Healthcare Law Today

JANUARY 11, 2023

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

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Hall Render

FEBRUARY 7, 2023

Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”).

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HIT Consultant

APRIL 1, 2024

However, a combination of efforts, including widespread collaboration between healthcare providers and payers to set specific heart disease-related clinical guidelines for appropriate care; the ability to provide feedback on compliance with those guidelines; and financial incentives for clinicians to comply helped lead the way.

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Bill of Health

OCTOBER 27, 2022

Newsom a legal principle that threatens to upend over a century of legal precedent recognizing the authority of state governments to ensure public health by mandating vaccines. The former actually further a state’s interest in promoting public health, unlike religious exemptions, which subvert this goal.

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C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

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SQA

FEBRUARY 26, 2024

After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

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AIHC

JUNE 14, 2023

Artificial Intelligence & Regulatory Compliance Written by Joanne Byron , BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS This article follows Part 1 - Basics of Artificial Intelligence (AI) and Healthcare Compliance published by AIHC on June 6, 2023.

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Healthcare IT Today

AUGUST 28, 2023

Mimi Winsberg, Co-Founder and Chief Medical Officer at Brightside Health We have been in an uncertain time for regulation around telemedicine, and there are a few key trends to watch. As a physician who is invested in complying with current regulations, I welcome clear regulatory guidelines from both the FDA and the DEA on these matters.

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HIT Consultant

APRIL 4, 2023

Regulatory Developments and Adapting Digital Health Startups If circumstances weren’t treacherous enough, digital health startups are bracing for impending regulatory changes. In Q1 2023, an acronym soup of federal agencies (FDA, CMS, DEA, FTC) announced preliminary steps and timelines for refining policies across digital health.

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Exeed Regulatory Compliance

MARCH 5, 2020

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

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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.). Counterfeit health products are imitations of authentic products. Health Advance Inc.

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

SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

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SQA

AUGUST 2, 2021

Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the United States Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in United States pharmaceutical supply chains. b) and 320.31(d)(3)).

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AIHC

AUGUST 2, 2022

Written by: AIHC Blogger This educational article is based on clinical information as of the publication date and primarily based on government and coding guidelines to assist coders, billers, clinical documentation improvement professionals and auditors address appropriate documentation for filing claims in the United States.

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SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. As a result, the patient received 2.5

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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. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

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Healthcare IT News - Telehealth

DECEMBER 16, 2020

“Regulators, for their part, have tried to smooth the way for a pivot to virtual during the public health emergency. ” The FDA is hinting that some of these changes could be here to stay. " “Some private insurers stepped in to help, too,” they added.

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Health Law Advisor

MARCH 7, 2023

Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications? DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications.

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HIPAA Journal

APRIL 5, 2023

To the HHS’ Office for Civil Rights in response to a patient complaint or compliance audit. To authorized public health authorities to prevent or control disease, injury, or disability. To authorized public health authorities to prevent or control disease, injury, or disability.

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Health Law Advisor

MARCH 1, 2023

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing. [1]

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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. in 2022, survey finds Senate votes to end COVID-19 national emergency Why are 600+ rural hospitals at risk of closing? buys industrial property in Rancho Cordova for $5.12

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

Hall Render

MAY 19, 2023

Supplemental Grant for Rural Health Programs UAMS to Study Affordable Care Act’s Impact on Breast Cancer Treatment Arkansas Children’s Hospital Auxiliary Donates $1.4 Supplemental Grant for Rural Health Programs UAMS to Study Affordable Care Act’s Impact on Breast Cancer Treatment Arkansas Children’s Hospital Auxiliary Donates $1.4

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Hall Render

SEPTEMBER 29, 2023

million patients Senate committee advances bill cutting hospital facility fees What Joint Commission, NQF’s affiliation means for hospitals Which health systems teamed up with Amazon, Google + Microsoft ALABAMA Alabama gets $3.6M in Stark law self disclosures: 3 things to know CMS’ staffing proposal will cost nursing homes $6.8B

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

Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. Where Hospital Price Transparency Compliance Is Lagging. FDA finalizes two guidances on including patient perspectives in medtech clinical trials. State health officer discusses Alabama’s COVID-19 peak. Here’s what’s on tap.

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Hall Render

MARCH 8, 2024

Penn Medicine to build cancer center in $400M project Pennsylvania hospital to pay $12K in overtime dispute Philadelphia health nonprofit lands $48.3M

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Healthcare IT Today

NOVEMBER 8, 2023

Many clinical data records can be exchanged between providers and regional public health agencies through health information exchanges. Moving beyond health system-wide or regional interoperability has been a challenge due to several financial and operational hurdles.

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Hall Render

MARCH 22, 2024

Banner Health to expand clinical AI to 33 hospitals, 6 states Banner reports $282.8M Nevada Medicaid must cover abortion services, judge rules Clark County health rankings improve, but physicians per capita still well below U.S. family sues hospital over life-altering injuries Calif.

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Hall Render

MARCH 3, 2023

million for youth mental health care KENTUCKY Pike County nursing home officials release statement following loss of Medicare agreement Three Humana executives drop $11.2M

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Drug & Device Law

DECEMBER 29, 2023

Executive Health Resources, Inc. , 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. At bottom, plaintiffs were improperly seeking to have courts second-guess the FDA’s methods and conclusions.

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