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

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

Property Rights and the Human Body

11808967A Canadian court made headlines this month when it decided, as a preliminary matter, that human tissue removed from the body for diagnostic medical tests is “personal property” that belongs to the hospital where the procedure was performed. The case was a medical negligence action brought against two doctors by the estate of Snezana Piljak, a woman who was diagnosed in 2009 with colorectal cancer and died in 2011. At issue in the case is whether the doctors were negligent in failing to diagnose the cancer in 2008 when a colonoscopy was performed on Ms. Piljak. The doctors had petitioned the Canadian court for access to liver tissue biopsied from Ms. Piljak in 2009 at Toronto’s Stonybrook Hospital. The court had to address the matter of tissue ownership before it could consider whether the defendant-doctors had a right to access the liver tissue in order to investigate whether Ms. Piljak had hereditary non-polyposis colorectal cancer (HNPCC or Lynch Syndrome). If the HNPCC were indicated by an examination of the tissue, the defendant-doctors would use that fact to mount a defense against the accusations of negligence. The court ruled that the tissue was personal property of the hospital (though it ultimately denied the defendant-doctors’ request to examine it for technical reasons). The decision that human tissue is “personal property” has important legal ramifications that might affect the biotech industry and genetic research community outside of Canada. The question of ownership of biospecimens has often been tangled up with the status of the biospecimens as personal property, though they are distinct questions.
Read the rest of this entry »

Comments Off on Property Rights and the Human Body
Filed under Biobanking, Genomics & Medicine, Genomics & Society, Patents & IP, Privacy

Biometrics: A Developing Regulatory Landscape for a New Era of Technology

eyeball_nJames Bond and Ethan Hunt have been using facial recognition, fingerprint scanning, and optical readers for years on the silver screen. In the real world, the use of technology that identifies unique physical characteristics of individuals (“biometrics”) is rapidly becoming more prevalent. In fact, the Department of Homeland Security uses facial scanning to identify potential terrorists, federal agencies have adopted fingerprint technology to confirm the identity and immigration status of aliens, and private entities have begun implementing palm and retina scanners and other identifiers to complete financial transactions or control access to secure information. Even the new iPhone 5 contains “Touch ID” technology, where a sensor quickly reads the user’s fingerprint and automatically unlocks the phone for the correct fingerprint.
Read the rest of this entry »

Comments Off on Biometrics: A Developing Regulatory Landscape for a New Era of Technology
Filed under Bioinformatics/IT, General Interest, Privacy

Judicial and Legislative Reactions in California to Maryland v. King, 133 S. Ct. 1958 (2013)

window where the light gets inThis year’s first news in the area of genetics and criminal law comes to us from California, where both the judicial and legislative branches are reacting to the U.S. Supreme Court decision in Maryland v. King. In Maryland v. King, the Supreme Court upheld DNA fingerprinting as a routine booking procedure for serious crimes as authorized by Maryland’s DNA Collection Act. Justice Kennedy’s opinion in King indicated it was intended to be a narrow ruling, focused on the specific facets of Maryland’s state statute. This narrow scope effectively left other DNA fingerprinting schemes open to constitutional challenges if they could be distinguished from the details of the Maryland statute. Among those schemes are California’s Proposition 69 and the Federal DNA Fingerprint Act of 2005. The latter scheme was upheld en banc (all the judges of the circuit sitting together, rather than in the usual three-judge panel) by the Third Circuit Court of Appeals in United States v. Mitchell in 2011 (United States v. Mitchell, 652 F.3d 387 (3rd Cir. 2011) (en banc), pet. for cert. filed (Nov. 22, 2011) (No. 11-7603, 11A384), cert. denied – S.Ct. – (Mar. 19, 2012).
Read the rest of this entry »

Comments Off on Judicial and Legislative Reactions in California to Maryland v. King, 133 S. Ct. 1958 (2013)
Filed under Genetic Testing/Screening, Genomics & Society, Privacy

Genomic Research Ethics: Special Rules for HeLa Cells

In her 2010 book The Immortal Life of Henrietta Lacks, Rebecca Skloot told the story of Henrietta Lacks and the cell lines derived from her cervical tumor biospecimen (cell lines known to scientists simply as “HeLa cells”). To make a long story short, in 1951 physicians at Johns Hopkins Hospital took a biopsy from a patient, Henrietta Lacks, and from that biospecimen developed the first human cancer cell line. The biospecimen was taken without Lacks’ knowledge or informed consent. No laws were broken in the creation of the HeLa cell lines that are now recognized (pdf) as “the most widely used human cell line in the world.” She died in 1951, and it was reportedly not until 1973 that her family learned about the HeLa cells (two years after Henrietta Lacks’ name was published as the source of HeLa cells in a scientific journal). As the table below shows, this incident occurred long before the adoption of regulations and ethical guidelines for biomedical research that, today, generally require researchers to obtain voluntary, informed consent from individuals before performing biomedical experiments.
Read the rest of this entry »

Comments Off on Genomic Research Ethics: Special Rules for HeLa Cells
Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Informed Consent, International Developments, Pending Regulation, Privacy

Ninth Circuit Orders Rehearing of Haskell v. Harris

1037193_dna_fingerprint_5When the Supreme Court issued the Maryland v. King opinion on June 3, 2013 upholding Maryland’s DNA Collection Act, numerous cases were pending in which similar DNA fingerprinting upon arrest statutes in other jurisdictions were being challenged. The dissenting justices encouraged cases to press forward and give the Court an opportunity to change its current Fourth Amendment course, with Justice Scalia writing, “I … hope that today’s incursion upon the Fourth Amendment, like an earlier one, will some day be repudiated.” It was only a matter of time for us to see just what the impact of the Maryland v. King decision will be.
Read the rest of this entry »

Comments Off on Ninth Circuit Orders Rehearing of Haskell v. Harris
Filed under General Interest, Genomics & Society, Privacy

DNA Fingerprinting as Routine Arrest Booking Procedure Upheld as Anticipated

1037193_dna_fingerprint_5

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.

Oral arguments in Maryland v. King were held on February 26, 2013, as reported previously here on GLR. Following oral arguments, I stated, “If forced to predict, I would anticipate a split decision that uses a broad definition of ‘identification’ and upholds this ‘fingerprint for the 21st Century;’ however, I haven’t the foggiest as to whether a biometric identification exception will be created or whether a balancing test will be applied to reach that decision.
Read the rest of this entry »

Comments Off on DNA Fingerprinting as Routine Arrest Booking Procedure Upheld as Anticipated
Filed under Genomics & Society, Privacy