A Constitutional Challenge to Alaska’s Genetic Privacy Statute

As part of its defense of a class action lawsuit that began in 2014, a genetic genealogy company (or DNA ancestry company as they are sometimes called) is challenging the constitutionality of the Alaska Genetic Privacy Act, arguing that the statute’s provisions are unconstitutionally vague. The State of Alaska is intervening in the lawsuit to defend the statute.

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 »

Filed under Genetic Testing/Screening, Genomics & Society, Informed Consent, Pending Litigation, Privacy

The EEOC’s Final Rule on GINA and Employer-Sponsored Wellness Programs to Take Effect This Month

Gina name tagOn May 17, 2016, the Equal Employment Opportunity Commission (EEOC), which is the agency charged with enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), issued a final rule changing how employers can set up incentives for the wellness programs they sponsor for their employees.

As previously reported on Genomics Law Report, on October 30, 2015 the EEOC had issued a proposed rule to amend the GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs. The EEOC indicated it had received more than 3000 public comments before the close of the comment period on January 28, 2016.

In short, the final rule allows employers to offer financial and in-kind incentives for an employee’s spouse to provide information about the spouse’s current or former health status as part of a health risk assessment in connection with a voluntary employer-sponsored wellness program so long as certain requirements are met.
Read the rest of this entry »

Filed under Genomic Policymaking, Genomics & Medicine, GINA, Legal & Regulatory, Privacy, Privacy, Privacy

Genetic Discrimination Case Against School District is Appealed to Ninth Circuit

classroom-1534186As Stephanie M. Lee reported for Buzzfeed in a well-written account (which contains links to the relevant court documents), an appeal was filed in January with the Ninth Circuit Court of Appeals in the case of Chadam v. Palo Alto Unified School District (4:13-CV-04129-CW). At issue in the case is whether the school district violated a boy’s rights when it decided to force him to transfer schools. The student’s parents allege the transfer decision was because he is a carrier of a genetic variant associated with Cystic Fibrosis or CF (although he has not exhibited symptoms of the disease), and the appeal argues the trial court erred in dismissing the complaint that the school district’s decision to transfer violated his rights under Title II of the American’s with Disabilities Act or ADA (42 U.S.C.A. §12131 et seq.), Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794), and the First Amendment of the U.S. Constitution. At the trial court level, the school district successfully defended its decision to transfer the boy by arguing it relied on medical advice and made the decision in an attempt to protect other children at the school who have CF.
Read the rest of this entry »

Filed under Badges, Genomics & Medicine, Genomics & Society, GINA, Privacy

EEOC Tries to Harmonize ACA’s Promotion of Employer Wellness Programs with GINA’s Ban Against Employer Access to Genetic Information of Employees and Employees’ Family Members

Gina name tagThe Equal Employment Opportunity Commission (EEOC) is responsible for enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), which prohibits employers from requesting genetic information (defined broadly) from their prospective, current, or former employees. GINA contains only six limited exceptions to this prohibition, one of which is an exception for wellness programs in which the employee’s participation is voluntary.

On October 30, 2015 the EEOC issued a proposed rule to amend GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs.
Read the rest of this entry »

Filed under Badges, General Interest, GINA, Legal & Regulatory, Privacy, Privacy, Privacy

The Burden of Enforcing GINA: EEOC v. Nestle Illustrates One Challenge in Pursuing Genetic Discrimination Claims

The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law making it illegal for insurers and employers to acquire and to use genetic information in certain contexts. Specifically, Title II of GINA prohibits employers with more than 15 employees, employment agencies, labor organizations, and joint labor-management training and apprenticeship program committees from using genetic information when making employment decisions (e.g. hiring, firing, promotions, placement, compensation, privileges, seniority, etc).

The employment discrimination provisions took effect on November 21, 2009, with an air of uncertainty, as the Final Rules implementing Title II of GINA were not issued by the Equal Employment Opportunity Commission (EEOC) until a year later (See 75 Fed Reg 68912-68939 [pdf], issued November 9, 2010) and did not take effect until January 10, 2011. (See previous GLR coverage of GINA Title II here and of GINA generally here).


