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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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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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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Bill of Health

OCTOBER 31, 2022

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes , creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development. However, the act of submitting an application to the FDA based on such research (e.g.,

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Healthcare IT Today

SEPTEMBER 20, 2024

The following is a guest article by Jay Nakashima, President at eHealth Exchange An FDA project aims to make it as easy as possible for clinicians to report adverse drug events and share important clinical data with public health agencies to investigate the event.

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Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key medical devices such as in vitro diagnostic tests, personal protective equipment, and ventilators.

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HIT Consultant

AUGUST 26, 2021

To date, the battle against COVID-19 has been waged largely in the field of public health, using a series of binary, black-and-white thresholds to measure progress. For that reason, the FDA is right to caution the public against an over-reliance on simple, negative/positive antibody tests. As the U.S.

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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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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

MARCH 5, 2021

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

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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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Bill of Health

JANUARY 30, 2023

While increased accessibility of mental health care services through telehealth is a valuable goal, if our aim is the well-being of patients, safety must be paramount. This shortage poses public health risks; Congresswoman Abigail Spanberger (D-VA) has urged the DEA and the U.S. About Cerebral Inc.

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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 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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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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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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Healthcare IT News - Telehealth

MAY 6, 2020

In the middle of the COVID-19 pandemic, connected health and RPM are more important than ever, because they enable physicians to monitor patients without having to come into contact with them, thus preventing the spread of the novel coronavirus.

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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

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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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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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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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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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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Healthcare IT News - Telehealth

MAY 30, 2023

The COVID-19 public health emergency came to an end on May 11. This also happens to coincide with the World Health Organization declaring an end to the COVID-19 global health emergency. What does the end of the public health emergency mean for the future of the healthcare industry?

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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. How long can I continue to do so? .

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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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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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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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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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Healthcare IT News - Telehealth

DECEMBER 16, 2020

The insights also can help healthcare organizations navigate vaccine distribution, as well as the ebbs and flows of patient volumes due to COVID-19 in the year ahead, according to the new report. “Regulators, for their part, have tried to smooth the way for a pivot to virtual during the public health emergency.

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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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Health Populi

JUNE 11, 2020

They also have a desire to exhibit more control,” Charlie Arnot, CEO of The Center for Food Integrity, said on the Professional Dairy Producers’ Dairy Signal webinar on consumer food trends during COVID-19. The International Food Information Council (IFIC) explored COVID-19’s impact on U.S.

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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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Health Populi

AUGUST 12, 2021

As connected devices proliferate within health care enterprises and across the health care ecosystem, cybersecurity risks abound. “During the chaos and confusion, threat actors launched cyberattacks,” Ordr observed in the wake of the public health crisis.

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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

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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