide association studies (GWAS) that required all NIH-funded GWAS research be deposited in a central data repository. Here’s the mission statement from the 2007 policy:
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Filed under Biobanking, Genomic Policymaking, Genomics & Society, Informed Consent, Privacy

Personalized Genomic Medicine and Health Care Justice

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Michelle L. McGowan Ph.D.Case Western Reserve University Department of Bioethics.

The most significant challenge to the promise of personalized genomic medicine hinges on the realization of health care justice. From a social justice perspective, meeting the basic health care needs of the population – locally and globally – is an urgent objective that dwarfs the goal of a genomic approach to medicine.

The challenge to proponents of personalized genomic medicine is to find a way to frame their aspirations and actions in a way that simultaneously moves towards realizing personalized medicine and global health care justice. However, the terminology and current direction of personalized medicine has the potential to hinder this effort.
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Filed under Badges, What ELSI is New?

Federal Privacy Regulation and the Financially Troubled DTC Genomics Company

LockLast month, the Genomics Law Report prepared a three-part series entitled What Happens if a DTC Genomics Company Goes Belly Up?  The series, which was originally published on Genetic Future (see Parts 1, 2 and 3), reviewed the privacy policies of several genomics companies to determine whether they prohibit the transfer of private data to third parties. We also discussed the fact that a bankruptcy court may approve such a transfer notwithstanding a policy to the contrary. In this post, we examine whether federal regulations may restrict the dissemination of private genomic data—including the new rules proposed earlier this month under the Genetic Information Nondiscrimination Act of 2008.

1. Is DTC Getting HIPAA? The Health Insurance Portability and Accountability Act of 1996 (HIPAA), the most prominent federal regulation governing the privacy of medical records, established the Privacy Rule to provide national standards for protected medical records. HIPAA’s Privacy Rule currently applies only to “covered entities” and business associates of covered entities. A covered entity is a health plan, health care clearinghouse, or a health care provider. Since a company providing genomic sequencing services is not a health plan or a health care clearinghouse, HIPAA will apply only if such a company is determined to be a health care provider or a business associate of a covered entity.
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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Pending Litigation, Pending Regulation, Privacy

Education, Not Regulation, Will Benefit Consumers of Recreational Genetics

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Blaine Bettinger, Bond, Schoeneck & King and publisher of  The Genetic Genealogist.

Genetic ancestry testing, the use of DNA to explore an individual’s recent or ancient genetic contributors, has been available to customers for almost a decade but has recently been a topic of much debate among bioethicists. The concerns often center around topics such as privacy, definitions of race, and emotional or psychological effects of test results, among others. These concerns, together with continuing advances in personalized genomics that have the potential to make our DNA an important part of how we shape our identity and interact with society, lead to the question of whether recreational genetics should be regulated in order to prevent any potential harms to consumers. Or, as some argue, will regulations hinder the field without providing any real benefit?
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Filed under Badges, What ELSI is New?

The Direct to Consumer Disconnect: Why the genomics community is going to have trouble talking to patients and doctors alike

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Matthew Herper, Forbes.

We can sequence DNA cheaper and faster, and even deal with all the data.

But if genomics is really going to impact medicine, we’re going to have to start bridging the gap between the companies and scientists doing this early work and the traditional medical establishment. The genoscenti like to talk about how everyone should have access to his own DNA. Your genes are a part of you, they say. How could they belong to anyone else?
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Filed under Badges, What ELSI is New?

Medical vs. “Recreational” Genomics: Drawing a Line in the Sand

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Allie Janson, University Health Network/Mount Sinai Hospital’s Fred A. Litwin Family Centre in Genetic Medicine and DNA Exchange.

To me, one of the most interesting aspects of genomics is the potential for it to be both medical and recreational in nature. Direct-to-consumer companies have picked up on the recreational aspect of genomics and run with it—successfully marketing their service as a fun and interesting glimpse “inside oneself.” Understandably, the medical community has been, and will be, slower and more cautious about incorporating weak gene variant-disease associations into medical care. However, as the 1000$ genome comes barrelling towards hospital doors, physicians may no longer have a choice. Patients will present with a symptom and a genome print-out in hand, and demand answers.
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Filed under Badges, What ELSI is New?