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. JAMA Health Forum. J Health Polit Policy Law. N Engl J Med.

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Bill of Health

SEPTEMBER 23, 2022

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols t hat Collect Real World Data: Considerations and Guidance. Food and Drug Administration or FDA), which contributes to the development of knowledge about the unapproved product’s safety. Belli, and Sage Gustafson.

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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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SQA

MARCH 25, 2021

SQA Regulatory Surveillance Summary #2, 2021. COVID-19 Pandemic Triggers Development of New Standard for Ventilators, 12 January 2021. PDA Technical Report 60-3 (TR 60-3), Process Validation: A Lifecycle Approach, Annex 2: Biopharmaceutical Drug Substances Manufacturing, March 2021.

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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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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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SQA

DECEMBER 10, 2021

SQA Regulatory Surveillance Summary #6, 2021. Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers, 02 August 2021. It is anticipated that ANVISA will review stakeholder feedback on the public consultation through November 2021, then issue a final regulation on UDI in December 2021.

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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. That’s such welcome news and a positive outlook for a healthier 2021.

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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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Health Populi

MAY 13, 2021

These are the key themes coming out of the 2021 Axios Harris Poll 100 on the most visible brands with high (and low) reputations among U.S. In the top-ranked “excellent” and “very good” brands numbered 1 through 50, we find five core health care brands that were most visible to U.S.

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HIT Consultant

OCTOBER 14, 2021

Before HLTH 2021 kicks off in Boston on October 17th, here are 15 predictions from digital health executives to watch: Siva Namasivayam, co-founder and CEO of Cohere Health. I expect the other trend will be focusing on mental health, especially in the context of the post-Covid era.

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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 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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Health Populi

JANUARY 18, 2021

CES 2021 featured some obvious quick-pivoting products that had the pandemic written all over them, with sessions invariably speaking to the way the public health crisis impacted companies and strategic plans. Joining Peloton in connected fitness at CES 2021 was NordicTrack, which recently announced its purchase of Precor.

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Healthcare IT Today

JULY 31, 2022

House of Representatives passed by a 416-12 vote the Advancing Telehealth Beyond COVID–19 Act of 2021 , which would extend the telehealth flexibilities put in place during the public health emergency until the end of 2024.

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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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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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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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Bill of Health

OCTOBER 27, 2022

In 2021, the Supreme Court articulated in Tandon v. 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. By Donna Gitter. Throughout that period, federal courts have respected those decisions. Donna M.

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Bill of Health

APRIL 14, 2023

FDA that federal courts have the power to modify the conditions under which the FDA can approve a drug, may seem separate. By that I mean, it is one thing to criticize the process of seeking out opposing viewpoints, but quite another to criticize the weight that the experts at the FDA gave them in making a final decision.

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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. New York’s Policy. less likely to receive the treatment than whites.

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SQA

SEPTEMBER 2, 2022

As became the case in May 2021, when the European Medical Devices Regulation (MDR) came online without an updated MRA between the EU and Switzerland, Swiss manufacturers of IVDs are now treated as any other “third country” manufacturers seeking CE Marking to sell their devices in the EU.

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HIT Consultant

APRIL 1, 2024

In 2021, the year with the most COVID-19 deaths (416,893), heart disease claimed 60% more lives (695,000) in the US. Data sharing between the health care and the public health sectors can lead to a greater understanding of the communities at heightened risk. But while the fatalities were stark – almost 1.2

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Kaiser Health News

JUNE 2, 2022

That 2021 law, which the Supreme Court refused to block, is in effect and has dramatically reduced abortions in the state. when the FDA approved mifepristone in 2000. Peter Pitts , a former associate commissioner at the FDA during George W. district court ruled in 2014 that a drug approved by the FDA couldn’t be banned.

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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. And we did see an increase again around early 2021, at the time of the Delta variant. First of all, we should think about the public health emergency.

