Health Science, Computers & Technology

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

Medicare DMEPOS Competitive Bidding Window is Now Open

The bidding window is now open for the Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program Round 2 Recompete and the National Mail-Order Recompete for diabetic testing...more

FDA Issues Draft Guidance on Medical Device Accessories

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” The draft guidance...more

Generic Drug Manufacturers to Face Failure-to-Warn Claims in California

On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20,...more

Novartis and Qualcomm Form Digital Health Investment Company

Novartis Pharmaceuticals has announced it has formed a joint investment company with Qualcomm Ventures, the venture investment group of Qualcomm....more

Life Sciences Alert FDA Issues Draft Guidance on General Wellness Products

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more

Stage 3 EHR Incentive Program, Health IT Certification Rules at OMB

HHS has sent to the White House Office of Management and Budget (OMB) for final regulatory clearance a proposed rule on Stage 3 meaningful use criteria for the Medicare and Medicaid Electronic Health Record (EHR) Incentive...more

Texas Torches Telemedicine? Board Issues Emergency Rule

The Texas Medical Board issued an Emergency Rule with proposed changes to the practice standards and disciplinary guidelines for remote prescribing via telemedicine consults. The Emergency Rule states that the use of online...more

Time to Get Rid of Those Post-it Notes with All Your Passwords!!!

This month, Governor Chris Christie signed into law a New Jersey bill requiring health insurance carriers (e.g., insurance companies, health service corporations, hospital service corporations, medical service corporations,...more

Electronic Distribution of Prescribing Information for Prescription Drugs & Biologicals

The FDA published a proposed rule on December 18, 2014 that would require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or...more

Key Issues Facing Places of Public Accommodation at the 25th Anniversary of the ADA

With all of the presents, decorations, and champagne now firmly in the rearview mirror, January is a time customarily spent reflecting on the year that was and planning for the year ahead. For places of public accommodation,...more

Bills to Repeal Medical Device Excise Tax Introduced

Congressman Erik Paulsen (R., Minn.) and Senator Orrin Hatch (R., Utah) recently introduced bills H.R. 160 and S.149, respectively. Both bills are part of an effort to repeal the 2.3% excise tax on medical device...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Can Digital Healthcare Innovation Be Patented? Eligibility of Digital Healthcare Technologies Under the New USPTO Eligibility...

Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more

NIH Announces New One-Grant-at-a-Time Policy

In a move designed to stretch budget dollars and spread the research wealth, the National Institute of General Medical Sciences (NIGMS) announced last week that starting next year, it will impose a one-grant-at-a-time policy...more

Ensuring Data Protection In The Implementation Of The EFPIA Disclosure Code: Key Challenges And How Pharmaceutical Companies Are...

The EFPIA Disclosure Code will, from 2016, require pharmaceutical companies to disclose details of payments and transfers of value made to healthcare professionals and healthcare organisations. The Code aims to promote,...more

FDA Proposes Additional Flexibility for Mobile Health Products

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

New York Attorney General Announces Proposal to Revamp State Data Security Laws

On January 15, 2015, New York Attorney General Eric Schneiderman indicated that he plans to propose legislation to update New York’s information security laws, including by revising the definition of “private information”...more

New Jersey Requires Encryption for Health Insurance Carriers; May Open Door to Class Action Suits over Violations Under State...

Gov. Chris Christie has signed into law S. 562, which, as its title states, “Requires health insurance carriers to encrypt certain information.” Violation of this new law constitutes a facial violation of the New...more

FDA Approves EnteroMedics’ Implantable Obesity Treatment Device

St. Paul, MN-based EnteroMedics Inc. recently announced that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system. ...more

Ethics in Pharmaceutical Sales: Strengthening Corporate Culture and Preventing False Claims Act Violations

“I didn’t set out to commit a crime. I certainly didn’t set out to hurt anyone… I was kind of a hero, because I helped the company make its numbers every quarter. And I thought I was doing a good thing. I thought I was...more

Blog: Next Round of HIPAA Audits to Begin “Expeditiously”

During a media roundtable held this week, the Director of the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) Jocelyn Samuels provided additional information regarding the long awaited next round...more

Medical Device Clinical Trial Data from Johnson & Johnson To Be Made Available

According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time.  The Yale University Open Data Access (“YODA”)...more

JP Morgan Healthcare Meets RESI: Reflections

On January 12-15, JP Morgan held its 33rd Annual Healthcare Conference (the “JP Morgan Conference”) in San Francisco, California. The JP Morgan Conference is held during the same time every year in the same place and is...more

Blog: 23andMe Advances Its Goal of Creating Commercialized Database from Consumer Genetic Testing

On January 12, 23andMe announced an agreement with Pfizer to provide the drug company with access to anonymous, aggregated information from consumers who bought 23andMe’s test over the past seven years to learn about their...more

FDA Proposes to Apply Risk-Based Framework to Accessory Devices

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more

2,455 Results
|
View per page
Page: of 99

Follow Health Updates on: