HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. – Fraud. For example, in furtherance of the laudable goal of enhancing access and affordability of hearing healthcare, the FDA does not require that a hearing health professional verify a member’s hearing loss to be eligible for an OTC device.

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FDA Public Health Fraud Medicare 98

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Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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FDA Informed Consent COVID-19 Fraud 40

The Health Law Firm

MAY 9, 2019

Unfortunately, many also find themselves defending their reputation after being accused of clinical research fraud or research misconduct. Although accusations of research fraud and misconduct have been present for decades, the number of complaints is on the rise, according to the Food and Drug Administration (FDA).

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Fraud FDA 40

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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Fraud FDA Governance HIPAA 52

HIPAA Journal

JANUARY 23, 2024

The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct. Holmes, along with former company president Ramesh Balwani, were charged with criminal fraud for making false claims about the company’s technology and misleading investors.

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Fraud FDA Medicaid Medicaid 83

Hall Render

MAY 28, 2024

With a deep understanding of the complexities of this field, Jemalyn works with health systems, hospitals, large physician practice groups and other health care organizations to navigate a broad range of strategic and operational issues including fraud and abuse, FDA compliance and corporate governance.

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Fraud FDA Compliance Governance 40

MedTrainer

JANUARY 12, 2024

Department of Health and Human Services focuses on preventing fraud, abuse, and waste in federal healthcare programs. Food and Drug Administration (FDA): The FDA regulates compliance in pharmaceuticals, medical devices, and biotechnology products. Office of Inspector General (OIG): This independent agency within the U.S.

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Compliance Fraud Medicaid Medicaid 52

Healthcare Law Today

JANUARY 11, 2023

Food and Drug Administration (FDA) prior to distribution. The lawsuit alleged that the device was not approved or authorized by the FDA and that the procedure was not covered by Medicare. The FDA has jurisdiction to regulate products that meet the definition of “device” under section 201(h) of the FDCA.

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FDA Governance Medicare Medicare 59

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

Healthcare IT Today

AUGUST 3, 2023

Fred Pinkett, Senior Director, Product Management at Security Innovation Meeting the new FDA requirements for medical device security will take more than just network security, it requires security upgrades in all aspects of systems, including their software.

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Fraud FDA Medical Billing Hospitals 96

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. 1, 2021). [2]

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FDA HIPAA Medicare Medicare 90

Hall Render

JANUARY 3, 2024

He represents clients in actions and investigations initiated under the False Claims Act and has experience working closely with state and federal authorities to resolve fraud and abuse-related matters. office and helps clients navigate the complex and ever-changing landscape of FDA regulation. Matt graduated with his J.D.

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Fraud Hospitals Compliance FDA 40

Healthcare IT Today

MAY 6, 2023

Read more… Preventing Genetic Testing Fraud: 5 Actions for Health Plans. Medicare payments for genetic testing quadrupled from 2016 to 2019, which has unfortunately led to a rise in a rise in fraud, waste, and abuse. On the heels of ViVE and HIMSS, they also discuss whether in-person conferences are back. at Valencell.

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Fraud Doctors Medicare Medicare 114

Verisys

NOVEMBER 30, 2022

Maintaining compliance and safeguarding against fraud and abuse in today’s changing healthcare landscape can be challenging. OIG, SAM DEA, GSA, FDA. organizations that receive any funds from Medicare, Medicaid, TRICARE, or other federal programs cannot afford to employ individuals or entities excluded from even one program.

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Regulatory Compliance Medicare Medicare Medicaid 52

Pharmacy Law Blog

MARCH 13, 2018

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. fraud suit – judge.” Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

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Fraud Governance Licensing FDA 52

Verisys

DECEMBER 1, 2022

FDA Disbarment. The goal of healthcare professionals, organizations, and others is to give patients high-quality care while safeguarding them against fraud and abuse. Other databases included in a FACIS Level 3 search. SAM ( including SDN ). Treasury Dept. State Dept.

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Medicaid Medicaid Fraud Governance 52

Healthcare Law Blog

MARCH 17, 2022

Like these other AOs, OIG found that while the Proposed Arrangement could generate fraud and abuse risks under both the Federal anti-kickback statute (i.e., Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented.

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US Department of Health and Human Services Informed Consent Medicare Medicare 52

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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Compliance HIPAA FDA Due Diligence 40

Healthcare Law Blog

MARCH 8, 2023

Food and Drug Administration (“FDA”) approved only a single manufacturing facility, which is located on the campus of the “Treatment Center.” Requestor does not have and would need FDA approval to transport the Drug to other treatment facilities aside from the Treatment Center.

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FDA Doctors Medicaid Medicaid 52

Health Blawg

NOVEMBER 15, 2018

Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device ; folks need to be aware of those lines, and of the shifting regulatory landscape.) The hope, of course, is that the clinical uses can prove themselves out and become more widely adopted.

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FDA Fraud Hospitals Health Insurance 60

Health Blawg

NOVEMBER 15, 2018

36 percent are using AI to detect patterns in health care fraud, waste and abuse. Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device ; folks need to be aware of those lines, and of the shifting regulatory landscape.)

