If a person has not been arrested, but her DNA information has been collected by one of her healthcare providers such as a primary care physician, diagnostic clinical laboratory, or hospital , that provider may furnish that information to law enforcement only under limited circumstances, with a more formal process. When DNA testing became widely available to police, courts had to decide whether a law enforcement officer could require an individual to provide a DNA sample shortly after an arrest, without a warrant.
The Supreme Court decided that, yes, this is permissible, in a case called Maryland v. King King :. To be clear, King merely decided that the Fourth Amendment permitted the government to collect DNA from arrestees without much formal process of law—unless a state makes such a law with more requirements. In short, federal and state governments remain free to enact laws that aim to strike a balance between the privacy interests of individuals and the public safety interests of communities as long as such laws do not infringe on Constitutional rights, including the right to be free from unreasonable searches and seizures.
Covered entities include health plans, healthcare clearinghouses, and healthcare providers who transmit any health information electronically in connection with a HIPAA-covered transaction.
PHI generally includes individually identifiable health information that is transmitted by or maintained in electronic media or any other form or medium.
Health information specifically includes genetic information. HIPAA permits covered entities or business associates acting on their behalf to make certain disclosures of PHI for law enforcement purposes, but there are significant constraints. The types of information that can be disclosed pursuant to this type of request includes: name and address, date and place of birth, social security number, ABO blood type and rh factor, type of injury, date and time of treatment, date and time of death, and a description of distinguishing physical characteristics.
However, DNA-related information may be disclosed through a more formal process. In other words, with a more formal process—specifically, a court order, court-ordered warrant, subpoena or summons issued by a judicial officer, a grand jury subpoena, or an administrative request—genetic information may be disclosed, as may other types of PHI. But there are thorny issues related to genetic privacy that still today don't have easy answers or iron-clad legislative protections.
And regulators aren't convinced they are doing right by consumers. A recent Fast Company report indicates that 23andMe and Ancestry are being investigated by the Federal Trade Commission over their policies for handling personal info and genetic data and how they share that info with third parties. It identifies you, so if you are going to entrust it to a company, you should try to understand what the consequences are," said Jennifer King, director of consumer privacy at Stanford Law School's Center for Internet and Society, whose research on the issue and interviews with individuals shows a lack of consumer knowledge.
Here are five of the biggest privacy risks for consumers sharing their DNA with testing companies. Obviously, this is not a risk that the genetic-testing industry alone faces, but it is an industry that has a unique set of information on its consumers. And there was a recent hack in the space. More than 92 million accounts from the genealogy and DNA testing service MyHeritage were found on a private server, the company announced earlier this month.
DNA data, specifically, was not breached, the company said. But a hack in this space is a concern, regardless. One of the most compelling signs that consumers have a positive view of these companies is that a majority agree to let them share DNA with researcher partners. All of these companies make clear that they will not share your DNA with any third-party unless you explicitly consent to it, but as 23andMe data shows, the vast majority of consumers opt in — at 23andMe, more than 80 percent.
Ancestry and Veritas do not provide data on the opt-in percentage. They also offer an option to consent separately to specific disease studies in which their DNA is used in conjunction with for-profit drug companies, such as the Parkinson's disease research conducted with Genentech and the lupus and IBD research conducted with Pfizer.
Indigo Agriculture holds the secret to pesticide-free crops. Consumers seem to have made the decision that altruism is the proper course of action: If their DNA can help find a cause of, or cure for, a disease, they want to be part of that process. But it also means that one day a drug company may be bringing a drug to market based, in part, on your DNA. It could be a drug they sell at a high profit but doesn't help the world become a better place.
Veritas Genetics CEO Mirza Cifric said what it learns from research becomes immediately available to consumers through updates to their own genome or publication that moves science forward. Marcy Darnovsky, executive director at the Center for Genetics and Society , said this research process also means that data is shared with and passes through many partners, and in her opinion, no matter what the testing companies say, they can't ensure what those partners are doing with your DNA.
An Ancestry spokeswoman noted that the decision to share DNA for research is not irrevocable, and consumers can request to revoke that permission at any time through their account settings. But King isn't convinced: "Quitting one of these services isn't as simple as just clicking Delete.
How do you verify that they've actually deleted your genetic profile or destroyed a physical sample? Many privacy experts are concerned that the only law currently covering genetic privacy, the Genetic Information Non-discrimination Act also known as GINA is too narrow in its focus on banning employers or insurance companies from accessing this information. There are some select groups of Americans who receive insurance from the government that results in them not being covered by GINA: individuals who receive their insurance through the Federal Employees Health Benefits, the Veterans Health Administration, the U.
However, some of these programs have internal policies that prohibit or restrict genetic discrimination, such as The Office of Personnel Management which oversees FEHB and U. Pitts says that direct-to-consumer testing companies have been less than forthright about these dangers, usually burying privacy disclaimers deep in their contracts and refusing to disclose how long they keep customer data or how it can be used.
New research published in the journal Nature found that genetic-testing companies frequently fail to meet even basic international transparency standards. Those who have agreed to the Informed Consent to Research will not be able to have genetic information removed from active or completed research projects but Ancestry states it would not use it for any new research projects.
Further, federal genetic privacy laws do not apply to life, long-term care or disability insurers. These companies are legally permitted to access genetic testing data and charge people higher prices or deny coverage based on their findings, Pitts said.
Some legislators have recently raised concerns about the privacy implications of DNA testing. While the FDA regulates consumer DNA tests related to health, Schumer wants the Federal Trade Commission to force testing firms to extract all of the buried fine print about how they might distribute DNA data and broadcast it loud and clear.
The state of Minnesota is also exploring legislation around direct-to-consumer DNA testing. Some critics, however, have called out these best practices for being voluntary and for lacking restrictions on the use or release of de-identified data. Both Ancestry and 23andMe have acknowledged the criticism that has come with more widespread use of their products.
But the companies maintain that their customers understand the trade-offs and have the opportunity to opt out at any time. Linda Avey, co-founder of 23andMe, concedes that nothing is foolproof. Based in southwest Florida, Amy has written about sustainability and the Triple Bottom Line for over 20 years, specializing in sustainability reporting, policy papers and research reports for multinational clients in pharmaceuticals, consumer goods, ICT, tourism and other sectors.
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