Privacy

Update on Chadam v. Palo Alto Unified School District

About a year ago we reported on a case involving allegations of genetic discrimination by a school district in California. According to the allegations, in fall 2012 the Palo Alto Unified School District used genetic information regarding cystic fibrosis in deciding to transfer a student away from his neighborhood school to another school.

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 »

Comments Off on Update on Chadam v. Palo Alto Unified School District
Filed under Genomic Policymaking, Genomics & Medicine, Genomics & Society, Pending Litigation, Privacy

FTC Muscles in on Health Privacy

600px-US-FederalTradeCommission-Seal.svgIn its July 29, 2016 decision in LabMD, Inc., the Federal Trade Commission clearly signaled its intent to get more involved in the regulation of health privacy. Specifically, the case indicates that the agency intends to go well beyond its traditional role of protecting consumers against deception and to begin scrutinizing the nuts and bolts of companies’ health data security practices.
Read the rest of this entry »

Comments Off on FTC Muscles in on Health Privacy
Filed under Legal & Regulatory, Pending Regulation, Privacy, Privacy

EU Adopts New Privacy Shield for Data Transfers to U.S.

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 »

Comments Off on EU Adopts New Privacy Shield for Data Transfers to U.S.
Filed under International Developments, Privacy, Privacy, 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 »

Comments Off on The EEOC’s Final Rule on GINA and Employer-Sponsored Wellness Programs to Take Effect This Month
Filed under Genomic Policymaking, Genomics & Medicine, GINA, Legal & Regulatory, Privacy, Privacy, Privacy

Recent Developments in European Law with Implications for the U.S. Life Sciences Industry

Safe HarborThe last several months have seen several developments in European privacy and intellectual property that have significant implications for life sciences interests—both commercial and academic—in this country. Here is a brief review:

1. Final Approval of Pending EU General Data Protection Regulation

On April 14, 2016, the Parliament of the European Union gave final approval to the long-discussed GDPR. It will replace the current regime of country-by-country laws under the 1995 Data Protection Directive. Whereas an EU Directive requires implementation by individual EU member states, the GDPR is a Regulation (much like a federal law in this country) that will take immediate effect in all EU countries in the spring of 2018.
Read the rest of this entry »

Comments Off on Recent Developments in European Law with Implications for the U.S. Life Sciences Industry
Filed under General Interest, International Developments, Legal & Regulatory, Pending Regulation, 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 »

Comments Off on Genetic Discrimination Case Against School District is Appealed to Ninth Circuit
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 »

Comments Off on 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
Filed under Badges, General Interest, GINA, Legal & Regulatory, Privacy, Privacy, Privacy