Health Care Law Brief

JUNE 2, 2022

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. Variety of Risks Present in Telehealth Arrangements. The severity and type of risk present in a telehealth business will vary—by jurisdiction, by provider type, by service offering, and by payor mix.

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Bill of Health

JUNE 1, 2022

Over the past two years, the Supreme Court has shown unprecedented hostility to efforts by both state and federal government to stop the spread of what every day turns out to be an even more deadly pandemic. These decisions are devastating, and likely signal a continued attack on government authority , but they are not a reason to give up.

COVID-19 293

COVID-19 Governance FDA COVID-19 Vaccine 293

Healthcare IT News - Telehealth

JULY 16, 2020

Mifepristone, in combination with misoprostol, is FDA-approved for abortions up to ten weeks' gestation. Given the potentially sensitive nature of reproductive health in particular, Yeh said telemedicine can present unique challenges. Colleen McNicholas, the chief medical officer at Planned Parenthood of the St.

COVID-19 170

COVID-19 Telemedicine FDA Public Health 170

AIHC

JUNE 14, 2023

The question remains, how will the use of AI be regulated for health care use? 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.

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

Bill of Health

NOVEMBER 15, 2023

health care system, but that are especially present for behavioral health needs like substance use, and are exacerbated by other challenges related to stigma, lack of employment, and fragmented or nonexistent care coordination. This reality reflects structural, policy, and legal misalignments common to the entire U.S.

Governance 167

Governance Public Health Telemedicine Medicaid 167

SQA

FEBRUARY 15, 2023

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

US Department of Health and Human Services 40

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

Bill of Health

APRIL 14, 2023

FDA that federal courts have the power to modify the conditions under which the FDA can approve a drug, may seem separate. These cases have no Constitutional implications, but rather resolve disputes in which billions of dollars are at stake either between private companies or between private companies and the federal government.

Governance 176

Governance FDA COVID-19 Public Health 176

Health Law Advisor

MARCH 7, 2023

Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications? DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Bill of Health

MARCH 27, 2023

Bard The White House is preparing to shut down their COVID Task Force this May, in conjunction with ending the public health emergency — the latest in a series of astounding and shortsighted decisions that put individual Americans at as great a risk from serious harm as a result of catching COVID-19 as at any stage in the pandemic.

COVID-19 332

COVID-19 Governance Public Health COVID-19 Vaccine 332

Health Law Advisor

MARCH 1, 2023

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing. [1]

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

HIPAA Journal

APRIL 5, 2023

Of those 300,000 complaints, more than 200,000 have been rejected because “the complaint did not present an eligible case for enforcement”. To authorized public health authorities to prevent or control disease, injury, or disability. To the Federal Drug Administration to report adverse events and track FDA-regulated products.

HIPAA 68

HIPAA Hospitals Compliance Medical Personnel 68

SQA

MAY 24, 2023

ANVISA Warns of New Cases of Botulinum Toxin Counterfeiting, 05 April 2023 ANVISA alerts health professionals and the population to the fact that new cases of adulteration/falsification of the drug Botox® 100U (botulinum toxin A), Batch Number C6835C3 have been identified.

FDA 40

FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. about how they use sunscreen products.

FDA 40

FDA Compliance Licensing World Health 40

Hall Render

MAY 13, 2022

FDA limits J&J COVID-19 vaccine due to rare blood clot risk. Now Durango’s public health agency is sounding the alarm. Oscar Health To Exit Colorado, Arkansas. Kansas Grantmakers in Health award $25,000 in grants in memory of former Kansas Health Foundation CEO Steve Coen. HHS awards $16.3M

COVID-19 40

COVID-19 Nurses Nursing Homes Hospitals 40

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

Hall Render

MARCH 25, 2022

FDA to revive facility visits. Dr. Lorna Breen Health Care Provider Protection Act becomes law. Here are the top health systems by patient reviews. Moderna wants the FDA to authorize its COVID-19 vaccine for kids under 6. Sensitive health data of 50 million Americans hacked or breached last year: analysis.

COVID-19 40

COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40

Hall Render

FEBRUARY 2, 2024

Mary’s welcome new board members Northeast Georgia Health System named one of nation’s top workplaces for diversity HAWAII How Adventist Health Castle achieved becoming a verified Level III Trauma Center Queen’s debuts $4.5M

Nursing Homes 40

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

SQA

AUGUST 2, 2021

It also presents information on some innovative methods for package integrity testing using existing technologies, including the potential impact of cryogenic conditions. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. b) and 320.31(d)(3)).

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Hall Render

MARCH 3, 2023

million for youth mental health care KENTUCKY Pike County nursing home officials release statement following loss of Medicare agreement Three Humana executives drop $11.2M

Nursing Homes 40

Nursing Homes COVID-19 Nurses Hospitals 40

SQA

OCTOBER 18, 2022

List Health Advance as an “Official Canadian Distributor” Include the text “Health Canada Approved” (Claims of endorsement by government authorities, such as Health Canada, are not permitted.). Counterfeit health products are imitations of authentic products. .” instead of BTNX Inc.

