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Category Archives: Prescription Drugs and Medical Devices

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Corporate Actors Held Individually Accountable in Recent False Claims Act Settlement

Posted in False Claims Act, Fraud and Abuse, Medicare, Pennsylvania, Prescription Drugs and Medical Devices, Trends
The Department of Justice (“DOJ”) has sent a clear message that individuals cannot hide behind the corporate shield in its recent settlement with Med-Fast Pharmacy, Inc. and the charges brought against its associated individuals and entities (“Med-Fast”). Under the agreement, which includes a $2.66 million payout by Med-Fast, the DOJ dropped civil charges against the… Continue Reading

Antidotes for America’s Addiction Crisis

Posted in Fraud and Abuse, OIG Fraud Alert, Prescription Drugs and Medical Devices, Trends
Opioid addiction and abuse has exploded into a national epidemic. Every three weeks, America faces a death toll equivalent to the September 11th attacks due to drug overdoses, 75 percent of which are from opioid use. With more Americans dying each year from drug overdoses than gun violence and car crashes combined, the issue has… Continue Reading

Hospital’s Turkey Dinner Is $850,000 Fine for Failure to Secure Mobile Medical Devices

Posted in HIPAA, HITECH, Prescription Drugs and Medical Devices, Privacy, Security
Just before Thanksgiving, Lahey Hospital and Medical Center (“Lahey”), a non-profit teaching hospital located in Burlington, Massachusetts, agreed to pay $850,000 for a breach of unsecured electronic protected health information (“ePHI”). Lahey will also be required to implement a corrective action plan. The breach occurred in 2011 when an unencrypted laptop was stolen from an… Continue Reading

Medical Devices a Target for Online Hackers

Posted in Cybersecurity, Prescription Drugs and Medical Devices, Privacy, Security, Technology
In the past few years, medical devices have become a major target for online criminals. Not only are medical devices considered to be one of the easiest and most vulnerable points of entry into a health care enterprise, they are one of the most difficult areas to remediate even when an attack has been identified.… Continue Reading

Effective November 1, 2015: New Jersey Expands Scope of Prescription Monitoring Program

Posted in Legislation, Prescription Drugs and Medical Devices
In July, New Jersey Governor Chris Christie signed legislation that expands the access, registration, and utilization of the New Jersey Prescription Monitoring Program (NJPMP). The legislation, Senate Bill 1998 (S-1998), is slated to take effect on November 1, 2015. S-1998 is part of a larger effort in New Jersey to fight prescription drug abuse. Governor… Continue Reading

21st Century Cures Act Passes House: Could Usher In Broad Reforms to Drug Approval Process

Posted in FDA, Guest Contributor, Legislation, Prescription Drugs and Medical Devices
On Friday, July 10th the U.S. House voted overwhelmingly to streamline the approval process of prescription drugs and medical devices by the FDA. If passed in the Senate and signed by President Obama, the “21st Century Cures Act” (the “Act”) would foster significant regulatory changes in the introduction of new drugs to the market. The… Continue Reading