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 123

Bill of Health

JANUARY 16, 2024

I write about cases, legislation, and policies related to reproductive health care — a lens that, on its own, can be self-defeating , neglecting actual access to care. The judge did so by suspending an FDA rule that required in-person ordering, prescribing, and dispensing of the pill by a provider.

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COVID-19 FDA Licensing Doctors 111

Healthcare IT Today

FEBRUARY 27, 2024

About Hamilton Beach Health Drawing on decades of experience as a trusted resource in the kitchen and beyond, Hamilton Beach Health empowers people to take control of their health with groundbreaking, digitally connected tools using in-home solutions. The product is patent protected, FDA cleared, and FSA, HSA, Medicare, and Medicaid eligible.

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FDA Licensing Medicaid Medicaid 92

HIT Consultant

DECEMBER 14, 2021

Ophelia’s goal is to engage the about 80 percent of people with OUD who are not engaging with the healthcare system. In order to prescribe buprenorphine, clinicians need a separate license from the federal government called an x-waiver, which only 5 percent have. They are not relying on referrals from the ER or PCPs to reach patients.

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Licensing Governance FDA Telemedicine 98

Verisys

NOVEMBER 30, 2022

License Verification & Monitoring. OIG, SAM DEA, GSA, FDA. State Licensing Boards and Agencies. Learn more about how Verisys can assist your HCOs in meeting all government and regulatory standards. How our clients use FACIS today: Pre-hire employee screening. Exclusions, Debarments, and Sanctions. Credentialing.

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Regulatory Compliance Medicare Medicare Medicaid 52

Healthcare IT News - Telehealth

DECEMBER 1, 2021

In terms of when the pandemic started, if you think about the numbers in December 2019 or January 2020, one-tenth of about 1% of the total appointments were telehealth related. During the pandemic, somewhere around in the second quarter of 2020, this number actually even went up to about 25% of the appointments.

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COVID-19 Public Health Doctors Governance 162

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

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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FDA Licensing 107

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 103

Healthcare IT News - Telehealth

MAY 30, 2023

A few of the more-narrower COVID-related flexibilities actually ended on May 11, but many others, like cross-state licensing waivers, were rolled back some time ago, and many will continue for some time, if not permanently. Regulators and payers still have some questions about efficacy and cost.

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Telemedicine COVID-19 Governance Medicare 189

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 139

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

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. Currently, little is known about the total costs of discovery, development, and commercialization of the mRNA platform technology for COVID.

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COVID-19 Vaccine COVID-19 Governance Public Health 144

Kaiser Health News

MARCH 15, 2023

While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use. ” she said.

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Doctors Prescription Drug Pricing FDA COVID-19 88

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. About Jack Wang. Principle 2: Evaluate the regulation competence of the suppliers.

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FDA Licensing Governance Telemedicine 96

Healthcare IT Today

DECEMBER 29, 2023

We’re all saturated by now with dire warnings about AI. Sara Shanti, a partner specializing in health care technology at law firm Sheppard Mullin , says that the Executive Order and recent FDA guidance “start to provide real direction on how to navigate patient risk.

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Department of Veterans Affairs FDA Doctors Licensing 112

Health Care Law Brief

JUNE 2, 2022

Recent reports by major newspapers and other health care media outlets have raised concerns about DTC platforms, particularly those platforms leveraging high patient-to-provider ratios to prescribe controlled substances. This kind of media attention has brought about increased scrutiny of these platforms by federal and state regulators.

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Public Health Compliance COVID-19 Licensing 52

Healthcare IT Today

JUNE 13, 2023

They also plan to offer APIs to labs and public health organizations, delivering test results securely through an app along with advice about how to handle the risk. Also, ixlayer utilizes only FDA-approved sample collection devices following best practice standards, everything in HIPAA compliant environment.

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COVID-19 Nurses FDA Licensing 108

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. About Healthcare Growth Partners (HGP).

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COVID-19 FDA Licensing 98

Kaiser Health News

MARCH 15, 2023

While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use. ” she said.

Doctors 52

Doctors Prescription Drug Pricing FDA COVID-19 52

HIT Consultant

MAY 9, 2022

In 2015, half of Americans believed renewing their driver’s license requires less paperwork than a trip to the clinic, and 29 percent of patients still had to physically transport test results, X-rays, or health records from one physician’s office to another, according to a survey conducted by Surescripts.

