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FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

Small-Breach Focus Shows Growing Scope Of HIPAA Probes

Flexing yet more enforcement muscle under the Health Insurance Portability and Accountability Act, on Aug. 18, 2016, the U.S. Department of Health and Human Services Office for Civil Rights announced that it will more widely...more

Outdated Business Associate Agreement Leads to Another Six-Figure HIPAA Settlement

On September 23, 2016, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Care New England Health System (CNEHS) agreed to pay $400,000 and enter into a corrective action plan...more

Amgen’s Humira Biosimilar Becomes the Fourth FDA Approved Biosimilar

On Friday, September 23, the FDA approved its fourth biosimilar, Amgen’s biosimilar version of AbbVie’s Humira®. Amgen’s biosimilar, Amjevita®, has been approved for treatment of rheumatoid arthritis, juvenile idiopathic...more

Manatt on Health Reform: Weekly Highlights - September 2016 #4

Marylanders can shop for coverage through the Marketplace’s new mobile app; Michigan expansion enrollees report increased access to care and improved health; and survey finds states’ eligibility and enrollment systems...more

Health Alert (Australia) 26 September 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland - 10 September 2016 - Inquest into the death of C - C was a 14 year old girl with multiple physical and...more

FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

UPDATE: Got Data? Actual Harm Not Required for FTC Enforcement Action for Lax Security Measures

As anticipated, things are getting even more exciting with the case previously covered in Password Protected. Specifically, LabMD is appealing the landmark data security case between it and the Federal Trade Commission...more

Yuba Sutter Medical Center Hit With Ransomware

Yuba Sutter Medical Center in California (Yuba Sutter) has notified its patients that it has suffered a recent ransomware attack that caused parts of its network to be incapacitated. As a result, patient files were unable to...more

Ugly details emerge on how Big Pharma fueled painkiller scourge

New information has surfaced about Big Pharma’s relentless campaign to sell the public on prescription, opioid painkillers-powerful, addictive drugs whose wide availability and abuse now has become a killer scourge that...more

Precarious steps: patent eligibility for healthcare IT

The healthcare IT market, comprising electronic medical records, diagnostic systems and medical devices, is expected to top $100 billion this year. But this growth is tempered by an often hostile landscape for patenting,...more

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

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

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