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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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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Healthcare Dive

JUNE 21, 2022

The AMA announced over 20 policies including those that declared climate change a public health crisis, urged the FDA to make over-the-counter oral contraceptives accessible and more.

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Healthcare IT News - Telehealth

DECEMBER 20, 2021

"The in-person dispensing requirements on medication abortion care have proven to be unnecessary during the pandemic, and the FDA did the right thing today by lifting them," said Kirsten Moore, director of the Expanding Medication Abortion Access Project, in a statement. ON THE RECORD.

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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

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

NOVEMBER 30, 2022

Now more than ever, a person’s access to abortion and other essential reproductive health care services depends on their state of residence and whether they have the means to travel to a state that protects access to abortion care. Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public.

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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

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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Bill of Health

JANUARY 7, 2022

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures. Ultimately, both the FDA and CDC gave their blessing to boosters.

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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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Bill of Health

AUGUST 8, 2022

On August 4, 2022, Health and Human Services (HHS) Secretary Xavier Becerra declared monkeypox a national public health emergency (PHE). Absent considerable public health interventions, considerably greater numbers of U.S. Monkeypox is America’s newest emergency—and not a moment too soon. Justifying a national PHE.

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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

AUGUST 4, 2022

Food and Drug Administration (FDA) plays a central role — it is the regulatory mechanism by which drugs like MDMA and psilocybin may soon become legal for medical use. non-medical) drug legalization: Does the FDA have the existing authority to regulate illicit drugs, should they become legal for adult recreational use?

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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

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 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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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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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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Healthcare It News

DECEMBER 30, 2022

One example is partnering with Healthy Together, which uses the agency's API to provide veterans with secure mobile access to their health records. FDA authorizes at-home COVID-19 tests from Amazon, Roche, Siemens. And it will help public health officials improve public health policy and lower overall costs.

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Healthcare IT Today

FEBRUARY 28, 2023

COVID-19 forced a spike in policy-makers’ interest and willingness to invest in public health; a spike that is unfortunately retreating to the old business as usual. I consulted several experts in health IT to ask how such IT could improve data collection and sharing in public health.

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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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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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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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HIPAA Journal

DECEMBER 22, 2022

Funding for the Centers for Medicare and Medicaid Services will increase by $100 million, the National Institutes of Health will receive an additional $2.5 This will help to ensure that telehealth and hospital-at-home programs can continue to provide convenient and accessible medical treatment for patients.

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C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

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Hall Render

FEBRUARY 7, 2023

Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”).

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Healthcare Law Today

JANUARY 25, 2023

Food & Drug Administration (FDA or Agency) the authority to order a mandatory recall of a cosmetic product and to suspend a facility registration if FDA determines there are serious adverse health concerns. Furthermore, MoCRA grants the U.S. MOCRA’s key provisions are outlined below.

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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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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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Healthcare IT Today

APRIL 28, 2023

The following is a guest article by Chris Anello, Director of Digital Platforms at iTech AG The COVID-19 pandemic pushed healthcare organizations to the edge and exposed both challenges and opportunities related to public health data.

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HIPAA Journal

MARCH 15, 2023

This month, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) published guidance to help healthcare delivery organizations effectively manage cyber risks associated with legacy technology.

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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

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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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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HealthIT Answers

DECEMBER 6, 2022

Food and Drug Administration is critical to protecting and promoting public health. The products the FDA regulates are in every supermarket, pharmacy, and home across the U.S. Cybersecurity touches every facet of the FDA’s broad, complex responsibility. By Vid Desai & Craig Taylor - The U.S.

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