Dot Compliance

JUNE 16, 2022

Government regulators have been doing their best to ensure that patients receive the safest and most efficient device possible. The two most relevant quality regulations for medical device manufacturers are the FDA 21 CFR Part 820 and the ISO 13485:2016. What are the main regulations governing medical device QMS?

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FDA Regulatory Compliance Compliance Governance 52

Healthcare Law Blog

JUNE 15, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. For a brief moment in time last April, the U.S. Fifth Circuit Order, at 2.

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FDA Governance Telemedicine Licensing 52

HIT Consultant

JANUARY 24, 2022

Are we putting enough safeguards and governance in place for AI-driven decision-making, particularly in areas of automated machine learning? That’s why the theme of a recent FDA-Project Data Sphere Symposium was entitled “The Art of the Possible.” Are humans in the process loop to verify both inputs and outputs of AI predictions?

Governance 98

Governance FDA Doctors COVID-19 98

SQA

AUGUST 2, 2021

These standards include but are not limited to the following list and are available at no charge in read-only format: ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk. ISO 13688:2013, Protective clothing – General requirements.

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

Healthcare IT Today

OCTOBER 29, 2023

Digital health funding has dropped to levels not seen since 2016 , with just $3 billion in global funding announced in Q3, according to the latest report from CB Insights. Point-to-point encryption vendor Bluefin is integrating with CORE payment products for government and healthcare customers.

Medical Billing 97

Medical Billing FDA Hospitals Governance 97

Dot Compliance

JANUARY 14, 2022

Common risk areas often include (but aren’t limited to): Cybersecurity Audit management Government pricing General data protection regulation. Key risk management regulations for Life Sciences companies include: ISO 12485:2016. This internationally recognized standard was revised and published in 2016. Source: [link].

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Compliance FDA Regulatory Compliance Governance 52

HIT Consultant

JUNE 29, 2023

It is also critical to provide education for sites to understand the latest guidance from the FDA, as this will empower clinical research associates and the investigators to be knowledgeable of what to look for at the site level, giving every patient the opportunity to participate without encountering biases or barriers.

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FDA Governance 96

Bill of Health

AUGUST 29, 2022

Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials. Comm’n of the States (March 2016), [link] (50 state survey on state constitutional rights to education). 251, 254 (2016). [18] & Tech. 439, 448 (2013). [15]

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

HIT Consultant

FEBRUARY 22, 2023

Regulators have increasingly prioritized diversity in clinical trials , with the FDA releasing draft guidance in April 2022. He was the 2016 Democratic Nominee for North Carolina Senate in the 9th District in a competitive race that garnered national attention by multiple national news outlets where he was endorsed by President Obama.

Patient Advocacy 98

Patient Advocacy Health Insurance FDA Governance 98

HIT Consultant

SEPTEMBER 2, 2022

Femtech a term coined by Danish entrepreneur Ida Tin in 2016 has become a revolutionary moment for women across the globe. In December 2021, the company received clearance from Food and Drug Administration (FDA) for its digital contraceptive device and the same is now being rolled out in the U.S.

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FDA World Health Nurses Governance 95

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.). United States Food and Drug Administration (FDA) – Regulations and Guidances. .” instead of BTNX Inc.

US Department of Health and Human Services 40

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

Healthcare IT Today

MAY 5, 2023

Department of Health and Human Services (HHS) analysis showed Medicare payments for genetic testing quadrupled from 2016 to 2019. The surge in genetic testing claims comes with a rise in fraud, waste and abuse across government and commercial payers. In 2021, a U.S. Common schemes include: Code stacking.

Fraud 62

Fraud Medicare Medicare Overpayments 62

Kaiser Health News

APRIL 6, 2022

About 30% of its funding comes from government grants and contracts. Since graduating in 2016, Weston has worked in development for Hope Connection International , a nonprofit his mother started to support survivors of abuse and addiction. million annually in criminal justice and emergency care costs.

Licensing 83

Licensing Public Health FDA Doctors 83

Hall Render

FEBRUARY 10, 2023

Dunleavy proposes extending Medicaid coverage for new mothers ARIZONA Banner Health pays $1.25M penalty over HIPAA failures from 2016 breach Arizona nursing school at risk of losing accreditation St. billion since pandemic U.S. million to UMass Memorial Health Care for COVID-19 costs Four Mass.

