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Identifying the likely beneficiaries of an emerging biosimilars market

Financial analysts have predicted that over the next five years, biosimilars will be a $10 billion market, so it is understandable why considerable attention and investment is being made in this space. However, while there is...more

White House Releases Draft Privacy Principles for the Precision Medicine Initiative

Six months after the Precision Medicine Initiative’s (Initiative’s) debut, the White House has released a working draft of proposed privacy and trust principles (the Principles) to govern future design and development efforts...more

HIPAA Security Requirements Aren't Cloudy, Especially to Whistleblowers

Earlier this month, the U.S. Department of Health and Human Services Office for Civil Rights (HHS OCR) announced that it had entered into a settlement agreement with St. Elizabeth's Medical Center (SEMC) in Brighton,...more

NIST releases draft guide for use of mobile devices for medical providers

The National Institute of Standards and Technology (NIST) cybersecurity center released a draft guide last week for health IT professionals to use to bolster security for the use of mobile devices in the health care industry....more

What’s the Secret to Successful Medical Device IP?

Every medtech inventor is looking for the same things—to make a difference for patients, fill an unmet medical need…and maybe, just maybe, become a successful public company or an in-demand acquisition target....more

Member information accessed through Healthfirst’s online portal during fraud scheme

On July 25, 2015, Healthfirst Inc. notified approximately 5,300 of its members that their information may have been compromised during a criminal fraud scheme perpetrated against it. The fraudulent scheme was discovered by...more

Guest Post - Just the Fax, Ma’am

While Bexis is on vacation, here is a guest post to take up some of the slack. Our guest blogger today is Henry Pietrkowski, a partner in Reed Smith's Chicago office. This one's a little different. It's about the impace of...more

Bio/Pharma IPR Challenges Nearly Double in 2015

Newly released statistics (2015-06-30 PTAB Statistics) from the USPTO reveal that the number of bio/pharma IPR challenges almost doubled in 2015, even though fiscal year 2015 still has three months to go. Last year, there...more

Healthcare & Life Sciences Private Equity Deal Tracker: Oncobiologics Secures $31 Million in Financing

Oncobiologics, based in Cranbury, N.J., is a biopharmaceutical company focused on developing and commercializing monoclonal antibody biosimilar therapeutics....more

MPT to Acquire GTCR-Backed Capella; Shows Value Added for PE in Hospital Space

MPT is a Birmingham, Ala.-based self-advised real estate investment trust. Capella is one of the largest for-profit hospital companies in the U.S. Based in Franklin, Tenn., Capella owns and/or operates seven hospitals across...more

“Everything Old is New Again” – Issues in Recent Cyber Insurance Litigation

Early days still for coverage litigation about cyber risks – whether under cyber insurance policies or other types of policies. This is not surprising given the relatively short history of cyber risks and even shorter history...more

Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more

Allergan Announces Plans to Acquire Oculeve for $125 million + Milestones

Allergan recently announced that it has agreed to buy Oculeve in an all-cash transaction. The deal is expected to close in the third quarter of 2015. Press releases state that Allergan will pay Oculeve $125 million upfront,...more

State Law Roundup: Legislatures Across the U.S. Revamp Data Breach Notification Laws

As the number of highly publicized data breaches continues to skyrocket and proposals for a federal data breach notification law stagnate, state legislatures around the country have been busy amending their own breach...more

For biosimilars in the US, Interchangeability with the Innovator Reference Product is the goal, but there is still much work to be...

During the BIO 2015 Convention in Philadelphia, there were several sessions directed to biosimilars. Biologic medicines now account for about one-third of annual drug approvals in the US (according to the Pharmaceutical...more

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s...more

Cloud Sharing Apps Scrutinized for ePHI

In a relatively short time period, the direct costs of document storage have dropped precipitously, and cloud-based document storage has become ubiquitous. Clearly, this is a wave of the future. But a recent settlement...more

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for...

On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

The Supreme Court Addresses Scope of Section 11 Liability for Statements of Opinion

As the Supreme Court recently explained in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S. Ct. 1318 (2015), that distinction is significant when it comes to liability under Section 11 of...more

ABA Resolution 105 on Punitive Damages Is Dead for Now

On the eve of the ABA's Annual Meeting next week, the ABA's Standing Committee on Medical Professional Liability announced its withdrawal of proposed Resolution 105 from consideration by the ABA House of Delegates. The...more

Does Delaware’s New Telemedicine Law Foreshadow Broader Payment Parity?

Nationwide, states continue to enact laws requiring commercial health plans to cover medical services provided via telemedicine to the same extent they cover medical services provided in-person. These laws are intended to...more

FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule...more

21st Century Cures Act – Provisions Relating to Digital Health: Interoperability and Information Blocking

On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the “bill”) by a vote of 344-77. In addition to increasing medical research funding and expediting the process of making breakthrough...more

Class action filed against UCLA following data breach

We previously reported that UCLA suffered a data breach affecting 4.5 million patients. Days following the announcement of the breach, plaintiffs filed a proposed class action lawsuit against UCLA, alleging that UCLA should...more

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