HIT Consultant

JUNE 7, 2023

Clinical protocols improve the quality of clinical decisions by offering explicit recommendations for clinicians who are uncertain about how to proceed, overturning the beliefs of doctors accustomed to outdated practices, and providing evidence-based recommendations that reassure practitioners about the appropriateness of their treatment policies.

Hospitals 98

Hospitals Compliance Electronic Medical Records Patient Satisfaction 98

Health Populi

JUNE 13, 2018

” That was written in the 2001-2010 period of healthcare spending, so an old story giving me feelings of déjà vu. In 2007, the year I launched Health Populi , the inaugural post focused on just this issue; the post was titled, “Health care is the #1 line item in our national economy…and taking more out of your pocket.”

Medicaid 63

Medicaid Medicaid Health Insurance Medicare 63

Bill of Health

JULY 13, 2022

I was living and working in Peru in 2001, when Karen Noelia Llantoy discovered she was pregnant with an anencephalic fetus. Nonetheless, the doctor who was to perform the surgery said approval from the hospital director was required. By Alicia Ely Yamin. Llantoy, a minor at the time, became profoundly depressed.

Governance 182

Governance Doctors Hospitals Public Health 182

HIT Consultant

SEPTEMBER 1, 2023

In 2001, Ellen Roche was administered a drug, hexamethonium, as part of a clinical study on asthma at Johns Hopkins University. The Johns Hopkins case illustrates the critical need for doctors and nurses to have unfettered access to e-books, articles, and other relevant literature at a moment’s notice.

Doctors 110

Doctors Hospitals COVID-19 Nurses 110

Bill of Health

SEPTEMBER 1, 2023

While it is not compulsory for the employee to take these 4 months of unpaid leave, the Act states further that the woman cannot return to work earlier than 6 weeks after giving birth, unless her doctor certifies that she is able to do so.

Health Insurance 162

Health Insurance Public Health Doctors 162

SQA

MAY 17, 2022

Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. Patients currently taking the products should consult with their doctor or healthcare provider about alternative treatment options.

FDA 75

FDA Compliance Informed Consent Hospitals 75

Healthcare IT Today

MAY 21, 2023

More than 60% of adults were willing to go to a pharmacy for vaccinations, though 54% preferred the doctor’s office for vaccines for their children. Disruption is the new normal for the hospital supply chain due to economic pressures and shortages, a new report from Deloitte concluded.

Nurses 79

Nurses Hospitals Telemedicine FDA 79

Bill of Health

MARCH 14, 2024

In 1992, a distressed 14-year-old girl named Amina came to her clinic asking for help, explaining that a man “had given her money to give to a doctor to make her period come.” She then served as Ghana’s Minister of Health from 1996 to 1998 and as Ghana’s Ambassador to the Netherlands from 1998 to 2001.

Doctors 113

Doctors World Health Governance Public Health 113

Hall Render

JUNE 14, 2024

million to expand training for healthcare jobs DELAWARE Abessinio Foundation makes $1 million gift to ChristianaCare’s Wilmington Campus ChristianaCare Builds Community With Habitat for Humanity Delaware to receive $4.9 to resolve alleged false claims Health care group offloads dozens of Florida facilities ahead of $1.2B

US Department of Health and Human Services 40

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

Health Populi

DECEMBER 20, 2024

Kleinke, titled his book from 2001 Oxymorons , we have lacked system-ness in U.S. As my long-time friend and colleague in the field, J.D. health care for decades.

COVID-19 118

COVID-19 Health Insurance Medicare Medicare 118

Hall Render

JULY 14, 2023

Stephen Dolter, CMIO of Omaha’s Children’s Revised proposal for Lincoln senior living home satisfies planners, but not neighbors NEVADA Expanded hospital seeks to make dent in Southern Nevada’s mental health needs Doctor explains Southern Nevada medication shortage Nevada secures $285M opioid settlement with Walgreens Sen.

US Department of Health and Human Services 40

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

Drug & Device Law

FEBRUARY 11, 2024

Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6. 9 (“Longitudinal” for the proposition that “adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications”), at *14 n.22

FDA 59

FDA Fraud Pharmaceutical Industry Doctors 59

Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. By the time, however, the cases progressed to summary judgment, the plaintiffs were not claiming any defect in TDF.

