Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key medical devices such as in vitro diagnostic tests, personal protective equipment, and ventilators.

FDA 98

FDA Public Health COVID-19 Compliance 98

Bill of Health

SEPTEMBER 23, 2022

Food and Drug Administration or FDA), which contributes to the development of knowledge about the unapproved product’s safety. However, EUAs are limited to public health emergencies, and RTT is only rarely used, so we concentrate here on EA, which is used by thousands of U.S. patients each year.

FDA 237

FDA Informed Consent Public Health 237

Healthcare It News

JULY 25, 2023

public health departments with implementing sexual health testing to reduce the incidence of rising sexually transmitted infections in their communities. "The COVID-19 pandemic led to disruptions in STI-related prevention and care activities and brought the realities of our strained public health infrastructure to light."

Public Health 246

Public Health COVID-19 Telemedicine FDA 246

Healthcare It News

DECEMBER 1, 2021

What's less certain, however, is what that utilization will look like in the future, particularly as the end of the public health emergency looms. What is driving all this, of course, is the regulatory changes during this public health emergency. First of all, we should think about the public health emergency.

COVID-19 340

COVID-19 Public Health Doctors Governance 340

HIT Consultant

OCTOBER 21, 2021

Food and Drug Administration (FDA) has contracted with them to use their Aetion Evidence Platform® to rapidly assess in-patient COVID-19 treatments and advance regulatory science to help determine when, where and how to use RWD. Enables rapid evidence generation for COVID-19 and future pandemics.

COVID-19 98

COVID-19 FDA Public Health 98

HIT Consultant

JANUARY 26, 2024

What You Should Know: – Deliberate AI , a digital health company harnessing AI to revolutionize mental health assessment, has secured a major milestone in its mission. – The collaboration between Deliberate AI and the FDA represents a giant leap in the fight against mental illness.

FDA 102

FDA Public Health 102

Bill of Health

JANUARY 28, 2022

A few years ago, a Bill of Health post titled Jelly Beans, Booze, and B-Vitamins proposed fortifying cheap wines, hard liquors, and malt liquors with thiamine (vitamin B1). The post suggested this as a public health measure to prevent Wernicke-Korsakoff syndrome (WKS) in the homeless alcoholic population.

FDA 162

FDA Public Health 162

Health Populi

JULY 28, 2020

This week, announcements from the Consumer Technology Association (CTA) and Withings further bolster the case for the private sector bolstering public health in this pandemic…and future ones to come beyond the Age of the Coronavirus. On 27th July, CTA announced the Association’s launch of the Public Health Tech Initiative.

Public Health 116

Public Health COVID-19 Telemedicine FDA 116

Bill of Health

MARCH 13, 2025

FDA and Food Marketing Institute v. From a public health perspective, the EPOs approach is commendable because it holds patentees accountable to real-world outcomes. Both serve essential public interestsone by promoting open science and public health, the other by incentivizing innovationand neither can be neglected.

Public Health 130

Public Health FDA Governance Compliance 130

Bill of Health

OCTOBER 6, 2023

The FDA approved S-ketamine to treat depression in 2019. Still, to me, the most promising route to access is probably through FDA approval (which means more clinical trials) and expanded insurance coverage. Yet, insurance coverage alone is an imperfect solution because millions of Americans have no health insurance.

FDA 264

FDA Health Insurance Public Health 264

Bill of Health

AUGUST 4, 2022

Food and Drug Administration (FDA) plays a central role — it is the regulatory mechanism by which drugs like MDMA and psilocybin may soon become legal for medical use. non-medical) drug legalization: Does the FDA have the existing authority to regulate illicit drugs, should they become legal for adult recreational use?

FDA 147

FDA Public Health 147

Mobi Health News

DECEMBER 15, 2020

Alongside step-by-step instructions, the Ellume COVID-19 Home Test's accompanying app automatically reports users' results to the relevant public health authorities.

COVID-19 128

COVID-19 FDA Public Health 128

HIT Consultant

APRIL 23, 2024

What You Should Know: Exo® (pronounced “echo”) , a medical imaging software and devices company, today announced its FDA-cleared cardiac and lung artificial intelligence (AI) applications are now available on Exo Iris™, Exo’s high-performance handheld ultrasound device.

FDA 94

FDA Public Health 94

HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. Health plans should be on the alert for potential pitfalls arising from the new regulations. Health plans can design hearing benefits that can mitigate this potential issue while maximizing member satisfaction at the same time. Introducing OTC hearing aids.

FDA 98

FDA Public Health Fraud Medicare 98

Bill of Health

APRIL 4, 2024

It provides several rules for sharing information and exceptions keyed directly to the realities of the health care setting, such as permitting information sharing for treatment, payment, or health care operations, some public health situations, and if certain identifiers have been stripped from the data set.

