HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. The regulations may provide an opportunity for health insurers to attract new members – and retain existing ones – with hearing loss. Health plans should be on the alert for potential pitfalls arising from the new regulations. million U.S.

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Bill of Health

JUNE 5, 2023

Liability Risks for Health Care Providers First, let’s consider the risks for health care providers who rely on AI tools like ChatGPT to treat patients. For these individuals, the possibility of medical malpractice claims and Health Insurance Portability and Accountability Act (HIPAA) violations looms large.

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Healthcare IT Today

MARCH 26, 2025

Federal and state agencies, including the Drug Enforcement Administration ( DEA ) and the Food and Drug Administration (FDA), are shaping the future of telehealth through evolving policies. The FDA also plays a key role in overseeing online pharmacies to ensure they comply with federal drug distribution laws.

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HIT Consultant

FEBRUARY 17, 2025

What You Should Know: – Highmark , a health insurance provider, today announced the addition of Virtual Pelvic Health powered by Sword Health to its suite of benefits. – The new program offers eligible members access to personalized, technology-driven care for pelvic health conditions, at no additional cost.

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Healthcare IT Today

JANUARY 14, 2025

The Swedish MRI Simulator Company Will Use the Latest Round of Capital to Secure FDA Approval for Corsmeds New MRI Scanning Software and Eliminate the Diagnostic Bottleneck in Imaging Corsmed , the Swedish Magnetic Resonance Imaging (MRI) software company, has secured $3.5M The company plans to file for submission with the U.S.

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HIT Consultant

MAY 19, 2024

– Humana, a health insurance provider, has become the first commercial payer to update its policy in response to the FDA’s recent clearance of NeuroStar TMS for adolescents aged 15-21 with MDD. Food and Drug Administration (FDA) granted clearance for NeuroStar TMS as a first-line add-on treatment for adolescent MDD.

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Bill of Health

JANUARY 26, 2024

Besides grants for “psychedelic” research, the FDA just released draft guidance on considerations for psychedelic clinical investigations with an ambiguous definition of what is considered to be a “psychedelic.” When we discuss FDA clinical trials , we’re talking big money , so clarity matters here.

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Health Populi

JUNE 5, 2022

Its longer more formal name was The Drug Price Competition and Patent Term Restoration Act of 1984, and it created a pathway for generic drug applications to the FDA. Fast-forward through the 1990s and the advent of PBMs — pharmacy benefit management companies — the intermediaries managing drug benefits for health insurance plans.

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Health Populi

MARCH 25, 2024

A screenshot of part of this evaluation is shown here, describing seven sites by cost to the consumer, process of evaluating-prescribing-ordering, and whether health insurance would cover the consumers’ cost of the medicine (generally, “no”). Stay tuned!

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Bill of Health

DECEMBER 6, 2024

US Legal Requirements for Quantum-Powered Medical Devices In the United States, some quantum-powered medical devices may be governed under the existing FDA regulatory framework. Foster Institutional Plasticity: Evolve institutions like the FDA and EMA to accommodate quantum technologies.

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Healthcare IT News - Telehealth

JANUARY 25, 2023

FDA is currently reviewing use of Selux's NGP Gram-Negative panel. With more than 50 specialties offering more than 20,00 appointments each week, patients without health insurance can book doctors' visits for a set price with no referrals required. Inspira Technologies said it received patent approval from the U.S.

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HIT Consultant

FEBRUARY 28, 2022

– XRHealth’s platform is FDA and CE registered and provides an immersive experience for users, transporting them to a virtual world for comprehensive therapeutic care. Patient care is covered by Medicare and is available under most major insurance providers.

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Bill of Health

OCTOBER 27, 2023

Namely, legal protections concerning personal health data may not apply when the entity offering the service is decidedly not a “provider.” To illustrate the issue, consider that the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) expressly covers genetic information as a form of health data.

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HIPAA Journal

DECEMBER 8, 2022

The online tool asks a series of questions about the nature of the app, the service it provides, the information it collects, and how that information is collected, shared, and used.

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HIT Consultant

DECEMBER 6, 2022

An ever-increasing number of clinical studies are showing that psychedelic treatments such as ketamine-assisted therapy can be very effective in improving symptoms for a wide range of behavioral health conditions over a sustained period of time. Psychedelic-Assisted Therapies.

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HIT Consultant

MAY 3, 2023

partners with leading health insurers and providers to integrate Minuteful Kidney™ in their kidney management programs. The company’s at-home urinalysis services enable providers and healthcare systems to reach high-risk, previously untested members and help close care gaps.

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Health Populi

APRIL 1, 2025

On the supply side of health care and especially public-sector health care services and public health systems and information, I publish this post on a day when major cuts to the CDC, the FDA, and other health agencies are announced.

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Bill of Health

MAY 19, 2022

Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance. The post Monthly Round-Up of What to Read on Pharma Law and Policy appeared first on Bill of Health. Epub ahead of print. Xiao R, Ross JS, Gross CP, Dusetzina SB, McWilliams JM, Sethi RKV, Rathi VK. JAMA Intern Med. 2022 Apr 18.

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HIT Consultant

JUNE 16, 2022

While hospitals have the money and resources to use a variety of Federal Drug Administration-approved sensors and instruments to gain a holistic view of the necessary health data and deliver the best possible care for patients, the consumer care marketplace is not yet that advanced. Patient Privacy and Data Security.

