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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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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COVID-19 COVID-19 Vaccine FDA Informed Consent 343

Health Populi

JUNE 11, 2020

More women than men tend to be thinking about food more often and eating more than usual in the pandemic era. The pandemic era has also been about “health,” which may be an obvious top-line finding. More women than men are concerned about a food’s role in weight.

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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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HIT Consultant

FEBRUARY 1, 2024

However, legitimate concerns about transparency and potential conflicts of interest exist if affiliate relationships or sponsored content are not disclosed. Patients often know more about their lived experience than their doctors, and sharing their first-hand experience can help others discover treatments they’re unaware of.

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Pharmaceutical Industry FDA Public Health Regulatory Compliance 111

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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Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In particular, we hear a lot about face masks and how they can help prevent the spread of COVID-19. When used for this purpose, a face mask becomes an important tool for public health policy as a source control device.

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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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Exeed Regulatory Compliance

JULY 31, 2020

It is a public health emergency of massive scale that has affected nearly all aspects of our life. In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease.

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FDA COVID-19 US Department of Health and Human Services Public Health 52

Bill of Health

JUNE 26, 2023

This prompted discussions about preventing recurrences, either through governmental regulation of biologics manufacturers or governmental manufacture of the biologics themselves. Once approved by the FDA, CalRx insulin will be made available at $30 to all Californians who need it. At the turn of the 20 th century, the unregulated U.S.

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Bill of Health

JULY 14, 2023

Bard Until more is known about how to mitigate the threat of AI-fueled persuasion in human subject research, a ban on its use is the only reasonable way to keep the promise that we, as a country, made to those harmed while participating in research. By Jennifer S.

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Exeed Regulatory Compliance

JULY 10, 2020

There have been many reports in the media about low-quality face masks and respirators flooding the market in recent months. The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. References FDA (2020, May).

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HIT Consultant

JUNE 10, 2022

In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. Wang, Chief Medical Officer of COTA, Inc.

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Health Outcomes FDA HIPAA Public Health 98

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

NOVEMBER 3, 2023

They ask patients to check boxes in answer to questions about their symptoms, treatment effects, and ability to function physically, emotionally, and socially. They thus may solicit very sensitive information about matters such as anxiety, depression, and sexual satisfaction. Chief among them is filling data gaps.

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Health Law Advisor

SEPTEMBER 12, 2023

The HHS recommendation is predicated, via the FDA, on a scientific and medical evaluation of marijuana, using a statutorily required eight-factor analysis. This effectively allows the DEA to adopt a different outcome than the FDA. The agencies rarely disagree on final scheduling placement. heroin, LSD, and ecstasy).

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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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Public Health Health Services Administration Patient Advocacy Governance 68

Healthcare IT Today

DECEMBER 1, 2023

The next public health pronouncement or clinical treatment might emerge from synthetic data : rows of totally invented people that contain no real data but reflects the actual characteristics of a population such as race, gender, and medical conditions. ” The FDA, VA, and others are using synthetic data.

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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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Dot Compliance

FEBRUARY 22, 2022

If you’ve developed a new pharmaceutical and want to market it to health care providers or the general public, you must take one first, unskippable step: you need to get it approved by the Food and Drug Administration. FDA regulations govern what you can claim about your product and whether you can even sell it at all.

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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. This kind of media attention has brought about increased scrutiny of these platforms by federal and state regulators. Does the platform treat certain data as consumer data?

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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. In terms of when the pandemic started, if you think about the numbers in December 2019 or January 2020, one-tenth of about 1% of the total appointments were telehealth related.

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Health Law Advisor

NOVEMBER 1, 2022

The motivation for this month’s post was my frustration with the techniques for searching the FDA’s 510(k) database. Here I’m not talking about just using the search feature that FDA provides online. That left me with just about 160,000 products. I then filtered for products that had an FDA clearance listed.

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Healthcare Law Today

JANUARY 11, 2023

Food and Drug Administration (FDA) prior to distribution. The lawsuit alleged that the device was not approved or authorized by the FDA and that the procedure was not covered by Medicare. The FDA has jurisdiction to regulate products that meet the definition of “device” under section 201(h) of the FDCA.

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HIT Consultant

APRIL 1, 2024

Such fatalities could dramatically change by making screening and treatment of heart disease ritualized and incentivized parts of health care. Several years ago, the CDC recognized that the rate of hypertension control in Minnesota was about 70%, far higher than the national average.

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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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COVID-19 FDA Public Health 128

Health Law Pulse

FEBRUARY 11, 2022

On the topic of the COVID-19 vaccine, the FDA announced today, February 11, 2022, that it was postponing an upcoming vaccine committee meeting in order to analyze new data concerning vaccine administration for children under the age of five. The post COVID-19 Update: New Variants and Vaccine Research appeared first on Health Law Pulse.

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COVID-19 COVID-19 Vaccine FDA Public Health 52

Bill of Health

APRIL 18, 2022

Are you ready to learn about “the most innovative piece of exercise equipment ever”? The Consumer Product Safety Commission (CPSC) and Food and Drug Administration (FDA) are also involved in exercise equipment regulation. By Jack Becker. Doesn’t everybody want to “lose those love handles nobody loves”?

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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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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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Bill of Health

SEPTEMBER 12, 2023

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent.

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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. There is some good news on the horizon. 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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Exeed Regulatory Compliance

JULY 20, 2020

There is a lot of conversation about testing. The Accuracy of Covid-19 Antibody Tests As we write this blog, the FDA has authorized 30 different antibody tests for Emergency Use. We will be providing more updates in the future about other recently authorized tests. In some cases, a second confirmatory test may be needed.

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Exeed Regulatory Compliance

MARCH 5, 2020

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

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US Department of Health and Human Services FDA Public Health COVID-19 52

Bill of Health

APRIL 7, 2022

is a service-oriented, curious Ghanaian native passionate about the intersections of community, wellbeing, and technology. Jonathan Perez-Reyzin is a law student at Yale Law School interested in health justice, criminal law, and the intersection of law and philosophy. Keep an eye out for their bylines! Kwasi Adusei , D.N.P.

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FDA Nurses Informed Consent Public Health 144

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. "And one thing I've heard plenty about is how important it is for Cerner to improve our revenue cycle solution."

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