HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. – Prescription hearing aids will require a consumer to have a prescription for a hearing aid from a physician, audiologist or a licensed hearing instrument specialist. These OTC hearing aids do not require a prescription. . yet is largely untreated.

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Bill of Health

OCTOBER 31, 2022

For instance, a study conducted in 2005 by the American Association for Advancement of Sciences revealed that 40% of respondents reported problems securing licenses for carrying out research; 58% reported delays due to licensing requirements; and 28% reported abandoning their research due to licensing issues.

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Bill of Health

APRIL 4, 2024

In a similar vein, FDA only considers medical AI that falls in one of its existing regulatory categories (most often medical device), and even then by way of Congressional action and FDA’s own interpretation of its authority, and its discretion only regulates a subset of medical AI. A different example has to do with how the U.S.

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Verisys

APRIL 8, 2025

However, most clients opt for the FACIS Level 3 background check as it is all-inclusive and protects them from employing individuals or vendors who are sanctioned by a state-level licensing board. Treasury Dept U.S. State Dept Which Level of FACIS Search Does Your Organization Need? The post What is FACIS?

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HIT Consultant

MARCH 6, 2025

– The collaboration will enable eligible Teladoc Health members enrolled in the Comprehensive Weight Care Program to receive convenient and affordable access to this FDA-approved medication. Personalized support: Tailored guidance and support to help members achieve their weight loss goals.

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Bill of Health

JUNE 5, 2023

medical licensing exam , diagnose illnesses , and even outshine human doctors on measures of perceived empathy , raising many questions about how AI will reshape health care as we know it. Food and Drug Administration (FDA). In the field of medicine, ChatGPT already has been reported to ace the U.S.

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Hall Render

MAY 11, 2022

Earlier this year, the Food and Drug Administration (“FDA”) announced a Proposed Rule regarding national standards for the licensing of prescription drug wholesale distributors (“Wholesale Distributors”) and third-party logistics providers (“3PLs”). Accordingly, FDA is proposing the withdrawal and replacement of the current 21 C.F.R.

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Healthcare It News

DECEMBER 1, 2021

As more and more wearable devices are becoming common in the technology, they have even started to get some FDA approvals as well. But one priority to address is the licensing-based requirement. But in addition to that, we do see a lot of trends toward increased use of remote patient monitoring.

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Healthcare IT Today

JANUARY 15, 2025

The trend is already clear, with FDA approvals for AI-related products rising significantly, from 650 devices in 2023 to 950 in 2024. The Consolidation Appropriations Act of 2023 requires strict cybersecurity measures for medical devices authorized by the FDA.

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C&M Health Law

FEBRUARY 1, 2022

Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. On January 31, 2022, the U.S.

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Healthcare IT News - Telehealth

AUGUST 6, 2024

UpScriptHealth also works with other medical device companies to increase access – for example, it powers telehealth consultations for Spark Biomedical's Sparrow Ascent, the only FDA-cleared, drug-free, non-addictive, non-invasive, wearable treatment technology for the relief of opioid withdrawal symptoms.

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HIT Consultant

DECEMBER 5, 2024

The platform includes licensed physical therapists, physicians, and board-certified health coaches to help individuals treat and prevent joint and muscle pain. 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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Health Law Advisor

SEPTEMBER 12, 2023

The HHS recommendation is predicated, via the FDA, on a scientific and medical evaluation of marijuana, using a statutorily required eight-factor analysis. In addition, only certain components of FDA’s eight-factor analysis bind the DEA. This effectively allows the DEA to adopt a different outcome than the FDA.

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Healthcare It News

NOVEMBER 12, 2021

CommonSpirit is developing the digital capabilities and clinical and administrative processes to provide these services, which will enable patients to have greater control over their care, empower education, increase engagement, target improved clinical outcomes and further support population health management. Twitter: @SiwickiHealthIT.

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Hall Render

OCTOBER 18, 2024

Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023.

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HIT Consultant

DECEMBER 15, 2022

Founded in 2021 with collaboration with Mayo Clinic, Anumana has licensed Mayo Clinic AI-ECG algorithms for low ejection fraction, pulmonary hypertension, and hyperkalemia, all of which have received Breakthrough Device Designation from the U.S. Anumana Background.

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HIT Consultant

JUNE 10, 2024

What You Should Know: – ALZpath , a leader in Alzheimer’s disease diagnostics, announced a licensing agreement with Roche for their innovative pTau217 antibody. ALZpath’s licensing strategy, making their pTau217 antibody available across various settings, aims to democratize access to this vital technology.

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Healthcare IT Today

JANUARY 24, 2024

They are still waiting on FDA clearance (like most in this space), but the concept is so simple and beautiful. Of course, these companies can’t say this is what they’re able to do until they get FDA clearance, but the early results seem promising. Here’s a look at how their demo worked for me.

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Hall Render

JULY 29, 2022

Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. SIPs are reviewed and authorized by the FDA and managed by States or Indian Tribes (“SIP Sponsors”). In May 2022, the U.S. Brief Discussion.

