Health Populi

OCTOBER 22, 2019

In the 2019 dictionary next to the word “stress,” we would find variations of a definition all deriving from Americans’ current worries about their money, the economy, and health care costs…then, family responsibilities and jobs. That’s quite a large chasm between these two numbers, about $2,400.

Prescription Drug Pricing 52

Prescription Drug Pricing Health Insurance Doctors Governance 52

Health Populi

AUGUST 13, 2019

Here are some details about these strategies, which I foresee will impact employees’ health care service flows in 2020. Looking forward, “nudging” employees to physician-based ACOs through strategic plan design (think: behavioral economics) and promoting virtual primary care services will gain traction in 2011-2022.

Health Care Access 58

Health Care Access Governance Health Insurance 58

HIT Consultant

DECEMBER 2, 2022

The report also reviewed deaths in more than 500 jails from 2016 to 2018, and found that “those relying on one of the five leading healthcare contractors had higher death rates than facilities where medical services are run by government agencies. before selling the company in 2011. At another facility in Texas, the U.S.

COVID-19 98

COVID-19 Nurses Health Services Administration Governance 98

HIT Consultant

AUGUST 13, 2011

Wagner Graduate School of Public Service Abstract: IT governance has been topic of interest for many years, and even though the concept has been embraced within the healthcare industry, the reality is that it’s still not operationally working well within most healthcare organizations. Click here to download this white paper.

Governance 40

Governance 40

Bill of Health

FEBRUARY 13, 2024

In the interview below, she shares more about her career and life. I’ve been privileged to be able to work not only with non-governmental and grass-roots organizations but also with national governments and courts, as well as with UN bodies. Can you share more about that initiative? Could you describe the work you do?

Public Health 160

Public Health Governance Bioethics Doctors 160

Healthcare IT News - Telehealth

MARCH 18, 2022

Healthcare IT News sat down with this digital health investor to talk about digital health investment trends during the pandemic and where he sees funding trending in 2022 and beyond. Norden is particularly passionate about funding companies focused on the Medicaid population – a traditionally tricky and often ignored area.

Medicaid 199

Medicaid Medicaid COVID-19 Telemedicine 199

HIT Consultant

DECEMBER 1, 2021

With healthcare commercial intelligence, companies can untangle the messy web of data on delivery systems, physicians, payors, patients, government organizations and more to identify the people, opportunities and organizations that are the best fit for products. About Jason Krantz.

COVID-19 98

COVID-19 Telemedicine Pharmaceutical Industry Patient Satisfaction 98

SQA

FEBRUARY 15, 2023

” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,

US Department of Health and Human Services 40

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

HIT Consultant

JANUARY 5, 2023

This approach originated in 2011, is a smarter way to stop the cycle of crime and an alternative to incarceration. For example, major hospitals and health systems have been wracked by instances of drug diversion, but what are they doing about it? About Susan P. Weinstein, Esp.

Hospitals 52

Hospitals Nurses Governance Public Health 52

Verisys

JULY 13, 2023

Verisys’ former VP of Pharma and Pharmacy Solutions, Joe Thompson, shared a prime example of how speaker programs introduce risk to the pharmaceutical company: “In 2011, one of the most prominent endocrinologists in my sales region was an active speaker for my previous company. He led multiple programs for us each year.

Compliance 52

Compliance Due Diligence Pharmaceutical Industry Fraud 52

Healthcare Law Blog

JANUARY 10, 2022

Enrollee Participation in Plan Governance (§ 422.107). CMS believes its proposals would improve Federal and State oversight of certain D-SNPs (and their affiliated MCOs) through greater information-sharing among government regulators. Key provisions of the Proposed Rule are summarized below. Comments are due by March 7, 2022.

Medicare 98

Medicare Medicare COVID-19 Medicaid 98

HIT Consultant

DECEMBER 26, 2021

Imagine taking hours to look at a patient’s historical record to see what previous visits were about and what treatments were given. About Dr. Kel Pults. March 2011). This could take quite a bit of time. For new clinicians today, this probably seems ridiculous, but it was reality not long ago. Enter the Active Archive.

Due Diligence 98

Due Diligence Compliance HIPAA Nurses 98

Total HIPAA

SEPTEMBER 30, 2019

ArcServe offers a variety of solutions for clients who need to comply with government regulations, like HIPAA, GDPR, SOX, etc. This way you and your team do not have to worry about surprise bills. IDrive has a HIPAA compliant cloud backup solution for just about everyone. Learn more about IDrive’s pricing tiers here.

HIPAA 52

HIPAA Compliance Governance Ransomware 52

HIT Consultant

JULY 22, 2011

The poll assessed current and future cloud computing use in healthcare, business, government, and education, and found that 28 percent of organizations (across all industries) use the cloud today in some capacity. Source: Healthcare Informatics 2011 August;28(8):18-24. Rick Schooler.

Hospitals 40

Hospitals HIPAA Electronic Medical Records Nursing Homes 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

CMS.gov

NOVEMBER 2, 2018

Just another name for a government-run, single payer system. Just another name for a government-run, single payer system. When listening to those advocating ‘Medicare for All’ it’s good to be skeptical about their promises. percent from 2011-2016, from $17.6 CMS BLOG: Medicare for All? keya.joy-bush@…. Medicare Part C.

Governance 55

Governance Medicare Medicare ACA 55

Kaiser Health News

JUNE 29, 2022

Congress should crack down on Medicare Advantage health plans for seniors that sometimes deny patients vital medical care while overcharging the government billions of dollars every year, government watchdogs told a House panel Tuesday. CMS is scheduled to release the audits later this year.