US Department of Health and Human Services 40

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

Hall Render

NOVEMBER 17, 2023

Jill Biden will lead new initiative to boost federal government research into women’s health Joint Commission says acute, critical access hospitals must join safety network Lawsuit claims UnitedHealth AI wrongfully denies elderly extended care Most Rural U.S. Compensation is key Is spine surgery expansion next for ASCs? Many more are waiting.

Nursing Homes 40

Nursing Homes Nurses Hospitals Doctors 40

Health Populi

SEPTEMBER 19, 2018

Over the ten years 2006 to 2016, deductibles increased an average of 176% and coinsurance, 67%. consumers have long-ranked the pharmaceutical industry relatively low, but above car salespeople and the Federal government. They’ll begin to apply to the FDA in early 2019 to make and sell the generic drugs.

Pharmaceutical Industry 52

Pharmaceutical Industry Hospitals Governance FDA 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. at 349 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance”). Medtronic, Inc. , 3d 1026, 1032 (N.D.

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FDA Governance Nurses Hospitals 59

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. T]he growing market for mifepristone. . .

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FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

SEPTEMBER 21, 2023

The parties’ contract required the supplier to deliver components that “meet FDA standards for medical devices.” The manufacturer claimed that the supplier breached the contract when it delivered components that, according to the manufacturer, violated the FDA’s Current Good Manufacturing Practices (CGMP) regulations. . § Ohio 2023).

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FDA Governance Compliance 59

Drug & Device Law

MARCH 3, 2022

have dockets heavy on administrative cases and other cases involving the functioning of the federal government and light on product liability cases. The MDL was established in June 2016. With more than eight years on the federal bench, that is not many decisions. Part of that may be that the D.D.C. Even the D.C. The first is pace.

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FDA Fraud Governance 59

Drug & Device Law

AUGUST 8, 2022

Furthermore, trade associations often serve to assist the government in areas that it does not regulate. 2016) (association’s “adoption of rules, policies, and procedures. . . Both state and federal governments allegedly relied on the defendant “accreditation process to help evaluate HCOs.” Such power rests solely with the FDA.”

Doctors 52

Doctors Fraud Licensing Compliance 52

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. The rulemaking process governing monographs was replaced with an administrative order process. Levine , 555 U.S. Plaintiffs Legal Committee , 531 U.S.

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FDA Governance Nurses 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. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

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

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. Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2016 WL 4496917, at *6 (W.D. 3d 281, 292 (6th Cir.

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FDA Governance 52

Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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FDA Governance 52

Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our 1938 (2016), but the lack of a presumption meant plaintiff’s claim was preempted. Contraceptive devices without a pharmacologic action have not avoided litigation.

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FDA Fraud Doctors Public Health 59

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

SEPTEMBER 7, 2023

We have also been following a challenge in the Southern District of West Virginia to state law effectively banning and criminalizing the use of medications that the FDA has approved specifically for abortion. The FDCA “does [not] mention any other specific procedure, device, cosmetic, or medication it instructs the FDA to regulate.”

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FDA Licensing Telemedicine Governance 59

Drug & Device Law

DECEMBER 6, 2022

According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. Plaintiff alleged that she consumed Tootsie Rolls from 2010 to 2016 apparently without knowing that they contained artificial trans fats in the form of partially hydrogenated oils (PHOs). Tootsie Roll Indus. LEXIS 982 (Cal.

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FDA Compliance Governance 59

Drug & Device Law

APRIL 20, 2023

Back when the Dobbs decision had been leaked but not yet issued, we offered that the decision would open the door to a range of challenges to FDA-approved drugs for medical abortion and emergency contraception, along with a wide range of other regulated medical products. 12, 2023), temporarily stayed , FDA v. 3d , 2023 WL 2825871 (N.D.

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FDA Doctors Public Health Governance 59

Drug & Device Law

DECEMBER 13, 2023

His most recent law review article — Grossi, “The Conservative Court on the Unacceptable Perils in Second-Guessing FDA Safety Decisions and Its Coming Review of Alliance for Hippocratic Medicine v. FDA (The “Abortion Pill Case”),” 31 Virginia J. FDA , 78 F.4 (We cannot comment on his post-retirement wardrobe.)

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