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.

FDA 105

FDA Hospitals 105

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.

FDA 282

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.

FDA 130

FDA 130

Bill of Health

APRIL 4, 2025

Noting the explosion in rates of obesity and chronic diseases among children caused by the ubiquity of inexpensive, good-tasting, super-sized, energy-dense foods, a presentation warned the CEOs that their companies could face a wave of litigation akin to the onslaught against Big Tobacco.

Public Health 147

Public Health FDA World Health Medicaid 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 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.

FDA 59

FDA Due Diligence Compliance 59

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.

FDA 354

FDA Public Health 354

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.

COVID-19 264

COVID-19 FDA Health Insurance Doctors 264

Bill of Health

JANUARY 23, 2025

1019 , passed in 2014, requires all materials that continue to use flame retardant materials to affix a label to the product informing the consumer of the chemicals present. Her research interests include genetics, environmental health sciences, novel biotechnologies, and the FDA regulatory process. Further, Senate Bill No.

Public Health 130

Public Health Governance FDA 130

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

FDA 78

FDA Hospitals 78

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.

FDA 52

FDA 52

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."

Telemedicine 218

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.

COVID-19 246

COVID-19 FDA Health Insurance Doctors 246

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.

FDA 140

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

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 Medicare Medicare Hospitals 194

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

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 80

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.

Patient Satisfaction 194

Patient Satisfaction Hospitals FDA 194

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%).

FDA 40

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.

Malpractice 289

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.

FDA 52

FDA State Policy Public Health Compliance 52

Bill of Health

OCTOBER 30, 2024

The lawsuits, arising from the desire to hold platforms accountable for exploiting children’s susceptibility to rewarding stimuli during development, present a novel theory of liability based solely on an algorithm’s ability to cause addiction rather than adverse mental health outcomes.

FDA 100

FDA Health Outcomes Public Health Governance 100

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.

FDA 52

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.

Compliance 52

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.

FDA 52

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.

FDA 52

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