HIT Consultant

APRIL 23, 2024

What You Should Know: Exo® (pronounced “echo”) , a medical imaging software and devices company, today announced its FDA-cleared cardiac and lung artificial intelligence (AI) applications are now available on Exo Iris™, Exo’s high-performance handheld ultrasound device.

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Hall Render

JANUARY 30, 2025

This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents. A statement disclosing FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling. Before the U.S.

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Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. This phaseout is scheduled to occur over four years, starting from the publication date of the Final Rule on May 6, 2024.

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FDA Compliance Regulatory Compliance Licensing 40

Bill of Health

APRIL 8, 2025

Published April 8, 2025 Author Jessica Samuels Share Share on LinkedIn Share on X Share on Facebook Share on Reddit Artificial intelligence ( AI ) is the use of computers or machine learning to simulate or imitate human intelligence. Food and Drug Administration (FDA) is responsible for the oversight of medical devices and products.

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Licensing FDA Electronic Medical Records Informed Consent 234

Bill of Health

JANUARY 23, 2025

Published January 23, 2025 Author Jessica Samuels Share Share on LinkedIn Share on X Share on Bluesky Share on Facebook For the past week, I have watched my beloved city of Los Angeles become engulfed in flames. About the author Jessica Samuels is a third-year dual degree law and public health student (J.D./MPH

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Bill of Health

MARCH 25, 2025

Published March 25, 2025 Author Spencer Andrews Share Share on LinkedIn Share on X Share on Bluesky Share on Facebook As many as one in four Americans will place a bet on this years March Madness tournament. The FDA also required cigarette companies to warn consumers of the addictive nature and potential harms of their products.

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Governance FDA Public Health 147

Health Populi

APRIL 1, 2025

While this report hit the virtual bookshelf about six months ago, I am revisiting it on this first day of the second quarter of 2025 because of its salience in this moment of uncertainties across our professional and personal lives — particularly related to health politics, global economics and trade, and the erosion of trust in institutions.

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Public Health Electronic Medical Records Regulatory Compliance FDA 62

Bill of Health

OCTOBER 30, 2024

Holding TikTok liable for addicting a generation to their app begins the process of remedying the mental health crisis in children. Jessica Samuels is a third-year dual degree law and public health student (J.D./MPH She has previously published work on the accuracy of ultrasound in predicting malignant ovarian masses.

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Bill of Health

OCTOBER 15, 2024

Jessica Samuels is a third-year dual degree law and public health student at Harvard University. Her research interests include genetics, environmental health sciences, novel biotechnologies, and the FDA regulatory process.

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FDA Public Health 100

SQA

AUGUST 1, 2024

These variations are required to be assessed by the authorities based on their impact on public health and the medicine’s characteristics. In addition, the ISPE Guide outlines the authority of State Boards of Pharmacy and their coordination of oversight with the FDA. Science and safety are at our core.

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SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. The following new measures are set to be introduced on 01 January 2025.

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SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. Core aspects of the future framework for medical devices are intended to apply from 01 July 2025.

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FDA Compliance Licensing World Health 40

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The government is aiming for the revised framework to now apply from July 2025.

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SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The government is aiming for the revised framework to now apply from July 2025.

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FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

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FDA Compliance Public Health World Health 52

SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

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FDA Compliance Public Health Governance 40

SQA

JUNE 3, 2024

Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025. FDA has prepared a draft document entitled Food and Drug Administrations Draft Report and Plan on Best Practices for Guidance.

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Bill of Health

MARCH 5, 2025

Published March 5, 2025 Author Jessica Samuels Share Share on LinkedIn Share on X Share on Bluesky Share on Facebook How do we know what is healthy? Food and Drug Administrations (FDA) new proposed rule on a front-of-package nutrition label, called a Nutrition Info box. This is the driving motivation behind the U.S.

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US Department of Health and Human Services FDA Public Health World Health 130

Bill of Health

NOVEMBER 25, 2024

Food and Drug Administration (FDA). The FDA maintains that low levels of BPA exposure are safe for humans. However, the FDA has recognized that low levels of exposure are not safe during infant development and no longer allows BPA-based baby bottles, sippy cups , or packaging for infant formula.

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Jane Sarashon

JANUARY 5, 2025

Welcome to the five key tech-trends for 2025, brought to life Sunday afternoon by Melissa Harrison, CTA’s Vice President of Marketing & Communications tag-teaming with Brian Comiskey, Senior Director, Innovation & Trends. As consumers have adopted base hardware technologies (e.g.,

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Healthcare Law Blog

AUGUST 25, 2022

Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. Essentially, the moratorium on the requirement that, to be eligible for a premium tax credit, household income must be at or below 400% of the federal poverty level, is extended through 2025.

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Healthcare IT Today

NOVEMBER 6, 2024

Food and Drug Administration (FDA) to explore its use for reporting adverse effects in clinical trials. With this knowledge, we successfully leveraged the viability of Networked FHIR for prior authorization with UC Davis Health, Regence, and other eHealth Exchange participants. The initial group of Designated QHINs has grown to seven.