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FDA Fraud Hospitals Health Insurance 60

Health Blawg

NOVEMBER 15, 2018

36 percent are using AI to detect patterns in health care fraud, waste and abuse. Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device ; folks need to be aware of those lines, and of the shifting regulatory landscape.)

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FDA Fraud Hospitals Doctors 60

Health Blawg

NOVEMBER 15, 2018

Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device ; folks need to be aware of those lines, and of the shifting regulatory landscape.) The hope, of course, is that the clinical uses can prove themselves out and become more widely adopted.

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FDA Fraud Hospitals Doctors 60

Health Blawg

NOVEMBER 15, 2018

36 percent are using AI to detect patterns in health care fraud, waste and abuse. Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device ; folks need to be aware of those lines, and of the shifting regulatory landscape.)

FDA 60

FDA Fraud Hospitals Doctors 60

Health Blawg

NOVEMBER 15, 2018

Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device ; folks need to be aware of those lines, and of the shifting regulatory landscape.) The hope, of course, is that the clinical uses can prove themselves out and become more widely adopted.

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FDA Fraud Hospitals Doctors 60

Health Blawg

NOVEMBER 15, 2018

Though, of course, at a certain point, an AI tool used in healthcare becomes subject to regulation by the FDA as a medical device ; folks need to be aware of those lines, and of the shifting regulatory landscape.) The hope, of course, is that the clinical uses can prove themselves out and become more widely adopted.

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FDA Fraud Hospitals Doctors 60

Bill of Health

SEPTEMBER 29, 2022

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. Background Context. Practical Implications.

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FDA Governance Fraud Licensing 130

Healthcare Law Blog

MAY 11, 2023

As part of the Arrangement, a laboratory and its parent company (the “Companies”) would provide a prepaid card, such as a Visa or Mastercard gift card, of up to $75 to certain individuals to encourage those individuals to return the sample collection kit associated with an FDA-approved colorectal cancer screening test (the “Test”).

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Medicare Medicare Fraud Compliance 52

Compliancy Group

AUGUST 14, 2023

Regulatory compliance in the healthcare industry plays a crucial role in patient safety, maintaining quality standards, and preventing fraud and abuse. Healthcare organizations are subject to numerous regulations that govern their operations, ranging from privacy and security requirements to billing and coding guidelines.

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Regulatory Compliance Compliance Compliance Officers Fraud 52

The Health Law Firm

JUNE 20, 2012

(KV) for making false or misleading statements to the US Food and Drug Administration (FDA). Appeals Court Ruling Revives Securities Fraud Class Action Lawsuit. In making this decision, the appeals court has renewed a securities fraud class action that was dismissed by a trial court in 2010.

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Fraud FDA 40

MedTrainer

APRIL 22, 2024

While adherence to these guidelines is voluntary, organizations implementing effective compliance programs are better equipped to identify and address potential compliance risks, mitigate fraud and abuse, and uphold the integrity of healthcare programs and services.

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Compliance HIPAA Licensing Fraud 52

Health Care Law Brief

JUNE 2, 2022

For example, the Department of Justice has aggressively pursued health care fraud claims against individuals and entities involved in non-compliant telehealth models. How will the marketing comply with the FDA rules regarding the marketing of prescription drugs and/or professional practice rules applicable to licensees?

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Public Health Compliance COVID-19 Licensing 52

Verisys

NOVEMBER 14, 2023

Verisys’ owned and maintained Fraud Abuse Control Information System (FACIS) is a provider data supersource.

Licensing 52

Licensing Medicaid Medicaid Governance 52

Innovaare Compliance

OCTOBER 6, 2022

The purpose of these audits is to evaluate a plan sponsor’s efforts to prevent, detect, and correct fraud, waste, and abuse (FWA) in the Medicare Part C and Part D programs. Plan sponsors will be notified in advance of the upcoming audit schedule and targeted universes under review for each audit type.

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Medicare Medicare Compliance Public Health 52

Verisys

JANUARY 18, 2022

Verisys’ owned and maintained Fraud Abuse Control Information System (FACIS) is a provider data supersource. Food and Drug Administration (FDA). FACIS draws from over 5,000 federal and state primary sources including (but not limited to): Office of Inspector General ( OIG). System for Award Management (SAM).

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Licensing Medicaid Medicaid Governance 52

AIHC

JUNE 6, 2023

Compromised personal data can have serious consequences, including identity theft, financial fraud, and job losses in addition to OCR HIPAA fines and costs associated with breach notifications. Also, general coding, documentation and billing oversight for compliance to payer guidelines should be maintained by workforce experts.

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Compliance Medical Billing HIPAA Due Diligence 59

AIHC

JUNE 6, 2023

Compromised personal data can have serious consequences, including identity theft, financial fraud, and job losses in addition to OCR HIPAA fines and costs associated with breach notifications. Also, general coding, documentation and billing oversight for compliance to payer guidelines should be maintained by workforce experts.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52