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Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

Cinfa Biotech Announces Positive Clinical Trial Results for Neulasta Biosimilar

by Goodwin on

Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta (pegfilgrastim). According to the...more

FDA Approves “First-of-its-kind” Infant Medical Device

The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus...more

China Announces Amendments to Regulation on the Supervision and Administration of Medical Devices

by Ropes & Gray LLP on

On May 19, 2017, China’s State Council promulgated the amendments to the 2014 Regulation on the Supervision and Administration of Medical Devices (“the Amendments”), which became effective immediately. The Amendments clarify...more

Last but Not Least, Texas Takes the Final Steps to Embrace Telemedicine

by McDermott Will & Emery on

As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been...more

Picking Up the Post-Preemption Pieces

by Reed Smith on

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case. Applying a ruling on in limines from one case to another can be a dicey proposition...more

The Future Of The Patient Protection And Affordable Care Act May Be Uncertain… But HIPAA Is Here To Stay

by Fraser Trebilcock on

While the future of the Patient Protection and Affordable Care Act and any potential replacement legislation is still in question, the Office for Civil Rights (“OCR”) within the U.S. Department of Health and Human Services...more

Brave New World: Compliance and the Transition to Value-Based Care

by Ropes & Gray LLP on

The U.S. health care system is in the midst of a fundamental shift, away from traditional “fee-for-service” models that reward providers for the quantity of services provided to patients, toward value-based models designed to...more

Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care—the First 100 Days

by Ropes & Gray LLP on

On Tuesday, May 2, Ropes & Gray hosted a teleconference, “Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care – the First 100 Days,” on the potential regulatory and...more

HIPAA Settlement With Wireless Health Services Provider Is Less Than Meets The Eye

by King & Spalding on

On April 24, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a $2.5 million HIPAA settlement with CardioNet, a wireless health services provider. CardioNet provides remote mobile...more

WannaCry Also Encrypted Hospital Medical Devices

The fall-out from WannaCry continues, particularly in the healthcare sector. There are new reports that WannaCry affected at least two hospital systems in the U.S. and encrypted medical devices (power injector systems)...more

Employers: Are You Ready for a Cyberwar? Attackers Using Ransomware are Saying Show Me Your Bitcoin!

by Dechert LLP on

Recently, the WannaCry ransomware attack impacted 150 countries and over 300,000 computers. Not all ransomware attacks are so massive but they all are fast moving and require swift action to prevent destruction and lose of...more

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

HHS Office of the Assistant Secretary for Preparedness and Response Issues Series of Cybersecurity Updates in Response to WannaCry...

In response to the WannaCry ransomware attack that infiltrated the computer systems of health care systems and other entities worldwide on or around May 12, 2017, HHS’ Office of the Assistant Secretary for Preparedness and...more

HHS Issues Cyber Threat Warning to US Hospitals and Medical Providers

by Davis Brown Law Firm on

In light of last week’s ransomware attacks overseas targeting hospitals and other providers, HHS is notifying providers in the United States of a warning issued by the United States Computer Emergency Readiness Team (US-CERT)...more

Health Care Weekly Preview from ML Strategies – May 2017

We are half way through May – are we having fun yet? There is a lot of activity this week in addition to ongoing talks in the Senate regarding their version of the American Health Care Act. The reauthorization of FDA User...more

FDA Approves Expanded Use of Small Molecule Drug Kalydeco on the Basis of In Vitro Data

On May 17, 2017, Vertex Pharmaceuticals small molecule drug Kalydeco® (ivacaftor) was approved by the U.S. Food and Drug Administration (FDA) for use in treating an expanded population of cystic fibrosis patients with...more

Weapons in the Cyber Defense Arsenal

by Wilson Elser on

In May 2017, the world experienced an unprecedented global cyberattack that targeted the public and private sectors, including an auto factory in France, dozens of hospitals and health care facilities in the United Kingdom,...more

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

“Lone Star” Joins the Rest of Nation as Texas Passes New Telemedicine Law

by Foley & Lardner LLP on

On May 12, 2017, the Texas State Legislature passed SB 1107, a law expanding the use of telemedicine in the Lone Star State. The bill is now on its way to Governor Abbot’s desk where he is expected to sign it into law....more

AAM/Biosimilars Council Comments on FDA Draft Guidance on Interchangeability

by Goodwin on

The Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, released comments today on FDA’s Draft Guidance on Considerations in Demonstrating Interchangeability With a Reference Product...more

Texas Legislature Approves Bill Reducing Barriers for Telemedicine

by Jones Day on

The Texas legislature passed S.B. 1107 yesterday, May 18, 2017. The bill, negotiated with input from the Texas e-Health Alliance and various other stakeholder groups, expands options for health care providers utilizing...more

Under the Dome: Inside the Maine State House

by Pierce Atwood LLP on

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. Spokesperson Says Governor Paul LePage Will Not Seek Senator King’s U.S. Senate Seat - A...more

Telehealth Expansion Finally Comes to Texas

by Morgan Lewis on

State legislature passes bill to expand telemedicine practice. The last six years have been a wild ride for telehealth providers in Texas. When the Texas Medical Board (TMB) issued emergency rules in 2011 that required...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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