Exeed Regulatory Compliance

OCTOBER 26, 2020

A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. COVID-19 continues to cause damage to both the public health and the economy at large. FDA is requiring additional post-market studies. CONTACT US.

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Exeed Regulatory Compliance

JULY 20, 2020

Antibody tests are a powerful tool to help fight COVID-19. The COVID-19 pandemic has hit us hard. When someone has COVID-19, their immune system responds with antibodies to fight the SARS-CoV-2 Coronavirus that causes this disease. Here is a quick overview of how they work and their accuracy.

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Medisys Compliance

APRIL 20, 2022

Billing and coding guidelines for various medical specialities are constantly getting updated due different COVID-19 variants. In fact, concerned authority extended the current COVID-19 pandemic telehealth waivers for five months beyond the end of the public health emergency. Shop & Stop, Walgreens and Walmart.

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Exeed Regulatory Compliance

OCTOBER 19, 2020

A “cocktail” of two potent monoclonal antibodies from Regeneron could be a breakthrough early intervention for COVID-19. COVID-19 has already claimed more than 220,000 lives, and as new cases continue to rise each day, there is fresh concern about many more lives at risk in the coming weeks. CONTACT US.

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Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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HIT Consultant

APRIL 1, 2024

John Auerbach, SVP Federal Health, ICF Given the attention paid to the devastating impact of COVID-19, one might assume it was the leading cause of death in the US. million Americans died of COVID in the last 4 years – heart disease remains the largest cause of death and by a landslide.

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Exeed Regulatory Compliance

MARCH 22, 2020

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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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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Bill of Health

JANUARY 19, 2022

COVID-19 antivirals must not affect HIV drug supply. Factors Associated with Compliance to the Hospital Price Transparency Final Rule: a National Landscape Study. A full posting of abstracts/summaries of these articles may be found on our? Barber M, Sarpatwari A, Cepuch C. Lancet HIV. 2021 Dec 8. Epub ahead of print.

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YouCompli

MARCH 29, 2023

CMS Updates to beneficiary PHE waivers that matter to healthcare compliance Sharon Parsley, JD, MBA, CHC, CHRC, contributes regularly to the YouCompli blog. In this article, she discusses several issues that hospitals and health systems need to consider as a result of the scheduled end of the COVID-19 public health emergency.

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Healthcare IT News - Telehealth

MAY 7, 2021

might be finally turning a corner in the COVID-19 pandemic. Overall, the COVID-19 pandemic has catapulted the importance of data analytics and data in general, said Lupu of Sanford Health. The director of the Centers for Disease Control and Prevention said recently that the U.S. " Dr. Roxana Lupu, Sanford Health.

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Health Care Law Brief

JUNE 2, 2022

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. For the reasons discussed below, DTC telehealth platforms should re-visit their compliance plans and be prepared for increased state and federal regulatory scrutiny.

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HIT Consultant

MARCH 7, 2022

January 2022 marked two years since the outbreak of COVID-19, with the healthcare system still working to adjust to a very challenging new reality. Similar to 2020, there were increases in demand in 2021 for infusion pumps to treat COVID-19 patients. Roger Massengale, Chief Commercial Officer, Eitan Medical.

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MedTrainer

OCTOBER 27, 2020

Keys to managing point-of-care testing compliance. On August 31, HHS released its guidance for PREP Act coverage for COVID-19 screening tests at nursing homes, which removed the states’ rights to limit antigen prescribing and testing for asymptomatic individuals. He serves on the MedTrainer Education and Development Board.

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MedTrainer

OCTOBER 27, 2020

Keys to managing Point-of-Care Testing Compliance. On August 31, HHS released its guidance for PREP Act coverage for COVID-19 screening tests at nursing homes, which removed the states’ rights to limit antigen prescribing and testing for asymptomatic individuals. He serves on the MedTrainer Education and Development Board.

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HIT Consultant

JANUARY 21, 2022

. – The Series B funding will allow Casana to accelerate FDA submission of the Heart Seat with the goal to obtain FDA approval and bring this important new device to patients in 2022. The biggest challenge for most home health monitoring devices is poor patient compliance. Novel Effortless Home Health Monitoring.

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Hall Render

JANUARY 11, 2023

The Tool is a result of collaborative efforts between the FTC, HHS Office for Civil Rights (“OCR”), HHS Office of the National Coordinator for Health Information Technology (“ONC”) and the Food and Drug Administration (“FDA”). Regulatory Landscape.

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HIT Consultant

AUGUST 18, 2021

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA. The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools. Here’s a look at what we’ve learned from COVID-19 era regulatory practices in clinical development.

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MedTrainer

FEBRUARY 19, 2024

Example: Needlestick injuries or accidental exposure to airborne diseases, like COVID-19 or tuberculosis. Why Incident Reporting is Essential Incident reporting is essential to maintain a healthcare organization’s compliance with state and federal regulations. Sentinel events: Result in severe or permanent harm or death.

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SQA

MARCH 25, 2021

COVID-19 Pandemic Triggers Development of New Standard for Ventilators, 12 January 2021. When the COVID-19 pandemic took hold, so too did the demand for ventilators. The approaches are intended to add value, support good business practices, and meet current compliance and regulatory expectations.

