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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COVID-19 COVID-19 Vaccine Licensing FDA 167

Bill of Health

APRIL 8, 2022

The Food and Drug Administration has authorized studies of psychedelics , including on a “breakthrough therapy” designation, but these drugs may not be handled by persons without a Drug Enforcement Administration license and outside an FDA approved setting.

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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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FDA Licensing Public Health 111

Natalia Mazina

AUGUST 16, 2022

Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug. Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug.

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COVID-19 Informed Consent FDA Licensing 98

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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Malpractice FDA HIPAA Doctors 208

Healthcare It News

APRIL 27, 2023

" According to an email from a Philips representative, the announcement marks the first commercialized use of the technology following two years of field testing, publication of a peer-reviewed clinical study and the FDA’s classification of RATE as a wellness device. The score has proven to be indicative of onset of infections.

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COVID-19 FDA Licensing Hospitals 176

Verisys

SEPTEMBER 21, 2023

The proposed rules explain that participating physicians and pharmacists must have an active unrestricted license and a Collaborative Agreement. PA Nurse Licensure Compact Washington: As of July 24, 2023, nurses who hold an active, unencumbered license via the Nurse Licensure Compact (NLC) are able to practice in the state of Washington.

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Healthcare It News

MAY 12, 2023

" Since launching its claims platform, a series of new capabilities, including prior authorizations and denials management, has been added. miRNA-based cancer diagnostics Ovarian cancer is highly lethal in part because of how difficult it has historically been to diagnose.

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HIPAA Medical Billing FDA Licensing 291

Verisys

DECEMBER 12, 2023

Rule 402(2) states that when a multistate licensee changes primary states of residence to another NLC party states, they shall apply for a multistate license in the new residence state within 60 days. 01ER ): Effective as a permanent rule on 11/13/2023. This has simplified CE requirements for regular and initial pharmacist renewal.

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Regulatory Compliance Compliance US Department of Health and Human Services Licensing 52

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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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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FDA Doctors Licensing Telemedicine 112

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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FDA Licensing 97

HIT Consultant

OCTOBER 17, 2022

Since its FDA clearance in 2020, the EyeArt system has been used in over 200 locations in 18 countries, including 14 U.S. It is the first and only technology to be cleared by the FDA for autonomous detection of both referable and vision-threatening diabetic retinopathy without any eye care specialist involvement.

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FDA Medicare Medicare Licensing 52

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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Licensing Governance FDA Telemedicine 98

MedTrainer

APRIL 22, 2024

For example, a healthcare IT vendor should include items related to HIPAA, while a checklist for a food vendor should focus on FDA or USDA regulations. Intellectual Property and Licensing Protect intellectual property rights through patents, trademarks, and copyrights.

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Compliance HIPAA Licensing Fraud 52

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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FDA HIPAA Medicare Medicare 90

Verisys

NOVEMBER 30, 2022

License Verification & Monitoring. OIG, SAM DEA, GSA, FDA. State Licensing Boards and Agencies. Verisys partners with health plans, background check organizations, healthcare and pharmacies, and provider organizations to ensure they understand any risks within their population. Exclusions, Debarments, and Sanctions.

Regulatory Compliance 52

Regulatory Compliance Medicare Medicare Medicaid 52

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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FDA Licensing 92

MedTrainer

JANUARY 12, 2024

Food and Drug Administration (FDA): The FDA regulates compliance in pharmaceuticals, medical devices, and biotechnology products. Regulatory agencies have the authority to impose monetary sanctions, revoke licenses, or exclude providers from federal healthcare programs as punitive measures.

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Compliance Fraud Medicaid Medicaid 52

SQA

MARCH 25, 2021

United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency, January 2021.

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COVID-19 FDA Public Health Licensing 52

Bill of Health

JANUARY 16, 2024

The judge did so by suspending an FDA rule that required in-person ordering, prescribing, and dispensing of the pill by a provider. We hear providers struggle with new legal risks: “I can’t keep providing services if I get [my license] taken away.”

