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Samsung Bioepis’s Etanercept Biosimilar Said to be Less Immunogenic than Enbrel

by Goodwin on

A research letter published by the British Journal of Dermatology from investigators in Samsung Bioepis’s biosimilar etanercept (SB4) clinical trials reports that, in addition to therapeutic equivalence between SB4 and...more

HHS Delays Compliance Date for Revised Common Rule

by Ropes & Gray LLP on

On January 17, 2018, just two days before a final rule that revised the Common Rule was scheduled to take effect, the United States Department of Health and Human Services (“HHS”) announced a six-month delay in the final...more

Dental Device Class Action Comes Back To Bite Plaintiffs

by Reed Smith on

You don’t see class actions going to trial very often, but that is what happened in Patricia A. Murray Dental Corp. v. Dentsply International, Inc., and the defendant device manufacturer came away with a defense verdict that...more

Medical Records Production Company Sues to Prohibit Enforcement of HIPAA Medical Record Payment Policies

by King & Spalding on

On January 8, 2018, CIOX Health, LLC filed a complaint challenging two HHS policies limiting whether and how much a HIPAA covered entity can charge for providing copies of medical records. According to the lawsuit filed in...more

New Jersey Bans and Caps Certain Manufacturer Gifts and Payments to Prescribers

by McDermott Will & Emery on

On January 16, 2018, New Jersey’s new regulations limiting gifts and payments from prescription drug and biologics manufacturers to prescribers were issued in the New Jersey Register and became effective. After receiving...more

Biosimilar Market Developments Continue Apace in 2018

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more

Connecticut Supreme Court Recognizes Common-Law Cause of Action for Unauthorized Disclosure of Confidential Medical Information

In a long-awaited decision concerning the confidentiality of medical records and patient privacy, the Connecticut Supreme Court recently concluded that the physician-patient relationship establishes a duty of confidentiality...more

HIPAA Breach Reporting: 2017 Trends and Mends

by McGuireWoods LLP on

With 2017 having drawn to a close, it is once again time for HIPAA covered entities to complete their annual breach reporting obligations to the U.S. Department of Health & Human Services Office for Civil Rights (“OCR”)....more

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

by Baker Ober Health Law on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

This Year May be a Game Changer for 340B Drug Discount Program, Take Two

I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more

OIG Issues Letter Declining to Impose Administrative Sanctions for Provision of Certain Free Drugs

by Holland & Knight LLP on

On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more

Generic drugs taking hold in the Asian marketplace: STAT News interview

by Hogan Lovells on

Aging populations and rising healthcare costs across Asia — particularly in Japan — have created new market opportunities for generic drug makers operating in the region. For originator drug manufacturers, that means...more

Don’t Forget Your FDA Valentine

by Arnall Golden Gregory LLP on

In addition to reauthorizing various user fee programs, the FDA Reauthorization Act of 2017 (FDARA), which was enacted last summer, added a one-time marketing status reporting requirement for holders of new drug applications...more

Connecticut Supreme Court: Health Care Providers Can Be Sued For Unauthorized Disclosures Of Confidential Information

by Jackson Lewis P.C. on

Physician practices and other health care providers respond to numerous requests for confidential patient information from patients and others. Mistakes made by employees fulfilling such requests for medical records or making...more

WORD OF THE DAY® – Fab Fragment

by Latham & Watkins LLP on

Latham Partner Judith Hasko explains the term Fab Fragment 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

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

by Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

Guest Post – No Way For Non-Resident Plaintiffs To “MacGyver” Their Way Into Illinois Court Due To Forum Non Conveniens

by Reed Smith on

Today’s post is another guest post from Kevin Hara, of Reed Smith, who is on his way to becoming a semi-regular blog contributor. This post is about forum non conveniens, which is more discretionary, and less enforceable...more

HHS OCR Announces a $2.3 Million HIPAA Settlement Bringing the Agency’s Settlement Total for 2017 to Over $19 Million

by Arnall Golden Gregory LLP on

On December 28th, the Department of Health and Human Services Office of Civil Rights (OCR) announced a $2.3 million settlement with 21st Century Oncology Inc. (21st Century) to settle potential violations of the HIPAA privacy...more

FDA Releases 2018 Roadmap: Focus On Digital Health Continues

by Kelley Drye & Warren LLP on

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities,...more

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more

FDA Proposes to Delay Off-Label “Intended Use” Rule

by Reed Smith on

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and...more

FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices

by Reed Smith on

On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug...more

Data Privacy + Cybersecurity Insider - January 2018 #2

by Robinson & Cole LLP on

Health Care Organizations Saw an 89% Increase in Ransomware in 2017 - Our experience last year is consistent with the conclusion of a new report issued by Cryptonite in its 2017 Health Care Cyber Research Report—that the...more

No Old Kentucky Home for Parallel FDCA-Based Tort Claims

by Reed Smith on

Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following: "In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the...more

Day 4 Notes on the 2018 JP Morgan Healthcare Conference

San Francisco (January 11, 2018) – The final day of the 2018 JP Morgan Healthcare Conference gave us food for thought about the topic of healthcare navigation, as well as updates on the home health sector. Post-acute has...more

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