HIT Consultant

OCTOBER 11, 2023

Food and Drug Administration (FDA) to advance the use of real-world data (RWD) in the U.S. Study Goals & Objectives The goal of the study is to better understand how patients with rare cancers present and are treated to inform drug development for life sciences companies and the FDA. community oncology setting.

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FDA 98

HIT Consultant

OCTOBER 4, 2024

Food and Drug Administration (FDA) for a groundbreaking tool in the fight against Alzheimer’s disease. This streamlined process generates quantitative results, presented in a standardized report alongside the images.

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FDA 98

HIT Consultant

OCTOBER 8, 2024

Food and Drug Administration (FDA). With its initial focus on cardiology, AccurKardia provides innovative cloud-based diagnostic tools, including AccurECG™4, an FDA-cleared Class II software as a medical device (SaMD) that offers fully automated, near real-time ECG interpretation.

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FDA Hospitals 105

Healthcare IT Today

MARCH 24, 2025

As a pioneer in the field of lymphedema detection and monitoring, ImpediMed offers the only FDA-cleared bioimpedance spectroscopy (BIS) technology for the clinical assessment of breast cancer-related lymphedema (BCRL) the SOZO Digital Health Platform. health payors now providing coverage for over 258 million covered lives.

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FDA Due Diligence Compliance 75

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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FDA HIPAA Informed Consent 282

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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FDA 130

Bill of Health

AUGUST 4, 2022

Food and Drug Administration (FDA) plays a central role — it is the regulatory mechanism by which drugs like MDMA and psilocybin may soon become legal for medical use. At least two questions are thus presented for those interested in any sort of recreational (i.e., By Jonathan Perez-Reyzin. Brown & Williamson Tobacco Corp. ,

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FDA Public Health 147

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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FDA Medicare Medicare Health Insurance 203

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 260

Total Medical Compliance Resources

NOVEMBER 11, 2024

Any contaminants that are present (dirt, blood, and other bodily fluids) must be removed prior to disinfection or sterilization. A contaminant being present acts as a barrier and prevents sterilization of the item. They can potentially harm the instruments and are not FDA approved to be used to clean instruments.

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FDA 52

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 246

Healthcare IT Today

DECEMBER 6, 2024

about getting FDA clearance for applying AI in healthcare. The day started with a sit-down interview with Raj Chopra, MD from Merge by Merative who spoke about the need for radiologists to become more aware of and involved in cybersecurity. That was followed by a conversation with Samir Shah, MD from Qure.ai

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FDA Hospitals 73

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 93

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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FDA 317

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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FDA Governance 140

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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FDA Doctors HIPAA 175

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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FDA Compliance Officers Compliance Regulatory Compliance 52

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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FDA Governance Health Insurance 193

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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Patient Satisfaction Hospitals FDA 195

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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FDA Public Health 40

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

Hall Render

JANUARY 30, 2025

According to the Final Guidance, if a firm follows FDAs recommendations and shares such information with HCPs, FDA would not consider this communication alone as evidence of the firms intention to promote the product for an unapproved use, nor does it require the firm to submit the communication to the Agency at the time of dissemination.

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FDA State Policy Public Health Compliance 52

HIT Consultant

FEBRUARY 21, 2025

RESP Biosensor: A Breakthrough in Continuous Lung Monitoring The RESP Biosensor is an FDA-cleared and CE-marked wearable device that continuously captures lung sounds, including cough, wheeze, and crackles. This technology has been used in various patient populations and disease states, such as chronic cough, COPD, asthma, and heart failure.

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FDA 52

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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FDA Doctors Telemedicine Health Outcomes 148

Dot Compliance

FEBRUARY 25, 2025

Every brochure, website, social media post, and sales presentation must adhere to strict guidelines FDA regulations, global standards, and constantly evolving requirements. However, this quick pace comes with a complex regulatory burden, particularly when it comes to promotional materials.

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Compliance FDA 52

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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FDA 101

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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FDA 52

HIT Consultant

DECEMBER 9, 2024

Cala kIQ: Non-Invasive Relief for Hand Tremors The Cala kIQ System, featuring FDA-cleared Transcutaneous Afferent Patterned Stimulation (TAPS) therapy, is the only clinically validated non-invasive wearable device for action hand tremor relief in adults with essential tremor (ET) and Parkinsons disease (PD).

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Medicare Medicare FDA 52

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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FDA 98

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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FDA 52

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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FDA 52

HIT Consultant

DECEMBER 5, 2024

This presents an opportunity to bridge the awareness gap and improve benefit utilization among individuals seeking MSK care. Access to the FDA-cleared Enso wearable device for non-invasive, non-addictive pain relief, tailored for those experiencing significant movement-related pain.

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FDA Licensing 52

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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Informed Consent FDA Public Health World Health 130

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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FDA 98

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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FDA Governance 52

Healthcare IT Today

JANUARY 16, 2025

Food and Drug Administration (FDA) clearance. The healthcare industry and biomedical device fields often prioritized keeping devices as static as possible to support clinical quality testing and FDA clearance requirements once manufactured. Is Paying off Tech Debt Worth It? As an example, a health system with an annual revenue of $2.5

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Ransomware FDA Governance Compliance 52

Physician Credentialing Company

OCTOBER 31, 2024

Medical history Physical examination Diagnostic procedures Therapeutic and preventive interventions Follow-up and outcomes Patient safety Category 3: Codes in this category are named temporary codes because they remain in this section till their FDA approval and evidence of their wide use by providers. When to use CPT code 99204?

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Medical Billing Compliance Doctors Medicare 52