FDA Fraud Presentation 
Healthcare IT Today
MAY 5, 2023
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.
HIPAA Journal
OCTOBER 21, 2022
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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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).
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Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.
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. Failure to do so can bring devastating consequences.
Healthcare Law Blog
MAY 31, 2022
These advancements, present challenges and raise novel questions as to how the current healthcare and life sciences legal regime would apply to the metaverse. In response to the growth of the metaverse and digital health generally, the FDA has been working to expand its guidance in the area. Data Privacy and Security. 1, 2021). [2]
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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