Florida Health Care Law Firm

MAY 5, 2022

The FDA does not regulate essential oils, just like it doesn’t regulate herbs or supplements. That means that there is no FDA approval for any essential oil. But if they say that their product is FDA-approved to do something specific, that is incorrect and they are open to fines and could be shut down.

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FDA Compliance Governance 52

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. Beware of new companies offering such services.

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Compliance Medical Billing HIPAA Due Diligence 59

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. Beware of new companies offering such services.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

Dot Compliance

FEBRUARY 22, 2022

FDA regulations govern what you can claim about your product and whether you can even sell it at all. For companies that manufacture drugs, biotechnology, and related products, demonstrating the safety and effectiveness of your goods to the FDA’s satisfaction has to be a top priority.

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FDA Compliance Governance Public Health 98

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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FDA COVID-19 Public Health Governance 40

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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FDA Governance Medicare Medicare 59

HIT Consultant

APRIL 12, 2023

With this acquisition, the consolidated Oxutrx_Spectrum company now has seven (7) process lines, including ISO Optics Lab capabilities, serving medical, commercial and government entities.

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FDA Governance Compliance 98

HIT Consultant

NOVEMBER 6, 2023

It will initially provide IoT manufacturers with a certification label that signifies their compliance with cybersecurity guidelines and best practices—while providing consumers with more confidence when purchasing internet-connected devices. This is why such government initiatives are so welcome.

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Governance Ransomware FDA Hospitals 111

Dot Compliance

JUNE 16, 2022

Maintaining compliance with safety and quality standards is a significant issue in medical device manufacturing. Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance.

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FDA Regulatory Compliance Compliance Governance 52

Health Care Law Brief

JUNE 2, 2022

For the reasons discussed below, DTC telehealth platforms should re-visit their compliance plans and be prepared for increased state and federal regulatory scrutiny. Do these encounters comport with telehealth encounter requirements set forth by applicable state laws, or government or private payor requirements?

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Hall Render

OCTOBER 18, 2022

Defendant pharmaceutical manufacturers applied for and received approval from the FDA to manufacture Gamunex at a facility converted for that purpose. FDA regulations require current Good Manufacturing Practices [cGMP] to be met or the drug shall be deemed adulterated and prohibited from sale. United States ex rel. at *1 & fn.

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FDA Governance Fraud Compliance 40

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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COVID-19 Governance Public Health FDA 98

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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FDA HIPAA Compliance Regulatory Compliance 45

Verisys

NOVEMBER 30, 2022

Maintaining compliance and safeguarding against fraud and abuse in today’s changing healthcare landscape can be challenging. Excluded from one means excluded from all, and the fines for non-compliance will likely be in the hundreds of thousands. OIG, SAM DEA, GSA, FDA. How many data sources is your organization monitoring?

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Regulatory Compliance Medicare Medicare Medicaid 52

Healthcare IT Today

AUGUST 28, 2023

Regarding medication, several new psychiatric treatments have been approved by the FDA, including Auvelity for major depressive disorder, the SAINT transcranial magnetic stimulation protocol for treatment-resistant depression, and Zurzuvae for postpartum depression. The No Surprises Act was signed into law in 2020 and took effect last year.

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US Department of Health and Human Services Telemedicine Hospitals Compliance 117

Healthcare Law Blog

MAY 31, 2022

However, traditional healthcare players, subject to the Health Insurance Portability and Accountability Act (“HIPAA”), may also find themselves innovating in this space (and grappling with how to stand up a HIPAA compliance program in the metaverse). 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] Healthcare Laws.

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FDA HIPAA Medicare Medicare 90

Natalia Mazina

DECEMBER 13, 2023

Because the changes are fairly recent, compounders want to know how and when they must be fully compliant, what enforcement vehicles are in the government arsenals, and what types of resources they must have to comply with the new requirements. Full compliance was due back on November 1, 2023.

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Compliance Hospitals FDA Governance 52

Dot Compliance

JANUARY 14, 2022

Common risk areas often include (but aren’t limited to): Cybersecurity Audit management Government pricing General data protection regulation. FDA’s Safer Technologies Program (SteP) for Medical Devices. For companies in the life sciences sector, risk refers to the probability of harm occurring and its potential severity.

