Bill of Health

MARCH 27, 2024

By Vincent Joralemon As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. This is typical—without a seal of approval from FDA, insurers are reluctant to pay for off-label treatments. for depression).

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Bill of Health

OCTOBER 17, 2023

Epigenetic changes from environmental exposures, cell-to-cell signaling behaviors, and the mutations present in diseased cells all profoundly inform how cells behave in whether and how they code the instructions that DNA offers. Disease isn’t always “written in the stars” for patients.

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Healthcare Dive

APRIL 6, 2022

Treatment is now widely covered by insurance, but the cost can still present hurdles for patients, depending on their coverage plans. There are some obstacles to use. Yescarta is expensive, priced by Gilead at $373,000 per patient.

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Mobi Health News

MARCH 16, 2021

The company’s digital therapy CureSight presents a new treatment method for amblyopia, also known as lazy eye, that doesn’t require patching. .

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FDA 110

Bill of Health

APRIL 13, 2022

In fact, a recent FDA regulatory forum toxicology expert review article has suggested that a medication’s 5HT 2B binding affinity (Ki) was considered a better predictor of VHD risk than measures of functional activity such as EC50.

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Healthcare IT News - Telehealth

JANUARY 19, 2021

Experts have repeatedly predicted that telehealth would present a major challenge for healthcare cybersecurity in the coming year. "FDA does not regulate telemedicine," she reminded co-panelists. But "if there's one thing FDA has really learned … it's that everybody has to be doing their part."

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Telemedicine Ransomware FDA COVID-19 218

Healthcare It News

FEBRUARY 1, 2022

Lastly, artificial intelligence (AI) gains significance and undergoes stronger scrutiny procedures in the US with more than a hundred new AI and machine learning (ML) based device approvals by the FDA. The new BCG Digital Ventures report is the second after its initial launch in 2021. ” THE LARGER TREND.

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COVID-19 FDA Health Insurance Doctors 241

Bill of Health

MARCH 4, 2024

But the most pertinent lobbying is currently working to shape the FDA’s guidelines for psychedelic therapy. FDA Psychedelic Draft Guidance When administrative agencies propose new guidelines or rule changes, companies, trade groups, academics, and engaged citizens reply with specific concerns.

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Healthcare It News

FEBRUARY 1, 2022

Lastly, artificial intelligence (AI) gains significance and undergoes stronger scrutiny procedures in the US with more than a hundred new AI and machine learning (ML) based device approvals by the FDA. The new BCG Digital Ventures report is the second after its initial launch in 2021. ” THE LARGER TREND.

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COVID-19 FDA Health Insurance Doctors 236

Bill of Health

MARCH 20, 2023

In February 2023, the FDA granted its first Orphan Drug Designation to a drug discovered and designed using AI; Insilico Medicine plans to begin a global Phase II trial for the drug “early” this year.

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Bill of Health

JANUARY 26, 2024

Besides grants for “psychedelic” research, the FDA just released draft guidance on considerations for psychedelic clinical investigations with an ambiguous definition of what is considered to be a “psychedelic.” When we discuss FDA clinical trials , we’re talking big money , so clarity matters here.

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Compliancy Group

NOVEMBER 4, 2024

One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry. The purpose of this list is to help businesses stay within compliance with FDA regulations and to safeguard public health.

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Healthcare IT News - Telehealth

JANUARY 23, 2024

He is head of the team behind a newly FDA-cleared cardiac device designed to help manage the challenges around heart failure. And a new study of the device Brady presented at the 2023 American Heart Association Scientific Symposium shows promising results.

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FDA Hospitals Medicare Medicare 171

Hall Render

SEPTEMBER 8, 2023

The Final Guidance provides recommendations on how to enhance consumer comprehension of promotional materials by making the language and presentation of quantitative information more accessible and consumer-friendly across various media formats. 57 out of 100) or percentages (57%). 57 out of 100) or percentages (57%).

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Bill of Health

NOVEMBER 3, 2023

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. Medical malpractice could occur for two reasons.

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Malpractice Bioethics HIPAA FDA 289

Healthcare IT News - Telehealth

AUGUST 2, 2022

" There are currently no FDA-approved OTC medications for hypertension. "For instance, if an individual is diagnosed with high blood pressure by a One Medical doctor, will he later be advertised over-the-counter blood pressure medications whenever he shops at Whole Foods Market?"

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Healthcare IT News - Telehealth

MARCH 14, 2022

Electronic Caregiver is presenting Addison the Virtual Caregiver in addition to its other RPM technology alongside care management company MD Revolution in HIMSS Booth 4109. Virtual-reality telemedicine. Individual patients can purchase "Flow Health" for $599.

