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Besides grants for “psychedelic” research, the FDA just released draft guidance on considerations for psychedelic clinical investigations with an ambiguous definition of what is considered to be a “psychedelic.”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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FDA Governance Health Insurance 191

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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FDA Medicare Medicare Health Insurance 98

Healthcare It News

FEBRUARY 1, 2022

Before joining BCGDV, they practised as medical doctors or worked in industries such as health insurance, medtech or pharma”, the company spokesperson informed Healthcare IT News. The report series aims to present “what industry leaders must know in order to navigate the changing means and modes of health care delivery.

COVID-19 219

COVID-19 FDA Health Insurance Doctors 219

Healthcare It News

FEBRUARY 1, 2022

Before joining BCGDV, they practised as medical doctors or worked in industries such as health insurance, medtech or pharma”, the company spokesperson informed Healthcare IT News. The report series aims to present “what industry leaders must know in order to navigate the changing means and modes of health care delivery.

COVID-19 211

COVID-19 FDA Health Insurance Doctors 211

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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FDA Health Insurance 98

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 FDA Informed Consent Health Insurance 157

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.

Overpayments 149

Overpayments Overpayment Medicare Medicare 149

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.

Compliance 84

Compliance HIPAA FDA Health Insurance 84

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.

FDA 95

FDA Health Insurance 95

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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FDA Compliance Hospitals Health Outcomes 98

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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FDA HIPAA Medicare Medicare 90

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.

Health Insurance 98

Health Insurance FDA Nurses Health Outcomes 98

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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COVID-19 FDA Health Insurance Public Health 98

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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Health Insurance Medicaid Medicaid FDA 90

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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FDA Telemedicine Health Insurance Hospitals 104

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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Prescription Drug Pricing Doctors FDA Health Insurance 134

AIHC

JUNE 14, 2023

The Federal Drug Administration & AI The Food & Drug Administration (FDA) released a discussion paper in 2019 and then an action plan on January 21, 2021 regarding Artificial Intelligence and Machine Learning, or AI/ML. NIST published prior documents related to AI.

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FDA HIPAA Compliance Regulatory Compliance 45

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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FDA Health Insurance Nurses 98

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.

Health Insurance 205

Health Insurance Hospitals FDA Medicaid 205

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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Health Insurance FDA 89

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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COVID-19 COVID-19 Vaccine FDA Public Health 108

Health Populi

MARCH 8, 2023

In addition, preventive services for women are part of ACA prevention list such as well-woman visits, all FDA-approved, -granted, or -cleared contraceptives and related services, and other female-focused care. It’s a lot — and has made a huge difference in public health access for those enrolled in ACA plans.

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ACA COVID-19 FDA Health Care Access 62

Healthcare IT Today

FEBRUARY 26, 2023

News A new report from Accenture, US health inequity: beyond the statistics , indicated that inequity in care contributes to an additional 3,400 Black infant deaths and an additional 9,200 Black cancer deaths annually. Proposed fixes include improved health insurance literacy – which could help could help 3.8

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Medicaid Medicaid FDA Health Insurance 93

Hall Render

JANUARY 11, 2023

The Tool is a result of collaborative efforts between the FTC, HHS Office for Civil Rights (“OCR”), HHS Office of the National Coordinator for Health Information Technology (“ONC”) and the Food and Drug Administration (“FDA”). Regulatory Landscape.

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Compliance HIPAA FDA Due Diligence 40

HIPAA Journal

OCTOBER 21, 2022

Compound prescription medications are not FDA approved but can be legally prescribed by a physician who determines that standard medications are not appropriate for a particular patient.

Fraud 59

Fraud HIPAA FDA Health Insurance 59

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.

Informed Consent 69

Informed Consent FDA Health Insurance HIPAA 69

Hall Render

AUGUST 10, 2023

This new Final Rule counts days of patients who receive from the demonstration (1) health insurance that covers inpatient hospital services or (2) premium assistance that covers 100 percent of the premium cost to the patient, which the patient uses to buy health insurance that covers inpatient hospital services.

Hospitals 40

Hospitals Medicare Medicare Medicaid 40

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.

Compliance 52

Compliance HIPAA Licensing Fraud 52

Healthcare IT Today

AUGUST 21, 2023

FDA’s Drug Supply Chain Security Act (DSCSA). Health Insurance Portability and Accountability Act (HIPAA) is another significant regulation that can impact RFID in healthcare applications.

HIPAA 88

HIPAA Regulatory Compliance Hospitals FDA 88

Jane Sarashon

JULY 29, 2022

” Well beyond our individual genetic codes, our health is made where we live, work, play, pray, learn, and shop… also well beyond hospitals and doctors’ offices in-between appointments, and often paid-for out-of-pocket quite separate from peoples’ health insurance plans.

COVID-19 67

COVID-19 Health Insurance Telemedicine Doctors 67

HIT Consultant

SEPTEMBER 12, 2023

In their annual Health Benefits Priorities survey, MBGH found that employers consider pharmacy costs extremely problematic. Ninety-one percent of employers cited million-dollar treatments approved by the FDA, and 89% pointed to specialty drug spending as a top threat. The pharmacy they go to matters. There are a lot of variables.

Doctors 118

Doctors FDA Health Insurance 118

HIT Consultant

AUGUST 21, 2023

Added to this complexity, regulations around the privacy and security of information, such as the Health Insurance Portability and Accountability Act [HIPAA] in the US, and GDPR throughout the EU must be adhered to. million patients affected by data breaches in 2021 alone.

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FDA Telemedicine Health Insurance Hospitals 98

SQA

JUNE 10, 2021

India Cancer Drug Manufacturer Agrees to Plead Guilty and Pay $50 Million for Concealing and Destroying Records in Advance of United States Food and Drug Administration (FDA) Inspection, 09 February 2021. FDA plant inspection and pay $50 million in fines and forfeiture.

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FDA COVID-19 COVID-19 Vaccine Compliance 52

Health Populi

JANUARY 7, 2019

This week’s heart-and-food tech announcements at #CES2019 coincide with an FDA recall on a popular drug prescribed to treat hypertension (high blood pressure). Using food and tech as medicine can help people avoid going on medications like statins and others for heart health. Limiting alcohol consumption.

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FDA Patient Advocacy Medicare Medicare 67

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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FDA Health Insurance Governance 83

Bill of Health

APRIL 4, 2024

The main federal health privacy law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) applies only to “covered entities” like health insurers, claims- processing clearinghouses, and health care providers and their business associates, and only to a subset of protected health care information.

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FDA Regulatory Compliance Malpractice Health Insurance 282

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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COVID-19 Hospitals Doctors Health Insurance 210