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Health Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Opioid Litigation Over Insurance Coverage – Coming to a Jurisdiction Near You

by Nexsen Pruet, PLLC on

A very recent appellate ruling in California provides a roadmap for opioid litigation over insurance coverage that is about to ramp up all over country. In Travelers Prop. Cas. Co. of Am. v. Actavis, Inc. et al, 2017 WL...more

WORD OF THE DAY® – 8+2+1

by Latham & Watkins LLP on

Latham partner Robbie McLaren explains the term 8+2+1 from the Book of Jargon® – Healthcare & Life Sciences. The Book of Jargon® – Healthcare & Life Sciences is one of a series of practice area and industry-specific...more

The Opioid Epidemic: Are We Headed Toward a Tipping Point?

by Burr & Forman on

Health care law and policy occupy a prime place in the current news cycle. Much of the attention revolves around the actions or inactions of Congress and the White House, particularly with regard to their impact on the future...more

C.D. Cal. Excludes Three Plaintiff Experts in Breast Implant Case

by Reed Smith on

It is not as if we are delighted to see efforts to resuscitate breast implant litigation, but we won’t groan when the rulings are as good as they are in Laux v. Mentor Worldwide, LLC, No. 2:16-cv-01026-ODW(AGR) (C.D. Cal....more

White Collar Courier: Delivering News and Providing Guidance in White Collar Matters

by Burr & Forman on

Before joining Burr & Forman, I was a federal prosecutor for a little over a decade focusing on health care fraud and general white collar matters. In that role, I was a member of a prosecution team that secured guilty...more

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

by Arnall Golden Gregory LLP on

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...more

Lessons To Be Learned From The Breach Of Nearly 500,000 Individual Health Records Reported In September 2017

by Jackson Lewis P.C. on

A recent report indicates that nearly 500,000 individual health records were breached in September 2017. This figure is taken from the 39 healthcare data breaches involving more than 500 records that were reported to the...more

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

by Reed Smith on

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information...more

Three Years Later, Foley Survey Reveals Positive Prognosis for Telemedicine

by Foley & Lardner LLP on

When we launched Foley’s inaugural Telemedicine and Digital Health Survey in 2014, it was apparent that health care executives weren’t ready to make telemedicine a significant focus of their business and patient strategies....more

New rules for expanded access in Italy

by Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Non-News: Warnings Claims For A Generic Drug Preempted (Still)

by Reed Smith on

We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to go back to bed. In trying to be discerning consumers of the news, it...more

FCC Closes Loopholes and Expands Telephone Consumer Protection Act “TCPA” Consumer Protections in Declaratory Ruling and Order

by Womble Bond Dickinson on

On July 10, 2015, the Federal Communications Commission (“FCC” or “Commission”) released a Telephone Consumer Protection Act (“TCPA”) Declaratory Ruling and Order (“TCPA Declaratory Ruling and Order” or “Order”) offering...more

2017 Health IT Leadership Summit Insights

by Arnall Golden Gregory LLP on

Arnall Golden Gregory was a gold sponsor of the Health IT Leadership Summit, held on November 7, 2017 in metro Atlanta. More than 500 people attended the Summit, which was created in 2010 by the Georgia Department of Economic...more

Louisiana Adopts Price Reporting Law

by Kelley Drye & Warren LLP on

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines WAC as “the manufacturer’s list price for the pharmaceutical drug or...more

PTAB Life Sciences Report - November 2017 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Sawai USA, Inc. v. Astellas Pharma Inc. PTAB Petition: IPR2018-00079; filed October 16,...more

OCR Clarifies Privacy Rule for Sharing PHI on Opioid Overdoses

In the wake of the national opioid overdose crisis, the Office for Civil Rights (OCR) has provided clarification on when covered entities are permitted to disclose patient information during opioid emergencies....more

West Virginia Plaintiffs Haunted by Past Excesses

by Reed Smith on

We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl...more

Recent FDA Steps to Advance Medical Device Access and Innovation

by K&L Gates LLP on

On November 6, 2017, U.S. Food and Drug Administration (“FDA” or “the Agency”) Commissioner Dr. Scott Gottlieb reiterated the Agency’s commitment to advancing medical device access and innovation by stating, “[o]ur goal is to...more

Window on Washington - Vol. 1, Issue 34

by Clark Hill PLC on

Short-term Continuing Resolution Likely Needed to Fund Government Past December Deadline: Republicans are focused on tax reform through Thanksgiving, and when lawmakers return from the upcoming holiday recess, they will have...more

Why Pet Owners Are Understandably Confused About Pet Medications.

by Fox Rothschild LLP on

FDA’s recent announcement that it is “withdrawing draft Guidance for Industry (GFI) #230, ‘Compounding Animal Drugs from Bulk Drug Substances’” reminded me that pet owners can become confused about what type of medications...more

No Voluntary Dismissal for Plaintiffs, and a Summary Judgment Win for Defendants, in Central District of California Risperdal Case

by Reed Smith on

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own...more

Data Privacy + Cybersecurity Insider - November 2017 #2

by Robinson & Cole LLP on

Michigan Governor Rick Snyder has signed into law the Cyber Civilian Corps Act, which established the Michigan Cyber Civilian Corps, dubbed MiC3. The corps has been in existence for three years but not statutorily deployed. ...more

A Question of Privilege: Court Wrestles With Attorney-Client and Work Product Issues in Data Breach Case

In a significant ruling addressing the scope of the attorney-client privilege and work product doctrine in a data breach case, a Federal judge in Oregon ordered Premera Blue Cross, the Washington-based healthcare services...more

CMS Announces New Policy for Biosimilars Payments Under Part B

by Goodwin on

As we previously reported, the Centers for Medicare and Medicaid Services (“CMS”) has been considering comments on a proposed rule regarding biosimilar payment policies. On Thursday, CMS issued a final rule for the 2018...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- 2017 Virginia Attorney General and New Jersey Governor Election Results- In Virginia’s AG race, Democrat incumbent AG Mark Herring defeated Republican John Adams by a margin of 53.3% to 46.7%. Virginia’s...more

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