HIPAA Journal

FEBRUARY 23, 2022

Title III: Tax-related health provisions governing medical savings accounts. Title V: Revenue offsets governing tax deductions for employers. Title II: Preventing health care fraud and abuse; administration simplification; medical liability reform. Title IV: Application and enforcement of group health plan requirements.

HIPAA 88

HIPAA Fraud Health Insurance Medicaid 88

Health Populi

FEBRUARY 27, 2020

McKinsey’s report included a chart akin to the one above from Manhattan Institute, graphically illustrating the growth of household costs with education, health care and housing fast-growing between 2002 and 2018. That is, government spending. did not save for old age. .”

Health Insurance 93

Health Insurance Public Health Governance 93

Healthcare Law Blog

NOVEMBER 21, 2022

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting cost-sharing subsidies for life-saving oncology drugs. 10] About OIG , HHS Office of Inspector General (last visited Nov.

Medicare 52

Medicare Medicare Governance Medicaid 52

Health Care Law Brief

APRIL 11, 2022

As early as 2002 and as highlighted in recent guidance , OIG has explained its longstanding concerns relating to the offering of incentives intended to induce beneficiaries to obtain federally reimbursable items and services when those incentives have been cash or cash equivalents. See, e.g. , id. at 77781, 77782–3, 77789–90, 77791.

Fraud 52

Fraud Medicare Medicare Compliance 52

SQA

FEBRUARY 22, 2021

Since the introduction of the exemption in 2002, the technology and manufacturing processes used to produce medical devices have changed dramatically. Require documentation about the device to be retained for five years (for non-implantable devices) or 15 years (for implantable devices). Allow the TGA to inspect production facilities.

COVID-19 52

COVID-19 Compliance Licensing Governance 52

Healthcare IT Today

NOVEMBER 16, 2023

The advisory board is composed of leading experts from healthcare, pharmacy, business, government, and health IT. About MIDAS Medication Integrity Diversion Accountability System (or MIDAS) creates software and other solutions to address failures in medication security which enable rising levels of medication diversion throughout healthcare.

Governance 89

Governance Hospitals Nurses 89

SQA

JULY 8, 2022

complaints received about unexpected results (i.e., Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D. It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

HIT Consultant

JUNE 29, 2023

These organizations can start conversations and dialogue within their communities, particularly those that have historically lacked knowledge about available clinical trials and/or have faced barriers to participation, to help drive diverse enrollment. to create long-term change.

FDA 98

FDA Governance 98

Health Populi

NOVEMBER 22, 2019

Several key data points under this macro finding tell the more granular story about low ROI in health spending in the U.S.: Health Populi’s Hot Points: This last chart compares gains in life expectancy (longevity) between two periods, 2002-2007 and 2012-2017. Look all the way to the left of the chart, and see that in the U.S.

Health Insurance 96

Health Insurance Doctors Governance Hospitals 96

SQA

MAY 24, 2023

Public Advisory: Robikids and Solmux are Unauthorized Syrups for Thinning Mucus and May Pose Serious Health Risks, 03 March 2023 Health Canada is warning parents and caregivers about two unauthorized children’s syrups for thinning mucus, Robikids and Solmux, seized from Kamshoppe, which advertised the products on Facebook.

FDA 40

FDA Licensing Governance Compliance 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? 5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. The allure is obvious.

FDA 98

FDA Licensing Hospitals Medicaid 98

HIPAA Journal

MARCH 30, 2022

However, when HIPAA was passed, the standards governing health care data, patients´ rights, and the flow of information were still several years away. It was not until 2002 that the Privacy Rule was published, and 2003 that the Security Rule was published. It was only when the provisions of a companion bill ( HR.3103

HIPAA 119

HIPAA Fraud Health Insurance Health Care Reform 119

SQA

AUGUST 2, 2021

The guide also provides information about the certification process, which will be helpful to any organization seeking to obtain certification or wanting to learn about the ISO 22000 certification process. ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Bill of Health

MAY 10, 2022

Bush, a Republican, anti-abortion supporter of government funded faith-based social services. Even in the progressive state of California, the education code promotes age-appropriate teaching about the Safe Surrender for Newborns law. It was signed in 1999 by then-Governor George W.

