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Privacy in the Post Roe v. Wade World: How Could Proposed HIPAA Restrictions on Reproductive PHI Affect Labs?

Privacy in the Post Roe v. Wade World: How Could Proposed HIPAA Restrictions on Reproductive PHI Affect Labs?

by Glenn S. Demby | Sep 28, 2023 | Essential, HIPAA-nir, Lab Compliance Advisor, Laboratory Industry Report, National Lab Reporter

Key points labs should know about the recently proposed OCR rule on privacy protections for PHI associated with reproductive health care.

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Expert Q&A: Developments in Noninvasive Prenatal Testing

Expert Q&A: Developments in Noninvasive Prenatal Testing

by Raeesa Gupte, PhD | Sep 28, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Special Focus-dtet

Diana W. Bianchi, MD, discusses how NIPT has evolved, key challenges, as well as her team’s research on using these tests to detect cancer.

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The Diagnostics Pipeline: Diagnostics Make Up One-Third of Total 2023 Recalls

The Diagnostics Pipeline: Diagnostics Make Up One-Third of Total 2023 Recalls

by Glenn S. Demby | Sep 25, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.

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How the Roe v. Wade Ruling Will Impact Prenatal Testing

How the Roe v. Wade Ruling Will Impact Prenatal Testing

by Glenn S. Demby | Jul 21, 2022 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Legislation-dtet

Without abortion rights, basic lab testing applications for those who are or want to become pregnant have new and ominous legal implications.

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Israeli Startup Salignostics Launches First Saliva-Based Pregnancy Test

Israeli Startup Salignostics Launches First Saliva-Based Pregnancy Test

by Glenn S. Demby | Jun 6, 2022 | Articles, News, Open Content

The company has successfully completed clinical trials in Israel on more than 300 women and is applying for CE marking and FDA approval.

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