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NY S00011
Bill
Status
3/3/2025
Primary Sponsor
James Skoufis
Click for details
AI Summary
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Requires manufacturers and entities providing non-invasive prenatal screening tests to include written notices explaining that these are screening tools only, not diagnostic tests, and that positive results require confirmatory diagnostic testing
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Mandates written notices be provided to patients at three points: before the test, with test results, and with any materials about prenatal testing services, with content approved by the Department of Health
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Directs the Commissioner to develop comprehensive informational materials on benefits and limitations of non-invasive prenatal testing, to be posted online in multiple languages for distribution by hospitals, obstetricians, midwives, and other healthcare providers
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Requires informational materials to include current recommendations from ACOG, Society for Maternal Fetal Medicine, and ACMG, along with a list of FDA and NYS Clinical Laboratory Evaluation Program approved screening tests
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Takes effect 180 days after becoming law, with rulemaking authority granted immediately to enable implementation
Legislative Description
Requires disclosure of information concerning non-invasive prenatal screening for chromosomal abnormalities including the benefits and limitations of non-invasive prenatal testing, the difference between non-invasive prenatal testing and prenatal diagnostic testing, and current recommendations from the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal Fetal Medicine, and the American College of Medical Genetics and Genomics (ACMG).
Last Action
referred to health
2/3/2026