Governance 301

Governance Public Health 301

Bill of Health

NOVEMBER 20, 2023

A long-running practice, with presidential endorsement in 2017 While the practice may have begun earlier, the legal framework for school expulsion of pregnant adolescents is typically traced to Education Act regulations adopted in 2002. These include when a student has committed an “offence against morality” or “entered into wedlock.”

Governance 144

Governance Hospitals Public Health 144

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

Drug & Device Law

AUGUST 28, 2023

Just think about how antivax nuts could attempt to attack COVID-19 (or any other) vaccine if the “substantial risk” of “future injury,” Hippo III , 2023 WL 5266026, at *6, necessary for standing to file suit amounts to only a ”fairly likely” possibility that “one of them” might suffer one of four purported “injuries.” 435, 436 (2002).

FDA 52

FDA Doctors Malpractice COVID-19 52

Drug & Device Law

SEPTEMBER 11, 2023

Just think about how routinely antivax nuts could attempt to attack COVID-19 (or any other) vaccine if the “substantial risk” of “future injury,” Hippo III , 2023 WL 5266026, at *6, necessary for standing to file suit amounts to only a ”fairly likely” possibility that “one of them” might suffer one of four purported “injuries.”

FDA 59

FDA Doctors Malpractice COVID-19 59

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. at 1291-93 (construing 19 U.S.C. at 1291-92. at 1293-94. Aleynikov , 676 F.3d

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

JUNE 1, 2023

3d 1024, 1033-34 (Alaska 2002) (quoting Coon ) (footnotes omitted). 2002) (citations and quotation marks omitted). 2002 WL 32007200, at *3 (Del. 4, 2002), aff’d , 845 A.2d 2002), the same court took much of that statement back: Frye does not make the trial judge a “gatekeeper” of all expert opinion testimony.

Governance 59

Governance Hospitals 59

Drug & Device Law

JANUARY 9, 2023

15, 2022), that we blogged about not too long ago , with the monstrosity that follows here. The rulemaking process governing monographs was replaced with an administrative order process. Erroneously, ASH-ADHD chose to rely most heavily on Levine , despite OTC drugs being governed by an entirely different approval scheme.

FDA 59

FDA Governance Nurses 59

Drug & Device Law

DECEMBER 26, 2023

They’re quite “blunt” about it, and we should be, too. The amendment clarifies that the preponderance standard applies to the three reliability-based requirements added in 2000 − requirements that many courts have incorrectly determined to be governed by the more permissive Rule 104(b) standard. emphasis added). Hall , 138 S.

Governance 52

Governance 52

Drug & Device Law

NOVEMBER 10, 2022

3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine. In Amiodarone Cases , No. A161023, 2022 WL 16646728 (Cal.

FDA 52

FDA Doctors Fraud Governance 52

Drug & Device Law

JUNE 13, 2022

Thus: [The defendant] also cites the FDA’s guidelines that indicate there is no need to warn about commonly known hazards. Somewhat surprisingly, at least until recently, there hasn’t been much case law addressing the FDA’s “commonly known” hazard exception. The most notable application of this exception was in Ellis v. Bard, Inc. ,

FDA 59

FDA Licensing Doctors Nurses 59

Drug & Device Law

NOVEMBER 18, 2022

We do not think these are controversial principles, but we find that they apply to more than a few of the cases giving rise to the decisions about which we expound. 2002 IL App. (2d) 2002 IL App. (2d) Sometimes, there is no fault or liability to be found. We also find that missing facts from complaints can speak volumes.

Governance 59

Governance 59

Drug & Device Law

JANUARY 30, 2023

Mensing , 564 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Myrick , 514 U.S. Myrick , 514 U.S. American Honda Motor Co. , American Honda Motor Co. , Moran , 536 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

APRIL 19, 2022

The prosecution offered up perfectly well-qualified expert witnesses who proposed to testify about a variety of things, but the one that matters for present purposes is that they intended to characterize the material at issue as “trade secrets.” July 3, 2019) (expert may not opine about “proximate cause”); Perez v. E.g. , Dalgic v.

FDA 72

FDA Governance 72