Health Law Advisor

AUGUST 10, 2023

According to the preamble to the 2011 Final Rule: A purchaser of an MDDS who has only used, configured, or modified the MDDS in accordance with the original manufacturer’s labeling, instructions for use, intended use, original design, and validation would not be considered a manufacturer for purposes of this regulation.

FDA 98

FDA Licensing Hospitals Medicaid 98

Health Populi

OCTOBER 24, 2022

These are shown in the first diagram from the report, breaking out factors that have exacerbated challenges on both the demand and supply side of the American health economy. Many of these were already in motion before the COVID-19 pandemic emerged; the public health crisis exacerbated several of them. In the U.S.,

COVID-19 54

COVID-19 Prescription Drug Pricing Health Insurance Health Care Reform 54

SQA

DECEMBER 10, 2021

The NMPA announcement also identifies several expert groups that will help steer the new authority; these groups will consist of universities, hospitals, healthcare provider networks, life sciences and medical device company representatives, and regulatory agencies. Real-world research requirements. Clinical data processing.

FDA 52

FDA Compliance Public Health Hospitals 52

Bill of Health

AUGUST 16, 2022

In 2011 , 45% of pregnancies in the United States were unintended, and, because there was a protected right to reproductive freedom, 42% of these were terminated through abortion at the request of the birthing parent. A Long History of Wrongful Prosecutions.

Bioethics 130

Bioethics Hospitals Public Health 130

Health Populi

NOVEMBER 7, 2019

Opioid-related deaths grew some 20% since 2011 in the U.S. health care versus the OECD peer nations. fall below the OECD average, and the proportion of people who self-report that they are in “good health” is the third highest in the OECD. and are impacting mortality rates in Canada, Estonia and Sweden, too. For the U.S.

Doctors 90

Doctors Medical Billing Health Insurance Public Health 90

HIT Consultant

JANUARY 5, 2023

Many individuals are incarcerated because of a low-level drug or drug-related crime ( e.g., when a healthcare professional diverts drugs in a hospital for personal use). This approach originated in 2011, is a smarter way to stop the cycle of crime and an alternative to incarceration.

Hospitals 52

Hospitals Nurses Governance Public Health 52

Healthcare Law Blog

JANUARY 26, 2023

The provisions also prohibit entities that receive federal funds from denying admission or discriminating against any applicant for training or study based on their reluctance or willingness to counsel, recommend, perform, or assist in certain health services or research activities because of their religious beliefs or moral convictions.

ACA 105

ACA Medicaid Medicaid Compliance 105

New Jersey Healthcare Blog

JANUARY 12, 2022

Below are the most recent health care related regulatory developments as published in the New Jersey Register from October-December 2021: On October 4, 2021, at 53 N.J.R. 103, which declared a Public Health Emergency for the state in response to COVID-19. The chapter applies to State psychiatric hospitals and DMHAS services.

Licensing 40

Licensing Medicaid Medicaid Nurses 40

Health Populi

OCTOBER 15, 2020

More than four times as many Black women believe that it’s a bad time to be Black in America in 2020 versus 2011, we learn from The Undefeated Survey on Race and Health from Kaiser Family Foundation (KFF). The public health pandemic has converged in 2020 with the negative impacts of financial stress and mental health tolls.

COVID-19 86

COVID-19 Public Health Governance Health Insurance 86

Hall Render

MARCH 16, 2022

It’s also the first bicameral legislation to include community project funding (previously known as “earmarks”) since they were banned in 2011. billion for the Public Health and Social Services Emergency Fund, a $352.2 Other Health Care Provisions. A section of the bill that would have provided $15.6 million increase.

COVID-19 40

COVID-19 Medicare Medicare FDA 40

SQA

JUNE 3, 2024

Novartis Pharmaceuticals UK Limited has a direct-to-pharmacy supply chain agreement based on the specialist use of the product and know the exact hospitals who have been supplied with the impacted batch. Accordingly, the intended users of TR-73-2 are applicants, i.e., pharmaceutical companies, their suppliers, and other interested parties.

FDA 40

FDA COVID-19 Licensing Nurses 40

C&M Health Law

JANUARY 25, 2023

Starting in 2023, the Administration will promulgate regulations to implement the Act’s provisions and to issue reports to Congress as required by statute, including on telehealth utilization, the Acute Hospital Care At Home program, pandemic preparedness efforts, and clinical trials reform, among others.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. at 226 (footnote and quotation marks omitted).

FDA 115

FDA Public Health Fraud Hospitals 115