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Compliance FDA Regulatory Compliance Governance 52

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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FDA COVID-19 COVID-19 Vaccine Compliance 52

HIT Consultant

JANUARY 24, 2022

Are we putting enough safeguards and governance in place for AI-driven decision-making, particularly in areas of automated machine learning? That’s why the theme of a recent FDA-Project Data Sphere Symposium was entitled “The Art of the Possible.” Are humans in the process loop to verify both inputs and outputs of AI predictions?

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Governance FDA Doctors COVID-19 98

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. In 2021, the Supreme Court articulated in Tandon v. Throughout that period, federal courts have respected those decisions.

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Healthcare IT Today

AUGUST 21, 2023

Industry Guidelines and Regulations Governing RFID Use in Healthcare Organizations such as the UnitVisID Alliance and GS1 Healthcare have established guidelines defining an industry-wide performance and data-handling specification for RFID-tagged products as they move through the supply chain with security and patient safety in mind.

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HIPAA Regulatory Compliance Hospitals FDA 98

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. In alignment with PHE’s conclusion, other government bodies are rolling back pandemic-era measures.

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FDA Medicaid Medicaid COVID-19 52

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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Licensing Medicaid Medicaid Governance 52

Exeed Regulatory Compliance

MARCH 21, 2020

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. There is one piece of good news that the FDA has very rapidly approved several tests in the last 2 weeks under the Emergency Use Authorization and more are expected to follow. What’s the secret to its success?

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FDA Governance 52

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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Medicaid Medicaid Fraud Governance 52

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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FDA Medicare Medicare Governance 100

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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HIPAA Journal

NOVEMBER 4, 2022

Warner suggests the only way to improve healthcare cybersecurity rapidly is through a collaborative effort involving the public and private sectors, with the federal government providing overall leadership. The program would standardize coverage elements and provide incentives for insurance companies to adopt them.

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HIPAA Governance FDA Medicaid 116

HIT Consultant

AUGUST 21, 2023

As well as privacy compliance, sensitive data must also be secured against possible breaches and malicious attackers, with over 22.6 These are important challenges to address, as they can have a large impact on patient safety, as well as data quality and governance. million patients affected by data breaches in 2021 alone.

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FDA Telemedicine Health Insurance Hospitals 98

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.

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US Department of Health and Human Services FDA Public Health COVID-19 52

Verisys

JANUARY 18, 2022

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. Food and Drug Administration (FDA). System for Award Management (SAM). Specially Designated Nationals (SDN).

Licensing 52

Licensing Medicaid Medicaid Governance 52

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

Bill of Health

APRIL 4, 2024

On top of that comprehensive rulebook, the European Data Strategy bundle of laws encompasses the EU General Data Protection Regulation (GDPR), the Free Flow of Non-Personal Data Regulation, the Data Governance Act and the Data Act, as part of the EC’s ambition to establish a single unified market for data. Sectoral US Laws In the U.S.,

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FDA Regulatory Compliance Malpractice Health Insurance 282

Health Care Law Brief

OCTOBER 27, 2021

This means that although ketamine is approved by the FDA for some medical uses, it is not specifically approved to treat depression. Such laws and regulations are largely governed at the state level, and there may be (i) considerable variations among state laws and (ii) frequent updates to such laws. Regulatory Licensure.

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Licensing Telemedicine COVID-19 FDA 40

HIPAA Journal

JUNE 27, 2022

Government entities are exempt. Any covered entity that fails to ensure personal data is kept private and confidential or does not allow Americans to exercise their rights under the ADPPA, will be held to account, with compliance enforced by the FDA and state attorneys general.

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HIPAA FDA Health Insurance Governance 57

Healthcare IT Today

MAY 5, 2023

The surge in genetic testing claims comes with a rise in fraud, waste and abuse across government and commercial payers. However, due to its nonspecific nature, this code can be abused by bad actors to request payment for services not covered, not performed or not FDA-approved. Common schemes include: Code stacking.

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