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New Federal Telemedicine Grants Announced; Florida Not Listed

The U.S. Department of Agriculture just announced new grant funding awarded to seven telemedicine and 11 distance learning projects across 16 states to use technology to expand access to health care, substance misuse...more

OIG Releases Series of Reports Focusing on Improper Medicaid EHR Incentive Payments

In August 2016, OIG released a series of reports focusing on the Medicaid electronic health record (EHR) incentive program for hospitals in West Virginia, Ohio, and Oklahoma. This continues a recent trend of reports focusing...more

Congressional Hearings Focus on Health Policy Issues - September 2016

A number of recent Congressional hearings have focused on health policy issues, including: ..Senate Health, Education, Labor, and Pensions Committee hearings on laboratory testing in the era of precision medicine, and...more

Can Antitrust Prevent Excessive Drug Price Increases?

The antitrust agencies are often asked to intervene in markets where pricing appears to be excessive to help protect consumers and stabilize markets. In the drug arena, healthcare providers, consumers and politicians have...more

Employee’s Wife Pleads Guilty to Charges After He Stole Patient Information

The Manhattan District Attorney announced this week that a former employee of Lenox Hill Hospital’s wife plead guilty to grand larceny, identity theft in the first degree, and criminal possession of stolen property after her...more

EPA IG's Concerns About Oversight of Hospital Disinfectants Reinforces Need for Robust Infection Control Programs

On September 19, 2016, the Inspector General (IG) for the Environmental Protection Agency (EPA) issued the latest in a long line of reports identifying flaws in EPA’s process for ensuring the efficacy of hospital-grade,...more

BREAKING NEWS: FDA Expected to Approve Amgen’s Humira Biosimilar Today

According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today. If approved, it will be the first biosimilar adalimumab...more

Aralez’s YOSPRALA wins FDA approval

On September 15, 2016, the U.S. Food and Drug Administration approved once-daily YOSPRALA™, a tablet that combines the anti-platelet agent, aspirin, with the anti-acid drug, omeprazole for decreasing the risk of...more

Manatt Digital - September 2016

Digital Health Continues to Grow - Investment into the digital health market topped $4.5 billion in 2015, and we are seeing an acceleration of investment in 2016. According to StartUp Health, investment into the digital...more

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist....more

Stop them in their tracks: key points in seeking a preliminary injunction against medical device infringers

In 2006, the US Supreme Court reversed years of jurisprudence by eliminating the presumption of irreparable harm in patent litigations,1 which previously had resulted in virtually automatic grants of injunctions to prevailing...more

FDA to Hold Public Meeting on Biosimilar User Fees

On September 13, 2016, FDA announced that it will hold a public meeting on October 20, 2016, from 9 a.m. to 2 p.m. at the FDA White Oak Campus in Silver Spring, Maryland, to discuss recommendations for the reauthorization of...more

Health Update - September 2016

The Election’s Impact on Healthcare: Preparing for Potential Scenarios - Editor’s Note: Election 2016 will have a major impact on federal and state healthcare policy. To be prepared for all the possibilities, it’s...more

Is your cybersecurity upgrade FDA reportable?

In today’s marketplace, technology evolves at a rapid rate, and must adapt to changing circumstances, such as threats to cybersecurity. For device companies, some types of modifications to devices post-market - potentially...more

Deal Watch: Teva and Regeneron Announce Fasinumab Collaboration

On September 20, Teva Pharmaceutical Industries Ltd. and Regeneron Pharmaceuticals, Inc. announced an agreement to develop and commercialize fasinumab, an investigational NGF antibody currently under development by Regeneron...more

Taking Measure of HIPAA Enforcement

Last month, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced the largest settlement to date for alleged violations of the Health Insurance Portability and Accountability Act (HIPAA)....more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

FDA Mandates Black Box Warnings For Opioids And Benzodiazepines

The Food and Drug Administration (FDA) recently decided to require so-called “black box warnings” on nearly 400 products, warning of the risks of combining certain opioid medications and central nervous system depressants...more

FDA Requesting Comments on Biomarker List

FDA has announced the opening of a docket (FDA-2016-N-2610) for interested parties (academic researchers, regulated industries, consortia, patient groups, etc.) to submit suggestions, recommendations and comments on a...more

CMS's Payment Suspensions Wreak Havoc: Understanding the Risks

CMS payment suspensions can cripple any provider's or supplier's operations. Yet, CMS has the authority to impose a payment suspension upon the mere existence of "reliable information" that an overpayment or fraud may exist....more

FDA Announces Public Hearing on Off-Label Communications; Registration Deadline October 19, 2016

The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more

FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm

As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell...more

Hackers Post Athletes’ Medical and Drug Testing Records Online

Hacking group Fancy Bear, reportedly a Russian group, who allegedly hacked into the Democratic National Committee emails which made headlines, has posted U.S. Olympians’ medical and drug testing records online. Although it...more

Law Revamping Medicare ID Cards to Be Revived

Lawmakers are again eyeing ways to modernize the Medicare system, including a revamping of the identification cards used by Medicare beneficiaries. On Wednesday, the House Ways and Means’ health subcommittee held a hearing on...more

FDA Announces Upcoming Public Meeting on Its Recommendations for Reauthorizing the Biosimilar User Fee Act

Today FDA announced that it will hold a public meeting on October 20, 2016 to discuss its proposed recommendations for the reauthorization of the Biosimilar User Fee Act, which permits FDA to collect fees and use them for the...more

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