HIT Consultant

APRIL 15, 2025

– The FDA granted a De Novo Classification Request for CT-132, signifying the novel nature of this digital intervention. This strategy aligns with the increasing interest and FDA draft guidance on Prescription Drug Use-Related Software (PDURS). Safety Information There are no contraindications to using CT-132.

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FDA 52

Healthcare IT News - Telehealth

APRIL 4, 2024

FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to the US market for the first time. European pedigree FDA clearance is significant for a system which is already CE-MDR medically certified in Europe. Find out more at Corsano Health.

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HIPAA Journal

APRIL 11, 2022

Food and Drug Administration (FDA) has issued new draft guidance for medical device manufacturers to help them incorporate cybersecurity protections into their products at the premarket stage, and to ensure security risks are managed for the full life cycle of the products. The FDA will then work on a final version of the guidance.

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FDA HIPAA 137

Healthcare IT News - Telehealth

APRIL 4, 2024

FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to the US market for the first time. European pedigree FDA clearance is significant for a system which is already CE-MDR medically certified in Europe. Find out more at Corsano Health.

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FDA Nurses Hospitals 160

Healthcare Dive

APRIL 21, 2023

The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.

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FDA 246

Bill of Health

OCTOBER 17, 2023

By Adithi Iyer The cultural, informational, and medical phenomenon that is 23andMe has placed a spotlight on precision medicine, which seeks to personalize medical care to each patient’s unique makeup. This information is highly personal to each patient, and reflects behavioral factors as well as genetics.

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Bill of Health

APRIL 30, 2025

These systems process information much as human intelligence does. As discussed in Part I , AI systems and humans have complementary strengths AI excels at processing vast information quickly, while humans provide contextual understanding and value judgments that AI currently lacks. NNF23SA0087056).

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Governance Regulatory Compliance Compliance Framework Compliance 162

Bill of Health

SEPTEMBER 23, 2022

Food and Drug Administration or FDA), which contributes to the development of knowledge about the unapproved product’s safety. Patients seeking to use a product via EA must have a serious or life-threatening condition for which there are no comparable FDA-approved treatments or clinical trial options available.

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HIT Consultant

OCTOBER 30, 2024

What You Should Know: – Abbott announced that its FreeStyle Libre 2 and 3 continuous glucose monitoring (CGM) systems have received FDA clearance for use during common imaging procedures, including X-rays, CT scans, and MRIs.

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HIPAA Journal

MARCH 30, 2023

Food and Drug Administration (FDA) will not authorize their use. trillion omnibus spending bill – The Consolidated Appropriations Act, 2023 – took effect and the FDA now requires all regulatory submissions for medical devices to include information about the cybersecurity measures that have been implemented for the devices.

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FDA HIPAA Governance Compliance 116

Bill of Health

NOVEMBER 16, 2024

In addition, information about fortified milk could easily be given by physicians to mothers during routine appointments. Since the repeal of the Enrichment Act of 1943, FDA has not required mandatory fortification. More controversially, however, FDA has regularly limited the type and amount of nutrient that can be added to a food.

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FDA Public Health 100

Bill of Health

DECEMBER 11, 2024

Each label, under its promises to improve mental speed, clarity, and even problem-solving skills, includes a warning that the previous statements have not been evaluated by the FDA and the product is not intended to diagnose, treat, cure, or prevent any disease. Food and Drug Administration (FDA) as dietary supplements, not medications.

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FDA 100

Bill of Health

NOVEMBER 29, 2023

By Vincent Joralemon Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Pfizer’s successful clinical trials for ED followed, leading to FDA approval of sildenafil citrate, marketed as “Viagra,” in 1998. This became Spravato, the first FDA-approved psychedelic therapy. Initially, the public is hesitant.

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Verisys

APRIL 8, 2025

T his information provides organizations with detailed reports for making well-informed hiring decisions. Our automated platform works diligently to provide updated reports regarding new regulatory information , ensuring that healthcare organizations are never left in the dark. jurisdictions across all provider types.

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Fraud Medicaid Medicaid Compliance 52

HIT Consultant

DECEMBER 3, 2024

AI will help analyze patient records (when available), personal demographic information, and vast amounts of treatment history to predict outcomes and recommend care pathways that will lead to better clinical outcomes. AI can automate the gathering of information. The FDA is approving digital therapeutics tools (i.e.,

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FDA Medicare Medicare Medicaid 111

Hall Render

APRIL 28, 2025

For more information on the 2024 LDT Final Rule, please see Hall Renders previous client alert and accompanying webinar. On May 6, 2024, FDA issued a Final Rule that formally classified all LDTs as medical devices subject to FDA oversight, ending its longstanding enforcement discretion policy. FDA and Molecular Pathology v.

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FDA Medicaid Medicaid Medicare 52

Healthcare It News

DECEMBER 16, 2022

Interoperability requirements: information blocking, the No Surprises Act and more. FDA and evolving regulations for digital therapeutics, software as a medical device. Automation, and how it can help clinician burnout and back-office processes. Cybersecurity and the patient safety risks of ransomware.

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COVID-19 Public Health Ransomware FDA 340

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

AUGUST 29, 2022

In 2022, the FDA ( Federal Food and Drug Administration ) will clear or approve over 1,000 medical devices. Here’s a breakdown of some of the most anticipated otc medical devices that have already received FDA approval. Some of these new FDA medical devices will truly impress you. PMA Applicant: Allergan.