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HIT Consultant

NOVEMBER 23, 2021

XRHealth has virtual clinics throughout the United States that treat patients remotely with VR/AR-based therapy while they are examined by a licensed XRHealth therapist. XRHealth Background.

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Healthcare IT Today

JANUARY 19, 2024

About XRHealth XRHealth operates state-of-the-art therapeutic care Virtual Rooms, utilizing proprietary FDA and CE-registered medical Extended Reality (XR) technology (virtual and augmented reality).

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HIT Consultant

DECEMBER 14, 2021

In order to prescribe buprenorphine, clinicians need a separate license from the federal government called an x-waiver, which only 5 percent have. At its core is buprenorphine (Suboxone), a medication used to treat withdrawal and cravings while also mitigating overdose risk. A major barrier to expanding access to MAT in the U.S.

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Hall Render

SEPTEMBER 15, 2023

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to be 5-HT2 agonists (e.g.,

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HIT Consultant

SEPTEMBER 21, 2022

The company operates state-of-the-art therapeutic care Virtual Clinics, utilizing proprietary FDA and CE registered medical Extended Reality (XR) technology (virtual and augmented reality). XRHealth is revolutionizing healthcare, bringing patient care into the Metaverse.

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Healthcare IT News - Telehealth

FEBRUARY 5, 2024

Patients with mental health issues frequently must wait many months before getting seen by a licensed clinician who can prescribe psychotropic medication. You contend telepsychiatry will continue to grow because it enables access to mental healthcare – which is a big challenge today.

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HIT Consultant

JULY 22, 2022

The Oncousticssolutions for ultrasound will be submitted for regulatory approval in the United States (FDA 510(k)), Canada (Health Canada medical device license) and the European Union (CE Mark). The OnX Liver Assessment Solution has not been cleared for clinical use and is For Investigational Use Only.

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Verisys

JULY 8, 2024

Stabilization Period: The FDA has established a one-year stabilization period from November 2023 to November 2024 to allow trading partners to fully implement and troubleshoot their electronic systems without disrupting the supply chain. Without centralized licensing and DSCSA standards, bad actors can easily put patient safety at risk.

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Healthcare IT Today

OCTOBER 7, 2024

SBOMs are a kind of inventory list that contains top-level components, sub-components, and dependencies, both direct and transitive, along with the associated licenses and security vulnerabilities. By delivering an SBOM to the medical organizations that use the devices, device manufacturers can assure users of the safety of the devices.

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Healthcare IT News - Telehealth

MAY 6, 2020

It also equips providers with Eko’s FDA-cleared AI to assist in remote screening for AFib, heart murmurs, tachycardia and bradycardia. In addition, the company is awaiting FDA approval for an onboard ECG feature for spot detection of atrial fibrillation. iRhythm Technologies.

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Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] How healthcare providers are licensed in the metaverse is also an open question. Medical Device Regulations. 1, 2021).

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Verisys

JULY 8, 2024

Stabilization Period: The FDA has established a one-year stabilization period from November 2023 to November 2024 to allow trading partners to fully implement and troubleshoot their electronic systems without disrupting the supply chain. Without centralized licensing and DSCSA standards, bad actors can easily put patient safety at risk.

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HIT Consultant

DECEMBER 15, 2021

Aidoc has seven FDA-cleared solutions and has won numerous awards including the prestigious UCSF ‘Best New Health Application of AI’ award and TIME’s 50 most genius companies. BELKIN Laser , a clinical-stage medical device company developing a disruptive automated one-second laser treatment for glaucoma, raised $13.75

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Dot Compliance

JANUARY 22, 2025

ISO 9001, FDA 21 CFR Part 11, ISO 13485 ). Cost and ROI Initial Investment: Consider the upfront costs of the eQMS, including licensing fees, implementation costs, and hardware requirements. Customization Options: Look for an eQMS that offers customization capabilities to tailor the system to your specific needs. GDPR, CCPA).

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Bill of Health

APRIL 7, 2023

Research centers and companies that received government funds are typically allowed to manage their contractual and licensing terms independently with their commercial partners. Despite this, the study notes that public research grants do not usually include safeguards to enhance public access or affordability.

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Healthcare IT Today

OCTOBER 18, 2023

A licensed clinician reviews patient responses and provides a diagnosis, care plan, prescriptions, or connects the patient to a different modality or setting for care when clinically appropriate. MDLIVE health coaching is powered by Welldoc ® , a digital health leader in chronic care with FDA-cleared solutions.

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HIT Consultant

SEPTEMBER 27, 2023

Industry leaders, IEEE SA members, and the FDA are all working together to create accuracy standards for this innovative technology. Once cleared by the FDA, these medical devices will be Class 2 software as medical device technology. License: Creative Commons attribution CC BY 3.0 DOI: 10.1097/MBP.0000000000000467

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Healthcare Law Today

DECEMBER 19, 2022

FDA Regulatory Considerations for the U.S. Market : Digital Health and Clinical Trials – (a) Determining whether product is regulated as a device; (b) FDA pathways; (c) Clinical trial issues; (d) Compliance issues when contracting with health care providers. We will have a networking reception immediately following the program.

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