Hall Render

AUGUST 10, 2023

New Medical Technologies Beginning in 2025, CMS will require add-on payment applicants to have completed an FDA marketing request and provide documentation of such filing and FDA acceptance of the application by May 1 (rather than the current July 1 deadline) of the year prior to the beginning of the FY in which CMS is considering the application.

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Healthcare IT News - Telehealth

AUGUST 19, 2020

AccessHealth’s licensed chemical dependency counselors are integrated within the medical adult clinics. In 2019, AccessHealth was able to reach a compliance rate of 71% by integrating multidisciplinary departments with medical concerns, such as mental health, nutrition, care coordination and social determinants of health.

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SQA

FEBRUARY 15, 2023

China’s drug MAH system has been implemented nationwide since the revised Drug Administration Law came into force in 2019. 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.

US Department of Health and Human Services 40

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

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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FDA Licensing Public Health 52

Hall Render

APRIL 19, 2024

to Study Treatments for Vascular Abnormalities Federal Appeals Court Hears Arguments on Nation’s First Ban on Gender-affirming Care for Minors Jason Demke Hired as COO at Mercy Hospital Fort Smit Pulaski Tech Awarded $5.7M

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SQA

MAY 17, 2022

The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements. United States Food and Drug Administration (FDA) – Regulations and Guidances. United States Food and Drug Administration (FDA) – Recalls.

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SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

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FDA Licensing Governance Compliance 40

SQA

SEPTEMBER 2, 2022

Compared to the 2016 revised version, the draft of the 2022 version includes 101 more articles to conform to the pharmaceutical policy reforms in the recent years and the Drug Administration Law revised in 2019. 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 US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections.

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FDA Compliance Licensing World Health 40

Healthcare IT Today

APRIL 18, 2023

In the words of Guillem Masferrer, Partner at Asabys leading this transaction, “We are very proud to see the evolution of Amelia Virtual Care since our investment in 2019 to become the leading global VR platform serving mental health professionals. Sanfeliu, Managing Partner at Asabys.

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Licensing FDA Hospitals Compliance 59

Healthcare IT News - Telehealth

MAY 6, 2020

It also equips providers with Eko’s FDA-cleared AI to assist in remote screening for AFib, heart murmurs, tachycardia and bradycardia. In addition, the company is awaiting FDA approval for an onboard ECG feature for spot detection of atrial fibrillation. iRhythm Technologies.

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COVID-19 FDA Hospitals Elder Care 200

Hall Render

MARCH 31, 2023

What happens if it disappears? Cooper signs bipartisan Medicaid expansion into law Greensboro medical office building sold for $1.65

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

HIT Consultant

SEPTEMBER 27, 2023

Industry leaders, IEEE SA members, and the FDA are all working together to create accuracy standards for this innovative technology. Once cleared by the FDA, these medical devices will be Class 2 software as medical device technology. 6 August 2019/[link] 119.008857 Deye Yang, Guomin Xiao, Jing Wei, Hong Luo. DOI: 10.1097/MBP.0000000000000467

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US Department of Health and Human Services FDA Licensing 115

SQA

FEBRUARY 26, 2024

This guidance does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are described in other guidelines ( MDCG 2020-1 on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software; MDCG 2019-16 on Cybersecurity for medical devices).

FDA 52

FDA Compliance COVID-19 Public Health 52

Hall Render

MAY 12, 2023

Cloud Hospital names Chief Quality Officer Tampa’s Lions Eye Institute adopts new name Troubled Cano Health records $60.6M

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

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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Drug & Device Law

MARCH 7, 2022

These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., It does not give him license to evade the less rigid ? It does not, however, give a plaintiff “license to evade the less rigid ? the threshold for permitting punitive damages. Medtronic, Inc. , 2, 2020). “In

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir. 472 (2013). (See

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Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 3d 639, 645 (7th Cir.

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FDA Licensing Compliance 59

Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” See 42 U.S.C. § See 21 C.F.R. 2022 WL 4305656, at *8.

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