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Cardinal Health Agrees to Settle Monopolization Claims

The Federal Trade Commission ("FTC") announced on April 20, 2015 that it had entered into a stipulated consent order ("Order") with Cardinal Health, Inc. ("Cardinal"). The Order, which is pending court approval, requires...more

Significant Guidance Released Regarding HIPAA Compliance

The Office of the National Coordinator for Health IT (ONC) released an updated version of the 2011 Guide to Privacy and Security of Electronic Health Information (Guide). The 62-page Guide provides significant guidance to...more

Legislation to Curb Medicare and Medicaid Fraud Would Increase Cost and Compliance Burdens on Health Care Providers

On March 25, 2015, a bipartisan group of U.S. Senators reintroduced the Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (“PRIME Act” or “Act”) following the lead of the U.S. House of Representatives,...more

Prosecutors Strike Gold in Retailers’ Dumpsters with Hazardous Waste Enforcement Action

Retailers should implement hazardous waste management plans, even for simple consumer goods, as California, New York and other states launch aggressive enforcement campaigns. In recent years, California prosecutors...more

Intellirod Spine Signs Licensing and Distribution Agreements With X-Spine Systems Inc.

Intellirod Spine LLC is, according to its website, a medical device company developing wireless sensing technologies for use in spinal care.  According to Orthopedic Design and Technology, Loadpro is the company’s forthcoming...more

Software Company to Face Suit Over Contract Restructuring

The United States District Court for the Northern District of California sustained a securities fraud complaint alleging that the defendants, a software company and its executives, had defrauded investors by failing to...more

Fourth Circuit Sustains Securities Fraud Claim Against Drug Manufacturer

On March 6, the US Court of Appeals for the Fourth Circuit found that the United States District Court for the Western District of North Carolina had erred in dismissing a class action lawsuit filed under Section 10(b) of the...more

Locke Lord QuickStudy: Montana and Wyoming Update Data Breach Laws

Montana and Wyoming have recently revised their data breach notification laws including their definitions of what constitutes Personally Identifiable Information (PII) subject to breach notification. ...more

Healthcare & Life Sciences Private Equity Deal Tracker: OrthoSensor Secures $19 Million in Financing

OrthoSensor has announced it has raised $19 million in a private placement of series C preferred stock. OrthoSensor, based in Dania Beach, FL, is a developer of intelligent orthopedic devices and data services....more

Omnicare: Section 11 Liability and Opinions

The Supreme Court defined the circumstances under which liability can be imposed for opinion statements under Securities Act Section 11. Specifically, the Court held that such liability could be imposed on two theories: One...more

2015 IPO Study

In this Issue: - Executive Summary - 2014 Overview - Year-Over-Year Analysis - Health Care - Technology, Media & Telecommunications - Energy & Power - Financial Services - Industrials -...more

Blog: HIPAA FAQ Series: Are Covered Entities Liable for Business Associates’ HIPAA Violations?

This post marks the beginning of a new series on this blog covering various frequently asked questions regarding the Health Insurance Portability and Accountability Act (HIPAA). ...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

The Healthcare & Technology Industries’ Burgeoning Emerging Growth Debt Market

The emerging growth debt market has grown significantly in recent years, with the majority of deals in the healthcare and technology spaces. Latham & Watkins partners Jim Morrone and Haim Zaltzman, who focus their practices...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

FDA Approves First US Biosimilar but Court Action Could Delay Market Entry

On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more

Mayo Clinic and Gentag, Inc. To Develop Wireless Sensors for Treatment of Obesity and Diabetes

Mayo Clinic and Gentag, Inc. have reached a joint intellectual property (IP) agreement to develop wearable biosensors designed to fight obesity and diabetes.  According to the press release, the agreement will allow certain...more

CMS Releases Updates to Its Medicare Advantage and Part D Plan Audit Protocols and Processes

On February 12, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released an updated version of its Medicare Advantage (“MA”) and prescription drug benefit (“Part D”) plan audit protocols and also announced the...more

Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

This post is the fourth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market....more

HIPAA and “Meaningful Use” Audits: Issues to Consider and How to Prepare

As more and more providers adopt electronic health records (“EHRs”) systems (and with new regulations concerning their required use for purposes of Medicare billing for chronic care management, their popularity can only...more

The U.S. Complaint Against the Government of China in the WTO, Including the Targeting of Chinese Medical Device Manufacturers

On February 11, 2015, the United States filed a complaint before the World Trade Organization (WTO), alleging that certain actions by the national, regional and local governments of the People’s Republic of China are in...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Blog: Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

Key Issues in Negotiating a Health Information Technology Agreement

Our partner, Dawn Crumel, recently spoke at American Health Lawyer Association’s Physicians and Hospitals Law Institute in Las Vegas, Nevada on key negotiation strategies for health information technology ("HIT" or "health...more

FDA Issues Draft Guidance on Medical Device Accessories

On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015)...more

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