Health Law Advisor

AUGUST 1, 2023

Both Colleen and Brad have decades of experience in FDA regulation, but we have different impressions on that topic, so we decided to inform the debate with a systematic look at the data. To tie the MDR data with the recall data, we are using K numbers, the numbers that FDA assigns during the course of a 510(k) review.

FDA 52

FDA COVID-19 Public Health 52

Jane Sarashon

JULY 27, 2022

The second graphic from the report breaks out the health consumer/health citizen from the health/care industry and ecosystem: Being that intelligent guardian for our health and fitness, including partnering with third parties for digital health tools and apps, and. It will be about health.”

US Department of Health and Human Services 52

US Department of Health and Human Services Doctors Public Health COVID-19 52

Healthcare IT News - Telehealth

DECEMBER 16, 2020

The virtual trial, to be sure, is not a new concept: One team of researchers counted more than 1,100 trials listed on ClinicalTrials.gov employing connected digital products for remote data collection in both 2017 and 2018, the organization observed. ” The FDA is hinting that some of these changes could be here to stay.

COVID-19 207

COVID-19 Hospitals Doctors Health Insurance 207

Health Populi

FEBRUARY 4, 2019

Consumers point to some organizations that they perceive may be working against their better health: these include fast food manufacturers, the entertainment industry, food processors (“Big Food”), the media, government agencies, and health insurance companies. Health care delivery in the U.S.

Doctors 123

Doctors Nurses Public Health Medical Billing 123

Health Law Advisor

MARCH 7, 2023

In 2018, Congress passed requirements under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, requiring DEA to create a special registration for opioid addiction treatment via telehealth by October 2019. Impact On Off-label Prescribing of Controlled Substances.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Healthcare IT Today

MAY 3, 2023

The excitement has been largely fueled by the renowned public health benefits of, and the seductive commercial opportunity for, a seamless hypertension management solution that is virtually invisible – part of what people are already wearing, such as smartwatches, earbuds, smart rings, and apparel.

FDA 102

FDA Public Health Licensing Telemedicine 102

Hall Render

FEBRUARY 23, 2024

CT’s Medicaid reimbursement rates lower than peer states: report Better safety training, reporting, escorts for CT home health care workers focus of new legislation D.C. biotech pins hopes on 3 drug approvals as battles with FDA continue Luxury senior living facility coming to D.C.

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

HIPAA Journal

JANUARY 23, 2024

The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct. Theranos and Homes denied the allegations and threatened to sue Carreyrou; however, in 2018, Homes stepped down from her position as CEO, and following an FBI investigation the company was shut down.

Fraud 70

Fraud FDA Medicaid Medicaid 70

AIHC

JANUARY 28, 2022

The policies in this IPPS and LTCH PPS final rule build on key priorities to close health care equity gaps and support greater access to life-saving diagnostics and therapies during the COVID-19 public health emergency (PHE) and beyond. billion in FY 2021, or 2.7 billion in FY 2021, or 2.7 percent.

Medicare 52

Medicare Medicare Hospitals Payment Systems 52

Healthcare IT News - Telehealth

MAY 6, 2020

The quickly evolving COVID-19 public health emergency has warranted the growing use of telehealth and non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and possible exposure to the virus. iRhythm Technologies.

COVID-19 180

COVID-19 FDA Hospitals Elder Care 180

Health Populi

JANUARY 18, 2021

CES 2021 featured some obvious quick-pivoting products that had the pandemic written all over them, with sessions invariably speaking to the way the public health crisis impacted companies and strategic plans. Sleep has been a key theme at CES, which I began to note in 2018 in this post on prescribing sleep for health at CES.

US Department of Health and Human Services 73

US Department of Health and Human Services COVID-19 Electronic Medical Records Hospitals 73

Jane Sarashon

DECEMBER 19, 2022

Heart health has become mainstream in digital health at CES, with wrist-tracking bands embedded various aspects of heart tracking, ear buds growing heart monitoring capabilities, and FDA-cleared blood pressure readings from the wrist from OMRON and Withings.

COVID-19 52

COVID-19 FDA Public Health Telemedicine 52

SQA

AUGUST 2, 2021

United Nations Industrial Development Organization, the new handbook , ISO 22000:2018 – Food safety management systems – A practical guide , provides in-depth and practical information to help organizations more effectively implement a food safety management system (FSMS) in accordance with ISO 22000:2018. PDA Technical Report No.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

OCTOBER 18, 2022

The UK sees the plans as an opportunity to introduce new regulations after Brexit in order to strengthen the public health sector. Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus.

