Healthcare Law Today

FEBRUARY 1, 2022

Improves clinical trials by requiring the Food and Drug Administration (FDA) to issue guidance on the use of digital health technologies in clinical trials; decentralized clinical trials; and other innovative designs to support development of new drugs. Senators Murray and Burr expect the legislation to progress this year.

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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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Exeed Regulatory Compliance

MARCH 21, 2020

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. Testing is critical to identify infected individuals, isolate them and contact trace other potentially infected individuals. More than 250,000 cases of infection and over 10,000 deaths have been reported.

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Compliance Now

AUGUST 1, 2022

Other types of contraceptive services or products approved by the FDA must also be covered, even if they do not fall into one of the categories listed above. Entities wishing to take advantage of these opportunities are permitted to self-certify or notify the government of their eligibility.

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Pharmacy Law Blog

MARCH 13, 2018

The federal judge refused the dismissal on the grounds that the government had sufficiently backed its allegations against both the company and its owner. The government had also adequately backed its allegations that RS knew it had been overpaid but had made no attempt to refund the difference to Tricare, according to the judge.

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Healthcare IT News - Telehealth

FEBRUARY 5, 2024

It does not require physical contact between caregiver and patient (though seeing a patient's affect in person can be better than via video). One of the great use cases for telemedicine has proven to be mental health. Rarely does mental health require in-person tests. Taking vitals is not necessary.

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Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases. -FDA

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Innovaare Compliance

MARCH 1, 2022

Examples of improper payments include: Unusual quantities or administration frequency of Part B drugs; Drugs for non-FDA approved indications (e.g., Contact us today to explore how we may be able to support your needs, improve your bottom line and your healthcare organization’s compliance processes.

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Bill of Health

NOVEMBER 15, 2023

drug policy using a whole-of-government (W-G) approach to assess where these misalignments are occurring among different agencies at the same level of government (referred to as horizontal W-G), and across different levels of government (referred to as vertical W-G). Code § 1701 et seq.

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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. 1301.28.

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The Digital Health Corner

JUNE 14, 2017

According to a study in the American Journal of Emergency Medicine ER physicians spend only 28% of their time in direct face to face patient contact and can go through 4000 computer mouse clicks in one shift. Relevant clinical patient management data workflow was not a priority and remains a major pain point for clinicians today.

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Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Contact an EBG attorney for more information on how to stay compliant. [1] Utah Code § 58-83-306.

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SQA

MAY 24, 2023

Having analyzed over 2000 responses received, the government will now take forward legislation to reform of the UK clinical trials regulatory framework that will: Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.

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Healthcare IT Today

APRIL 23, 2023

Believe it or not, that figure placed healthcare fifth among all industries, behind education, finance, insurance, and government. Communications provider Windstream Enterprises announced Contact Center as a Service functionality powered by Talkdesk. Noyo achieved SOC 2 Type II compliance for its benefits data management platform.

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Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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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. United States FDA – Guidances for Devices.

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Health Law Advisor

APRIL 5, 2022

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). I use the word “may” there because the FDA data set is inadequate to support a firm conclusion. of that guidance, and FDA refers to these as “concurrent.”

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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, 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.

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Health Law Gurus

JULY 7, 2020

Towards that end, the United States government and federal agencies are collaborating with private biopharmaceutical companies to accelerate the vaccine development. The FDA provides rapid interactive input to developers/scientists on how best to advance their studies to clinical development (i.e.,

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SQA

FEBRUARY 26, 2024

This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies. Anyone feeling unwell, for example with symptoms of eye infection, such as reduced vision or red and painful eyes, should contact a healthcare professional and tell them that they have been using a recalled eye gel.

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Healthcare IT Today

FEBRUARY 28, 2023

For missing demographic information, the state, through a partnership, contacted the labs and made sure they captured the desired data. The FDA has left a lot of clinical decision support free from regulation, but I have a feeling that Lane’s bold system would require FDA approval.

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Hall Render

JUNE 3, 2022

Colorado hospital first to implant FDA approved stent. Monkeypox vaccine offered to close contacts of patient at Massachusetts General Hospital. Most Oregon hospitals owe federal government for early pandemic loans. Bakersfield Rehabilitation Hospital Opens in Bakersfield, California. is different. Longtime spokeswoman for Mass.

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Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. FDA finalizes two guidances on including patient perspectives in medtech clinical trials. Florida health officials face hurdles with limited supply of monoclonal antibody from government. Omicron amplifies hospital staffing shortages, contact tracing challenges.

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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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Hall Render

MARCH 16, 2022

2471 ) that funds the federal government for the remainder of FY 2022. The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. Your primary Hall Render contact.

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Hall Render

MARCH 11, 2022

FDA final guidance presses industry to be ‘recall ready’ Final vaccine mandate deadlines still in play, despite removal vote. Kansas panel backs bill to limit government officials’ authority over masking, religion. Boston hospitals lead effort to recoup debt from Kuwaiti government. Double dipping scheme.’

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Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

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Drug & Device Law

MARCH 30, 2023

About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. The side it picked was against public health and the authority of FDA, which is charged by Congress with protecting public health.

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Drug & Device Law

JUNE 27, 2023

23, 2023), because if you substitute FDA for FAA in this case it is precedent for precluding personal jurisdiction over FDA consultants and others who assist manufacturers in obtaining approval of prescription medical products. As far as the terms of the contract, they are governed by New York law.

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Drug & Device Law

JUNE 15, 2022

It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on this Blog. Subsection (a) shall not be construed to affect the authority of a State, Tribal, or local government—. “(1) b) Exceptions.—Subsection b) Exceptions.—Subsection

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Drug & Device Law

MARCH 19, 2024

Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Therefore, plaintiff’s claims could not possible “arise out of or relate to” that defendant’s contacts with Rhode Island. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements.

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