Stefan Hankin on Online Harassment
What Does the Supreme Court Ruling in Alice v. CLS Mean to a Software Entrepreneur?
A Moment of Simple Justice - Revenge Porn
Why Cyber Security?
How Fenwick Partners Caught the Tech Wave
How is Graphene Currently Used and What is the Hope for the Future?
What is Graphene? Fenwick Patent Attorney Has the Answer
Two Tips for Inventors Filing Patent Applications
Are Criminal Laws the Right Response to Revenge Porn?
Why Law Firms Are Starting to Think Like Media Companies
Schoenbrod: SCOTUS Ruling Helps EPA Deal With a "Stupid Statute"
Protecting and Enforcing Your High Technology Intellectual Property - Webinar Replay
Did the IRS Just Help or Hurt the Bitcoin Economy?
Legal Tech Startups: Separating Hype from Opportunity
Jail Time for Revenge Porn Offenses?
Polsinelli Podcast - Conducting Business in China
Rolling Out LPM Software at Akin Gump
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
Emerging Strategies for Protecting Global IP Rights
Data Center Networks – Interview with Jeff Moerdler, Member, Mintz Levin
The Georgia Composite Medical Board enacted a new regulation governing the standards for telemedicine practice. The regulation, titled Practice Through Electronic or Other Such Means, is found under Georgia Comp. Rules and...more
A decision has been made in the case against Omnicare, Inc. that will net a former Omnicare pharmacist more than $17.2 million in the ensuing settlement.
The settlement with the Department of Justice orders Omnicare,...more
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
On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices.
On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more
The Centers for Medicare and Medicaid Services (CMS) released a guide for physicians to prepare for the Dispute Resolution period of the Physician Payments Sunshine Act. The CMS guide is available on the CMS Open Payments...more
Community Health Systems, Inc. (the “Company”), one of the largest hospital organizations in the country, announced via a public filing (Form 8K) made yesterday with the Securities and Exchange Commission (“Report”) that the...more
The Tennessee-based acute-care hospital chain Community Health Systems, Inc. (CHS), reported on August 18 that information on approximately 4.5 million patients was stolen from the company. CHS is one of the largest hospital...more
Community Health Systems Inc. (“CHS”), a Tennessee-based hospital provider, has reported it was the target of data hackers who were able to obtain identification information belonging to approximately 4.5 million CHS...more
On August 18, 2014, Community Health Systems, Inc. (CHS) publicly confirmed, in a filing with the Securities and Exchange Commission (CHS filing), that its computer network was attacked between April and June 2014 by hackers...more
On June 25, 2014, the OIG issued a Special Fraud Alert addressing compensation paid by laboratories to referring physicians. This Special Fraud Alert supplements prior OIG guidance which emphasizes that providing free or...more
Community Health Systems, Inc. (“CHS”) reported yesterday that the information of approximately 4.5 million individuals has been affected by a Chinese cyber-attack. CHS and its affiliates own and operate 206 hospitals in 29...more
On February 18, 2014, the New Jersey Division of Consumer Affairs (the “DCA”) adopted new regulations which incorporate print-based security features into all New Jersey Prescription Blanks (NJPBs). The DCA has recently...more
In This Issue:
- Stakeholders Urge FDA to Provide Clarity on Biosimilars
- Ebola Crisis Continues
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
On August 7, 2014, CMS announced via email that it has temporarily suspended the Open Payments system “to investigate a reported issue.” Although CMS did not offer further explanation, our understanding is that the system has...more
The Centers for Medicare & Medicaid Services (CMS) announced last week that the Open Payments system was available again after it was taken off-line on August 3, 2014 to “resolve a data integrity issue.” Because the Open...more
Community Health Systems announced yesterday, August 18th, that hackers broke into its computers and stole data on 4.5 million patients. ...more
As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the...more
In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more
HHS Office of Inspector General (OIG) recently released a report concluding that the entity responsible for overseeing the testing and certification process for electronic health records (EHRs) did not fully ensure that...more
This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former...more
In This Issue:
Judgments; Legislation; and Reports.
Excerpt from Judgments:
25 July 2014 (published 8 August 2014) - Cotterell v Redcliffe Assembly  QCAT 357 -
On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more
Last week, the American Telemedicine Association (ATA) approved its new telepathology guidelines, which provide updated guidance on specific applications, practices, benefits, limitations, and regulatory issues that may arise...more
The United States Office of Inspector General (“OIG”) recently issued a “Special Fraud Alert” focusing on two potentially illegal trends that it has detected in arrangements between laboratories and their referring...more
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