Exeed Regulatory Compliance

JULY 6, 2020

There is a lot of controversy over the use of face masks during the current Covid-19 pandemic. Let us understand how they help and how FDA plans to regulate them. Since the onset of the COVID-19 pandemic, there has been a lot of conversation surrounding the shortages of Personal Protective Equipment (PPE).

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Health Law Pulse

FEBRUARY 11, 2022

Although receiving the COVID-19 vaccine remains one of the best ways to combat the severity of one’s symptoms, Dr. Van Kerkhove warned that the vaccine could become less effective as the virus continues to evolve. The post COVID-19 Update: New Variants and Vaccine Research appeared first on Health Law Pulse.

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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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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.

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Exeed Regulatory Compliance

JULY 10, 2020

The FDA’s updated policies are striving to make sure PPE is both available and regulated for safe use. The medical landscape is constantly changing, particularly during the COVID-19 pandemic. We recently discussed the FDA’s policy for Face Masks during COVID-19.

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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.

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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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Mobi Health News

MARCH 29, 2021

According to FDA documents, the test is intended to help stop the spread of COVID-19 among Amazon employees. .

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Exeed Regulatory Compliance

OCTOBER 26, 2020

A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. COVID-19 continues to cause damage to both the public health and the economy at large. FDA is requiring additional post-market studies. CONTACT US.

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Medisys Compliance

APRIL 20, 2022

Billing and coding guidelines for various medical specialities are constantly getting updated due different COVID-19 variants. As Public Health Emergency (PHE) has extended beyond 16 th April 2022 by 90 days, various waivers are continued, making no change in billing guidelines in pandemic.

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Bill of Health

APRIL 7, 2023

By Aparajita Lath Two articles published last month in the BMJ analyze the public investment and financing of mRNA COVID-19 vaccines, highlighting the extensive government funding that has supported the development of mRNA technology from 1985 to 2022. It is generally known that the U.S. It is generally known that the U.S.

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Exeed Regulatory Compliance

JULY 20, 2020

Antibody tests are a powerful tool to help fight COVID-19. The COVID-19 pandemic has hit us hard. Months into this global health crisis, we are still struggling to get it under control. False Negative: Test is negative; i.e. antibodies are not found in the blood sample that came from a confirmed COVID-19 patient.

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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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Health Law Pulse

MARCH 30, 2022

Yesterday, March 29, 2022, the CDC launched a new calculator designed to help individuals exposed to COVID-19 discern how many days of quarantine and/or isolation are necessary. Users are first prompted to select whether they have tested positive for COVID-19 or whether they had close contact with someone who had COVID-19.

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Health Law Pulse

DECEMBER 30, 2021

Since its first detection, the Omicron variant of COVID-19 has been reported in numerous countries worldwide and in most of the United States. It is likely more transmissible than the other variants of COVID-19 and has officially surpassed the Delta variant contraction rates.

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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

JANUARY 24, 2022

Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set. The CDC, through its vaccine provider agreements, prevents physicians and parents from pursuing off-label use of COVID-19 vaccinations in young children.

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Health Law RX

JULY 25, 2022

Employers who are conducting automatic COVID-19 testing of employees or gathering test results of employees’ families should beware: the Equal Employ­ment Opportunity Commission (“EEOC”) has issued new guidance limiting the former and has penalized a healthcare practice recently for doing the latter. Returning to Work After COVID-19.

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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. Over 160,000 public and private labs. Hospitals and health care providers. Health plans. From the emergence of the COVID-19 pandemic in the U.S.

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VW Health Care Law Blog

JUNE 29, 2020

One unintended consequence of COVID-19 has been the paradigm shift within the healthcare industry which has turned to prioritize value-based, patient centric remote monitoring solutions and non-contact technologies.

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HIT Consultant

APRIL 1, 2024

John Auerbach, SVP Federal Health, ICF Given the attention paid to the devastating impact of COVID-19, one might assume it was the leading cause of death in the US. million Americans died of COVID in the last 4 years – heart disease remains the largest cause of death and by a landslide.

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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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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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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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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. Tandon , a religious rights case unrelated to vaccines, arose in March 2020 during the start of the COVID-19 pandemic in the U.S., Donna M.

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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 Law Today

FEBRUARY 1, 2022

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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HealthIT Answers

JUNE 29, 2022

By Jeff Shuren MD JD & William Maisel MD - Since the beginning of the COVID-19 pandemic, the demand for medical devices has far exceeded anything we have seen in previous public health emergencies. The FDA's Center for Devices and Radiological Health has worked to address these unprecedented demands.

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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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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 IT Today

JUNE 13, 2023

The previous articles in this series laid out some of the issues in health care affecting testing , and the value of data. Speeding up Test Development We’ve seen with COVID-19 how quickly a virus can evolve and how hard it is to design both tests and vaccinations that accommodate different variants.

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Health Populi

JUNE 24, 2021

The economic and healthcare system impacts of this were explored in the Post-Covid Healthcare Landscape , delivered by Fitch Solutions’ Jamie Davies and Beau Noafshar, leaders in the Pharmaceuticals, Healthcare, and Medical Devices groups. The forecast is that these backlogs could persist “for years” in the NHS.

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Health Care Law Brief

JUNE 2, 2022

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. How will the marketing comply with the FDA rules regarding the marketing of prescription drugs and/or professional practice rules applicable to licensees?

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Health Populi

FEBRUARY 28, 2021

With a third vaccine approved by the FDA for licking COVID-19, brought to market by Johnson & Johnson, the U.S. can expect an uptick in vaccinations among fellow health citizens. The chart here comes from IQVIA’s latest study into COVID-19’s impact on U.S.

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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 It News

OCTOBER 13, 2021

"That same year, FDA approved smart pills. And last year, a COVID-19 vaccine was researched, developed and deployed almost four years ahead of the normal timeline for a new vaccine. "COVID-19 showed the world what's wrong: Not enough focus on public health, prevention and equity.

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Healthcare IT News - Telehealth

DECEMBER 1, 2021

By now, it's become a truism that telehealth use saw an enormous jump in 2020 , spurred by the COVID-19 pandemic and enabled by the relaxation of federal regulations. 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.

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