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Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

Bill of Health

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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Preventing Genetic Testing Fraud: 5 Actions for Health Plans

Healthcare IT Today

The following is a guest article by Erin Rutzler, Vice President of Fraud, Waste, and Abuse at Cotiviti In Delaware, more than 250 Medicare patients underwent unnecessary genetic testing based on telehealth consultations that often lasted less than two minutes— costing Medicare thousands of dollars per patient. In 2021, a U.S.

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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

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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Pharma Sales Rep Pleads Guilty to Healthcare Fraud and Criminal HIPAA Violations

HIPAA Journal

A pharmaceutical sales rep has pleaded guilty to conspiring to commit healthcare fraud and wrongfully disclosing and obtaining patients’ protected health information in an elaborate healthcare fraud scheme involving criminal HIPAA violations. Alario pleaded guilty to his role in the healthcare fraud scheme earlier this month.

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Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device was not Approved or Cleared before Commercialization

Healthcare Law Today

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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Repercussions of Clinical Research Fraud and Misconduct that Healthcare Professionals Need to Know

The Health Law Firm

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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Top 5 Legal Issues in Digital Health to Watch for in 2022

Healthcare Law Blog

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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