Health Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
News & Analysis as of

Expanding Capacity for Health Outcomes (ECHO) Act Requires Exploration of Digital Health Opportunities

On December 6, 2016, the US House of Representatives passed the Expanding Capacity for Health Outcomes Act (S. 2873) (the ECHO Act), which was unanimously passed by the US Senate on November 29, 2016. The ECHO Act seeks to...more

The Digital Download - Alston & Bird’s Privacy & Data Security Newsletter – November 2016

Updates on the EU: German DPA Publishes First Privacy Shield Guidelines, Requires German-Law Contracts for Transfers. On June 7, 2016, the European Commission adopted the EU-U.S. Privacy Shield. One question that many...more

Health Canada releases revised guidance on the submission requirements for biosimilar biologic drugs

On December 2, 2016, Health Canada released the revised Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs. The Guidance is intended to assist biosimilar companies to navigate the...more

Updates on Rituximab Proposed Biosimilars

The past few days have seen a lot of activity on the rituximab biosimilar front. ..According to a joint press release, Sanofi and JHL Biotech, a biopharmaceutical company based in China, formed an alliance to collaborate...more

Mylan-Biocon Publish Positive Results for Proposed Trastuzumab Biosimilar

Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Earlier this week, an article published in the Journal of the American...more

Stopping The Sale of Gray-Market Medical Devices

On November 3, 2016, the US Court of Appeals for the Second Circuit approved an injunction against about 200 importers and sellers preventing them from importing and selling gray market blood-glucose test strips. The case was...more

OCR Issues Alerts Regarding Phishing Email Disguised as Official OCR Audit Communication

The HHS Office for Civil Rights (OCR) published an alert on November 28 describing a phishing email being circulated on mock HHS departmental letterhead under the signature of OCR Director Jocelyn Samuels. The email prompts...more

2016 Breach Roundup, Part I: U.S. State Data Breach Notification Laws Highlights and Trends

In many respects, 2016 has been a remarkable year, but one constant with recent history is that multiple states (six this year) amended their breach notification statutes. As is commonly stated, the U.S. ...more

21st Century Cures Act Includes Prohibition on Information Blocking and Mandates for Additional HIPAA Guidance

On November 30, 2016, the U.S. House of Representatives voted strongly in favor of the 21st Century Cures Act (the Act), an expansive health bill that addresses the discovery and development of new medical therapies as well...more

Behavioral Health: A Growing Interest in the Commonwealth

Massachusetts policy makers are increasing their focus on behavioral health treatment and how this relates to overall state health care spending. This issue was heavily discussed at the Health Policy Commission’s (HPC) annual...more

Amgen and Allergan Submit European Application for Avastin® Biosimilar

We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also...more

Congress weighs approval for sweeping, $6.3 billion 21st Century Cures Act

It’s almost 1,000 pages, culminates at least three years of work, and provides a $6.3 billion boost for an array of health-related agencies and initiatives. Will the U.S. Senate join the House in bipartisan passage of the...more

UMass Amherst Settles HIPAA Violations with OCR for $650,000

The Office for Civil Rights (OCR) has announced that the University of Massachusetts Amherst (UMass) has agreed to settle an investigation against it as a result of a malware infection for $650,000, along with implementing a...more

HHS Issues Warning About Phishing Campaign Disguised As Official Communication

As part of its efforts to assess compliance with the HIPAA Privacy, Security and Breach Notification Rules, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) engages in audits of covered...more

New HHS clinical trials registry regulations set to go into effect in January 2017: top points in one chart

Nearly a decade after Congress directed significant expansion of the national clinical trials database, www.ClinicalTrials.gov, the US Department of Health and Human Services (HHS) has issued final implementing regulations...more

Refined 21st Century Cures Act Passes in House and Heads to Senate Next Week

Yesterday, we reported that the House of Representatives was set to vote on a revised draft of the 21stCentury Cures Act...more

OCR Alerts Listservs About Fake Phishing Email to Covered Entities and Business Associates

On November 28, 2016, the Office for Civil Rights (OCR) issued an Alert to its listservs that a phishing email is being circulated on “mock HHS Departmental letterhead under the signature of OCR”s Director, Jocelyn Samuels”...more

Health Alert (Australia) November 28 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales - 23 November 2016 - Tolley v Secretary, NSW Ministry of Health in respect of Northern NSW Local...more

OCR Examines Hybrid Entity Designation in Latest HIPAA Settlement

On November 22, 2016, the University of Massachusetts Amherst (UMass) agreed to pay $650,000 and enter into a corrective action plan to settle allegations that it violated the HIPAA Privacy and Security Rules in connection...more

FDA Issues Interim Response to AbbVie’s Citizen Petition on Interchangeability

About 12 months ago, AbbVie filed a Citizen Petition asking the FDA to take certain steps to tighten and clarify its procedures for making interchangeability determinations. Earlier this year, both Sandoz and GPhA urged the...more

Navigating the ACA in the Trump Era

On November 8, 2016, the future of the Patient Protection and Affordable Care Act (ACA) became more uncertain. Republicans in Congress have been working to repeal the ACA since it was passed in 2010, and now, with control of...more

Beware of Phishing Email Disguised as Official OCR Audit Communication

The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) has posted an alert (and a follow-up alert) warning health plans, health care providers, and their vendors of a mock communication...more

Coherus Announces Marketing Authorization Application to the EMA for Pegfilgrastim Biosimilar

Coherus BioSciences, Inc., a global biosimilar company, is currently advancing three late-stage clinical products towards commercialization, namely CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and...more

FDA Regulatory and Compliance Monthly Recap — November 2016

OPDP issues fifth untitled letter of the year to Supernus for misrepresenting Oxtellar XR in KOL video - In its fifth untitled letter in 2016, the OPDP raised concerns about a Spanish KOL video suggesting Supernus’...more

Success for Pfizer’s Trastuzumab Biosimilar in Phase 3 Clinical Trials

Today, Pfizer reported that their trastuzumab biosimilar to Roche’s Herceptin® has shown equivalence in a Phase 3 clinical trial measuring objective response rate (ORR) when taken in combination with paclitaxel to treat...more

4,954 Results
|
View per page
Page: of 199

Follow Health Updates on:

JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×