Reproductive Genetic Screening: More Questions Than Answers

Lots of Babies

The Genomics Law Report has published a couple of guest commentaries recently dealing with genetic screening—a topic our own Adam Doerr also addressed in two posts this summer dealing with “wrongful life” claims brought against sperm banks by children with genetic diseases inherited from their donor fathers. Such claims are premised on the failure of the sperm bank to conduct genetic screening that could have detected the defective genes—thereby avoiding the conception of the child on whose behalf the wrongful life claim is brought.

In this post, I look at a recent gamete screening controversy—the revelation that a man fathered at least two dozen children, all but two through the donation of his sperm to a bank, despite having a potentially serious genetic defect—and examine numerous issues the story raises. Many relate to whose interests are valued the highest. Should the wellbeing of the children born of the process—the only people involved who have no say in the matter—come first, or does respect for the autonomy of the parents control? I do not attempt to answer the questions posed, but seek to encourage discussion with respect to the need for clearer policies and guidance in a number of these areas.

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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, International Developments, Legal & Regulatory

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

What Happens if a DTC Genomics Company Goes Belly Up?

The following post was originally published in three parts on September 14, 15 and 16 in Genetic Future.

BankruptcyDirect-to-consumer (DTC) genomics companies are not immune to the current recession. When TruGenetics, a new player in the DTC genomics space, announced in June that it would be handing out 10,000 free genome scans, both Genetic Future and the Genomics Law Report raised questions about the financial viability of its business model, particularly in the current economic climate. Sure enough, on August 21, TruGenetics announced that it had been unable to secure funding sufficient to support its business model as contemplated. Frequent readers know that TruGenetics is not the only DTC genomics company that is struggling. The financial struggles of deCODE Genetics have been well chronicled (see here, here and here) and even new market leader 23andMe has undergone a dramatic shift in its top management as it pursues a new round of financing.

Ultimately, it was a recent headline here at Genetic Future—“deCODE Genetics on the brink of insolvency”—that started us thinking: what would happen if an established DTC genomics company actually went bankrupt? More specifically, what would happen to the genomic (and other) data held by the company? Genomic data is likely to be the company’s most valuable asset. Can that data be sold off to help meet the company’s debts? Bankruptcy can be a confusing and arcane process, with real risks and uncertainties for companies, their creditors and their customers.

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Filed under Direct-to-Consumer Services, Genomics & Society, Legal & Regulatory, Patents & IP, Privacy, Uncategorized

What Happens When a Personal Genomics Company Goes Bankrupt

The first and second installments of a three-part series of guest posts by GLR contributors Daniel Vorhaus and Lawrence Moore are up today at Daniel MacArthur’s excellent Genetic Future blog. In this series, we consider what would happen to all of the personal information provided by customers of a personal genomics company if the company went bankrupt. In part one of the series, posted yesterday, we considered the legal relationship between consumer and company and reviewed the privacy policies of TruGenetics and 23andMe. In part two, we get into the legal issues governing the consumer information under the bankruptcy laws. Tomorrow, in the final post in the series, we discuss what all this means for consumers of personal genomics companies.

Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Legal & Regulatory, Privacy