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On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials.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

8 Things Healthcare Providers Should Know About E-Signatures

Electronic signatures can be legally valid to execute documents that require written signatures, and electronic documents can be legally valid when applicable laws require documents to be in writing....more

Anti-Kickback and Stark Law: Pitfalls and Problems

When you think your life is tough in the FCPA compliance arena, just remember you could be head of compliance for a pharmaceutical company or hospital responsible for domestic anti-kickback and Stark law compliance....more

Key Issues Facing Places of Public Accommodation at the 25th Anniversary of the ADA

With all of the presents, decorations, and champagne now firmly in the rearview mirror, January is a time customarily spent reflecting on the year that was and planning for the year ahead. For places of public accommodation,...more

Nothin’ from Nothin’ Leaves Nothin’

Axiom Worldwide Inc. v. Excite Medical Corp. et al. - The U.S. Court of Appeals for the Eleventh Circuit affirmed a district court’s $1.32 million judgment in favor of a medical device maker, ruling that it never owned...more

Cybersecurity Resolutions for the New Year

In this presentation: - Why cybersecurity matters - Recently-implemented cybersecurity rules and laws - Rapid reporting of cyber incidents and additional cybersecurity measures coming soon -...more

Healthcare & Life Sciences Private Equity Deal Tracker: Vascular Dynamics Secures $17 Million in Financing

Vascular Dynamics, headquartered in Mountain View, Calif., provides minimally invasive solutions for the treatment of refractive or resistant hypertension....more

IT Maintenance Crucial for HIPAA Compliance

The Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) recently announced an agreement with a medical center to settle charges stemming from the center’s failure to prevent malware from infecting its...more

Blog: FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015. This guidance is a first for the FDA and comes as a product of...more

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