Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar.

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Dot Compliance

OCTOBER 10, 2022

When the product itself cannot be examined, process validation guarantees that the procedures used to make the device comply with FDA rules. From 2011 to 2015, the top FDA warning letter citation for design controls was design validation. Typically, validation is carried out by a series of tests and inspections.

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FDA Compliance 52

Dot Compliance

OCTOBER 10, 2022

When the product itself cannot be examined, process validation guarantees that the procedures used to make the device comply with FDA rules. From 2011 to 2015, the top FDA warning letter citation for design controls was design validation. Typically, validation is carried out by a series of tests and inspections.

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FDA Compliance 52

HIT Consultant

MAY 24, 2023

Meantime, there are current therapies approaching the FDA approval process, but they come at a high cost and don’t stop cognitive degeneration, but instead only extend life by several months. The economic burden of AD also impacts mental health and productivity.

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Medicare Medicare FDA Governance 97

HIT Consultant

MAY 9, 2022

In 2015, half of Americans believed renewing their driver’s license requires less paperwork than a trip to the clinic, and 29 percent of patients still had to physically transport test results, X-rays, or health records from one physician’s office to another, according to a survey conducted by Surescripts.

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FDA COVID-19 Public Health Compliance 98

Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

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

Dot Compliance

NOVEMBER 21, 2022

To find out the benchmark for satisfying global standards of Quality Management System, consult ISO 9001:2015 or ISO 13485:2016. Those who require a Quality Management System for Manufacturing can read EU MDR and EU MDD publications from EU agencies to learn more about the infrastructure needs for QMS.

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Compliance FDA 52

Verisys

NOVEMBER 14, 2023

With proven credentialing software, you never have to worry about scalability if you’re rapidly hiring and credentialing more healthcare providers. Department of Justice (DOJ) U.S. Treasury Department U.S. Many healthcare organizations find themselves in a merger and suddenly serve more providers than their staff can handle.

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Licensing Medicaid Medicaid Governance 52

Verisys

JANUARY 18, 2022

Food and Drug Administration (FDA). With proven credentialing software, you never have to worry about scalability if you’re rapidly hiring and credentialing more healthcare providers. ISO 9001:2015 (quality management). System for Award Management (SAM). Specially Designated Nationals (SDN). Drug Enforcement Agency (DEA).

Licensing 52

Licensing Medicaid Medicaid Governance 52

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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

The Digital Health Corner

JUNE 14, 2017

According to most recent statistics from the Office of the National Coordinator, use of EHRs has increased from 20% in 2004 to 87% in 2015. I’d like to discuss what I believe are five areas of significant opportunity for quality technologies. EHRs were designed as documentation centers for billing and regulatory purposes.

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Patient Satisfaction Hospitals FDA Governance 87

Healthcare IT News - Telehealth

DECEMBER 16, 2020

In March, as states were issuing stay-at-home orders, the FDA published pandemic-specific guidance for trial sponsors, institutional review boards and investigators on how to ensure the safety of their trial participants and reduce risks to trial integrity, while sustaining compliance with good clinical practice.”

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COVID-19 Hospitals Doctors Health Insurance 210

Health Populi

JANUARY 2, 2020

At CES 2013, David Van Sickle, CEO and founder of Asthmapolis, spoke in a CES keynote panel about the usefulness of health data in the cloud. Healthcare is getting serious at #CES2020, blurring into the medical and FDA regulated turf which Omron pioneered last year launching its 80+-patented blood pressure watch, the HeartGuide.

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Dot Compliance

DECEMBER 7, 2022

Ensuring Compliance with ISO 9001, EU MDR, FDA & More 6. A quality management system (QMS) is a codified system (paper or software-based) for documenting roles, processes, and procedures to develop goods that comply with FDA, ISO, EU MDR, and other regulatory standards as well as client expectations. The Bottom Line. QMS Timeline.

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FDA Compliance Records Management 52

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.

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Medicaid Medicaid COVID-19 Telemedicine 202

SQA

SEPTEMBER 2, 2022

Ma rketing authorization holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’. United States Food and Drug Administration (FDA) – Regulations and Guidances.

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FDA COVID-19 Nursing Homes Compliance 91

SQA

OCTOBER 18, 2023

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products. about how they use sunscreen products. These products are widely used by Canadians.

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FDA Compliance Licensing World Health 40

Health Populi

JANUARY 4, 2023

” Withings’ research found that we urinate about seven times a day, but only test our urine, on average, once a year. launch date to be determined based on FDA clearance timing. Courbebaisse recognizes that, “Everyday, we learn more about how technology can improve outcomes.” ” Prof.

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COVID-19 FDA Doctors Hospitals 62

Health Law Advisor

OCTOBER 3, 2022

Over the spring and summer, I did a series of posts on extracting quality information from FDA enforcement initiatives like warning letters , recalls , and inspections. But obviously FDA enforcement actions are not the only potential sources of quality data that FDA maintains. OCCUPATION: NON-HEALTHCARE PROFESSIONAL.

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FDA 52

HIPAA Journal

JANUARY 23, 2024

Carreyrou published the story in 2015 that revealed the company was using third-party technology rather than its own, as its own technology was inefficient. The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct.

