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The Heartbleed Bug's Impact on EHR Systems

As reported in the media, a serious vulnerability in the popular OpenSSL cryptographic software library, called the Heartbleed bug, was recently discovered. This vulnerability permits the theft of information, including...more

Health Law Insights Newsletter - April 2014

In This Issue: - Federal Updates - State Updates - HIPAA Updates - Excerpt from Centers for Medicare & Medicaid Services Issues Guidance for Meaningful Use Hardship Exception: The Centers...more

2014 Resolutions Series: Trapped in an unhealthy IT vendor relationship? How to make the best of a difficult situation

My client, “Hal”, head of IT procurement for a large regional hospital system called me yesterday morning and declared “I hate vendors!” One of the hospital’s key vendors had just delivered a set of unexpected and “urgent”...more

Legal and Ethical Risks of Healthcare Businesses in China

Recent disputes and controversies involving Chinese subsidiaries of foreign pharmaceutical companies have sounded warning bells on legal and ethical issues regarding participation in China’s rapidly growing and evolving...more

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more

Overview of Primary Provisions of U.S. and French Sunshine Reporting Requirements

2013 was a year of unprecedented scrutiny of financial relationships between manufacturers and health care professionals, such as physicians. Both the United States and France imposed sweeping new reporting and disclosure...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

MoFo BioMeter - Vol. 3, Issue 1, March 2014 - Q4 and FY 2013 BioMeter Shows Rebound in Value for Late Stage Products and Strong...

The full-year 2013 BioMeter analysis shows across-the-board increases in BioMeter value, with an average of $33.9 million for all transactions, up from approximately $21.2 million in 2012. Increases occurred for each stage of...more

China Cracking Down On Pharmaceutical Corruption

Stricter Blacklist Regime - On December 25, 2013, the National Health and Family Planning Commission of China (“National Health Commission”, former Ministry of Health) issued the amended Provisions Regarding the...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

Notifications and Names: FTC Workshop Explores Effect of State Legislation and Naming Conventions on Follow-On Biologic...

Biologic medicines represent some of the most significant—both clinically and financially— pharmaceutical products in the United States today. Biologics have had remarkable success in the treatment of patients with many...more

TransCardiac's State Court Complaint Avoids Raising Federal Question

Judge Totenberg remanded the case brought by TransCardiac Therapeutics, Inc. (“TransCardiac”), against Ajit Yoganathan, Ph.D, Jorge H. Jiminez, Ph.D., Vinod H. Thourani, M.D., Emory University, Georgia Tech Research...more

FDA Issues Revised Draft Reprints Guidance

On February 28, 2014, the Food and Drug Administration (“FDA”) released a revised draft guidance for industry entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“Revised...more

New Mexico Moves One Step Closer to Becoming the 47th State with a Breach Notification Law

46 states plus Washington, D.C. have data breach notification laws. Alabama, Kentucky, New Mexico and South Dakota still do not have a comprehensive notification law outside of the public sector. That may change soon...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

Privacy and Security Becoming More Increasingly Critical

Privacy and security continue to be critical considerations for all businesses. While such considerations in the healthcare industry have received a lot of attention over the past years with the increasing requirements under...more

China Compliance Update: Commercial Bribery Risks Remain Very Real in China

The enactment of new legislation, as well as new and continuing investigations, demonstrates that Chinese regulators have not slowed down their efforts to ferret out corruption in the pharmaceutical sector and related...more

FTC Workshop Seeks to Spark Biosimilars Competition

Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day...more

FTC’s 50th Data Security Settlement Sends a Message: Be Careful with Overseas Contractors

The Federal Trade Commission (FTC) sent a message about the importance of imposing appropriate security measures on—and monitoring—vendors with access to confidential consumer information. The FTC issued a 20-year consent...more

Perspectives - January 2014

In This Issue: - Considerations in the Cloud: Managing the Risks - United States V. Sperry: A Revived Threat to Owners, Directors, Managers and Directors of Distressed Organizations - Board Membership &...more

Protect Your Blindside: Identify All HIPAA Business Associates/Subcontractors

Under the recently enacted Health Information Technology for Economic and Clinical Health (HITECH) Act, and implementing regulations, the definition of the HIPAA term "Business Associate" has been expanded. A "Business...more

Great Investment For Doctors: Joint Venture Pharmacies

With reimbursement levels declining, health care organizations, including pharmacies and physicians, continue to look for ways to diversify their businesses. A very attractive vehicle for increasing revenues has been...more

China Solicits Comments on Good Supply Practices for Medical Devices

The China Food and Drug Administration (the “CFDA”) recently published a draft regulation, Good Supply Practices for Medical Devices (the “Draft GSP”), for public comment through January 20, 2014. The first-ever regulation...more

Reverse payment deals under the microscope in the EU

Lessons from the latest Commission decision on agreements affecting generic entry: - The European Commission’s crack down on so-called “reverse payment” agreements continues. - In the EU these agreements may...more

Planes, trains and Over-the-Counter pills

This Reed Smith client alert looks at the recent amendments to the Human Medicines Regulations 2012, which came into force in November 2013....more

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