FDA 288

FDA Malpractice Regulatory Compliance Health Insurance 288

Bill of Health

JUNE 26, 2023

Once approved by the FDA, CalRx insulin will be made available at $30 to all Californians who need it. This initiative will come with enormous savings to the public: it will bring down the price of insulin by 90%, saving cash-paying patients between $2,000 to $4,000 annually.

Pharmaceutical Industry 195

Pharmaceutical Industry Governance FDA Public Health 195

The Digital Health Corner

NOVEMBER 28, 2016

Digital health technology has seen an incredible growth in the last few years, fueled by a combination of consumerization of wearable technologies, ubiquity of mobile devices, proliferation of technology incubators, attention by government health and regulatory agencies and involvement of large companies heretofore not focused on healthcare.

Public Health 68

Public Health Health Services Administration Patient Advocacy Governance 68

Compliancy Group

NOVEMBER 4, 2024

One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry. The purpose of this list is to help businesses stay within compliance with FDA regulations and to safeguard public health.

FDA 52

FDA Compliance Officers Compliance Regulatory Compliance 52

Bill of Health

MARCH 13, 2023

The FDA’s primary responsibility is over claims that appear on product labels (including packaging, product inserts, and promotional material at the point of sale), and the FTC regulates claims made in advertising in general. FDA regulations prescribe different standards for different products and claims.

FDA 189

FDA COVID-19 Public Health 189

HIPAA Journal

DECEMBER 22, 2022

Funding for the Centers for Medicare and Medicaid Services will increase by $100 million, the National Institutes of Health will receive an additional $2.5 This will help to ensure that telehealth and hospital-at-home programs can continue to provide convenient and accessible medical treatment for patients.

FDA 115

FDA COVID-19 Governance Medicaid 115

Healthcare IT Today

JANUARY 9, 2025

In this video, President Jay Nakashima explains the role they play, particularly in public health, scaling FHIR and TEFCA. eHealth Exchange is working with the industry and with regulators to improve response rates so public health agencies can get the data they need to protect Americans health.

Public Health 67

Public Health FDA 67

Bill of Health

APRIL 7, 2023

Together, these articles underscore the injustice of the present moment and emphasize the need to reform intellectual property protections for government-funded inventions of public health significance. Recent Research on Public Funding of mRNA Technology The first of the two new articles is an in-depth empirical study of U.S.

COVID-19 Vaccine 147

COVID-19 Vaccine COVID-19 Governance Public Health 147

HIT Consultant

OCTOBER 29, 2024

This trend is expected to accelerate, bringing with it various public health challenges, including a rising prevalence of late-life depression. And now studies have shown that it is effective for older adults as well, leading to its FDA label expansion for late-life depression in patients ages 68-86.

FDA 98

FDA Public Health 98

C&M Health Law

FEBRUARY 1, 2022

Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. On January 31, 2022, the U.S.

FDA 52

FDA Licensing Public Health 52

NEJM

MARCH 10, 2023

The FDA has long conducted its oversight of prescription drugs and other products with deference from courts. But mounting judicial skepticism of agency authority threatens to upend this norm.

FDA 40

FDA Public Health 40

Mobi Health News

MARCH 5, 2021

The system delivers its results to a companion app in about 20 minutes, according to the agency.

COVID-19 131

COVID-19 FDA Public Health 131

Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

COVID-19 52

COVID-19 FDA Medical Device Industry Public Health 52

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.

FDA 94

FDA Health Insurance Public Health 94

Mobi Health News

MARCH 18, 2021

The agency will allow some COVID-19 tests to be used at home for regular asymptomatic testing.

COVID-19 111

COVID-19 FDA Public Health 111

Healthcare Law Today

FEBRUARY 1, 2022

It also requires that the Secretary report to Congress on the state of the SNS, and to issue guidance and hold annual meetings with public health officials and stakeholders on how states, territories, and Tribes can access the SNS. Modernizes public health data through biosurveillance and infectious disease data collection.

COVID-19 98

COVID-19 FDA Public Health Health Services Administration 98

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 147

Telemedicine FDA HIPAA Licensing 147

Bill of Health

NOVEMBER 3, 2023

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement.

Malpractice 289

Malpractice Bioethics HIPAA FDA 289

Dot Compliance

FEBRUARY 22, 2022

If you’ve developed a new pharmaceutical and want to market it to health care providers or the general public, you must take one first, unskippable step: you need to get it approved by the Food and Drug Administration. FDA regulations govern what you can claim about your product and whether you can even sell it at all.

FDA 98

FDA Compliance Governance Public Health 98

HIT Consultant

JUNE 10, 2022

In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. Wang, Chief Medical Officer of COTA, Inc.

Health Outcomes 98

Health Outcomes FDA HIPAA Public Health 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

JULY 14, 2023

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

Informed Consent 130

Informed Consent FDA Public Health World Health 130

Hall Render

JANUARY 30, 2025

This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents. A statement disclosing FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling. Before the U.S.

FDA 52

FDA State Policy Public Health Compliance 52