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In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape.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.,

FDA 40

FDA Licensing Compliance 40

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.

Compliance 52

Compliance Licensing FDA Hospitals 52

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.

COVID-19 173

COVID-19 COVID-19 Vaccine Licensing FDA 173

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.

COVID-19 98

COVID-19 Informed Consent FDA Licensing 98

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.

FDA 111

FDA Licensing Public Health 111

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.

FDA 288

FDA Malpractice Regulatory Compliance Health Insurance 288

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.

Malpractice 213

Malpractice FDA HIPAA Doctors 213

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.

COVID-19 199

COVID-19 FDA Licensing Hospitals 199

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.

Telemedicine 110

Telemedicine FDA HIPAA Licensing 110

MedTrainer

JUNE 4, 2024

Pharmacy compliance rules require staff to properly manage electronic prescriptions, maintain mandatory licenses, and complete continuing education (CE) courses. Pharmacies are governed by federal agencies, including the Drug Enforcement Administration ( DEA ) and the Food and Drug Administration ( FDA ).

Compliance 52

Compliance Licensing Governance FDA 52

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.

HIPAA 307

HIPAA Medical Billing FDA Licensing 307

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.

Licensing 52

Licensing Nurses FDA Compliance 52

Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.

FDA 40

FDA Compliance Regulatory Compliance Licensing 40

HIT Consultant

MAY 2, 2024

Informed Decision-Making: The platform provides data-driven insights for various stages of drug development, including indication selection, licensing, and asset management. Benchmarking Preclinical Assets: BioLogicAI compares preclinical drug candidates to existing drugs and FDA-approved medications, informing development strategies.

FDA 52

FDA 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.

FDA 98

FDA Licensing 98

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).

FDA 117

FDA Licensing Hospitals 117

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.

FDA 131

FDA Doctors Licensing Telemedicine 131

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.

FDA 111

FDA Compliance Licensing HIPAA 111

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.

Regulatory Compliance 52

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

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.

Telemedicine 64

Telemedicine FDA Licensing Governance 64

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.

FDA 98

FDA Licensing 98

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.

Patient Satisfaction 98

Patient Satisfaction FDA Licensing 98

Healthcare IT Today

MAY 3, 2023

Moreover, the market for FDA-approved BP monitoring solutions that encourage routine measurements is well into the billions [ 22 , 23 ]. For some R&D efforts, the answer is quite simple – FDA approval has simply not been achievable due to the inability to pass critical performance standards.

FDA 117

FDA Public Health Licensing Telemedicine 117

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.

Licensing 98

Licensing Governance Telemedicine FDA 98

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).

FDA 90

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

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.

FDA 51

FDA Licensing 51

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.

COVID-19 52

COVID-19 FDA Public Health COVID-19 Vaccine 52

SQA

SEPTEMBER 2, 2022

United States Food and Drug Administration (FDA) – Regulations and Guidances. FDA Proposes Benefit-Risk Considerations for Product Quality Assessments, 20 June 2022. The FDA is announcing the availability of a draft guidance for industry entitled Conducting Remote Regulatory Assessments, Question and Answers.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

HIT Consultant

JULY 11, 2024

Food and Drug Administration (FDA). However, as of 2023, the FDA orders they meet specific security guidelines — patches must be available periodically and in emergencies, and manufacturers must submit a software bill of materials. Research — and real-world events — demonstrate implantable pacemakers are vulnerable to cyberattacks.

FDA 115

FDA Hospitals Governance Ransomware 115

Bill of Health

JUNE 12, 2024

In these spin-offs, does one approach the Church Lab with a request for licensing or are there collaboration agreements with the Harvard Office of Technology Review? The practicality I’ve noticed over the years is that no matter what we aim at, there’s the very severe, shorter-term FDA trial. GC: Both are possible.

FDA 240

FDA Licensing Bioethics 240

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.

COVID-19 52

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.

FDA 116

FDA Licensing Medicaid Medicaid 116

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.

FDA 117

FDA Licensing 117

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.

Compliance 52

Compliance Fraud Medicaid Medicaid 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.

FDA 52

FDA Licensing 52

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

FDA 98

FDA Telemedicine Hospitals Licensing 98