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Twenty years ago, you have about a one in six chance of knowing someone who has had his DNA sequenced. Today, almost all Americans can name a person who has undergone some form of genetic testing.
The rise of DNA data is causing increasing concern among legal experts that the United States is not effectively protecting consumers from the many privacy risks they face. "In the name of heaven, what is the law in genomics? It's not easy to answer this question, "said Susan M. Wolf to an audience at the University of Minnesota last Thursday, where he is a professor of law and health policy. "We have 50 states. Several federal agencies are involved. Because of the mosaic of laws, genetic anonymity is almost never guaranteed. But the legal landscape is so fragmented that to remedy this situation, the first problem is to determine which rules apply to which data.
Megan Molteni covers genetic technology, medicine and sharks for WIRED.
Thus, Wolf and dozens of other lawyers, doctors and other players in the DNA testing world have spent the last three years building a searchable public database of all federal laws, regulations, guidelines and professional standards. currently governing the field of genomics. . The project, called LawSeq, also assesses the sector's most important legal challenges and seeks consensus on how decision-makers should consider a future rich in DNA. The project, funded to the tune of $ 2 million by the National Institutes of Health, addresses other aspects of genetic data law, but it is the privacy debate that dominated the third and The group's last conference in Minneapolis last week, which coincided with the one-year anniversary of the arrest of the Golden State Killer, using genetic evidence.
"In the United States, we have chosen to protect genetic information separately rather than resorting to more general privacy laws, and most people who have taken a look at it concluded that it was a very bad idea, "said Mark Rothstein, law professor at Brandeis. Director of the Institute of Bioethics, Health Policy and Law of the University of Louisville. On the other hand, the European Union has designated DNA as personal data and has made its alleged illegal collection illegal in the context of the recent overhaul of consumer protection. In the United States, different laws govern genetic data based on their location and use. "It's basically a shortcut, because lawmakers here do not want to pass general legislation," Rothstein said.
The problem with this system lies in the fact that genetic data can have multiple uses other than the original ones. Suppose you participate in a research study or a clinical trial that generates DNA data. A federal law protecting human subjects, called the United States Common Rule, requires that you be informed of how your data could be shared before signing a consent document. In 2016, Congress passed the 21st Century Treatment Act, which also provides all federal research subjects with a confidentiality certificate. This prevents researchers collecting your genetic data from communicating them to law enforcement agencies or other government agencies. And if this information were to be obtained illegally, through hacking or other violation, it would be inadmissible in court.
But let's say you want to add this genetic information to your electronic health record so that it is available to your doctor. From now on, these data become personal health data, governed by the Act on Portability and Responsibility for Health Insurance. Under the HIPAA Act, your genetic data can not be disclosed to your school or employer, but law enforcement officials have the right to access it without a warrant if you are the victim or suspect of a crime. criminal investigation.
Now that your DNA data is in your medical records, your insurance provider can also access it. That is why, in 2008, Congress passed the Genetic Non-Discrimination Act, or GINA, which prevents health insurance companies from denying coverage or raising prices based on the genetic predisposition of a person with various health conditions. (They can still do this if their genes make you actively sick – GINA becomes virtually useless once you have symptoms.) GINA does not apply to long term care insurance, either. 39; life insurance or disability insurance, although it prohibits employers. use it to decide who is hired, fired, promoted, or given an increase. Rothstein said the best genetic non-discrimination law ever enacted in the United States was President Obama's Affordable Care Act, Health Care Reform Act. The controversial legislation, which faces new legal challenges from the Trump administration, specifically guarantees that insurance companies can not use pre-existing conditions to deny coverage.
But neither the common rule, nor the ACA, nor GINA protect against many other potential uses of DNA data. Suppose you are looking to buy a condo in a retiree community. If your condo association wants you to submit DNA test results indicating that your application has no genetic predisposition to Alzheimer's, this would be legal in all states except California. Schools may also require DNA testing at admission or to remove children from certain genetic predispositions.
This is not yet the case, but as researchers anticipate things like academic success and income potential through people's genes, hypothetical scenarios that would not be protected under existing laws get closer to reality. Add to that the fact that millions of Americans are sending their DNA to companies such as 23andMe, Ancestry and other consumer direct testing companies, which are not covered by the HIPAA law, and you can start to understand the magnitude of the problem. "There will come a time when we may need a special law on the confidentiality of genetic data," said Barbara Evans, director of the Center for Biotechnology and Law and the University of Houston. "As DNA moves outside the HIPAA protected domain, we are approaching the time when Congress may need to step up its efforts."
Evans and other members of the LawSeq project believe that Congress should consider the problem of anonymized data. In the United States, as long as a genomic record of a person is private personal information such as name, address, date of birth, phone number and 14 other identifiers, it can be shared among researchers, posted in public databases and bought and sold by various companies. . Many say that this characteristic of genetic laws in the United States has been vital in turning genetic code strings into useful products such as new drugs, tests, and other targeted therapies. After all, the promise of precision medicine lies in collecting huge amounts of data.
But scientists have repeatedly shown that with enough data, it was possible to link a person's name to a string of his genetic code. In addition to biomedical research, DNA has been a boon to genealogy enthusiasts who have uploaded their genetic profiles to public genealogy websites such as GEDmatch. By using these open databases to generate maps of distant cousins, it is now possible to identify just about every white person in America from their DNA alone. Law enforcement agencies have seized on this mine potential new avenues for the resolution of several cases – such databases have helped in the arrest of more than 50 suspects in the past 12 years month.
To address this gap, US policymakers could reclassify DNA as personally identifiable information. But Ellen Wright Clayton, co-founder of the Center for Biomedical Ethics and Society in Vanderbilt and one of LawSeq's leaders, was quick to point out that it would not stop people from putting their personal genetic records on the Internet. "It's the biggest threat to privacy right now," she said. It is not enough to withdraw genetic tests yourself, because DNA connects families between different regions and generations. "The law has nothing to say about the fact that I can prevent my sisters, cousins or children from spreading their genomic sequence."
Given all the shortcomings of the US legal system, the question now could be whether genetic privacy is already dead. Depending on the recipient, the answers range from absolute nihilism (Facebook does not support your data and users still use it, why would DNA be so different?) To a cautious hope that the uses of Genetic data could always be limited without unduly interfering with research or public health. Such legislation could, for example, be inspired by something like the Fair Credit Reporting Act, since genetic information is prohibited for certain activities.
Brad Malin, biostatistician at Vanderbilt, director of his health information privacy lab, sums it up as follows: "Sometimes we feel like we do not have privacy, and sometimes we need privacy, and then something changes, the law, the technology, the adoption and the pendulum turn around, "he said. "Right now, we are somewhere in between where some people give up their privacy while others want it. Those who give up their genomic data may infringe on the privacy of others, but it is a great experience. "
If we are wrong now, he said, what is the worst that can happen? We lose privacy for a generation. And then half a generation after that. And half a generation after that. The geneticists in the room laughed. Lawyers, not so much.
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