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Health Criminal Law Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

Criminal Overreach

by Reed Smith on

Come visit us in our office whilst we are poring over a brief and, with minimal provocation, we will put aside the task at hand and start gabbing about our days as a prosecutor. Come sit next to us while we are pouring a...more

FDA Announces Import Staffing Change at International Mail Facilities

Earlier this month, The Washington Post reported that Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that he was reallocating three dozen employees to international mail facilities (IMF), as well as...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

The Office of the National Coordinator Releases Guidance on Recent International Ransomware Campaign

by Foley & Lardner LLP on

With the news of the newest international ransomware campaign that is currently affecting some organizations within the Health Care sector, it is important to not only educate staff on necessary precautions, but also be aware...more

Reimbursement Manager Pleads Guilty for Prior Authorization Process Issues

by Bass, Berry & Sims PLC on

On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Former Lutonix VP Pleads Guilty to Trade Secret Theft

by Knobbe Martens on

On May 9, 2017, according to court records, Christopher Barry, former Vice President of R&D at Lutonix Inc., pled guilty to stealing Lutonix’s trade secrets in the form of several confidential electronic files....more

WannaCry Malware and Medical Device Security

by Knobbe Martens on

The WannaCry virus has infected and frozen computers in many industries around the world. According to a news source report, the virus has extorted doctors and hospital administrators for the keys to unlock and regain access...more

Ransomware Attack – Quick Facts

By now, you may have heard about the global ransomware attacks affecting health care and other organizations throughout the world, in particular the United Kingdom, but also in the United States. The ransomware variant,...more

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

POD Update: Physician Investor of Physician-Owned Distributor Sentenced to Nearly 20 Years in Prison

by Ropes & Gray LLP on

On January 9, 2017, a physician was sentenced in federal court in the Eastern District of Michigan to 19 years, 7 months in prison for his role in criminal health care fraud totaling $2.8 million. The settlement has some...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Employee’s Wife Pleads Guilty to Charges After He Stole Patient Information

The Manhattan District Attorney announced this week that a former employee of Lenox Hill Hospital’s wife plead guilty to grand larceny, identity theft in the first degree, and criminal possession of stolen property after her...more

DEA Rejects Petitions Seeking to Reschedule Marijuana

by Morgan Lewis on

The long-awaited decision maintains the illegal status of marijuana under federal law. On August 12, the US Drug Enforcement Agency (DEA), despite much speculation to the contrary, published in the Federal Register its...more

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more

Ransomware Attacks on ePHI May Be a Data Breach Under HIPAA

by Snell & Wilmer on

On July 11, 2016, the Office of Civil Rights (“OCR”) at the Department of Health and Human Services issued new HIPAA guidance regarding the growing epidemic of malicious computer software known as “ransomware”....more

New Anti-Corruption Laws on the Health Care Sector in Germany: Is There Any Impact on the Food Industry?

by King & Spalding on

Germany recently adopted new anti-corruption laws that now criminalize “taking bribes in the health care sector” and “giving bribes in the health care sector.” These new laws have implications for certain segments of the food...more

Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty

The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached...more

Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more

Federal Jury Acquits Former Warner Chilcott President

by Ropes & Gray LLP on

On June 17, 2016, a federal jury in the District of Massachusetts acquitted Carl Reichel, the former president of specialty pharmaceutical manufacturer Warner Chilcott, on a single count of conspiracy to violate the federal...more

DOJ Suffers Criminal Trial Setbacks: Warner Chillcott President Acquitted

by Michael Volkov on

Last week was a tough week for the Justice Department’s criminal prosecutors. Before everyone gets out their Yates Memorandum trending claims, it is important to recognize that DOJ’s loss in several high profile cases does...more

Kansas Heart Hospital pays ransom but attackers renege on their word

In a rare and twisted result, Kansas Heart Hospital was hit with a ransomware attack on May 18th, and made the decision to pay a “small amount” to the attackers in order to get its data back. Kansas Heart stated that no...more

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Cybersecurity

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