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COVID-19 FDA Licensing Doctors 111

Mobi Health News

MARCH 1, 2018

Qualcomm Life announced an exclusive licensing agreement with AlertWatch, creator of an FDA-cleared intelligence care software that assists in the care of patients in the operating room. The deal will give Qualcomm Life the exclusive rights to sell AlertWatch, which the company plans to showcase at HIMSS 2018.

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FDA Licensing 45

Verisys

NOVEMBER 14, 2023

Primary source verification must be done to confirm a provider’s education, professional license and certifications, medical training, work history, references, and more. Provider information should be continuously monitored for any changes to exclusion or license status. However, verifying a provider’s credentials is essential.

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Licensing Medicaid Medicaid Governance 52

HIT Consultant

MARCH 13, 2023

Seagen Background Seagen is a pioneer in ADC technology, with four of the twelve total FDA-approved and marketed ADCs using its technology industry-wide. billion of revenue in 20231, representing 12% year-over-year growth, from its four in-line medicines, royalties and collaboration and license agreements.

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FDA Licensing 52

Healthcare Law Today

JANUARY 20, 2022

A CLIA certificate is not required in the following situations: An at-home test is self-administered by a patient in accordance with the Food and Drug Administration’s (FDA) authorization and labeling. CLIA-certified facilities may use at-home tests if the FDA has authorized the tests for that setting.

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COVID-19 FDA Licensing Medicaid 52

Healthcare IT Today

FEBRUARY 27, 2024

The product is patent protected, FDA cleared, and FSA, HSA, Medicare, and Medicaid eligible. Hamilton Beach Brands licenses the brands for Wolf Gourmet countertop appliances, CHI premium garment care products, Clorox True HEPA air purifiers, and Brita Hub countertop electric water filtration appliances.

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FDA Licensing Medicaid Medicaid 78

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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FDA Hospitals Telemedicine Licensing 96

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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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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COVID-19 Public Health Licensing FDA 133

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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COVID-19 Vaccine COVID-19 Governance Public Health 144

Health Care Law Brief

OCTOBER 27, 2021

This means that although ketamine is approved by the FDA for some medical uses, it is not specifically approved to treat depression. In many states, operating a ketamine clinic does not require a specific regulatory facility license. 8] Often times, the process of obtaining such license requires disclosure of non-physician ownership.

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Healthcare IT Today

JUNE 10, 2023

Factors including FDA approval, a clear value proposition, demonstrated ROI, and an understanding of regulatory processes can all work in a founder’s favor. Hone care vendor Tytocare received FDA approval for a product that analyzes lung sounds captured a handheld device. Navigating Long Buying Cycles in Healthcare Innovation.

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FDA Compliance Licensing Hospitals 88

HIT Consultant

DECEMBER 16, 2021

Pear intends to incorporate both newly acquired and licensed assets into Pear’s depression candidate, which will require clinical evaluation, and if promising, would then be evaluated in a potential pivotal clinical trial to support FDA submission. Pear’s end-to-end platform discovers, develops, and delivers PDTs to patients.

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COVID-19 FDA Licensing 84

Healthcare IT Today

JULY 25, 2022

They purchase the technical solutions such as algorithms and software licenses with no R&D or engineering capabilities on staff. RPM devices work as medical devices which are governed by the FDA and related departments. Principle 2: Evaluate the regulation competence of the suppliers.

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FDA Licensing Governance Telemedicine 82

SQA

JUNE 10, 2021

The CDSCO has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017. FDA plant inspection and pay $50 million in fines and forfeiture. Guidance on the Licensing of Biosimilar Products, 06 May 2021.

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FDA COVID-19 COVID-19 Vaccine Compliance 52

Health Care Law Brief

JUNE 2, 2022

For example, New York continues to maintain a professional licensing waiver that enables certain providers, licensed out of state, to render care within the state, for the duration of the declared state of emergency. Provider Licenses. What types of providers will render care via telehealth?

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Public Health Compliance COVID-19 Licensing 52

HIT Consultant

MAY 12, 2022

Notable transactions in the consumer and member tech category include: Pear Therapeutics , software-based medicine provider, made its mark in 2017 as its tool became the first digital therapeutic approved by the FDA with claims to improve clinical outcomes.

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COVID-19 FDA Licensing 98