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FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

Blog: OIG Reports Targeting Medicare Part D Fraud Issued on the Heels of National Medicare Fraud Sweep

The Health and Human Services (HHS) Office of Inspector General (OIG) released two reports yesterday related to Medicare Part D fraud. The OIG report, Ensuring the Integrity of Medicare Part D, “synthesizes numerous OIG...more

Health care worker sent to jail for HIPAA violations

When we train employees on HIPAA, we always remind them that HIPAA violations carry significant penalties-both civil and criminal. Our favorite line is “Keep your day job.” Stealing patient information is never worth the...more

Blog: Key Takeaways from Government Enforcement Panel at ACI Sunshine Conference

Recently, representatives from the United States Attorney’s Office for the Northern District of Georgia, United States Attorney’s Office for the District of New Jersey, and Medicaid Fraud Control Unit (MFCU) for the Office of...more

The Medicaid Fraud Control Units: Fiscal Year 2014 Report

The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2014 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCUs)...more

Fraud So Complicated It Takes a Neurosurgeon

Generally, when a doctor is convicted for fraud, the misdeeds are limited to a single category of fraud. Maybe the doctor charged for procedures that weren’t performed; maybe there were kickbacks for referrals; or maybe...more

Hospital CFO Must Pay $4.4 Million For Falsely Attesting To Meaningful Use

The Health Information Technology for Economic and Clinical Health Act, adopted in 2009, pumped billions of dollars into hospitals and physicians (through the Centers for Medicare and Medicaid) in order to stimulate them to...more

Blog: Fraud Watch: Laboratory Referrals Under Government Scrutiny

Significant recent regulatory and enforcement activity related to laboratory fees and services continues to demonstrate an increased focus on this industry. Government enforcers are active in cases involving both the...more

Update on the DOJ's Criminal Investigation into Generic Pharmaceuticals

The Department of Justice Antitrust Division's (DOJ's) investigation into the generic pharmaceutical industry may be expanding. On March 15, 2015, a third generic manufacturer disclosed that it received a subpoena from the...more

Medical Device Companies Face Severe FCA Penalties for TAA Violations

A spate of recent multi-million dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act (FCA) if they misstate the country of origin of their products in...more

Seventh Circuit Upholds Physician’s Conviction for Violation of the Anti-kickback Law Based on Expansive Definition of “Referral”

On February 10, 2015, the U.S. Court of Appeals for the Seventh Circuit upheld the conviction of Dr. Kamal Patel for violation of the anti-kickback law, reinforcing a broad definition of “referring” under the statute (U.S. v....more

HIPAA' s Criminal Charges Pack a Heavy Punch

Almost all healthcare providers and health plan administrators are familiar with the detailed requirements of the privacy and security rules under the Health Insurance Portability and Accountability Act (HIPAA). Violations...more

2014 Year in Review: OPDP Warning and Untitled Letters

In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more

Ethics in Pharmaceutical Sales: Strengthening Corporate Culture and Preventing False Claims Act Violations

“I didn’t set out to commit a crime. I certainly didn’t set out to hurt anyone… I was kind of a hero, because I helped the company make its numbers every quarter. And I thought I was doing a good thing. I thought I was...more

Federal Prosecutors Charge NECC Employees with Second Degree Murder: A Shot Across the Bow to Healthcare Companies Navigating...

Federal prosecutors charged the head pharmacist and the president of New England Compounding Center (NECC), a now-bankrupt Massachusetts compounding pharmacy, with second-degree murder and racketeering in the U.S. District...more

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more

Vascular Solutions Indicted

The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical...more

Red Notice Newsletter - October 2014

Welcome to the October 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. - This month on the anticorruption front, a Texas company agrees to pay more than $5 million to settle allegations...more

The Pain Drain - The Continuing Impact of Pain Management on Health-Care Providers

Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past...more

Face video scan can trigger data protection breach?

Data protection breaches of health related sensitive data might occur through a mere video scanning an individual’s face according to a recent research....more

FBI Warning to Health Care Sector Holds True

In April of this year, the FBI issued a Private Industry Notification (PIN) to the health care industry warning of the “likely increase [in] cyber intrusions against health care systems.” In the same month, and into June of...more

Federal Prosecutors Bring Criminal Charges against Individual for Alleged HIPAA Violation

Federal prosecutors in the Eastern District of Texas recently brought criminal charges under the Health Insurance Portability and Accountability Act (“HIPAA”) against a former East Texas hospital employee. The former...more

Los Angeles County Sues Hospital Owner for False Surgical Implant Claims to County Workers’ Compensation Program

On July 18, 2014, the County of Los Angeles (“the County”) filed a lawsuit in Los Angeles Superior Court again Michael D. Drobot, Sr., his son Michael R. Drobot, Jr. and their controlled entities, Pacific Hospital of Long...more

DEA Schedules Tramadol As A Schedule IV Controlled Substance

On July 2, 2014, the Drug Enforcement Administration (DEA) published its Final Rule placing tramadol into Schedule IV of the Controlled Substances Act (CSA). Tramadol is a synthetic opioid analgesic used in the...more

Hospital Executive Indicted for Allegedly Lying about Meaningful Use of Electronic Health Records

A hospital executive was recently indicted for allegedly submitting a false attestation regarding a hospital’s “meaningful use” of electronic health records (“EHR”) technology through the Medicare EHR incentive program. This...more

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