New york state non permitted lab test request 2025

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All clinical and forensic laboratories and blood banks located in or accepting specimens from New York State must hold a New York State Department of Health clinical laboratory permit. Research testing is considered clinical if a patient-identified result is generated.
New York Civil Rights Law 79-1 was enacted in 1996 to protect the privacy of genetic information by prohibiting the performance of Genetic Tests on biological samples without the prior written informed consent of the individual tested, restricting the disclosure of the results of Genetic Tests, limiting additional
No person shall own or operate a clinical laboratory located in or accepting specimens from New York state or own or operate a blood bank which collects, processes, stores and/or distributes, human blood, blood derivatives or blood components, in New York state unless a valid permit has been issued as provided in
The Genetic Information and Nondiscrimination Act (known as GINA) of 2008 is a federal law that prevents health insurance carriers from using or requesting genetic information to make decisions about coverage, premiums, or eligibility.
Under New York State Public Health Law (Article 5, Title V, Section 574) and regulations (Part 58- 1.10 (g) of 10NYCRR), laboratories performing testing for any specimens collected in the State of New York must hold a New York State clinical laboratory permit or have test request approval for specific tests.
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Who Should Get Genetic Testing? You should consider getting genetic testing if you have: A recent or current cancer diagnosis at a young age. Multiple types of any cancer or multiple people with cancer in your family.
This direct access testing option is available for tests for which a Federal Food and Drug Administration (FDA) approved test kit or collection device is available over-the-counter (OTC) without a prescription, and for tests for the same purpose.
New York: Bill on privacy of genetic testing results introduced to Senate Committee. Senate Bill 2398, introduced to the New York State Senate Codes Committee on January 17, 2025, aims to amend civil rights law by ensuring genetic testing results are only disclosed to patients and their direct health care providers.

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