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CMS Releases Broad Data on Prescribing Patterns of Physicians and Providers Under Medicare Part D

In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more

What Does Pharmacogenomics Have To Do With Product Liability? – Potentially Everything

Recently, Bexis attended the DRI drug and device committee spring conference. Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner. On...more

FDA Makes More Electronic Submissions Mandatory

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and...more

China FDA Releases Guideline for Medical Device Registration Studies

On May 19, 2015, the China Food and Drug Administration (“CFDA”) unveiled the Technical Guideline Governing Medical Device Clinical Evaluation (“Guideline”). The long-awaited Guideline explains the methodology for clinical...more

Think You Know Your HIPAA-Related Obligations? Read the ONC’s New Privacy and Security Guide to Find Out

In 2013, we alerted you to the expansion of the definition of the term “business associate” under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Now, the Office of the National Coordinator for Health...more

Blog: CareFirst Discloses Data Breach

CareFirst, a Blue Cross Blue Shield plan serving the Washington D.C. metro area, became another in a line of health insurers to suffer a data breach as a result of hackers. CareFirst and the FBI are examining the breach...more

Hospitals Rally to Defend 340B

A consortium of hospitals from across the country has delivered a letter to Congressional leaders, urging them to preserve the federal 340B program in its present form. Neither the content nor the timing of the letter was...more

CareFirst announces breach of 1.1 million records in cyberattack

Following in the footsteps of Anthem and Premera, CareFirst, a Blue Cross Blue Shield plan servicing customers in Maryland, Washington, D.C. and Virginia announced yesterday that it too has been the victim of a...more

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

CMS Updates Part D Prescribing Regulations

CMS published an interim final rule with comment period (IFC) on May 6, 2015 that modifies a previously-adopted regulatory requirement regarding qualifications to prescribe Part D drugs. By way of background, under a final...more

Patent Profile: DermTech Receives Patent for Method of Detecting Melanoma in Human Subjects

The U.S. Patent and Trademark Office recently issued a notice of allowance for U.S. Application No. 14/199,900, which is entitled "Diagnosis of Solar Lentigo by Nucleic Acid Analysis." The '900 application, which is assigned...more

Congress Could Be Coming For Dietary Supplements Soon

The next chapter in the saga of New York State Attorney General Eric T. Schneiderman's investigation of the dietary supplements industry may take place on Capitol Hill. On April 2, Schneiderman and the state attorneys general...more

Health Update - May 2015

Building a Culture of Health: The Value Proposition of Retail Clinics - Editor’s Note: Since first emerging on the healthcare landscape more than 15 years ago, retail clinics have seen significant growth. There are now...more

CareFirst Suffers Cyberattack, Data Breach of 1.1 Million Customers’ Information

BREAKING NEWS: Health insurer CareFirst BlueCross BlueShield disclosed today that hackers gained access to one of its databases, exposing personally identifiable information for approximately 1.1 million people....more

Insurance Recovery Law - May 2015 #2

Recent Lawsuit Underscores Critical Lessons for Purchasers of Cyber Insurance - Why it matters: Columbia Casualty Company v. Cottage Health Systems was filed on May 7, 2015, in the Central District of California. Cottage...more

Health Care Update - May 2015 #3

In This Issue: - 21st Century Cures Markup; Full Committee to Take Up this Week - Senate Finance Committee Solicits Health Bills for Upcoming Markup - Implementation of the Affordable Care Act - Federal...more

CMS Proposes Final Meaningful Use Objectives and Measures in EHR incentive programs Stage 3 Proposed Rule

On March 30, 2015, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (Proposed Rule) setting forth meaningful use criteria for Stage 3 of the Medicare and Medicaid Electronic Health Record Incentive...more

ONC Releases Updated Guide to Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic...more

Recent Lawsuit Underscores Critical Lessons for Purchasers of Cyber Insurance

Columbia Casualty Company v. Cottage Health Systems, No. 2:15-cv-03432, was filed on May 7, 2015 in the Central District of California. Cottage Health is one of the first cases nationwide—if not the first case—in which the...more

Sweet Home No More, Innovator Liability Leaves Alabama

On May 1, 2015, Alabama Gov. Robert Bentley signed into law a bill to “provide that a manufacturer is not liable ... for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by state...more

Medical Device Tax Repeal Heating Up

Following up on the hearing from B. Braun Medical Inc. advocating for the repeal of the medical device tax, according to news sources, more than a dozen House Democrats are pressuring leadership to advance a bill repealing...more

Health Alert (Australia) - May 18, 2015

In This Issue: Judgements; Legislation; and Reports. - Excerpt from Judgments: Queensland - 8 May 2015 - Vega Vega v Hoyle [2015] QSC 111 - The Queensland Supreme Court has held that...more

CNA Denies Cyber Insurance Claim

Key takeaway: The insurance applications and underwriting questionnaires prepared in connection with cyber insurance do matter. Cyber security, and cyber insurance, have dominated the industry headlines for several...more

Ontario Superior Court States Clear Rule on Pre-Certification Production of Medical Records in Class Actions

On March 20, 2015, Justice Belobaba released his reasons in Dine v Biomet, a motion concerning the production of medical records prior to a certification motion. The case is a proposed product liability class action...more

Jawbone and Oscar Lead Record Breaking Month for Digital Health Financings

Two blockbuster deals drove digital health financings to record levels in April. The month saw a total of nearly $790 million in deal flow, with the ten largest financing transactions of the month matching the first quarter...more

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