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FDA’s Breakthrough Designation Now Includes Health Equity Provision

FDA’s Breakthrough Designation Now Includes Health Equity Provision

by Ron Shinkman | Apr 26, 2024 | Clinical Diagnostics Insider, FDA-dtet

Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions

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Building a Home for Health Equity

Building a Home for Health Equity

by Michael Schubert, PhD | Apr 26, 2024 | Clinical Diagnostics Insider, Special Focus-dtet

The laboratory’s role in reaching underserved patient populations: an interview with Richard Levenson, Keisuke Nakagawa, and Michele Mitchell

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Increasing Fees, Decreasing Access to Data in New CMS Proposal

Increasing Fees, Decreasing Access to Data in New CMS Proposal

by Tara Cepull, MA | Apr 25, 2024 | CMS-lca, Essential, Lab Industry Advisor

New policies aim to better protect data against increasing cyberattacks, but academics say the changes will limit critical research

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A Modern Healthcare Collaboration

A Modern Healthcare Collaboration

by Michael Schubert, PhD | Jan 4, 2024 | Essential, Health care reform-nir, Inside the Lab Industry-lir, Lab Industry Advisor

Labs, patients, and technology must all work together to deliver forward-thinking patient-centered care.

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A 21st Century Response to the Cures Act

A 21st Century Response to the Cures Act

by Michael Schubert, PhD | Nov 24, 2023 | Clinical Diagnostics Insider, Inside the Diagnostics Industry-dtet

Patients’ unfettered access to complex test results can lead to confusion and distress—but generative AI can help.

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