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How well such predictions work currently, however, has been questioned. Additional risks that people can be identified from research, clinical information, or biospecimens arise because most genomic research involves other data about participants, including their demographics, medical history, their activities, and their social and built environment. These other data can be more easily identifiable in the current data environment than are genomic data themselves.
In light of all these developments, a critical question is how likely is it that someone will try to reidentify the source of a deidentified sample.
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Recent investigations have suggested that in many circumstances, it simply may not be worth the attacker's while to identify someone from his or her deidentified DNA, given the costs of attempting to do so, especially if the biobank protects the data. Nonetheless, efforts may be warranted to create incentives to decrease the probability of reidentification as well as to ameliorate any adverse consequences that might occur were inappropriate identification to occur. Part of the solution to deter reidentification in the first place may be to adopting the proposal by the Working Group of the Precision Medicine Initiative that Congress adopt penalties for inappropriately reidentifying or otherwise misusing data.
Individuals may have a variety of motives for surreptitious genetic testing, such as to covertly determine parentage, to uncover whether a romantic partner is being unfaithful, or to discover sensitive medical information such as disease or carrier status, perhaps about a potential partner. In the law enforcement context, police use surreptitious forensic testing as an investigatory tool to gather evidence against an individual suspected of a crime and to facilitate identification of a suspect.
The rise in surreptitious testing has been made possible by the increasing sensitivity and availability and decreasing cost of genetic testing and analysis. Numerous studies have documented the proliferation of companies offering these services directly to consumers and, in some cases, law enforcement. A recent survey of 90 DTC companies operating in the USA revealed that nearly one-third appeared to offer some form of surreptitious testing, generally alongside paternity and other family relationship tests.
The most obvious issue raised by surreptitious testing, generally in the context of testing performed by private citizens, is the lack of consent. A less obvious concern, present in both the civilian and law enforcement contexts, relates to the underlying quality of the samples being analysed. Unlike testing performed on samples collected in more controlled settings, surreptitious testing generally involves analysis of samples containing DNA of questionable quality or in limited quantity, greatly increasing the possibility of erroneous results, which might have serious consequences for the individual being tested.
Data on how frequently individuals engage in surreptitious testing are sparse, but a recent survey of Canadian consumers of DTC services provides some insight into the frequency with which individuals submit the genetic material of others for testing. The frequency with which surreptitious testing appears to occur might not be surprising in light of the paucity of relevant federal and state law on the subject and the limited scope of the laws that do exist.
Despite repeated calls from legal scholars and government advisory committees for increased oversight of surreptitious testing and stricter laws governing nonconsensual collection and analysis of the genetic material of others, no comprehensive federal laws currently prohibit the practice. However, federal laws, such as the ACA or GINA, may provide some limited protection against the practice if it were to be undertaken to limit access to employment or health insurance.
Instead, the USA relies on a patchwork of state laws that place varying restrictions on the practice depending on the purpose of the testing or the context in which it is performed. Still unclear is the extent to which courts will be willing to recognize a property interest in genetic material sufficient to support causes of action for surreptitious testing under common-law torts such as conversion or invasion of privacy. The result of this heterogeneity is that DTC companies are left to set their own policies governing surreptitious testing and the submission of another individual's sample without their consent.
According to the Best Practices recently developed and adopted by industry leaders in conjunction with the Future of Privacy Forum, companies should require separate express consent from consumers that are submitting samples on behalf of others. Surreptitious testing by law enforcement agencies also raises privacy concerns, an issue that has gained renewed attention in the wake of revelations surrounding the arrest of the suspected Golden State Killer.
While it appears that investigators in this case obtained a court order before performing this surreptitious testing although not before searching the genealogy website , police in many jurisdictions are not required to seek approval from a court before engaging in this practice. Police have this freedom because the state laws that place restrictions on surreptitious testing generally do not apply to surreptitious forensic testing, and the Fourth Amendment has thus far provided little protection in the context of surreptitious genetic testing by law enforcement.
Although the Supreme Court has not specifically ruled on the issue of surreptitious genetic testing, it has established that individuals have no reasonable expectation of privacy in abandoned property. In this article, we have focused primarily on issues of genetic privacy in the context of healthcare, but our analysis necessarily addresses health information more generally as well. A lot of health information provides insights or at least clues into the individual's genetic makeup, so that the two cannot readily be separated.
Moreover, a person's current condition or phenotype can be more pertinent to privacy concerns than his or her genes. Thus, treating genetic data as exceptional, as deserving special protection, is generally unwarranted and in many cases not achievable or even counterproductive.
Concerns about genetic privacy and health information privacy more broadly fall into two large categories—the ability to control where data about individuals go and the extent to which individuals can be assured that data about them will not be used to cause them harm.
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In the healthcare system, patients are asked to sign an acknowledgement of a covered entity's notice of privacy practices when they seek care, which may lead them to believe that their health privacy is vigorously protected, but the law's protection may be illusory. The HIPAA Privacy Rule has numerous exceptions permitting access to individually identifiable health information, which reflect policy trade-offs between individual control and social uses.
But until recently, even when these exceptions were invoked, there was little risk that genetic information would be shared because personally identified health information rarely contained much genetic data. One incontestable fact is that the landscape is evolving as more genetic and genomic data are becoming available.
Within the healthcare system, more genetic tests are coming into clinical use, increasingly using broad-based platforms with the capacity to uncover variants potentially pertinent to conditions beyond the initial clinical indication. A crucial change in the ecology of genetic information is the emergence of DTC genetic testing and interpretation, so far used by millions of people and largely escaping regulation, except in some cases when these companies offer to provide health-related results.
The most common use by far is to explore one's ancestral origins and to find relatives. The latter use necessarily requires identifiable genetic information in order to make or disprove relationships. The most prominent of these companies have explicit privacy policies and usually require people to give permission before they are placed in contact with a putative relative.
Many companies encourage surreptitious testing. Clearly, there is room here to require more robust privacy policies that allow people to decide whether they want to communicate with a purported relative and to forbid surreptitious testing. One of the most significant challenges is that many people take genetic data about themselves, which they often received from DTC companies, and post them online in an identifiable form to find their relatives, to share with other people with similar conditions, or to promote research.
These actions necessarily reveal information about their relatives, as has been made clear by the use of GEDMatch to identity criminal suspects. At present, a person has no ability to prevent his or her relatives from revealing their own information.
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Moreover, there are no limits on who can access these data or for what purpose. Our research has demonstrated that increasing amounts of genetic information are generated, analysed, shared, and stored by diverse individuals and entities. Even when health information is stored at compliant healthcare institutions, the combination of broad exceptions and compelled disclosures precludes informational health privacy. The latter group varies widely in the extent to which they are likely to protect data about a person, which depends on their motives and business models.
Other disclosures of genetic information occur when individuals voluntarily make their identified genomic data public; in many cases, people do this without considering or regardless of the impact on themselves or their relatives. There is little that can be done to prevent these voluntary disclosures except to ensure that individuals are aware of the possible consequences.