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The Health Law Firm Blog

JULY 20, 2023

Board Certified by The Florida Bar in Health Law On April 14, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. By George F. Indest III, J.D., The test, made by Texas-based company, InspectIR Systems, is authorized for those [.]

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The Health Law Firm Blog

APRIL 24, 2022

Board Certified by The Florida Bar in Health Law On April 14, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. By George F. Indest III, J.D., The test, made by Texas-based company, InspectIR Systems, is authorized for those [.].

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Health Populi

JANUARY 9, 2019

All health/care is retail now in America. who have health insurance must take on a deductible of some amount, which compels that insured individual to spend the first dollar on medical services up until they meet their financial commitment. I say this as most people in the U.S. In the median U.S.

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Healthcare IT News - Telehealth

DECEMBER 16, 2020

In March, as states were issuing stay-at-home orders, the FDA published pandemic-specific guidance for trial sponsors, institutional review boards and investigators on how to ensure the safety of their trial participants and reduce risks to trial integrity, while sustaining compliance with good clinical practice.”

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Healthcare Law Blog

MAY 31, 2022

The FTC’s increasing interest in health information that sits outside of HHS/OCR’s reach is likely to only expand in light of health-related metaverse use cases. In response to the growth of the metaverse and digital health generally, the FDA has been working to expand its guidance in the area. Medical Device Regulations.

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Jane Sarashon

DECEMBER 30, 2024

Note that smartwatches have also added sensors and apps related to cardiovascular health, so well add these into the heart-mix. And we’ll listen to innovation updates delivered on panels during the Digital Health Summit, as well. The graphic shows the recently FDA-cleared blood pressure monitor from Withings, the BPM Pro 2.

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Healthcare IT News - Telehealth

DECEMBER 13, 2024

The AI could suggest that patients with psoriasis who are on topicals or creams may need systemic treatments, and could be advised about orals or biologics that are available and FDA-approved. "Then the patient has to take that message to their physician to have that conversation," Ahadome said.

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HIT Consultant

NOVEMBER 9, 2022

TytoCare’s holistic Home Smart Clinic solves this Home Healthcare Delivery Gap™ by offering health plans and providers all the elements required to make virtual primary care programs successful.

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HIT Consultant

DECEMBER 12, 2022

Americans are ready for the pharmacist as prescriber: When the FDA authorized pharmacists to prescribe Paxlovid to widen access to timely treatment, it signaled a recognition that pharmacists’ roles can indeed expand to include prescribing, even in limited ways.

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Health Populi

JUNE 24, 2021

The third chart details some of these points: On the macroeconomic side of the forecast, we see increasing private consumption, higher inflation, less public sector support (e.g., PPP in the US), and in emerging markets, currency weakness. We also expect innovation to come out of pharma and biotech labs, and who will pay for new-new therapies?

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HIT Consultant

FEBRUARY 22, 2023

Regulators have increasingly prioritized diversity in clinical trials , with the FDA releasing draft guidance in April 2022. especially, affordable healthcare depends on having health insurance. Financial burdens In the U.S. On top of this disparity, clinical trial participation can be incredibly costly.

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Healthcare IT Today

SEPTEMBER 3, 2023

Health insurance consumers are increasingly comfortable with digital tools, the latest Voice of the Member survey from Cognizant said. Remote monitoring company AION Biosystems received FDA 510(k) clearance for iTempShield , a device worn on the skin to measure body temperature. That said, operating margins were 1.1%

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Health Populi

MAY 30, 2018

This is important because in 2017, one in four new drugs approved by the FDA were designed to treat a small population, falling. Of the 14 new treatments launched and approved by the FDA in 2017, all were priced over $100,000 in the U.S., into the precision medicine category. and the median reached $150,000.

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HIT Consultant

FEBRUARY 20, 2024

US health insurance companies have traditionally neglected non-pharmacological therapies for migraine. They will now have access to a clinically proven, non-invasive solution for managing both acute and preventive migraine attacks.

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Health Populi

JANUARY 11, 2019

I’ve asserted for many years that connectivity and broadband are a social determinant of health. Without online access, people can’t seek jobs, get educated, enroll in health insurance, socially connect with other people, and seek health information for self-care or diagnosed conditions on WebMD or “Dr.

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Healthcare IT Today

AUGUST 20, 2023

Only 45% of consumers are fully satisfied with their health insurance , according to a survey from HealthEdge, and 40% blame insurers for the high cost of care. That said, 66% trust their health plan more that the government or non-traditional entities such as Amazon or Walmart to their health insurance.

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HIT Consultant

AUGUST 8, 2023

TMS, and the more advanced form called Deep Transcranial Magnetic Stimulation (Deep TMS), are noninvasive, well tolerated, do not require anesthesia or cause systemic side effects, are administered in a doctor’s office in less than 30 minutes, and are covered by most health insurance plans. Ten years later, Mark S. George, M.D.

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Health Populi

JULY 28, 2020

In 2020, CES featured several hundred digital health exhibitors and a growing array of Internet of Things-connected devices adjacent to health and wellness, with representation from beyond “pure” wearable health tech ranging from FDA-cleared blood pressure watches from Omron to health insurer Humana in the exhibit hall.

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