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Health Populi

OCTOBER 8, 2021

More Boomers are concerned with health data app privacy than Gen Z consumers, as the chart illustrates. adults said that health monitoring apps were not an invasion of privacy; 32% said they were, Morning Consult found. Even so, 2 in 3 adults said they would likely get an app to track a medical condition that was approved by the FDA.

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Health Populi

AUGUST 12, 2021

During the first year of the COVID-19 pandemic, the health care sector was profoundly affected by cyber-attacks on connected devices, we learn in the report, Rise of the Machines 2021: State of Connected Devices – IT, IoT, IoMT and OT from Ordr. 32% of medical imaging devices were running on unsupported operating systems, and.

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AIHC

JANUARY 28, 2022

billion in uncompensated care payments for FY 2021, a decrease of approximately $60 million from FY 2020. For FY 2021, CMS will use a single year of data on uncompensated care costs from Worksheet S-10 of hospitals’ FY 2017 cost reports to distribute these funds, in part because CMS has conducted audits of this data.

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Bill of Health

JANUARY 16, 2024

The judge did so by suspending an FDA rule that required in-person ordering, prescribing, and dispensing of the pill by a provider. Coeytaux explains: “It wasn’t clear that it was legal… My role is to push and say we need you to do your part so we can get closer to this vision.”

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Kaiser Health News

NOVEMBER 27, 2023

billion bond measure in 2024 to revamp and expand community-based behavioral health programs, including thousands of new treatment beds. per 100,000 people in 2021. per 100,000 people in 2021. Prescription Drugs Florida A DeSantis proposal submitted to the FDA in 2020 includes allowing imported medications from Canada.

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HIT Consultant

APRIL 4, 2023

The truth remains that the founder-friendly market of 2021 and early 2022 has tilted sharply toward investors. The IPO Market and Q1 Q1 2023 logged another quarter with zero digital health IPOs. Top of mind is the announcement to end the COVID-19 public health emergency (PHE), which is slated to expire on May 11, 2023.

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Healthcare IT News - Telehealth

FEBRUARY 5, 2024

Despite the end of the public health emergency, individuals and informed political leaders will continue to work with pharmacies to continue access to vital care for individuals in need of medication for mental health because mental health is part of overall health. Your third prediction concerns medication.

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Health Law Pulse

DECEMBER 30, 2021

As of December 25, 2021, the CDC reported the Omicron variant represents almost 60% of the reported cases of COVID-19 as compared to the Delta variant’s roughly 40% of cases. On December 28, 2021, the FDA announced its observations from a preliminary study of the Omicron variant related to testing and detection.

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SQA

FEBRUARY 26, 2024

European Commission (EC) New Measures to Fight Organized Crime and Drug Trafficking, 18 October 2023 In 2021 alone, 303 tons of cocaine were seized in the EU. PCPC will continue to offer feedback to the FDA on the agency’s implementation of MoCRA and is encouraging member companies to prepare for registration and listing.

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Healthcare IT Today

FEBRUARY 15, 2024

With more than 700 US FDA-approved AI applications, healthcare providers grapple with navigating the complex landscape of niche AI solutions. Operational since 2021, CARPL was founded by Dr. Vidur Mahajan, a physician with an MBA from the Wharton School of Business who has spent more than 12 years in the diagnostics industry.

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AIHC

JUNE 14, 2023

The question remains, how will the use of AI be regulated for health care use? The Federal Drug Administration & AI The Food & Drug Administration (FDA) released a discussion paper in 2019 and then an action plan on January 21, 2021 regarding Artificial Intelligence and Machine Learning, or AI/ML.

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Natalia Mazina

JANUARY 11, 2022

The order explains that: “… the heightened transmissibility of the Omicron variant has increased the need for widely available, affordable COVID-19 At-Home Test Kits that can be administered by members of the public at their convenience. i) is authorized for use by the FDA, (ii) detects the presence of the SARS-CoV-2 virus, and.

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