Health Science, Computers & Technology

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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

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

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Nov. 28 describing a phishing email being circulated on mock HHS departmental letterhead under the signature of OCR...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

OCR Warns of Phishing Campaign Disguised as Official OCR Communication

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Monday describing a phishing campaign disguised as an email from OCR. The email is being circulated on mock HHS...more

Bipartisan Legislation Proposes Telehealth Solutions for Effective Chronic Disease Management

Collaborative efforts between congressional offices and various health care stakeholders, as well as the feedback provided in response to the Bipartisan CHRONIC Care Working Group Policy Options Document released in December...more

The U.S. Department of Health and Human Services Publishes Two Free Resources to Help Practices Navigate Healthcare IT

The U.S. Department of Health and Human Services (“HHS”), Office of the National Coordinator (“ONC”) has published two free online playbooks to assist healthcare providers navigate healthcare information technology (“IT”)....more

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

Momenta Announces Positive Phase III Results For Its Humira biosimilar

Today Momenta Pharmaceuticals announced that M923, a biosimilar candidate of AbbVie’s Humira (adalimumab), met the primary endpoint in a Phase III trial of M923 for treatment of patients with moderate-to-severe chronic plaque...more

HIPAA Settlement Emphasizes Importance of Accurate Hybrid Entity Designations

On November 22, 2016, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced that University of Massachusetts Amherst (UMA) agreed to settle allegations relating to the HIPAA Privacy...more

Pharmaceutical Product Liability Class Action Filed Relating to Olmetec Drug

Earlier this month a proposed class action was filed in Montreal by the Consumer Law Group alleging that Merck, Shering-Plough and Daiichi Sankyo (the Defendants) provided inadequate warnings about the drugs Olmetec and...more

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