Hall Render

MAY 20, 2022

AHA asks HHS to continue the public health emergency until conditions stabilize. Considerations for Social Determinants of Health Screening Design. COVID-19 public health emergency set to be extended. Covid-19 remains a public health emergency in US, administration says. Arkansas Gets $3.9M

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C&M Health Law

FEBRUARY 1, 2022

Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. On January 31, 2022, the U.S.

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SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The document will become effective 6 months after publication (10 September 2023).

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SQA

DECEMBER 16, 2022

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. The adoption of the PIC/S Guide to GMP (PE009-15, 01 May 2021) commenced on 01 July 2022 from which point, GMP inspectors will use the new Guide to GMP during inspections.

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SQA

SEPTEMBER 2, 2022

As became the case in May 2021, when the European Medical Devices Regulation (MDR) came online without an updated MRA between the EU and Switzerland, Swiss manufacturers of IVDs are now treated as any other “third country” manufacturers seeking CE Marking to sell their devices in the EU.

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Healthcare Law Blog

OCTOBER 25, 2023

Effective January 1, 2022, an individual in Oregon who acts as a pharmaceutical representative for more than 15 days during the calendar year must have, and renew annually, a license from the Department of Consumer and Business Services (“DCBS”). ix] Nevada.

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SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. According to the public notice, the Center for Drug Evaluation implemented internal changes in January 2021 that have been evaluated and are now being published in draft form for public comment.

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Hall Render

MARCH 31, 2023

County-owned buildings facing potential earthquake risk Gilead drops option to buy cancer therapeutics company Health and Life Organization Inc. What happens if it disappears? buys industrial property in Rancho Cordova for $5.12

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Hall Render

APRIL 15, 2022

FDA clarifies cybersecurity recommendations for device makers in new guidance. HHS reveals strategy on social determinants of health. HHS extends COVID-19 public health emergency for another 90 days. Prices are soaring — but not for health care. Social Determinants of Health Worsened Specialty Care Access.

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Hall Render

FEBRUARY 18, 2022

Lawmakers call on Biden to end public health emergency. License wait times reach crisis levels for healthcare workers. Meet new FDA chief Dr. Robert Califf: 5 things to know. from California health firm. Kaiser sees net income top $8B in 2021, operating income fall sharply. of Public Health website.

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Hall Render

MARCH 25, 2022

FDA to revive facility visits. Dr. Lorna Breen Health Care Provider Protection Act becomes law. Here are the top health systems by patient reviews. Moderna wants the FDA to authorize its COVID-19 vaccine for kids under 6. Sensitive health data of 50 million Americans hacked or breached last year: analysis.

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AIHC

FEBRUARY 2, 2022

Effective for dates of service on or after July 1, 2021: Dental providers should no longer submit claims with codes D1701–D1704 or D1707. COVID-19) for discharges occurring on or after April 1, 2020, through the duration of the COVID-19 public health emergency period. • as the primary diagnosis and B97.29

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Hall Render

SEPTEMBER 15, 2023

million in 2021, more than the hospital spent on charity care in three years Could telehealth be the solution for the nursing shortage in hospitals? Jefferson Health thinks so Financially struggling rural Pa. hospital creates GoFundMe page with $1.5M

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

SQA

OCTOBER 18, 2022

Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada.

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

Hall Render

APRIL 26, 2024

Vincent discord reignites after hospital revokes doctors’ privileges New Mexicans to Know: Army veteran Nancy Parson brings passion for health care to Las Cruces Army veteran Nancy Parson brings passion for health care to Las Cruces Missed deadlines lead to $11.5M

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Hall Render

OCTOBER 27, 2023

leads in life expectancy Utah nonprofit pharmaceutical company is fixing the market, producing 80 drugs VERMONT Vermont hospital training staff to be nurses Mental health urgent care takes root in Vermont The state’s health care regulator looks for input in ‘hospital transformation’ process Vt.

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Healthcare Law Blog

AUGUST 25, 2022

Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. Negotiation-Eligible Drugs.

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Hall Render

APRIL 14, 2023

NATIONAL 94% of Organizations Experienced a Cyberattack in 2022 AHA blog: Strengthening crisis management in rural health care Biden signs bill ending Covid-19 national emergency Cancer drug shortages are creating dire circumstances for some patients CMS Releases FY24 IPPS Proposed Rule, Seeks to Boost Rates by 2.8%

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

SQA

FEBRUARY 26, 2024

European Commission (EC) New Measures to Fight Organized Crime and Drug Trafficking, 18 October 2023 In 2021 alone, 303 tons of cocaine were seized in the EU. PCPC will continue to offer feedback to the FDA on the agency’s implementation of MoCRA and is encouraging member companies to prepare for registration and listing.

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Hall Render

NOVEMBER 17, 2023

to expand behavioral health services Michigan teaching hospital to bring in consultants amid debt covenant breach Trinity Health to grow West Michigan orthopedic practice after settling federal lawsuit Healthcare giant McLaren reveals data on 2.2 Supreme Court won’t hear COVID vaccine case filed by N.J.

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Hall Render

JANUARY 7, 2022

FDA expands use of Pfizer vaccine, green-lights boosters for children 12-15. Fitch Ratings: Kronos ransomware attack harms healthcare public finance sector. Health systems eye outpatient sector as hospital M&A continues to slump. Inflation jump took a bite out of 2021 physician compensation. Georgia Dept.

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Hall Render

JANUARY 21, 2022

CVS, Uber partner on health equity initiative. Fauci says FDA could authorize Pfizer’s Covid vaccine for kids under 5 in the next month. Nursing home industry reacts to health care worker vaccine mandate. Ransomware: 2,300+ local governments, schools, healthcare providers impacted in 2021. Louisiana reports first C.

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Hall Render

APRIL 21, 2023

into cutting opioids in hospitals ISU and University of Utah partnership aims to combat Idaho’s mental health crisis Presbyterian-UnityPoint merger moves forward St. into cutting opioids in hospitals ISU and University of Utah partnership aims to combat Idaho’s mental health crisis Presbyterian-UnityPoint merger moves forward St.

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

Hall Render

SEPTEMBER 29, 2023

of Iowa Health Care North Liberty campus Ex-nurse at Sioux City nursing home tied to deaths says she was ordered to falsify records Mercy, St. s health care industry leaders focus on job development COVID levels in RI dipped during the summer. Margaret’s CEO blames $7.3 Luke’s panel explores Pa.’s out of 5 NCQA rating R.I.’s

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

Hall Render

MARCH 11, 2022

FDA final guidance presses industry to be ‘recall ready’ Final vaccine mandate deadlines still in play, despite removal vote. How Nonprofit Hospitals, Health Systems Compensate Executives. Encompass Health’s home health unit attracts acquisition interest-sources. Florida health system CEO resigns.

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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. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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Drug & Device Law

FEBRUARY 29, 2024

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not. What could be better than preemption?

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Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

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