US Department of Health and Human Services 40

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

Hall Render

JUNE 9, 2023

Thomas among 4 getting As Kentucky’s nursing workforce looks fairly stable, says new survey by state Board of Nursing Louisville hospital designated as Kentucky’s first ‘verified burn center’ Nine CHI Saint Joseph Health foundations, facilities and services awarded $900,000 Spalding University School of Nursing receives record investment (..)

Nurses 40

Nurses COVID-19 Nursing Homes Hospitals 40

HIT Consultant

FEBRUARY 10, 2022

Real-world data, or data extracted from sources such as patient medical records or health information, has been widely recognized by the FDA as paramount to the development of medical innovations and advancements.

Hospitals 52

Hospitals FDA Public Health Doctors 52

Health Populi

SEPTEMBER 19, 2018

Wages increased about 2.6%, and consumer prices, 1.3%, based on the 2019 Segal Health Plan Cost Trend Survey. Segal forecasts that medical cost trends will moderate for 2019, lower than 2018 rates. in 2018 — still several times greater than wage growth expectations. in 2019, compared with 17.7% The vast majority of U.S.

Pharmaceutical Industry 52

Pharmaceutical Industry Hospitals Governance FDA 52

Kaiser Health News

APRIL 6, 2022

Freeman, who interned at TROSA in 2018 and later spent two months on staff in the medical department. It’s been well documented that these medications greatly reduce the risk of opioid overdose death, and the FDA-approved drugs are considered the “ gold standard ” for treatment. It’s not the majority.”

Licensing 83

Licensing Public Health FDA Doctors 83

Hall Render

JULY 14, 2023

billion behavioral health contract to Centene Idaho Drops Panel Investigating Pregnancy-Related Deaths as US Maternal Mortality Surges Kootenai Health CEO to retire after nonprofit conversion Kootenai Health on track for nonprofit conversion Ammon Bundy a no-show for beginning of St. to 18 central Mass. Not everyone is happy.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Bill of Health

APRIL 26, 2024

Jackson Women’s Health Organization on June 24, 2022, multiple state supreme courts have done their own “about face” on reproductive rights. In the first of two pivotal decisions this term, the Court will decide whether FDA properly expanded access to mifepristone. Supreme Court. Hodge, Jr. , Jennifer L.

Public Health 100

Public Health FDA 100

Health Populi

JANUARY 29, 2019

paid for prescription drugs in 2018, with roughly four times the number of health citizens. More philanthropic organizations targeting neglected tropical and public health diseases. The first FDA cleared DTx was reSET from Pear Therapeutics, cleared in November 2018. using consumer-generated technology.

Prescription Drug Pricing 96

Prescription Drug Pricing FDA Patient Advocacy Governance 96

Health Populi

AUGUST 3, 2018

A new poll jointly conducted by Politico and the Harvard Chan School of Public Health bolsters my read on the latter issue – prescription drug pricing, which has become a mass popular culture union. There may be no other issue on voters’ collective minds for the 2018 mid-term election that so unites American voters.

Prescription Drug Pricing 67

Prescription Drug Pricing FDA Public Health Medicare 67

Kaiser Health News

SEPTEMBER 8, 2022

The same federal judge in Texas who tried — unsuccessfully — to strike down the entire Affordable Care Act in 2018 has ruled that portions of the health law’s preventive care benefit package are unconstitutional. to fund more efforts for public health preparedness. He has also helped pull together a bill with Sen.

Department of Veterans Affairs 52

Department of Veterans Affairs US Department of Health and Human Services COVID-19 Public Health 52

Drug & Device Law

FEBRUARY 3, 2022

Litigation over this PMA device has produced two separate preemption decisions that we deemed among our ten worst of the particular year ( #6 in 2018 and #6 in 2021 ). 1407, talks about “pretrial proceedings” only—have been quite plaintiff friendly. Middling expert rulings continued to trip over preemption, among other things.

FDA 59

FDA Public Health Doctors Governance 59

Drug & Device Law

JUNE 28, 2022

Jackson Women’s Health Org. , June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications.

FDA 116

FDA Public Health Federal Policy Doctors 116