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False Claims Act settlement calls into question some medical product rebate practices: revised
  • Hogan Lovells
  • USA
  • June 25 2010

On June 4, 2010, the Department of Justice (DOJ) announced that the United States had reached settlement of a qui tam action under the federal False Claims Act (FCA) with St. Jude Medical, a manufacturer of cardiac pacemaker and defibrillator devices.

mHealth in the UK: mobile health is on the move - part 1
  • Penningtons Manches LLP
  • United Kingdom
  • August 14 2015

It is predicted that by 2017 3.4 billion people worldwide will own a smartphone and half of them will be using mobile health applications (mHealth

Life sciences: product regulation and liability in Japan
  • YUASA and HARA
  • Global, Japan
  • July 11 2018

A structured guide to product regulation and liability laws in Japan

Patentability of methods of medical treatment and medical devices in Europe
  • Locke Lord LLP
  • European Union
  • May 7 2009

The European Patent Convention (EPC) proscribes the patenting of methods of medical treatment.

The new era of FCPA enforcement
  • Dorsey & Whitney LLP
  • USA, Global
  • August 29 2011

It has been over thirty years since the U.S. became the first country to pass anti-corruption legislation known as the Foreign Corrupt Practices Act.

The Brexit Effect on Medical Devices
  • Knobbe Martens
  • United Kingdom, European Union
  • July 7 2016

The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European

Top ten electronic health record system expectationsrequirements: beyond 'meaningful use'
  • Epstein Becker Green
  • USA
  • March 31 2010

Much industry attention and hype surrounds the incentive payments made available to providers under the HITECH portion of the American Recovery and Reinvestment Act of 2009 for implementing an Electronic Health Record (EHR) system.

Providing reimbursement advice has significant risks for manufacturers
  • Foley & Lardner LLP
  • USA
  • August 2 2010

As part of product support, many device manufactures provide advice to their customers (including hospitals and physicians) as to how products may be billed to federal health care programs, including Medicare and Medicaid.

New legal framework for transparency in interactions between industry and HCPs
  • Baker McKenzie
  • France
  • February 1 2012

The Law of 19 December 2011 provides for (a) a new set of transparency rules regarding the interests that experts involved in the various decision-making processes around life sciences products may have with companies in the life sciences sector.

Guidance addressing regulation of smartphone and tablet computer apps
  • Hogan Lovells
  • USA
  • July 25 2011

On 19 July 2011, the Food and Drug Administration (FDA or the Agency) issued a draft guidance document clarifying FDA's view on the regulatory status of mobile medical applications for handheld devices.