Source: https://www.genomicslawreport.com/index.php/category/general-interest/
Timestamp: 2017-07-21 14:31:56
Document Index: 306866542

Matched Legal Cases: ['§18', '§18', '§18', '§18', '§12131', '§ 794', '§12131', '§ 794']

General Interest - Genomics Law Report A publication of the law firm
The Alaska Genetic Privacy Act (AK ST §18.13.010 et seq.) was passed into law in 2004. The state statute imposes a consent requirement that effectively prohibits surreptitious genetic testing and declares that a DNA sample and the results of any genomic analysis are the “exclusive property of the person sampled or analyzed.” More specifically, it requires prior written informed consent for the collection, analysis, retention, or disclosure of DNA samples and test results. The statute makes exceptions to the consent requirement for DNA identification registries like CODIS, law enforcement purposes, paternity testing, newborn screening, and emergency medical services. There are both civil and criminal enforcement mechanisms in the statute. Affected individuals can bring private civil court actions against violators of the statute (AK ST §18.13.020), while another provision criminalizes violations as Class A Misdemeanors (AK ST §18.13.030). The statute (AK ST §18.13.020) provides that a victim is entitled to compensation from the violator in the amount of $5,000 or, in instances in which the violation “resulted in profit or monetary gain to the violator,” $100,000. Read the rest of this entry »
Posted by Jennifer Hutchens on May 16, 2017
In a recent conversation with John Conley about his April 25 post on the ACB v. Thompson Medical ruling by the Court of Appeal of Singapore, I made a couple of points, and he asked me to write them up to briefly comment on the topic for the Genomics Law Report.
First, the real damage caused by loss of genetic affinity is that the couple’s baby will never share any of the inherited (genetic) traits of the husband. For the mother who brought the case, this is significant because those traits (presumably) are an important part of the couple’s initial attraction and, ultimately, the mother’s implicit desire to have a child with a man with those specific traits. For the husband, of course–who is not the named plaintiff–the fact that the child is not biologically related to him is an even more definitive loss.
Second, it is curious that the husband was not the plaintiff (or at least a plaintiff) in the case. Given that his total genetic exclusion was not by his choosing, it could be argued that the husband was even more injured than the mother. After all, it is the husband who had the total “fracture of biological parenthood,” not the mother, as she has provided 50% of the child’s genetic makeup.
Jennifer Hutchens is a Robinson, Bradshaw lawyer who focuses on health care and life sciences.
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We mentioned in January that the Ninth Circuit Court of Appeals reversed the District Court’s earlier decision to grant a motion to dismiss and is instead allowing the case of Chadam v. Palo Alto Unified School District to move forward. At that time, we explained that this case should remain high on the watch list for genetic rights advocates, as it involves whether a genotype (such as carrier status for an autosomal recessive condition like cystic fibrosis) is a “perceived disability” under the Americans with Disabilities Act (42 U.S.C.A. §§12131 et seq.) and Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794). Read the rest of this entry »
In its March 22, 2017 decision in ACB v. Thomson Medical, the Court of Appeal of Singapore (the city-state’s supreme court) approved an award of damages for loss of “genetic affinity” against a fertility clinic that negligently fertilized a mother’s egg with sperm from an anonymous donor rather than her husband. The plaintiff and her husband had sought help from the four defendants, a group of related medical entities and practitioners, to conceive a child in vitro. The wife is an ethnically Chinese Singaporean and the husband is a Caucasian of German descent. After multiple attempts at fertilization, the wife gave birth to a baby girl (referred to in the opinion as “Baby P”). The family noticed that Baby P’s skin tone did not match that of either parent, nor that of their older child. They also learned that Baby P had a blood type that could not be reconciled with the parents’ types. Further medical investigation revealed that the wife’s egg had been fertilized not with the husband’s sperm, as the couple had intended, but with the sperm of an anonymous donor of Indian ethnicity. Read the rest of this entry »
