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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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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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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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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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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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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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

JANUARY 24, 2022

Food and Drug Administration (FDA)-approved product for a different population, use or dosage than it was approved for, is very common in medicine. It also runs counter to our approach on other cutting-edge questions regarding the implementation of COVID-19 vaccinations, such as their use in pregnant women or mix-and-match boosters.

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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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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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Bill of Health

APRIL 4, 2024

It provides several rules for sharing information and exceptions keyed directly to the realities of the health care setting, such as permitting information sharing for treatment, payment, or health care operations, some public health situations, and if certain identifiers have been stripped from the data set.

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Bill of Health

NOVEMBER 16, 2024

by Jessica Samuels For 100 years, food fortification , the practice of deliberately increasing the content of vitamins and minerals in a food, has been essential to combating public health crises. Public Health Service recommended that all women of reproductive age get 400 micrograms (mcg) of folic acid per day.

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Bill of Health

MARCH 28, 2022

Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2. By James Lytle. Recent guidance from the U.S. less likely to receive the treatment than whites.

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Healthcare It News

OCTOBER 13, 2021

"That same year, FDA approved smart pills. "COVID-19 showed the world what's wrong: Not enough focus on public health, prevention and equity. "In the five years since I last talked at CHC, there have been some amazing medical breakthroughs," said Feinberg in his virtual keynote address.

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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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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

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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Compliancy Group

NOVEMBER 4, 2024

One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry. The purpose of this list is to help businesses stay within compliance with FDA regulations and to safeguard public health.

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Bill of Health

MARCH 13, 2023

The FDA’s primary responsibility is over claims that appear on product labels (including packaging, product inserts, and promotional material at the point of sale), and the FTC regulates claims made in advertising in general. FDA regulations prescribe different standards for different products and claims.

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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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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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Bill of Health

APRIL 13, 2022

In fact, a recent FDA regulatory forum toxicology expert review article has suggested that a medication’s 5HT 2B binding affinity (Ki) was considered a better predictor of VHD risk than measures of functional activity such as EC50.

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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 - 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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Healthcare IT News - Telehealth

DECEMBER 1, 2021

What's less certain, however, is what that utilization will look like in the future, particularly as the end of the public health emergency looms. What is driving all this, of course, is the regulatory changes during this public health emergency. First of all, we should think about the public health emergency.

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Bill of Health

JANUARY 30, 2023

With the Secretary of Health and Human Services declaring a public health emergency due to COVID-19 on 1/31/2020 , practitioners were permitted by state law to “dispense controlled substances not only in their home states but also in states with which their home states have reciprocity.”

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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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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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Bill of Health

NOVEMBER 25, 2024

Food and Drug Administration (FDA). The FDA maintains that low levels of BPA exposure are safe for humans. However, the FDA has recognized that low levels of exposure are not safe during infant development and no longer allows BPA-based baby bottles, sippy cups , or packaging for infant formula.

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Mobi Health News

MARCH 5, 2021

The system delivers its results to a companion app in about 20 minutes, according to the agency.

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Healthcare IT Today

MAY 3, 2023

The excitement has been largely fueled by the renowned public health benefits of, and the seductive commercial opportunity for, a seamless hypertension management solution that is virtually invisible – part of what people are already wearing, such as smartwatches, earbuds, smart rings, and apparel.

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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

MARCH 18, 2021

The agency will allow some COVID-19 tests to be used at home for regular asymptomatic testing.

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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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Bill of Health

OCTOBER 27, 2022

Newsom a legal principle that threatens to upend over a century of legal precedent recognizing the authority of state governments to ensure public health by mandating vaccines. The former actually further a state’s interest in promoting public health, unlike religious exemptions, which subvert this goal. Donna M.

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