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

mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes

For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the legal and regulatory landscape in which mHealth technologies reside is only now beginning to take shape.

As mHealth developers, funders and even users consider investing in the field, or including in particular mHealth technologies, they should keep in mind the emergent and fluid nature of the mHealth regulatory landscape. Here, we outline the likely key players and discuss several recent and projected initiatives with respect to the oversight of mHealth technologies:


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Filed under Genomic Policymaking, Genomics & Medicine, Industry News, Legal & Regulatory, Mobile Health, Pending Regulation, Privacy