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4 Steps for Operationalizing the FDA’s Call To Improve Health Outcomes for All Patients

HIT Consultant

In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. Wang, Chief Medical Officer of COTA, Inc.

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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

First, let’s examine the new regulatory framework the FDA established. Health plans offering the OTC benefit can also leverage the opportunity to educate members about the significant role hearing aids can play in improving their overall health. – What new opportunities will arise? Introducing OTC hearing aids.

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The FDA Releases New Draft Guidance on Considering Health Care Disparities When Reviewing Proposed Devices

C&M Health Law

Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). If this latest draft guidance is finalized after a period of public comment, the agency will incorporate the proposed language into the 2018 guidance.

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Senate Committee’s PREVENT Pandemics Act Draft Released: What to Know

Healthcare Law Today

It also requires that the Secretary report to Congress on the state of the SNS, and to issue guidance and hold annual meetings with public health officials and stakeholders on how states, territories, and Tribes can access the SNS. Modernizes public health data through biosurveillance and infectious disease data collection.

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Heart Disease: Still the Silent Killer Despite Prevention Options

HIT Consultant

Among its efforts is a focus on promoting community-level health behaviors, such as increasing screening efforts; reinforcing the benefit of prescription and over-the-counter medications; and targeting communities that are at elevated risk for heart disease due to social and economic conditions.

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Psychedelic Inequities and Unexplored Risk: Colonization, Commercialization, and Regulation

Bill of Health

By excluding diverse contributions to the psychedelic field, we risk establishing psychedelic practices that exacerbate racial health inequities (disparities) in which people of color experience worse health outcomes as compared to whites on a population level.

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Optellum, AI Lung Cancer Diagnosis Innovator, Secures $14M Series A Funding to Accelerate Expansion

Healthcare IT Today

Optellum is the leader in AI-enabled lung cancer diagnosis , and the first and only medtech company to attain FDA clearance, CE-MDR in the EU, and UKCA in the UK for its software platform Virtual Nodule Clinic. This disparity highlights a critical need for diagnosis and treatment at the earliest stage possible.

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