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Fraud FDA Medicaid Medicaid 70

HIT Consultant

NOVEMBER 29, 2022

It has been approved by the United States Food and Drug Administration (FDA) and is currently a generic drug (e.g., About Jin Han Kim Jin Han Kim is the Co-Founder, Chairman, and CEO of Standigm , a workflow AI-driven drug discovery company headquartered in Seoul, South Korea and subsidiaries in Cambridge, U.K.

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FDA Doctors Governance 98

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. ISO5356-1:2015, Anesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. b) and 320.31(d)(3)).

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

Hall Render

DECEMBER 22, 2023

governor pushes new Medicaid expansion proposal with work requirement Missouri state senator wants voters to have say in KU Health System, Liberty Hospital merger Kansas ACLU request to halt excessive wait times at Larned turned down by judge ‘Who cares about us?’: Accused Of Filing False Claims Settles For $14.7M

Nursing Homes 40

Nursing Homes Nurses Hospitals COVID-19 40

Kaiser Health News

MAY 13, 2022

They were expressing concerns about the privacy of this information — especially for people who live in states with strict limits on abortion — and how it might be used against them. “Hacking is criminal, there’s no question about it,” Savage said. “Now.” The short answer is yes. Ron Wyden (D-Ore.)

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US Department of Health and Human Services HIPAA Governance Health Insurance 101

Health Populi

NOVEMBER 13, 2018

First, let’s talk about those many hats that Lisa wears. The Tech-Tonics podcast , co-hosted with David Shaywitz, was an early entrant into that medium, launching in 2015 (today, podcasts in healthcare are multiplying like rabbits). Lisa started the Venture Valkyrie blog in 2010. conversations from which to learn.

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FDA Doctors 74

Hall Render

DECEMBER 29, 2023

NATIONAL 4 largest healthcare data breaches of 2023 Anesthesia practices sue CMS over reimbursement method Antitrust enforcements hit a high in 2022, with health deals impacted ASCs face leadership exodus CMS floats appeals process over observational stays CMS proposes additional Medicare appeals processes FTC eyes healthcare mergers, report shows (..)

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

Hall Render

APRIL 21, 2023

That may be about to change. Mississippi Dept. Billion in Community Benefit in 2021 OhioHealth buys land in Canal Winchester – 3 miles from competitor’s ER Quipt Home Medical inks $26M stock deal with Beacon Securities, Canaccord Genuity Corp., European expansion North Texas podiatrist and patient recruiter convicted in $8.5M

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

Drug & Device Law

DECEMBER 4, 2023

On a host of issues, CPAP II makes a recommendations about state law – but without any basis in existing state law. Undisputedly, the complaint at issue “allege[d] no specific facts about any specific plaintiffs or specific injuries.” 28, 2023) (“ CPAP II ”), is entirely Mr. Hyde. 2023 WL 7019287, at *3. 2023 WL 7019287, at *3.

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Fraud FDA Hospitals Doctors 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. That rationale is about as far from the Supreme Court’s holdings in TwIqbal , quoted above, as it is possible to be. [T]he Back in 2008, the United States Supreme Court held, in Riegel v.

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FDA Governance Nurses Hospitals 59

Drug & Device Law

APRIL 28, 2022

There seems to be a political angle to just about every contested regulation of speech and, of course, politics makes strange bedfellows. 155 (2015), spelled out what makes a restriction on speech content-based and, thus, presumptively invalid. The Supreme Court decision in Reed v. Town of Gilbert , 576 U.S.

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FDA Governance 59

Drug & Device Law

AUGUST 8, 2022

Recently, we have become concerned about personal injury plaintiffs deciding to sue these kinds of organizations because they don’t like some standard that stands between them and the pot of gold at the end of the litigation rainbow. 2015 WL 6393869 (S.D. Such power rests solely with the FDA.” Heck, even lawyers get rated.

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Doctors Fraud Licensing Compliance 52

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. There was nothing new or different about them. Another year bites the dust.

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

Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. 15, 2022), that we blogged about not too long ago , with the monstrosity that follows here. Levine , 555 U.S. Just compare the felicitous result in Truss v.

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FDA Governance Nurses 59

Drug & Device Law

JUNE 2, 2022

We are just simple defense hacks writing about product liability law and some other things that matter to medical product manufacturers. Although the male authors here agree wholeheartedly that individual choices about women’s contraception, reproduction, and sexual health are not for us to make.) As we discussed here , McCormack v.

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FDA Licensing 127

Drug & Device Law

MAY 13, 2022

472 (2013), as readers of this blog are aware, the United States Supreme Court held that a state law design defect claim against a generic drug manufacturer was pre-empted because the manufacturer could not “redesign” a drug to comply with state law tort duties without first obtaining FDA approval. Bartlett , 570 U.S. 3d 281 (6th Cir.

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Fraud FDA Nurses Hospitals 59

Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

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FDA Governance 52

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . March 29, 2019); Byetta Cases , 2015 WL 883211, at *1 (Cal. Bayer HealthCare Pharmaceuticals, Inc. , 3d 1223, 1233 (11th Cir.

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