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HIPAA Public Health FDA Health Insurance 80

Bill of Health

APRIL 14, 2025

Until April 7, 2025, pharmaceutical products had been one of those exceptions Published April 14, 2025 Author Jessica Samuels Share Share on LinkedIn Share on X Share on Facebook Share on Reddit Over the past few weeks, the Trump administration has imposed numerous tariffs on imports to the U.S. health care system and abroad.

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Hall Render

MAY 20, 2022

AHA asks HHS to continue the public health emergency until conditions stabilize. Considerations for Social Determinants of Health Screening Design. COVID-19 public health emergency set to be extended. Covid-19 remains a public health emergency in US, administration says.

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Hall Render

MAY 13, 2022

FDA limits J&J COVID-19 vaccine due to rare blood clot risk. US faces deficit of 450,000 nurses by 2025. Now Durango’s public health agency is sounding the alarm. Oscar Health To Exit Colorado, Arkansas. 340B hospitals amplify loss projections as more drugmakers unveil restrictions. HHS awards $16.3M

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Jane Sarashon

DECEMBER 12, 2024

Most health citizens in the U.S. trust the CDC, NIH, and FDA, and most people also want the 47th incoming President Donald Trump to strengthen health/care institutions — from the VA and FDA to Medicare, Medicaid, as well as the CDC and Affordable Care Act. public health. Twelve percent of U.S.

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FDA Public Health Medicaid Medicaid 52

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 as opposed to the current 5%. reduction in 2023.

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Medicaid Medicaid Medicare Medicare 104

Hall Render

JUNE 7, 2024

News ranks hospitals in health equity. for behavioral and mental health services SOUTH CAROLINA Could SC’s health agency merger bill be revived, or will it have to wait until 2025? These hospitals earn top honors. million bird flu shots to U.S. million bird flu shots to U.S. to get $40.7M

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US Department of Health and Human Services Nurses Hospitals Nursing Homes 40

Hall Render

JUNE 28, 2024

less than MU Health projected Lutheran Family and Children’s Services Expands Services in Kansas City Kansas City groups support designating gun violence as public health crisis Fitch downgrades Missouri hospital MONTANA Organizations request Montana health department investment following Medicaid redetermination Montana offers $15.8M

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US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Hall Render

FEBRUARY 23, 2024

CT’s Medicaid reimbursement rates lower than peer states: report Better safety training, reporting, escorts for CT home health care workers focus of new legislation D.C. biotech pins hopes on 3 drug approvals as battles with FDA continue Luxury senior living facility coming to D.C.

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Hall Render

SEPTEMBER 20, 2024

Vincent, Indianapolis Colts announce new partnership Franciscan Health launches 24/7 ambulance to help patients in rural counties Lilly to make $1.8B Mary’s Hospital helps high-risk babies Reasons behind 3 recent CON denials St.

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US Department of Health and Human Services Nurses Hospitals Nursing Homes 40

Hall Render

JUNE 21, 2024

NATIONAL 50% of U.S. to buy property. Who’s pursuing ASCs in 2024?

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US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Hall Render

DECEMBER 29, 2023

Here’s how to find quality care CEOs turn attention from recovery to growth ARKANSAS Statistics show many northern Arkansas locations considered maternity care deserts How broadband expansion is bolstering rural healthcare Arkansas leaders work to close gap between medical school graduates and in-state residencies Program in south Arkansas provides (..)

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Nursing Homes US Department of Health and Human Services COVID-19 Nurses 40

Hall Render

MARCH 8, 2024

Tammy Jackson is new vice president of patient care services and CNO at SSM Health UChicago Medicine nurses plan 1-day strike OSF HealthCare plans to build a new hospital in Illinois with wide range of services Illinois public health adopts new COVID guidelines These Are The Top 5 ‘Best Hospitals’ In Illinois Illinois Association of Medicaid (..)

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Nursing Homes Nurses Hospitals COVID-19 40

Hall Render

JANUARY 22, 2025

The Original Proposed Rules were expected to be finalized prior to the end of the COVID-19 public health emergency. Barring Congressional intervention, the final rule is expected to become effective on February 18, 2025. Continuity of Care via Telemedicine for Veterans Affairs Patients Additionally, in consultation with the U.S.

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Telemedicine Department of Veterans Affairs COVID-19 FDA 40

Hall Render

JANUARY 17, 2025

OrthoIndy to merge with Evansville, Fort Wayne practices St. healthcare fraud scheme New Orleans launches tool to help doctors find reproductive care drug amid tight state restrictions MAINE Owner of Woonsocket hospital expands into Maine St.

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Nursing Homes Nurses Hospitals Medicaid 40

Hall Render

AUGUST 23, 2024

renovation Maryland nursing home under historic oversight after state investigation This MD Hospital Listed Among Americas Greatest In New List Black-owned Laurel radiology practice sues UM Medical System alleging unfair bidding practices MASSACHUSETTS A closer look at the health systems trying to buy Steward’s Mass. hospitals Gov.

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