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Compliance Now

JANUARY 20, 2022

In the same recent FAQs requiring health plans to pay for the cost of over-the-counter COVID-19 testing, the DOL also provided additional guidance on this rule as it relates to colorectal cancer screening and contraceptive coverage. Colorectal Cancer Screening. Contraceptives.

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HIT Consultant

OCTOBER 21, 2022

US hospital systems validate the safety, clinical utility, and robustness of newly FDA-approved devices, 510(k) cleared, before adopting them into clinical practice. Every six months, CMS puts out a compliance score for each hospital. Rolland Carlson, CEO of Immunexpress. They are asking: how do we standardize? The answer is two-part.

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Exeed Regulatory Compliance

JULY 31, 2020

How Emergency Use Authorization of Medical Products Helps Provide Relief During a COVID-19 Major Crisis. The current COVID-19 global pandemic continues to remain out of control. Examples include the current COVID-19 pandemic, an act of bioterrorism, military conflicts, nuclear accidents or an environmental disaster.

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Bill of Health

OCTOBER 27, 2022

Tandon , a religious rights case unrelated to vaccines, arose in March 2020 during the start of the COVID-19 pandemic in the U.S., Such an approach is not supported by the law and will lead to dangerous consequences for a nation facing outbreaks of polio and monkeypox, alongside the ongoing threat of COVID-19.

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SQA

JUNE 10, 2021

Due to the COVID-19 pandemic, there was an increase of 39.2% Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. FDA plant inspection and pay $50 million in fines and forfeiture. on regulations published by ANVISA.

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HIT Consultant

AUGUST 24, 2022

These include a curated leading genomics database for pathogens to better enable pathogen detection and characterization, a sequencing-based assay to detect SARS-CoV-2 genetic variants, which recently received expanded FDA EUA , and clinical-grade metagenomics assays.

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Dot Compliance

FEBRUARY 3, 2022

Food and Drug Administration’s (FDA) goals for the industry. The FDA too is requiring medical device manufacturers to provide greater visibility into their supply chain operations so the industry can better predict supply shortage risks and take action to mitigate them.

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Hall Render

SEPTEMBER 1, 2023

operating margin, $1B net gain halfway through its first year Illinois public health officials warn of “rising COVID-19 activity” St. ALABAMA American Family Care opens new health care center in Northeast Birmingham doctors secure $13.9M

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HIT Consultant

NOVEMBER 17, 2021

As with countless global industries, clinical trials were forced to move key functions online as COVID-19 swept the world in early 2020. Further underscoring this trend, 93% of sites also reported that they would allow sponsors or CROs to conduct remote monitoring, compared to 74% pre-COVID. Improving Protocol Compliance.

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Healthcare IT News - Telehealth

DECEMBER 16, 2020

The insights also can help healthcare organizations navigate vaccine distribution, as well as the ebbs and flows of patient volumes due to COVID-19 in the year ahead, according to the new report. ” The FDA is hinting that some of these changes could be here to stay. Healthcare right-sizes after the telemedicine explosion.

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Dot Compliance

JANUARY 4, 2022

The COVID-19 pandemic accelerated the development and adoption of medical solutions that allow clinicians to diagnose and treat patients remotely. For manufacturers the challenges of developing connected devices range from connectivity to regulatory compliance, but perhaps most important is cybersecurity. While only 43% of U.S.

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HIT Consultant

APRIL 4, 2023

In Q1 2023, an acronym soup of federal agencies (FDA, CMS, DEA, FTC) announced preliminary steps and timelines for refining policies across digital health. Top of mind is the announcement to end the COVID-19 public health emergency (PHE), which is slated to expire on May 11, 2023.

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HIT Consultant

MAY 9, 2022

In 2020, as healthcare organizations have transitioned some employees to remote work and expanded virtual care offerings to help keep patients and providers safe amid the COVID-19 pandemic, the benefits of reducing paper-based processes in favor of digital ones have perhaps never been clearer.

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Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview. I distribute products under an EUA, what do I do now?

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Healthcare Law Today

NOVEMBER 9, 2022

Prior to the federal COVID-19 Public Health Emergency (PHE), to initiate treatment with buprenorphine at an OTP, a practitioner needed to perform a complete in-person physical evaluation. The covered benefit includes MAT for patients with OUD, a leading treatment modality that combines prescribing FDA-approved medication (e.g.,

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Health Law Advisor

MARCH 7, 2023

Telemedicine Prescribing During the COVID-19 PHE During the COVID-19 PHE, among many other regulatory flexibilities, federal and state prescribing requirements were relaxed. This deadline came and went, also without meaningful action taken by DEA. Are the proposed record-keeping obligations reasonable and/or sufficient?

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Exeed Regulatory Compliance

MARCH 5, 2020

A novel coronavirus, now called SARS-CoV-19, was first detected in the Hubei province of China in early December 2019. There is now an FDA policy released on 29 Feb. An EUA issued before an emergency could permit use of an MCM during an emergency without the need for further authorization by FDA.

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