Bill of Health

OCTOBER 5, 2023

Food and Drug Administration (FDA) has also begun to consider the regulation of clinical algorithms. In 2021, the FDA released an action plan for the regulation of artificial intelligence and machine learning in medicine, which included supporting the development of methods to evaluate algorithms for bias.

FDA 157

FDA Governance Public Health Hospitals 157

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 [.].

COVID-19 40

COVID-19 FDA Doctors Health Insurance 40

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.

Malpractice 208

Malpractice FDA HIPAA Doctors 208

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Besides grants for “psychedelic” research, the FDA just released draft guidance on considerations for psychedelic clinical investigations with an ambiguous definition of what is considered to be a “psychedelic.”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

FDA 191

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.

FDA 97

FDA Medicare Medicare Health Insurance 97

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-19 229

COVID-19 FDA Health Insurance Doctors 229

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-19 221

COVID-19 FDA Health Insurance Doctors 221

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.

FDA 97

FDA Health Insurance 97

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.

Medicare 98

Medicare Medicare 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.

HIPAA 157

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 87

Compliance HIPAA FDA Health Insurance 87

C&M Health Law

JANUARY 25, 2023

The Act also contains provisions eliminating the opt-out for non-federal governmental health plans for mental health parity requirements and ensuring compliance with mental health and substance use parity requirements. The Act also provides investments in Medicaid and the Children’s Health Insurance Program (CHIP).

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

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 90

FDA Health Insurance 90

Healthcare Law Blog

JANUARY 11, 2022

Department of Health & Human Services, Department of Labor, and the Treasury (“Tri-Agencies”) published guidance about how health plans and health insurance issuers must reimburse OTC COVID-19 tests. 23, 2020) at 6. 10, 2022) at 5.

COVID-19 52

COVID-19 Health Insurance FDA Fraud 52

Kaiser Health News

FEBRUARY 9, 2023

The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. The Trump-appointed judge’s decision could ban the drug nationwide, meaning it would be barred even in states where abortion continues to be legal.

Medicare 65

Medicare Medicare FDA Health Insurance 65

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.

FDA 98

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.

FDA 90

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.

COVID-19 98

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.

Health Insurance 92

Health Insurance Medicaid Medicaid FDA 92

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.

Patient Advocacy 98

Patient Advocacy Health Insurance FDA Governance 98

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%

FDA 105

FDA Telemedicine Health Insurance Hospitals 105

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.

Prescription Drug Pricing 128

Prescription Drug Pricing Doctors FDA Health Insurance 128

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.

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

Health Populi

SEPTEMBER 2, 2020

Health Populi’s Hot Points: To answer what that “next normal” for health consumers will be requires foresight on several key factors that will shape health consumer demand after the pandemic: Payment, where out-of-pocket costs have played a role in people seeking care before the pandemic, and certainly during the COVID-19 crisis.

COVID-19 174

COVID-19 COVID-19 Vaccine Telemedicine FDA 174

HIT Consultant

FEBRUARY 6, 2023

” In the past, employee benefits for women were considered excellent if they offered paid time off, maternity leave, and health insurance. Despite these needs, the future of femtech companies meeting the health needs of millions of women looks bright.

FDA 98

FDA Health Insurance Hospitals Doctors 98

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.

FDA 98

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.

Health Insurance 89

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?

COVID-19 108

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.

ACA 62

ACA COVID-19 FDA Health Care Access 62

Kaiser Health News

FEBRUARY 9, 2023

The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. to achieve universal health insurance coverage, something every other developing nation already has, but we have not yet been able to achieve.

US Department of Health and Human Services 52

US Department of Health and Human Services Medicare Medicare FDA 52

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

Medicaid 95

Medicaid Medicaid FDA Health Insurance 95

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 62

Fraud HIPAA FDA Health Insurance 62

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.

Compliance 40

Compliance HIPAA FDA Due Diligence 40

Health Populi

MAY 20, 2024

The FDA does not test compounded drugs for efficacy or safety, but allows companies to produce them if there is a shortage of FDA-approved versions of the product. Because the GLP-1 drugs are in an official drug shortage situation, and Hims can create a compounded version with the same active ingredients as Wegovy and Ozempic.

FDA 68

FDA Medicaid Medicaid Medicare 68