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FDA COVID-19 Public Health Compliance 98

Verisys

JANUARY 18, 2022

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. Food and Drug Administration (FDA). Treasury Department.

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Licensing Medicaid Medicaid Governance 52

Redox

OCTOBER 12, 2023

The FDA has approved more than 500 AI and machine learning models for medical use—most of which are in radiology. In 2022, the FDA announced that some types of risk-scoring tools were to be regulated as medical devices. They should also factor in ongoing licensing fees as well as expenses for data processing, storage, and management.

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FDA Hospitals Medicare Medicare 69

Bill of Health

SEPTEMBER 29, 2022

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. Background Context. The Duty of Disclosure. 37 CFR 1.56(a).

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FDA Governance Fraud Licensing 130

Pharmacy Law Blog

MARCH 13, 2018

To learn about a similar case involving a Florida compounding pharmacy, click here to read one of my prior blogs. The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits.

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Fraud Governance Licensing FDA 52

Healthcare IT Today

JULY 29, 2022

About Oncoustics. The Oncoustics solutions 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 Hospitals 52

Healthcare Law Blog

AUGUST 9, 2023

8] The court in Members of the Medical Licensing Board of Indiana, et al. 20 will take effect, including: requirements for all surgical abortions to take place in hospitals; licensing requirements for abortion clinics; expanded practice authority for certified nurse midwives; and new provisions for the “safe surrender” of an infant. [22]

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Licensing Informed Consent Nurses FDA 52

Innovaare Compliance

OCTOBER 6, 2022

Annual Election Period (AEP) is about two weeks away when Medicare Advantage Prescription Drug Plans (MAPD) will be signing up new enrollees by the thousands. According to the Centers for Medicare & Medicaid Services (CMS), enrollment in MAPD keeps rising. In 2022, 48% of all eligible Medicare beneficiaries are enrolled in MAPD.

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Medicare Medicare Compliance Public Health 52

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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US Department of Health and Human Services FDA COVID-19 World Health 40

Jane Sarashon

JULY 29, 2022

Just about one year ago, DG appointed the company’s first Chief Medical Officer, which I covered here in Health Popul i in a post titled, “Dollar General, the Latest Retail Health Destination? Here’s another lens on the Optum health consumer data. Hot Dog) appeared first on HealthPopuli.com.

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COVID-19 Health Insurance Telemedicine Doctors 69

AIHC

JUNE 6, 2023

ChatGPT has become one of the most talked about advancements in technology. AIHC recommends reading OpenAI’s blog posted about the data breach: [link] Conclusion Medical software dealing with patient data must be secure and HIPAA compliant.

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Compliance Medical Billing HIPAA Due Diligence 59

Hall Render

APRIL 19, 2024

Can lawmakers do anything about it? to Study Treatments for Vascular Abnormalities Federal Appeals Court Hears Arguments on Nation’s First Ban on Gender-affirming Care for Minors Jason Demke Hired as COO at Mercy Hospital Fort Smit Pulaski Tech Awarded $5.7M healthcare? MAINE St. HCA Midwest unveils $9.3M ’ NEVADA Gov.

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Nursing Homes Nurses Hospitals Doctors 40

Healthcare IT Today

JANUARY 19, 2024

Similarly, unlike previous upsurges, this momentum feels more mature – less about experimentation and ‘shiny objects’, more about real-world applications at scale. Joseph Zabinski, Ph.D., Sandeep Akkaraju, CEO & Co-Founder at Exo As healthcare costs in the U.S.

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Hospitals Governance FDA Licensing 108

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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AIHC

JUNE 6, 2023

ChatGPT has become one of the most talked about advancements in technology. AIHC recommends reading OpenAI’s blog posted about the data breach: [link] Conclusion Medical software dealing with patient data must be secure and HIPAA compliant.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

Healthcare IT Today

JANUARY 6, 2023

What’s most important and impactful about telehealth is the technology’s ability to enable care and improve accessibility. It’s no longer possible to build these businesses on just topline growth and hope you can figure out unit economics in the future; rather, you have to think about building sustainable businesses from day one.

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US Department of Health and Human Services Doctors Telemedicine Public Health 113

SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

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FDA Licensing Governance Compliance 40