Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

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AIHC

JUNE 6, 2023

AI Use in Healthcare Research & Quality As posted in the American Institute of Healthcare Compliance (AIHC) June monthly newsletter, the Agency for Healthcare Research & Quality (AHRQ) grantee is testing AI for use to improve breast cancer screening accuracy and efficiency.

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Innovaare Compliance

OCTOBER 6, 2022

Adult vaccine recommended by ACIP is a covered Part D drug when licensed by the US Food and Drug Administration (FDA) under the Public Health Service Act for use by adult populations and administered in accordance with recommendations of ACIP. or Contact Us. appeared first on Inovaare.

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Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. As a result, FDA has now established additional requirements for authorization of Respirators made in China.

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Healthcare Law Today

JANUARY 11, 2023

Food and Drug Administration (FDA) prior to distribution. As part of a deferred prosecution agreement, which must be approved by the court, Jet Medical admitted that it distributed misbranded devices and agreed to implement enhanced compliance measures. and Martech Medical Products Inc., Pre-submission Meetings.

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HealthIT Answers

DECEMBER 6, 2022

Food and Drug Administration is critical to protecting and promoting public health. The products the FDA regulates are in every supermarket, pharmacy, and home across the U.S. Cybersecurity touches every facet of the FDA’s broad, complex responsibility. By Vid Desai & Craig Taylor - The U.S.

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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. Donna M.

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MedTrainer

OCTOBER 27, 2020

Keys to managing point-of-care testing compliance. In an effort to combat the spread of the virus and to help nursing homes protect the health and safety of their residents, the U.S. Department of Health and Human Services is distributing SARS-CoV-2 antigen diagnostic tests to more than 14,000 facilities. Read the full article.

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MedTrainer

OCTOBER 27, 2020

Keys to managing Point-of-Care Testing Compliance. Keys to managing point-of-care testing complianceIn an effort to combat the spread of the virus and to help nursing homes protect the health and safety of their residents, the U.S. Non-compliance is costly, with penalties in excess of $400 per day, or over $8,000 for each instance.

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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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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. The post Part 2: Who Regulates Healthcare AI?

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Healthcare IT Today

NOVEMBER 12, 2023

News The 2024 Medicare Physician Fee Schedule continues many telehealth flexibilities first adopted during the public health emergency, such as an expanded scope of originating sites an expanded definition of qualified practitioners. RapidAI received FDA clearance for Rapid SDH , which helps to detect bleeding in the brain.

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SQA

MARCH 25, 2021

The approaches are intended to add value, support good business practices, and meet current compliance and regulatory expectations. United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Pharmaceutical Inspection Co-Operation Scheme (PIC/S).

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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

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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Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key medical devices such as in vitro diagnostic tests, personal protective equipment, and ventilators.

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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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Exeed Regulatory Compliance

JULY 31, 2020

It is a public health emergency of massive scale that has affected nearly all aspects of our life. In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease.

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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

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. There is some good news on the horizon. CONTACT US.

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HIT Consultant

MAY 9, 2022

The legislation mandated healthcare providers to modernize their internal recordkeeping, allowing for the swifter dissemination of medical information to support public health efforts and better medical care. PDF security features like encryption and redaction can help healthcare organizations achieve greater levels of compliance.

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Exeed Regulatory Compliance

JULY 20, 2020

The Accuracy of Covid-19 Antibody Tests As we write this blog, the FDA has authorized 30 different antibody tests for Emergency Use. The second risk is related to the FDA Emergency Use Authorization process itself. Under normal circumstances, FDA would require a lot more data on clinical validation before approving these tests.

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Medisys Compliance

APRIL 20, 2022

As Public Health Emergency (PHE) has extended beyond 16 th April 2022 by 90 days, various waivers are continued, making no change in billing guidelines in pandemic. In fact, concerned authority extended the current COVID-19 pandemic telehealth waivers for five months beyond the end of the public health emergency.

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Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Part 820 ), unless they fall under an exemption.

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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 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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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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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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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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Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

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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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Healthcare Law Today

JANUARY 25, 2023

Food & Drug Administration (FDA or Agency) the authority to order a mandatory recall of a cosmetic product and to suspend a facility registration if FDA determines there are serious adverse health concerns. Furthermore, MoCRA grants the U.S. MOCRA’s key provisions are outlined below.

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SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

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SQA

AUGUST 8, 2023

Additional concerns were noted with respect to: Temperature/humidity controls Calibration inspection and/or qualification of equipment, including computerized systems Equipment usage logs Release of finished products Change Control Records Quality Agreement(s) Specifications for finished products Retention samples Bausch Health, Canada Inc.

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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

SEPTEMBER 1, 2023

ALABAMA American Family Care opens new health care center in Northeast Birmingham doctors secure $13.9M operating margin, $1B net gain halfway through its first year Illinois public health officials warn of “rising COVID-19 activity” St. Warner, Kaine announce nearly $1.4M

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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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