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FDA Issues Guidance on Use of Real-World Evidence for Medical Devices

by Arnall Golden Gregory LLP on

On August 31, 2017, the Food and Drug Aministration issued a final guidance titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” In the guidance, which finalizes the agency’s July...more

In the Wake of Harvey and Irma, OCR Reminds Providers of HIPAA Rules

As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR)...more

CHMP Adopts Positive Opinions on BI’s CYLTEZO® and Samsung Bioepis’s ONTRUZANT®

by Goodwin on

On September 15, Boehringer Ingelheim (BI) and Samsung Bioepis each issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...more

Health Update - September 2017

Using Telehealth as a Tool for Health System Integration - As discussed in our August Health Update article on patient engagement and digital health—the first in our new digital health series—the advent of digital and...more

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

by Holland & Knight LLP on

On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

Research into Cannabidiol (CBD) Progresses

by Knobbe Martens on

Kalytera Therapeutics, clinical-stage pharmaceutical company, recently announced plans for clinical trials focused on the treatment of Graft versus Host Disease using Cannabidiol (CBD), a compound found in cannabis. This...more

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

Legal Implications and Initial Takeaways from the Equifax Data Breach

On September 7, Equifax, one of three nationwide credit-reporting agencies that compile and evaluate the financial history of consumers, announced that it suffered a security breach in which sensitive information of...more

Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

by Stinson Leonard Street on

In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions...more

Social Media Success: Trends in Pharma Digital Strategies

by Knobbe Martens on

Information, the majority (73%) of pharmaceutical marketing teams expect to use or continue to use the popular social media forum Facebook to facilitate their digital marketing strategies over the next one to two years....more

Recall Highlights Medical Device Cybersecurity Issues

by Knobbe Martens on

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more

Global Privacy & Cybersecurity Update Vol. 15

by Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Comments on Improvements to IoT Device Security - On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the...more

Judge Talwani Dismisses Diagnostic Patent Infringement Case under Section 101

In a recent patent infringement case relating to a method for diagnosing a neuro-muscular disorder, Judge Indira Talwani in the District of Massachusetts found the asserted patent claims to be patent ineligible because the...more

FDA Approves First Cancer-Treatment Biosimilar -- Amgen's Mvasi

Earlier on September 14, 2017, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple...more

Medical Monitoring Class Certification Fails

by Reed Smith on

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing...more

New Jersey Joins Wave of States Proposing New Rules for Drug Marketing and HCP Interactions

by Hogan Lovells on

Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully, consider how they might engage with the...more

Joint Commission Introduces New Accreditation Standards for Telehealth Services

by Foley & Lardner LLP on

The Joint Commission has proposed changes to its accreditation standards to account for direct-to-patient telehealth services. The new standards will apply to Joint Commission-accredited hospitals and ambulatory health care...more

FDA Approves Amgen’s Biosimilar of Avastin®

by Goodwin on

Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of...more

The Biggest Health Care Data Breaches in 2017

Health Data Management (HDM), using information compiled by Protenus Breach Barometer, published a list this week of the biggest health care data breaches so far in 2017....more

Digital Currencies and Blockchain in the Medical Arena

by Knobbe Martens on

Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that...more

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

by Knobbe Martens on

On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio,...more

Northern District of New York (Quickly!) Holds that the MDA Expressly Preempts Essure Suit

by Reed Smith on

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from...more

A Little Help From HIPAA

by McGuireWoods LLP on

HIPAA’s Security Rule requires that Covered Entities perform “periodic” Security Risk Assessments. All too often, however, this regulatory obligation is ignored altogether, performed extremely sporadically, or treated as a...more

Congressional Task Force Issues Report on Cybersecurity in the Health Care Industry

by Polsinelli on

Recently, the Health Care Industry Cybersecurity Task Force (the “Task Force”) issued its Report on Improving Cybersecurity in the Health Care Industry (the “Report”). The Task Force, which was created by Congress as part of...more

Takeda Pharmaceuticals Explores GI Devices in New Partnership with Nanotechnology Company

by Knobbe Martens on

Takeda Pharmaceutical Company, a Japan-based global pharmaceutical company, recently announced an agreement with BioSurfaces Inc., a small Massachusetts research company, to research the development of medical devices for the...more

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