Waldman: Stop Immunizing Websites That Allow Harassment
A Moment of Simple Justice - Snitching Ain't Easy
Data Privacy: The Next Frontier of Corporate Compliance
What are the Implications of Alice v. CLS?
After SoundCloud & Wunderlist: How Berlin plans to grow its startup scene
Diversity and Technology in Focus for Morgan Lewis's Incoming Chair
Diversity and Technology in Focus for Morgan Lewis's Incoming Chair
PREVENTING AND RESPONDING TO DATA BREACHES IN AN ERA OF CYBER INSECURITY
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?
On November 17, 2014, the Food and Drug Administration (“FDA”) released a draft guidance entitled Rare Pediatric Disease Priority Review Vouchers, which describes an incentive program for the development of drugs intended to...more
On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more
The Massachusetts Attorney General announced Friday that her office had reached a settlement with Beth Israel Deaconess Medical Center (BIDMC) surrounding a 2012 data breach in which a physician’s unencrypted personal laptop...more
FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more
Essential Medical, Inc., a privately held medical device company aiming to create and commercialize new vascular closure devices for femoral punctures after cardiac catheterization procedures, announced that it has...more
On November 12, 2014, the Seventh Circuit upheld the dismissal of a False Claims Act action challenging a retail pharmacy chain’s practice of billing Medicaid for the price differential between the higher Medicaid-negotiated...more
Health care providers have not escaped the recent proliferation of data breach class actions, but plaintiffs generally have been unsuccessful in bringing claims based on the Health Insurance Portability and Accountability Act...more
Under the American Recovery and Reinvestment Act of 2009, eligible health providers who demonstrate “meaningful use” of certified electronic health record (EHR) technology can qualify for incentive payments under the Medicare...more
In This Issue:
- Connecticut Supreme Court: HIPAA Does Not Preempt Negligence Claims
- CMS Removes Continuing Education Exemption to Physician Payments Sunshine Act
- Federal Government and New York...more
The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more
In honor of National Rural Health Day on November 20, it’s important to recognize the challenges — and opportunities — facing health care providers in delivering the highest quality care to rural populations. Our recent...more
The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing...more
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
On November 6, 2014, CMS announced changes to its Medicare Benefit Policy Manual and Medicare Claims Processing Manual related to coverage of items and services in Category A and B Investigational Device Exemption (IDE)...more
National Institute of Standards and Technology (NIST) has published draft recommendations aimed at securing the confidentiality of sensitive federal information located within non-federal entities’ information technology...more
Plaintiff Files Third Amended Antitrust Claim Against Highmark -
A long running antitrust dispute in Western Pennsylvania continued on October 1, when a Pennsylvania hotel (Cole’s Wexford Hotel) filed a third amended...more
This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more
On November 14, 2014, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) withdrew a proposed rule that would have provided guidance on a variety of topics related to the...more
The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing...more
On Friday, October 31, 2014, FDA posted on its website an audio recording, transcript, and slides from its October 23, 2014 webinar discussing the draft guidance document titled “Framework for Regulatory Oversight of...more
Based on a notice posted on its Office of Pharmacy Affairs (OPA) website, the Health Resources and Services Administration (HRSA) intends to issue in 2015 proposed guidance addressing key policy issues raised by the various...more
With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And...more
Our recent survey of senior-level health care executives reinforced that lack of reimbursement remains the primary barrier to providers in adopting telemedicine services. Of our respondents, 41 percent indicated that their...more
The Department of Health and Human Services (HHS) has withdrawn its greatly anticipated 340B Drug Pricing Program (340B Program) proposed regulations. The proposed regulations, nicknamed the 340B Program “Mega-Regs,” had been...more
In very broad terms, the 340B program allows some safety-net health care providers to provide qualifying patients with affordable prescription drugs. In January, the Office of Pharmacy Affairs (OPA) of the Health Resources...more
Find a Science, Computers & Technology Author »
Back to Top