What are the Implications of Alice v. CLS?
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Diversity and Technology in Focus for Morgan Lewis's Incoming Chair
PREVENTING AND RESPONDING TO DATA BREACHES IN AN ERA OF CYBER INSECURITY
Stefan Hankin on Online Harassment
What Does the Supreme Court Ruling in Alice v. CLS Mean to a Software Entrepreneur?
A Moment of Simple Justice - Revenge Porn
Why Cyber Security?
How Fenwick Partners Caught the Tech Wave
How is Graphene Currently Used and What is the Hope for the Future?
What is Graphene? Fenwick Patent Attorney Has the Answer
Two Tips for Inventors Filing Patent Applications
Are Criminal Laws the Right Response to Revenge Porn?
Why Law Firms Are Starting to Think Like Media Companies
Schoenbrod: SCOTUS Ruling Helps EPA Deal With a "Stupid Statute"
Protecting and Enforcing Your High Technology Intellectual Property - Webinar Replay
Did the IRS Just Help or Hurt the Bitcoin Economy?
Legal Tech Startups: Separating Hype from Opportunity
Jail Time for Revenge Porn Offenses?
Polsinelli Podcast - Conducting Business in China
Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more
In this issue:
- Health Care Decisions — Who Decides?
- Medical Software Licensing — Tips from the Trenches
- An Ounce of Prevention — The Importance of Periodic Corporate Audits
Recent Trends in HIPAA Liability -
Since the passage of the 2013 HIPAA Omnibus Rule, there has been a substantial increase in HIPAA enforcement actions brought by the Department of Health and Human Services, including...more
On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more
A health organization narrowly averted paying a potential $4 billion in damages under the California Confidentiality of Medical Information Act (CMIA) for losing the medical records of more than 4 million patients. Plaintiffs...more
On August 29, 2014, two whistleblower developments of particular interest to health care and life science entities emerged from the Securities and Exchange Commission ("SEC") and the Eighth Circuit Court of Appeals,...more
There has been question for some time whether in evaluating certain discount arrangements involving clinical laboratory tests under the federal antikickback statute (FAS), discount charges should be measured against the...more
In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more
This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former...more
I do not profess to be an expert in the complexities of metadata in an electronic medical record (EMR). In simple terms, it is analogous to leaving footprints in the sand; although these do not wash away with high tide. In...more
California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56 et seq. (“CMIA”), provides that an individual may recover $1,000 nominal damages (plus actual damages if any) based on the negligent release of...more
Until last week, Sutter Health was looking at a potential jury verdict in excess of $4 billion against several of its affiliated hospitals in a class action suit filed under the California Medical Information Act, California...more
LEGISLATIVE ACTIVITY -
On Monday, July 28, the House Committee on Energy and Commerce, Subcommittee on Health will hold a markup to consider two bills: H.R. ____, a bill to require the Secretary of Health and Human...more
The California Court of Appeal recently held that in order to recover under California’s Confidentiality of Medical Information Act (CMIA), Civ. Code §§ 56 et seq., a plaintiff must plead and prove that the “stolen medical...more
Last week, the California Third District Court of Appeal dismissed what may have been the largest health data breach class action in history. Consistent with a trend of similar dismissals, the California state appellate court...more
On June 25, the U.S. Department of Justice announced that it had settled with Omnicare Inc. in two matters alleging that kickbacks resulted from below-cost discounts offered to skilled nursing homes as an inducement to select...more
In This Issue:
Judgments; Legislation; and Reports.
Excerpt from Judgments:
New South Wales (NSW) -
22 July 2014 - Lane v Northern NSW Local Health District (No 3)  NSWCA 233 -
In a case against Sutter Health involving records from a stolen office computer, the California Court of Appeal recently issued a decision limiting plaintiffs’ ability to state a claim and obtain statutory damages under the...more
Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more
According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more
On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more
It’s an ancient conundrum; if a tree falls in the forest, and no one is there to hear it, does it make a sound? Privacy litigation may well offer the closest jurisprudential equivalent; if data is stolen, but no one does...more
In its recent decision in Eisenhower Medical Center v. Superior Court, 226 Cal. App. 4th 430(Cal. App. 4th Dist. 2014), the Court of Appeal of California, Fourth District, had occasion to consider whether a medical facility’s...more
- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback...more
On June 23, 2014, a U.S. District Court in Pennsylvania held that the first relator to file a qui tam complaint under the FCA is the only relator eligible to recover a portion of the settlement, notwithstanding the existence...more
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