Read the rest of this entry »

1 Comment »
Filed under Genetic Testing/Screening, Genomics & Society, GINA, Legal & Regulatory, Pending Regulation, Privacy

On Genetic Rights and States: a Look at South Dakota and Around the U.S.

SD H.B. 1260, introduced in South Dakota on January 26, 2012, is an act that would govern the use of genetic information. By any standards – and especially by legislative standards – the two-page bill (pdf) is succinct and should not be considered a state variation of GINA, as the bill does not speak to non-discrimination issues.

The bill’s brevity should not, however, be mistaken for a narrowness of purpose. In under 200 words, the South Dakota bill, if passed, would (1) grant property rights to individuals in their DNA samples and genetic information, (2) prohibit surreptitious testing, (3) call into question many forensic and law enforcement uses of DNA, (4) eliminate newborn blood spot screening without explicit consent and (5) impose broadly worded informed consent requirements on all collections and uses of individual genetic data. So much for inefficient government.
Read the rest of this entry »

Filed under Biobanking, General Interest, Genomic Policymaking, Genomics & Society, Industry News, Informed Consent, Legal & Regulatory, Pending Regulation

Alabama’s “Genetic Information Privacy Act” & the Ongoing Need for Personal Genomics Leadership

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Thanks to technological innovation and a corresponding decline in cost, an increasing number of individuals are finding themselves with the task – or at least the opportunity – of accessing and interpreting their own genetic information. Over the past year, several state legislatures have taken notice.

Following on the heels of legislation passed or proposed in California, Vermont and Massachusetts, the Alabama House of Representatives is considering a bill by Representative Henry (pre-filed on January 23, 2012 and scheduled for first read on February 7, 2012) titled the “Genetic Information Privacy Act” (2012 AL H.B. 78). While the bill is relatively brief, its effects as written may reach far beyond those intended.

A New Bar for Informed Consent. First, the bill in its current form would require signature on separate informed consent documents to obtain, retain, or disclose genetic information. As drafted the bill would provide an exception for the insurance industry, permitting a single, integrated informed consent document if the genetic information is being obtained, retained, or disclosed “for the purpose of obtaining insurance” (Page 4, Line 25).


Read the rest of this entry »

Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Industry News, Informed Consent, Legal & Regulatory, Pending Regulation, Privacy

A New Law to Raise GINA’s Floor in California

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a post-doctoral researcher at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Earlier this fall, California Governor Jerry Brown signed SB559 (pdf), the bill referred to as “CalGINA” (i.e., the California Genetic Information Nondiscrimination Act). The bill was double-jointed with AB887 (pdf), the Gender Nondiscrimination Act, which ultimately meant that CalGINA would only take effect if Governor Brown also signed AB887 into law. He did so on October 9, 2011, so both laws are scheduled to take effect on January 1, 2012.
Read the rest of this entry »

Filed under Genomic Policymaking, GINA, Legal & Regulatory, Pending Regulation

News Roundup: Perception Gaps and Progress in Personalized Medicine

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

Personalized Medicine’s Perception Gaps. A new report released this week by the biopharmaceuticals company Quintiles (pdf) examines the perspectives of four key stakeholder groups – biopharma executives (n=200), managed care executives (n=153), physicians (n=503) and patients (n=1,000) – across a wide range of personalized medicine issues.

The report contains a number of interesting statistical nuggets about how these groups perceive their strengths, weaknesses and future role in the advancement of personalized medicine. These include the following:


Read the rest of this entry »

1 Comment »
Filed under General Interest, Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Industry News

Weekly Roundup: UK Insurance Genetics Moratorium Renewed & Breast Cancer Patents, Research in the News

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

UK Insurers Continue Moratorium on Predictive Genetic Tests. In 2008 the United States passed the Genetic Information Nondiscrimination Act (GINA). Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II of GINA addresses the use and misuse of genetic information by employers. In the United Kingdom, which provides universal health coverage through the government-funded National Health Service (NHS), discussion of genetic nondiscrimination has largely focused on the employment context (see, e.g., the 2009 report on Genomic Medicine from the House of Lords). To date, however, the United Kingdom has not enacted a formal prohibition on the use of genetic information by either employers or insurers.


Read the rest of this entry »

1 Comment »
Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, GINA, Industry News, International Developments, International News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP