Healthcare Dive

AUGUST 30, 2022

Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.

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HIT Consultant

JANUARY 26, 2024

What You Should Know: – Deliberate AI , a digital health company harnessing AI to revolutionize mental health assessment, has secured a major milestone in its mission. – The collaboration between Deliberate AI and the FDA represents a giant leap in the fight against mental illness.

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NEJM

MARCH 10, 2023

The FDA has long conducted its oversight of prescription drugs and other products with deference from courts. But mounting judicial skepticism of agency authority threatens to upend this norm.

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HIT Consultant

OCTOBER 21, 2021

Food and Drug Administration (FDA) has contracted with them to use their Aetion Evidence Platform® to rapidly assess in-patient COVID-19 treatments and advance regulatory science to help determine when, where and how to use RWD. Enables rapid evidence generation for COVID-19 and future pandemics.

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Healthcare It News

JUNE 28, 2024

Nayyar's most recent USA Today and Wall Street Journal bestselling book, Dead Wrong: Diagnosing and Treating Healthcare's Misinformation Illness , explores the profound personal and public health risks associated with digitally propagated mis- and disinformation. Like what you hear?

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. Health plans should be on the alert for potential pitfalls arising from the new regulations. Health plans can design hearing benefits that can mitigate this potential issue while maximizing member satisfaction at the same time. Introducing OTC hearing aids.

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C&M Health Law

FEBRUARY 1, 2022

Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. On January 31, 2022, the U.S.

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Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).

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Hall Render

JUNE 21, 2024

Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). In May 2024, the U.S. Below are some highlights from the Final Guidance.

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Bill of Health

SEPTEMBER 23, 2022

Food and Drug Administration or FDA), which contributes to the development of knowledge about the unapproved product’s safety. However, EUAs are limited to public health emergencies, and RTT is only rarely used, so we concentrate here on EA, which is used by thousands of U.S. patients each year.

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Bill of Health

FEBRUARY 8, 2022

Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time. Up until a few days before, the public was expecting approval to possibly drag into summer. Doctors and parents used the group to collectively make public calls to agencies like the FDA and U.S. Solutions for the Future.

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YouCompli

MARCH 29, 2023

In this article, she discusses several issues that hospitals and health systems need to consider as a result of the scheduled end of the COVID-19 public health emergency. Department of Health & Human Services (HHS) reports that 80% of the U.S. population previously received at least one COVID-19 vaccination.

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Bill of Health

JANUARY 28, 2022

A few years ago, a Bill of Health post titled Jelly Beans, Booze, and B-Vitamins proposed fortifying cheap wines, hard liquors, and malt liquors with thiamine (vitamin B1). The post suggested this as a public health measure to prevent Wernicke-Korsakoff syndrome (WKS) in the homeless alcoholic population.

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Health Populi

JULY 28, 2020

This week, announcements from the Consumer Technology Association (CTA) and Withings further bolster the case for the private sector bolstering public health in this pandemic…and future ones to come beyond the Age of the Coronavirus. On 27th July, CTA announced the Association’s launch of the Public Health Tech Initiative.

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Bill of Health

APRIL 21, 2023

FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. public investment in the development of mRNA COVID-19 vaccines. Eroding Judicial Deference to the FDA – Consequences for Public Health. J Health Polit Policy Law. 2023 Mar 6;20(3):e1004190. N Engl J Med.

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Health Populi

NOVEMBER 3, 2021

At the same time, CTA has published a paper on Advancing Health Equity Through Technology which complements and reinforces the PHTI announcement and objective. Tribal health departments. Over 160,000 public and private labs. Hospitals and health care providers. Health plans. value-based).

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Healthcare It News

DECEMBER 16, 2022

Talking points: The future of the Public Health Emergency and the flexibilities it allows. A "perfect storm" of financial stress for hospitals and health systems. FDA and evolving regulations for digital therapeutics, software as a medical device. Like what you hear? Labor shortages and supply chain challenges.

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Kaiser Health News

OCTOBER 7, 2024

senators have pressed the FDA to take steps to eliminate pulse oximetry’s racial bias, which has caused delays in treatment and worse health outcomes, and more recently has raised concern about the reliability of hospital AI tools that draw on reams of data from the devices. . The FDA’s response was modest.

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C&M Health Law

NOVEMBER 3, 2022

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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Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

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Mobi Health News

DECEMBER 15, 2020

Alongside step-by-step instructions, the Ellume COVID-19 Home Test's accompanying app automatically reports users' results to the relevant public health authorities.

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Bill of Health

OCTOBER 6, 2023

The FDA approved S-ketamine to treat depression in 2019. Still, to me, the most promising route to access is probably through FDA approval (which means more clinical trials) and expanded insurance coverage. Yet, insurance coverage alone is an imperfect solution because millions of Americans have no health insurance.

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Bill of Health

FEBRUARY 16, 2022

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes.

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Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview.

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VW Health Care Law Blog

JUNE 29, 2020

COVID-19 has created a demand for digital health technologies to provide relief for public health professionals and individuals alike. This is not to say that digital technologies … Continue reading Coronavirus is Deregulating Healthcare One FDA Guidance At a Time.

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Hall Render

SEPTEMBER 8, 2023

Under the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations , “drug promotional labeling and prescription drug advertising must be truthful and non-misleading, convey information about the drug’s efficacy and its risks in a balanced manner and reveal material facts about the drug.”

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HealthIT Answers

SEPTEMBER 27, 2023

Food and Drug Administration has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency's technological advancement and the alignment with its broader public health mission. Berrellez - The U.S.

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Bill of Health

NOVEMBER 15, 2023

health care system, but that are especially present for behavioral health needs like substance use, and are exacerbated by other challenges related to stigma, lack of employment, and fragmented or nonexistent care coordination. This reality reflects structural, policy, and legal misalignments common to the entire U.S.

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Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. As a result, FDA has now established additional requirements for authorization of Respirators made in China.

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HIT Consultant

MAY 19, 2024

. – Humana, a health insurance provider, has become the first commercial payer to update its policy in response to the FDA’s recent clearance of NeuroStar TMS for adolescents aged 15-21 with MDD. Food and Drug Administration (FDA) granted clearance for NeuroStar TMS as a first-line add-on treatment for adolescent MDD.

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The Digital Health Corner

NOVEMBER 28, 2016

Digital health technology has seen an incredible growth in the last few years, fueled by a combination of consumerization of wearable technologies, ubiquity of mobile devices, proliferation of technology incubators, attention by government health and regulatory agencies and involvement of large companies heretofore not focused on healthcare.

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Bill of Health

APRIL 7, 2023

Together, these articles underscore the injustice of the present moment and emphasize the need to reform intellectual property protections for government-funded inventions of public health significance. Recent Research on Public Funding of mRNA Technology The first of the two new articles is an in-depth empirical study of U.S.

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Healthcare IT News - Telehealth

JULY 25, 2023

public health departments with implementing sexual health testing to reduce the incidence of rising sexually transmitted infections in their communities. "The COVID-19 pandemic led to disruptions in STI-related prevention and care activities and brought the realities of our strained public health infrastructure to light."

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Bill of Health

JUNE 26, 2023

Once approved by the FDA, CalRx insulin will be made available at $30 to all Californians who need it. This initiative will come with enormous savings to the public: it will bring down the price of insulin by 90%, saving cash-paying patients between $2,000 to $4,000 annually.

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HIT Consultant

MARCH 19, 2023

However, few health systems, medical practices, or providers are prepared for the extraordinary public interest in a treatment for Alzheimer’s disease – especially not one targeting mild cognitive impairment (MCI) and early dementia due to Alzheimer’s disease – that is likely headed their way soon. billion marketing the medication.

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HIT Consultant

SEPTEMBER 12, 2024

The Obesity Crisis and GLP-1 Medications Obesity is a major public health concern in the United States, affecting over 42% of the population. FDA-Regulated Quality: Medications are sourced from an FDA-regulated 503B compounding pharmacy, ensuring the highest standards of safety and effectiveness.

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Bill of Health

SEPTEMBER 16, 2024

MPH 2025) is a third-year dual degree law and public health student. Her research interests include genetics, environmental health sciences, novel biotechnologies, and the FDA regulatory process. Prior to law school, she worked as an analyst at ClearView Healthcare Partners. Jessica Samuels (J.D./MPH

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