US Department of Health and Human Services 40

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

Hall Render

OCTOBER 6, 2023

The CDC has stopped printing them Telehealth Visits Decline 46%, But Telebehavioral Healthcare Still High URAC to offer health equity accreditation Walgreens CIO is latest to leave in company’s C-suite shakeup AI is creating a complex landscape for healthcare executives ALABAMA Alabama hospital to remain on Cerner after sale Alabama gets $3.6M

US Department of Health and Human Services 40

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

Hall Render

OCTOBER 6, 2023

The CDC has stopped printing them Telehealth Visits Decline 46%, But Telebehavioral Healthcare Still High URAC to offer health equity accreditation Walgreens CIO is latest to leave in company’s C-suite shakeup AI is creating a complex landscape for healthcare executives ALABAMA Alabama hospital to remain on Cerner after sale Alabama gets $3.6M

US Department of Health and Human Services 40

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

AIHC

AUGUST 2, 2022

Written by: AIHC Blogger This educational article is based on clinical information as of the publication date and primarily based on government and coding guidelines to assist coders, billers, clinical documentation improvement professionals and auditors address appropriate documentation for filing claims in the United States.

US Department of Health and Human Services 98

US Department of Health and Human Services FDA Licensing Compliance 98

Healthcare IT Today

FEBRUARY 28, 2023

COVID-19 forced a spike in policy-makers’ interest and willingness to invest in public health; a spike that is unfortunately retreating to the old business as usual. I consulted several experts in health IT to ask how such IT could improve data collection and sharing in public health.

Public Health 101

Public Health COVID-19 FDA Governance 101

SQA

FEBRUARY 26, 2024

During the operation, food supplements, cannabidiol in various presentations, testosterone, perfumes, and sibutramine tablets were identified, including about 6,000 units of electronic cigarettes and 35,500 packs of cigarettes. The products found, subject to retention and seizure, were retained by the Federal Revenue Service.

FDA 52

FDA Compliance COVID-19 Public Health 52

Hall Render

DECEMBER 8, 2023

health care Skilled nursing providers embrace bill nixing staff mandate, despite uncertain fate US News to begin rating ASCs ALABAMA Birmingham business lands pharmacy contract with Louisiana hospital Madison Co. CT presents draft settlement in YNHH-Prospect hospitals sale Mandell-Braunstein family gifts $2.5M NATIONAL 8.5M

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses COVID-19 40

Bill of Health

JANUARY 7, 2022

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures. Ultimately, both the FDA and CDC gave their blessing to boosters.

Public Health 339

Public Health FDA Governance COVID-19 Vaccine 339

Kaiser Health News

APRIL 6, 2022

About 30% of its funding comes from government grants and contracts. In presentations, they often share a 2017 study — conducted by an independent research institute at TROSA’s request — which found TROSA saves the state nearly $7.5 million annually in criminal justice and emergency care costs.

Licensing 83

Licensing Public Health FDA Doctors 83

Healthcare IT Today

FEBRUARY 15, 2024

With more than 700 US FDA-approved AI applications, healthcare providers grapple with navigating the complex landscape of niche AI solutions. CARPL is also creating an impact in the public health space by working with the Government of India to enable large-scale Tuberculosis Screening Programmes in the most remote regions of the country.

FDA 83

FDA Governance Hospitals Health Outcomes 83

Kaiser Health News

JUNE 2, 2022

when the FDA approved mifepristone in 2000. Some legal and drug regulatory experts argue that because the FDA is the federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human drugs, states wouldn’t have the power to overrule its stamp of approval and outlaw the abortion pill.

FDA 83

FDA Public Health Governance 83

Kaiser Health News

NOVEMBER 27, 2023

“We’re not going to be like California and have massive numbers of people on government programs without work requirements,” DeSantis said at a presidential primary debate in Southern California earlier this year. California bans short-term health plans. citizen or lawfully present in the country.

COVID-19 Vaccine 107

COVID-19 Vaccine COVID-19 Medicaid Medicaid 107

Health Populi

MARCH 23, 2020

Based on what you are hearing from candidates running for president in 2020, how confident are you that the vaccine will be available to the American public at little or no cost?” health citizens. In the immediate moment in the U.S., We find ourselves in the U.S. Congress has yet to finalize a plan for U.S.

COVID-19 70

COVID-19 Public Health Doctors Governance 70

Drug & Device Law

DECEMBER 29, 2023

Executive Health Resources, Inc. , 2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. At bottom, plaintiffs were improperly seeking to have courts second-guess the FDA’s methods and conclusions.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

FEBRUARY 3, 2022

The two claims presented to the jury in Redick were for breach of express warranty and a novel negligence claim under North Carolina law. 2022 WL 171503, *1. So, each of the ascribed court errors and allegedly prejudicial developments during trial was rejected in a patient decision.

FDA 59

FDA Public Health Doctors Governance 59

Drug & Device Law

SEPTEMBER 14, 2023

1, 2023), which concerned an APA-based challenge to FDA public statements on the use of ivermectin to treat or prevent COVID-19 in humans. Over the last three years or so, we have written plenty on ivermectin , hydroxychloroquine , and government measures to combat the COVID-19 pandemic. LEXIS 23401 (5th Cir. at *29-30.

FDA 59

FDA COVID-19 Doctors Public Health 59

Drug & Device Law

MAY 10, 2022

Nor can they include the logo of a federal or state government agency, so as not to suggest affiliation with any such agency. Finally, they cannot use the word “recall” except “when referring to a product that has been recalled by a government agency or through an agreement between a manufacturer and government agency.”

Governance 52

Governance FDA Doctors Public Health 52