Medicare 105

Medicare Medicare Governance Overpayments 105

C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

MAY 19, 2023

In 2011 (during the Obama Administration), the FDA completed the REMS for mifepristone, mandating that it “only be prescribed by certified physicians, dispensed in certain healthcare facilities, and taken in the provider’s clinic.” That argument contravened the standing holdings of just about every other abortion case in history.

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FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

OCTOBER 23, 2023

Despite that waiver, subsequent plaintiffs have successfully converted Riegel ‘s dictum about parallel claims – that “a damages remedy for claims premised on a violation of FDA regulations” would be “‘parallel,’ rather than add to, federal requirements” – into a widely recognized exception to the broad express preemption recognized in Riegel.

FDA 59

FDA Governance Nurses Hospitals 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. 2011 WL 13186258, at *2 (C.D. Wells Fargo Bank , 2011 WL 1833020 (D.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

JUNE 1, 2023

2011) (recognizing a “gatekeeping requirement” whereby “a circuit court must make a preliminary assessment of whether the reasoning or methodology underlying expert testimony is valid and whether the reasoning and methodology used by the expert has been properly applied to the facts”); Green v. 2011 WL 5042330, at *3 (Del. 2011), cert.

Governance 59

Governance Hospitals 59

Drug & Device Law

MARCH 25, 2022

604 (2011), and Mutual Pharmaceutical Co. Third , the defendant “fully informed” the FDA about the relevant risk. In particular, it is appropriate to consider, and credit, the positions the FDA took in the amicus brief that the government filed in Albrecht itself. at *12-13 (other citations and footnote omitted). Answer: yes.

FDA 52

FDA Governance 52

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. That’s about the only thing that DeCostanzo got right. “[P]laintiff alleges she suffered a physical injury in the form of defective immunity, among others.

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FDA Public Health Fraud Hospitals 115

Drug & Device Law

NOVEMBER 10, 2023

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. A procedural rule, such as Rule 23 governing class actions, should not, and legally cannot , change that result. Valsartan , 2023 WL 1818922, at *24.

FDA 59

FDA Governance Fraud 59

Drug & Device Law

DECEMBER 29, 2023

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. There was nothing new or different about them. The prescribing cosmetic surgeon knew about it. Another year bites the dust. Polansky v.

FDA 105

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

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

SEPTEMBER 26, 2022

He was most interested in learning more about the compensation systems provided by the National Childhood Vaccine Injury Act and the PREP Act. After listening to, and thinking about, the Vaccine Act presentations, we can’t be sure, but we don’t think that Vaccine Act claims fit very well into the usual P-side MDL business model.

Nurses 59

Nurses Governance Hospitals 59

Drug & Device Law

FEBRUARY 20, 2023

223, 238 (2011), the United States Supreme Court reacted to a plaintiff’s unconstrained claims of “alternative” vaccine design: [T]he [design] decision is surely not an easy one. Finally, there is no evidence in the record about the feasibility of increasing the costs of [the drug]. In Bruesewitz v. Wyeth LLC , 562 U.S.

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

NOVEMBER 22, 2022

915 (2011), which added the “at home” limiter to the “continuous and substantial business” standard for general personal jurisdiction. Justice Kagan “suggested” that “this whole idea of consent-by-registration came about because it was, you know, necessary in a pre- International Shoe world and was now an anachronism.”

Governance 72

Governance 72

Drug & Device Law

MAY 26, 2023

Are we down to talk about NPP and its impact on reproductive rights litigation? The oldest Supreme Court decisions we know about relating to products regulated by the FDCA or its predecessor, the Pure Food Act, are McDermott v. Both talk a fair amount about “commerce” and the respective roles of the states and federal government.

FDA 59

FDA Licensing Doctors Governance 59

Drug & Device Law

OCTOBER 7, 2022

One of the reasons that Congress included an express preemption provision in the MDA is because a jury in a state law product liability trial about a specific patient has no business deciding whether a class III device should have been approved, a decision FDA makes based on an evaluation of its safety and efficacy (i.e., 2022 WL 4536240, *1.

FDA 59

FDA Fraud Doctors Public Health 59

Drug & Device Law

MAY 10, 2022

It is hard to ignore a television ad that sounds like a red flag warning about a medication you are currently taking. Nor can they include the logo of a federal or state government agency, so as not to suggest affiliation with any such agency. 557 (1980), as the “governing framework for analyzing commercial speech restrictions.”

Governance 52

Governance FDA Doctors Public Health 52

Drug & Device Law

MARCH 31, 2023

Criticizing attempts to sue publishers of scientific content, here in 2011, and again, here in 2013. Scientific literature about the risks and benefits of prescription medical products does not – at least in the absence of academic fraud such as the actual falsification of data (see, here ) – subject the speaker to tort liability.

Medical Personnel 59

Medical Personnel COVID-19 Fraud Doctors 59

Drug & Device Law

JANUARY 30, 2023

Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. 555 (2009), and rated only a “ cf. citation in PLIVA, Inc. Mensing , 564 U.S. 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. ,

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

MARCH 11, 2024

The Carson litigation isn’t about prescription medical products, but rather about a herbicide – Roundup. An express preemption clause precludes Silkwood ’s airy speculation about unstated congressional intent. “The Monsanto Co. , 4th 980 (11th Cir. Medtronic, Inc. , is exactly what a pre-emption clause. . . Riegel , 552 U.S.

Governance 52

Governance 52

Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. Rather, it flies in the face of the most recent (2011) amendments to Rule 407. Before 2011, Rule 407 used to at least mention causation ? Emphasis added).

FDA 52

FDA Governance 52