Do I need an expert witness in my case?
Electronic Medical Records: Help or Hindrance?
How Does King v. Burwell Decision Affect the Affordable Care Act?
Antitrust Law Issues for Health Care Providers
Variables Affecting Medical PL Settlement Values
Polsinelli Podcast - Is a Single U.S. Food Agency a Reality?
The Biggest Obstacle to Value-Based Care
Technology in Healthcare
Do healthcare professionals have to report legal trouble to their licensing board?
Health Care Enforcement: The Impact on Private Equity Investments
Polsinelli Podcasts: Cloud Computing, From Cybersecurity to Confidentiality Issues
Polsinelli Podcast - Pharmacy Compounding: What's Next in Regulation?
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
A Moment of Simple Justice - Vaccines
Government's Health Care Fraud "Cash Cow" Keeps Mooing
Government’s Health Care Fraud “Cash Cow” Keeps Mooing
Uncovering Factory Farming - The Effects of Ag Gag Laws
Intellectual Property Law Issues for Health Care Providers
Polsinelli Podcast - Republicans Gain Control of the U.S. Senate - How That May Impact Health Reform
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
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
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
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.
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
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
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
Oncobiologics, based in Cranbury, N.J., is a biopharmaceutical company focused on developing and commercializing monoclonal antibody biosimilar therapeutics....more
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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more
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