Health Science, Computers & Technology

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New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

Telemedicine in the UAE

Telemedicine is a product of 20th century information and communication technologies. It is generally defined as the provision of healthcare services from a healthcare professional to a patient from a remote location using a...more

Health Update - May 2016

Actions to Advance Infant and Early Childhood Mental Health - Editor's Note: Children's earliest experiences—both positive and negative—impact their brain formation and in turn their social and emotional, physical,...more

Also In the News - Data, Privacy, & Security Practice Report - May 2016 #2

K&S Client Alert: Third Try Is A Charm: Defend Trade Secrets Act Of 2015 Enacted Into Law—For the third consecutive year, Congress introduced legislation to create a federal civil cause of action for trade secret...more

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

Patient and Provider Groups Urge FDA to Institute Meaningful and Memorable Names for Biosimilars

A coalition of patient and provider groups sent an open letter to Leah Christl, FDA’s associate director for therapeutic biologics and biosimilars, urging FDA to use meaningful names for biosimilars instead of random ones. ...more

Illinois Enacts Sweeping Changes to the Illinois Personal Information Protection Act

On May 6, 2016, Illinois joined a growing number of states that have strengthened their data breach notification requirements and expanded the definition of protected personal information. Effective January 1, 2017, HB1260...more

FDA issues guidance on the use of EHRs in clinical investigations

The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all...more

Medicare Part B Drug Payment Model

The Department of Health and Human Services (HHS) has proposed a major, national payment model that would, if implemented, significantly impact how Medicare pays for drugs provided through the Part B program. Under the...more

FDA’S Draft Guidelines for 3D Printing of Medical Devices

On May 10, 2016, the FDA issued a document entitled Technical Considerations for Additive Manufacturing Devices. The document consists of 25 pages of “draft” guidelines that provide the FDA’s “initial thinking on...more

Despite Barriers, Community Speciality Clinics are Eager to Adopt Precision Medicine Tools

Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights...more

Newest Ponemon study released on health care data breaches

The Ponemon Institute has recently released its Sixth Annual Benchmark Study on Privacy & Security of Healthcare Data. The study has included business associates for the past two years. The study included information received...more

Is Overreporting Adverse Event Information Always In A Company’s Best Interest?

Recently, we moderated a panel at the Food and Drug Law Institute’s Annual Conference, where a senior Food and Drug Administration official participated. The individual from the Center for Drug Evaluation and Research made an...more

Mass Appeal of Off Label Use

Hardly a week goes by without our blogging about accusations of off label promotion. This week is no exception. On Monday, we discussed a nice New York opinion rejecting a plaintiff argument that off label promotion saved a...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special...more

FDA Releases Draft Guidance for 3D Printed Medical Devices

On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations...more

MACRA for Health IT Vendors – New Rule Presents New Opportunities

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and the corresponding proposed rule, published on May 9 and going into effect on January 1, 2017, will directly impact health IT vendors. Most significantly,...more

The E-Cigarettes Industry Fights Back Challenging the FDA in Federal Court

Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in...more

Your daily dose of financial news The Brief – 5.17.16

Gannet’s still after Tribune Publishing, and it’s upped its ante after Tribune “resoundingly rejected” early overtures – NYTimes... The Journal walks us through the fall of the Laplanche empire at Lending Club with a...more

Guest Post - Implied Certification: An Eradicated Pest or Here to Stay?

Today’s guest post is courtesy of Reed Smith’s Lindsey Harteis. She’s been following the big-deal UHS v. Escobar False Claims Act that the Supreme Court could decide any day now (or could wait until the end of June), which...more

Intermedix data breach class action case dismissed

We previously reported that Intermedix was sued in a class action lawsuit regarding the data breach involving millions of patient records....more

Senate Finance Report Puts another Nail in the POD Coffin

On May 10, 2016, the Senate Finance Committee Majority Staff released a long-awaited report entitled “Physician Owned Distributorships: An Update on Key Issues and Areas of Congressional Concern” (Report). The Report follows...more

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