In 2014, the U.S. Department of Health and Human Services amended the HIPAA regulations to make clear that all laboratories, which were previously exempted, are subject to this obligation. The entire field of genetics grew from a culture of data sharing, such as the work that led to the reference human genome sequence used by scientists around the world. Unless patients’ rights to their own genetic information are enforced, other labs may also choose to follow their own prerogatives at the expense of patient autonomy. We all have these genes, but people with certain mutations have a much higher risk of experiencing breast, ovarian, prostate, and other cancers. Should patients have the same right to access their genetic information from a laboratory as they would a copy of their MRI, X-rays, or physical exam records? It will not share its data with NIH-funded public data initiatives, and by denying the patients’ requests for their own data, it is blocking them from contributing as well. The law is straight-forward: Patients are guaranteed access to their health information — including their genetic data — under HIPAA. Myriad did not rescind its prior position that it was not obligated to provide the genetic data and thus continues to violate HIPAA. In effect, Myriad dictated what part of their own genetic information they could obtain. Responsible, patient-centered data sharing is crucial for discovering the relationships between all genetic variants and more effective ways of diagnosing cancer risk and making treatment decisions, as recognized by President Obama’s new Precision Medicine Initiative and the National Cancer Moonshot Initiative spearheaded by Vice President Biden. The largest single repository of human genetic data in the world is not at any university, research institute, or pharmaceutical company. seeking to guarantee patients’ rights to their own genetic data. The law is straight-forward: Patients are guaranteed access to their health information — including their genetic data — under HIPAA. And second, and potentially of even greater importance, the patients all want to contribute their genetic data to collaborative research initiatives. Yesterday afternoon, on the eve of the filing of our complaint, Myriad suddenly reversed course. And earlier this year, HHS released guidance stating that with respect to genetic testing, patients have a right to access “not only the laboratory test reports but also the underlying information generated as part of the test,” including “the full gene variant information generated by the test, as well as any other information in the designated record set concerning the test.”. In 2013, the U.S. Supreme Court struck down these patents, concluding that they unlawfully claimed products of nature as intellectual property, in a case filed by the ACLU on behalf of 20 scientific and women’s health organizations, geneticists, genetic counselors, and patients. First, they want to be able to confirm Myriad’s interpretation of their genes, including any variants it classified as benign, and to be able to monitor their own health as scientific understanding of genetics deepens. On the other side is a corporate laboratory with a vested interest in maintaining proprietary control over patient data. In an important step forward for Barbara, Ken, and the other patients, it provided them with additional genetic information it had previously withheld. It therefore became clear that Myriad held the data and that they could provide it to patients. But this time, you should own your own data. Unfortunately, Myriad specifically said it wanted to “voluntarily” provide the additional information, not that it was doing so because it recognized the rights of all patients to access their full genetic records. By: Sandra Park, Senior Staff Attorney, ACLU Women's Rights Project. Patients like Barbara and Ken have good reasons for seeking all of their genetic data. 2017 Legislative Recap Part Two: Criminal Justice and Privacy and... 2017 Legislative Recap Part One: First Amendment Bills, Five Reasons Armed Domestic Drones Are a Terrible Idea. Trump’s Last-Ditch Census Move Could Shape the Electoral Map for the Next Decade, THE FIGHT AHEAD FOR TRANSGENDER NORTH DAKOTANS, The ACLU of North Dakota Recognizes Transgender Day of Remembrance, Health Insurance Portability and Accountability Act.
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