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Health Science, Computers & Technology

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

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

Speaking of the First Amendment...

by Reed Smith on

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice...more

Press Release Mistake Leads to $2.4 Million HIPAA Penalty for Health System

by Nossaman LLP on

On May 10, 2017, the U.S. Health and Human Services Department Office for Civil Rights (“OCR”) announced an agreement whereby Memorial Hermann Health System (“MHHS”) will pay a $2.4 million penalty for releasing a patient’s...more

Global Inquiries into Drug Price Increases

European competition authorities announced this week an investigation into Aspen Pharmacare’s recent price hikes of five cancer drugs. The European Commission said in a press release that it had “information indicating that...more

Potential HIPAA Pitfalls for Developers of Healthcare Apps

by Perkins Coie on

As federal and state governments struggle to address future healthcare regulation, demand for healthcare that is cheaper, better and faster continues to surge. Every day, new healthcare apps are being developed to respond...more

Are Healthcare Systems Being Held Hostage by Ransomware?

by Revision Legal on

Healthcare ransomware is one of the biggest cybersecurity concerns in existence and it may have particularly serious implications for healthcare systems. Ransomware is a form of malicious software code that is somehow...more

Let’s Get Clinical: ClinicalTrials.gov Reporting Requirements Now in Effect

by Arnall Golden Gregory LLP on

The compliance date for the Final Rule implementing the clinical trial reporting requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA), also known as FDAAA 801, arrived on April 18, 2017. The...more

Dr. Reddy’s to Install GE Healthcare’s FlexFactory

by Goodwin on

GE Healthcare announced today that Dr. Reddy’s will install GE Healthcare’s FlexFactory in Dr. Reddy’s facility in Hyderabad, India. According to the press release, “FlexFactory will help Dr. Reddy’s increase its capacity to...more

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

by Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. Please see full...more

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