MedTrainer

JANUARY 12, 2024

In this blog post, we’ll outline who regulates healthcare compliance, how rules are enforced, and why organizations need a robust compliance platform to stay in the good graces of regulators. Healthcare compliance is the process of following the laws, regulations, and ethical standards that govern the healthcare industry.

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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. At the time of writing this blog, the novel coronavirus is rampant in over 150 countries across the world. FDA policy issued on 29 February 2020 , provided the impetus to the MedTech industry which has risen to the occasion.

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Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] Medical Device Regulations. Healthcare Laws.

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MedTrainer

JUNE 4, 2024

Pharmacy compliance is adhering to laws, regulations, and professional standards governing pharmacy practice. Pharmacies are governed by federal agencies, including the Drug Enforcement Administration ( DEA ) and the Food and Drug Administration ( FDA ).

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Exeed Regulatory Compliance

MARCH 5, 2020

It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article. This is where FDA’s Emergency Use Authorization (EUA) comes into play and offers an opportunity for the medical industry to rally and help.

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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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Verisys

DECEMBER 1, 2022

A check of government exclusion lists is essential because many healthcare groups receive financing from federal sources. FDA Disbarment. Learn more about how Verisys can assist your HCOs in meeting all government and regulatory standards. FACIS Level 3 background screening of federal sources. SAM ( including SDN ). State Dept.

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Innovaare Compliance

MARCH 1, 2022

4] Multiple reasons accounted for the rising expenditures for MA beneficiaries which will be subject for a different blog. Examples of improper payments include: Unusual quantities or administration frequency of Part B drugs; Drugs for non-FDA approved indications (e.g., annually on average between 2021 and 2029 compared to 4.4%

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SQA

JUNE 10, 2021

Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. The Government of Canada’s number one priority is to protect the health of Canadians. FDA plant inspection and pay $50 million in fines and forfeiture.

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Healthcare Law Blog

FEBRUARY 1, 2022

In the attached article , we highlight some of the key legal considerations that the digital health industry can expect in the coming year from the perspective of: (1) telehealth related laws and regulations, (2) FDA, (3) privacy and cybersecurity, (4) fraud and abuse, and (5) antitrust issues.

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AIHC

JUNE 6, 2023

Due-diligence is necessary to ensure their system has been tested, is compliant to government and payer standards and is affordable moving forward as AI evolves and our system or contract service with the company advances. AI technology would empower these professionals. Beware of new companies offering such services.

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Verisys

NOVEMBER 30, 2022

OIG, SAM DEA, GSA, FDA. Learn more about how Verisys can assist your HCOs in meeting all government and regulatory standards. 5,600+ Total Sources. 2,500+ State Sources. FBI, PHS, ORI, DOJ, TRICARE. Medicare opt out. 94 District Courts. 52 AG Sources. 42 Heat Sources. 38 Medicaid Sanctions. 36 State Level Procurement.

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MedTrainer

JULY 13, 2023

Laws Are Behind the Technology Governing bodies are racing to keep up with the AI evolution, but very few have released policies to help guide compliance professionals. For example, when a human incorrectly codes an item, it happens one time.

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AIHC

JUNE 6, 2023

Due-diligence is necessary to ensure their system has been tested, is compliant to government and payer standards and is affordable moving forward as AI evolves and our system or contract service with the company advances. AI technology would empower these professionals. Beware of new companies offering such services.

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Verisys

NOVEMBER 14, 2023

A healthcare facility’s accountability and overall reputation are dependent upon rigorous credentialing processes compliant with governing regulatory bodies, such as the National Committee for Quality Assurance. It is critical for hospitals and health systems to know that everyone on the staff is compliant and in good standing at all times.

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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).

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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. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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Healthcare Law Blog

MARCH 17, 2022

The three-component Therapy includes the following: (1) a device to process patient bone marrow (after an extraction procedure); (2) a device to re-inject processed bone marrow into cardiac tissue; and (3) an FDA-approved guide catheter to facilitate placement of processed bone marrow into cardiac issue.

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Healthcare Law Blog

AUGUST 3, 2022

is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. The FDA even required warnings on the probes’ packaging, “restricted for single person use only,” and “[d]o not re-use.”.

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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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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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Healthcare Law Blog

DECEMBER 11, 2023

Of particular note is a newly unveiled framework for deciding whether the Government may exercise “march-in” rights and take a pharmaceutical company’s drug patents developed with federal funds and share them with other companies.

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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

JULY 8, 2022

It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products. The guide emphasizes the effect that cryopreservation and recovery may have on cell viability and cell function.

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Healthcare IT News - Telehealth

JANUARY 13, 2021

"The FDA’s policy imposes an unnecessary, unjustifiable, irrational, and undue burden on women seeking an abortion during the current pandemic," Sotomayor argued. In July, Judge Theodore Chuang blocked the FDA in-person requirements during the COVID-19 crisis. WHY IT MATTERS. THE LARGER TREND. ON THE RECORD.

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

SQA

FEBRUARY 26, 2024

This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies. PCPC provided feedback to the FDA on the development of an efficient electronic submission program (Cosmetics Direct) and recognizes that the FDA’s development of Cosmetics Direct is ongoing.

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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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Healthcare Law Blog

APRIL 14, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Following the U.S.

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Health Law Advisor

JULY 21, 2023

Food and Drug Administration (FDA) as breakthrough devices. [1] 5] However, devices in earlier stages of the FDA approval process often lack the clinical evidence needed to satisfy the “reasonable and necessary” criteria to justify CMS’s establishment of a national coverage standard.

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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. A section of the bill that would have provided $15.6

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Healthcare Law Blog

JUNE 15, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. May 17, 2023 : The Fifth Circuit heard oral arguments from the FDA, Danco, and the Plaintiffs. Had the U.S.

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Drug & Device Law

MARCH 3, 2022

have dockets heavy on administrative cases and other cases involving the functioning of the federal government and light on product liability cases. As we said above, we know this case outside of the Blog, so we will not comment on every aspect of the decision. Part of that may be that the D.D.C. Even the D.C. 3d at 167-73.

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Drug & Device Law

DECEMBER 12, 2022

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. 300aa-10, et seq. The damages alleged in the complaint were “physical and emotional injury” purportedly by “a defective immunity to pertussis” and “receiving a painful injection. . . 300aa-11(a)(2)(a).

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Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). 2370 (2022), which the Blog recently wrote about here. A little background is in order. ATTR-CM only affects about 150,000 Americans, who are mostly elderly.

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Drug & Device Law

DECEMBER 27, 2022

What follows is from the non-Dechert side of the Blog. Filing a citizen’s petition, Valisure shocked the FDA into an ill-advised recall by reporting that “tests found NDMA in ranitidine in excess of 3,000,000 ng [nanograms] per pill” – far above FDA’s 96 ng/day “daily limit.” 3d 1152 (S.D. 2022 WL 17480906, at *1.

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