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Healthcare IT News - Telehealth

JULY 22, 2024

The health system's centralized MRI services at its Orlando campus, though effective, presented areas where AdventHealth could deliver a more consumer-centric experience. THE PROBLEM Expanding advanced MRI services to the community hospitals presented its own set of challenges.

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HIT Consultant

MARCH 6, 2024

This influx of capital marks a pivotal moment in BHT’s mission to reshape bone health for postmenopausal women, closing right in time for de novo FDA clearance. Presently, more than 64 million individuals in the US are grappling with osteopenia and osteoporosis.

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Health Populi

AUGUST 9, 2019

Lisa Gill of Consumers Union, publisher of Consumer Reports , was one of several dozen presenters at a recent FDA hearing on CBD regulatory issues (detailed below in the Hot Points ). Here’s a link to the FDA’s FAQs on CBD. Already, we know from the Consumer Reports FDA testimony from May 2019 that one in five U.S.

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HIT Consultant

MAY 22, 2024

Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE). Joint research efforts have produced numerous oncology studies presented at prestigious conferences like the American Society of Hematology (ASH) and the American Association of Cancer Research (AACR). Wang, COTA’s chief medical officer.

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HIT Consultant

MAY 3, 2023

The financing will be used, among other things, to advance the clinical programs of the company’s product in the United States towards its first FDA approval.

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Health Law Advisor

APRIL 4, 2023

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times. But with the static presentation, I thought I would graph it in a bar chart.

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HIT Consultant

AUGUST 3, 2023

Food and Drug Administration (FDA). The submission has passed the first milestone of the review process, an initial review for completeness, and is now under full review by the FDA. Evie Ring’s Clinical Performance One of the most critical components of the FDA submission is the ring’s clinical performance.

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Healthcare IT Today

JANUARY 8, 2024

It maintains the most rigorous security certifications and holds over 100 patents and numerous regulatory registrations, including FDA clearance and CE marking. A Certified B Corporation, Volpara is the preferred partner of leading healthcare institutions around the world. For more information, visit volparahealth.com.

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Bill of Health

JULY 14, 2023

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

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Health Law Advisor

MARCH 3, 2023

Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives. [1] However, FDA found that consumers do not appear to understand the nutritional differences between plant-based milk and cow-derived milk. On February 22, 2023, the U.S.

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Exeed Regulatory Compliance

MARCH 22, 2020

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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Healthcare IT Today

JANUARY 5, 2024

The app-based digital therapeutics are the only FDA-authorized app-based treatments for SUD and OUD, respectively. In recently presented data , reSET and reSET-O users saved Massachusetts $2,011 per user in healthcare resource-related costs.

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Health Law Advisor

DECEMBER 6, 2022

I thought this month might be an opportunity to show how two different FDA databases produce quite different results when they should be the same. For context, I should explain that I didn’t set out to find differences in the FDA data sets. I don’t know why, and frankly I hope the FDA changes that. Background.

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Health Law Advisor

MARCH 1, 2023

To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works. And what better first topic than data on FDA responses to FOIA requests. FDA has been releasing data on its FOIA process, specifically its FOIA logs , for a few years. We were wrong.

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Healthcare IT Today

AUGUST 12, 2024

SONU is the world’s first FDA De Novo-authorized, AI-enabled, wearable medical device for the treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis for at-home use by individuals 22 years of age and older. SONU provides a new non-pharmaceutical treatment option for patients and clinicians.

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Health Law Advisor

MAY 2, 2023

In prior posts here and here , I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. Chances of Success by Topic Given those topics, I wanted to understand which topics are likely to succeed in getting information from FDA. Here’s what I found. Who is asking what?

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HIT Consultant

JUNE 23, 2022

The incubator will culminate in a demo day, with the cohort presenting their solutions to a panel of industry stakeholders. The second track will identify an additional eight startups to participate in a high-touch, eight-week incubator concentrated on curating introductions to key potential U.S.

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Health Populi

AUGUST 12, 2021

In health care, outdated operating systems present some of the greatest risks: 15% of medical devices and 32% of medical imaging tools run on outdated operating systems. In this Rise of the Medical Machines, the major risks for health care organizations were that, 68% of health care deployments had more than 10 FDA recalls.

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Health Law Advisor

JANUARY 31, 2023

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. FDA does note that if such measures cannot eliminate cross-contact, manufacturers will often use advisory statements to alert allergic consumers to the potential for cross-contact.

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HIT Consultant

JUNE 30, 2022

This is also driven by the use of home wearable solutions and increased awareness of heart health resulting in more patients presenting for additional diagnosis. Apple – Apple first gained FDA approval in September 2018 for its app for the detection of atrial fibrillation (AF) or sinus rhythm using the Apple Watch Series 4 onward.

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