FDA 105

FDA Doctors 105

Drug & Device Law

DECEMBER 4, 2023

2001). “[A] federal court in a diversity case should be reluctant to expand state common law.” Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. 341 (2001). 2001), aff’d , 358 F.3d Camden County Board of Chosen Freeholders v.

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

NOVEMBER 9, 2023

341 (2001)), calls “off-label use,” so we go with the majority naming convention. That’s a significant step forward, since it aligns the FDA’s view of permissible science more closely to what doctors (and Medicare) actually rely on in clinical situations. Plaintiffs Legal Committee , 531 U.S. T]he studies or analyses. . .

FDA 64

FDA Health Insurance Nurses Medicare 64

Drug & Device Law

OCTOBER 26, 2023

341 (2001) (a Bone Screw case). Plaintiffs point to no FDCA requirement that such information be included in an order for medicine to be delivered to the doctor who ordered it. Moreover, “it would be nonsensical to require directions for patient use for a drug that is injected into the patient by a doctor in a clinical setting.”

FDA 59

FDA Doctors 59

Drug & Device Law

SEPTEMBER 11, 2023

341 (2001), is so important. Even worse is standing based on the “considerable mental and emotional stress on emergency-room doctors,” purported injury from “divert[ing] time and resources away from their ordinary practice to treat [adverse reaction] patients, and even the possibility of increased malpractice insurance costs.

FDA 59

FDA Doctors Malpractice COVID-19 59

Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. Even worse is standing based on the “considerable mental and emotional stress on emergency-room doctors,” purported injury from “divert[ing] time and resources away from their ordinary practice to treat [adverse reaction] patients, and even the possibility of increased malpractice insurance costs.

FDA 52

FDA Doctors Malpractice COVID-19 52

Drug & Device Law

AUGUST 11, 2023

We’re not doctors, we just play them on TV.) 341 (2001), state tort claims are inappropriate vehicles for criticizing what the FDA considered in making a regulatory decision or the conclusion it reaches.) At least that was our take-away. Note: Don’t take medical advice from lawyers. Which brings us around to Novotney v.

FDA 52

FDA Fraud Doctors 52

Drug & Device Law

JULY 24, 2023

341 (2001). Without any consideration of what actual doctors did for actual patients with actual diseases, all that was proven was the maxim “garbage in, garbage out.” It is not clear that [defendants] will − or even can − avail themselves of a TPP-by-TPP causation defense using doctor-by-doctor testimony.

Fraud 52

Fraud FDA Doctors 52

Drug & Device Law

DECEMBER 9, 2022

And the court agreed, finding that “the undisputed facts reflected that [the doctor] testified she read the IFU, relied on the warnings provided by [the defendant], believed she had a comprehensive informed consent process, and would have passed on a warning about the risk of severe and chronic pain to patients. 2001), aff’d sub nom.

Doctors 64

Doctors Fraud Informed Consent 64

Drug & Device Law

AUGUST 22, 2022

She also tried to sue three new defendants – a doctor, a medical society and the FDA itself. 341 (2001). This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. Plaintiffs Legal Committee , 531 U.S. 2019 WL 6766574, at *3.

Informed Consent 59

Informed Consent FDA Doctors 59

Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.”

FDA 59

FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. 1978), where a hypertensive patient was injured after being injected with the defendant’s drug – despite warnings that “expressly directed the doctor administering the drug to refrain from giving it to a patient with hypertension.” 2001), aff’d , 358 F.3d

Doctors 59

Doctors Licensing Informed Consent Hospitals 59

Drug & Device Law

MARCH 31, 2022

2001) (“irrespective of the theory of recovery. . . Thus, the two sides of the Baltimore opinion remind us of the classic “ The Strange Case of Doctor Jekyll and Mister Hyde.” E.g. , Ford Motor Co. General Accident Insurance Co. , 2d 362, 370 (Md. The first part is rational, restrained, and full in accord with governing precedent.

Governance 52

Governance FDA Doctors Hospitals 52

Drug & Device Law

FEBRUARY 1, 2022

341 (2001) as impermissible attempts at private enforcement of the FDCA. The court did dismiss plaintiff’s breach of express warranty claim because plaintiff failed to allege that any of the “purported warranties” were made to her or her doctor and for lack of the required pre-suit notice. Plaintiffs’ Legal Comm. , The court agreed.

Fraud 59

Fraud FDA Doctors 59