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HIT Consultant

OCTOBER 22, 2024

Gait analysis can reveal crucial information about the health of various body systems, including nervous, musculoskeletal, and cardiorespiratory functions. OneStep’s AI-Powered Platform Key Features OneStep’s FDA-listed, AI-powered platform offers continuous, real-life monitoring of patient gait and mobility.

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FDA 98

Bill of Health

APRIL 4, 2025

The settlement compelled the tobacco companies to pay billions of dollars to the states to compensate them for Medicaid costs incurred by smokers, placed limits on tobacco advertising, and funded public information efforts. The toddler milk case may sidestep these causation challenges.

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Public Health FDA World Health Medicaid 235

Hall Render

APRIL 17, 2025

The Food and Drug Administrations (FDA) Office of Prescription Drug Promotion (OPDP) started 2025 with two Untitled Letters, one in February and one in March, potentially signaling more enforcement for the year. The exhibit booth was submitted to the FDA for review under the cover of Form FDA 2253.

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FDA 52

HIT Consultant

OCTOBER 4, 2024

Food and Drug Administration (FDA) for a groundbreaking tool in the fight against Alzheimer’s disease. By providing clinicians with easy access to this crucial data, MIMneuro with Centiloid scaling empowers them to make more informed decisions about patient care.

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FDA 98

HIT Consultant

APRIL 3, 2023

What You Should Know: – Today, Butterfly Network announced it received 510(k) clearance from the FDA for a groundbreaking AI-enabled tool named AI-enabled Auto B-line Counter that will help physicians assess adults’ lungs and accelerate providers’ abilities to make informed treatment decisions.

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HIT Consultant

JULY 2, 2024

What You Should Know: – Eli Lilly’s Kisunla™ (donanemab-azbt) has been approved by the FDA as a treatment for adults in the early stages of Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) and mild dementia, who have confirmed amyloid plaque buildup in the brain.

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HIT Consultant

MARCH 15, 2023

– TytoCare , a virtual care company enabling accessible, high-quality primary care from home, today announced that it received FDA clearance for its Tyto Insights for Wheeze Detection, paving the way for its rollout in the US.

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HIT Consultant

SEPTEMBER 30, 2024

Vicky Britton, Associate Principal of Social Media Intelligence The vast amount of data available to patients and consumers—from web sources, social media, wearables, and AI chatbots—has democratized health information on an unprecedented scale. This shift presents unique opportunities and challenges for the healthcare industry.

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Public Health FDA 98

Bill of Health

JUNE 5, 2023

Existing versions of ChatGPT are not HIPAA compliant , and there is a risk of a patient’s protected health information being accessible to OpenAI employees or used to train ChatGPT further (although providers can opt out of the latter). Food and Drug Administration (FDA).

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Malpractice FDA HIPAA Doctors 213

Bill of Health

MARCH 13, 2025

Published March 13, 2025 Author Gabriela Lenarczyk Share Share on LinkedIn Share on X Share on Bluesky Share on Facebook Transparency rules in clinical trials attempt to strike a balance between ensuring essential safety and efficacy data reaches the public, and preserving truly proprietary information that fosters innovation.

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Public Health FDA Governance Compliance 130

Bill of Health

APRIL 4, 2024

The main federal health privacy law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) applies only to “covered entities” like health insurers, claims- processing clearinghouses, and health care providers and their business associates, and only to a subset of protected health care information.

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FDA Malpractice Regulatory Compliance Health Insurance 288

HIT Consultant

SEPTEMBER 17, 2024

and Ascensia Diabetes Care announced that the FDA has cleared the Eversense® 365 CGM system. – This marks a significant advancement in diabetes management, offering a fully-implantable, long-term continuous glucose monitoring (CGM) solution for individuals with Type 1 and Type 2 diabetes aged 18 and older.

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FDA 98

HIT Consultant

AUGUST 23, 2023

What You Should Know: Welldoc® , a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®.

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FDA 98

HIT Consultant

JULY 21, 2022

What You Should Know: – RapidAI , the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity , the newest addition to the RapidAI platform. The key benefits of Rapid Hyperdensity include: 1.

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FDA Hospitals 98

Healthcare It News

MAY 12, 2023

"Adding this new non-invasive, molecular-based risk assessment tool to our portfolio will be another significant step forward in arming physicians with information to determine an appropriate treatment pathway," said Nicole Sandford, president and CEO, in Thursday's announcement.

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HIPAA Medical Billing FDA Licensing 356

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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Healthcare IT Today

DECEMBER 22, 2024

Because theres so much happening out there in healthcare IT we arent able to cover in our full articles, we still want to make sure youre informed of all the latest news, announcements, and stories happening to help you better do your job. It’s initially being used in Stelo, Dexcom’s FDA-cleared over-the-counter glucose biosensor.

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Medicare Medicare FDA Telemedicine 84

HIT Consultant

FEBRUARY 5, 2023

“AI automation is the new frontier and we’re excited to be the world’s first to receive FDA clearance to use AI for musculoskeletal ultrasound. This application will blow the doors open for physiotherapists and orthopedic clinicians to use ultrasound to deliver faster patient care.”

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FDA 94