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A few noteworthy events have occurred since our last coverage in February 2016. The two sides are engaged in what is called an interference proceeding. The U.S. Patent and Trademark Office (USPTO) determined preliminarily that the two sides were claiming patent rights to the same technology and initiated the interference to let them fight over who had priority. Under the pre-2013 version of the Patent Act that applies here, the key question would be who invented first. Read the rest of this entry »
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Posted by John Conley on March 29, 2017
On January 18, 2017, in one of its last official acts, the outgoing Obama administration issued a final revised version of the Common Rule—the regulation that governs the treatment of human subjects in all federally funded research. This was the culmination of a process that began in 2011 when the Department of Health and Human Services (HHS) issued an Advance Notice of Proposed Rulemaking, or ANPRM, that envisioned major changes to the original 1991 Common Rule. Then, on September 8, 2015, HHS and 15 other federal departments and agencies released a Notice of Proposed Rule Making (NPRM) that proposed specific changes to the Common Rule and opened a 90-day public comment period. Read the rest of this entry »
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Filed under Genomics & Medicine, Informed Consent, Patents & IP
Genetic nondiscrimination laws are stronger in California than anywhere else in the United States. CalGINA (S.B. 559), which took effect five years ago, extended genetic nondiscrimination rights beyond the narrow scope of the federal statute known as GINA, the Genetic Information Nondiscrimination Act of 2008, which prohibits genetic discrimination in employment and health insurance contexts. However, this case was interesting to Genomics Law Report largely because the plaintiffs did not rely on CalGINA in their complaint against PAUSD but instead focused on protections against “perceived disability” provided under the Americans with Disabilities Act or ADA (42 U.S.C.A. §§12131 et seq.) and Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794). The school district had convinced a federal district court to dismiss the complaint, but the plaintiffs filed an appeal in January 2016. Read the rest of this entry »
Posted by Jennifer K. Wagner on August 4, 2016
The premise underlying the draft guidance is the controversial and—as yet—legally untested assertion that genomic analyses of all kinds are “medical devices” that Congress has, by statute, authorized the FDA to regulate. If they are, then the FDA would have the power to bring them under its current risk-based classification scheme for medical devices or to create a new scheme for them. If they are not medical devices, then the effort to regulate them might exceed the FDA’s statutory authority and conceivably amount to an unconstitutional regulatory overreach. Both draft guidance documents avoid any mention of the overarching debate, a subject covered extensively on Genomics Law Report, surrounding FDA oversight of all laboratory developed tests (LDTs) and in vitro diagnostic multivariate index assays (IVDMIAs). As others have noted, it is impossible to consider these new pieces of draft guidance outside of that context. Nonetheless, even the FDA asserts (via Twitter and elsewhere) that the two new drafts are intended to facilitate the Precision Medicine Initiative (PMI) and are distinct from the agency’s expressed intention to regulate LDTs. These pieces of draft guidance also give a policy-based reason for pause, as they could be another example of governance by guidance, a highly problematic approach as highlighted recently by John Conley with regard to the HIPAA right to access lab data and results. Read the rest of this entry »
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Filed under Badges, Direct-to-Consumer Services, FDA LDT Regulation, General Interest, Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Legal & Regulatory, Pending Regulation
Posted by John Conley on July 18, 2016
Back in April, we reported on some new developments in European Union law that have implications for the life sciences industry. One of these developments was in the privacy area—the final approval of the EU’s new General Data Protection Regulation (GDPR). The GDPR will have enormous significance for medical research and practice, since it will govern the collection and use of health data related to EU citizens. This month has brought a complementary and equally significant development, this time dealing with the transfer of personal data—including health data—from the EU to the U.S.
On July 12, 2016, the European Union announced that it had formally adopted the long-awaited EU-U.S. Privacy Shield to permit the transfer of personal data from EU countries to the United States. Read the rest of this entry »
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Filed under International Developments, Privacy, Privacy, Privacy