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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The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days.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FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices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

North Carolina Legislative Report

Lawmakers returned to Raleigh for the Regular Session April 25, 2016. The MVA Public Affairs Legislative Report on North Carolina will be distributed weekly during session to keep you up to date on the latest legislative...more

Ukraine simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or Canada

On 20 April 2016 the Cabinet of Ministers of Ukraine adopted Resolution No. 312 amending the Procedure for State Registration (Registration Renewal) of Medicinal Products (the Procedure.) The changes took effect on May 13....more

Ukraine simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or Canada...

On 20 April 2016 the Cabinet of Ministers of Ukraine adopted Resolution No. 312 amending the Procedure for State Registration (Registration Renewal) of Medicinal Products (the Procedure.) The changes took effect on May 13....more

What's New with HIPAA?

A number of new developments have taken place related to Health Insurance Portability and Accountability Act (HIPAA) privacy and security compliance, and enforcement is increasing. Healthcare providers, health plans and other...more

Congress acts on opioid drug epidemic as judge unseals OxyContin files

Here are some developments worth watching in the nation’s battle against the epidemic of opioid drug misuse that killed 28,000 Americans in 2014 alone...more

Judgment Issues For Plaintiffs In ANDA Case

Sleet, J. The court issues findings of fact and conclusions of law and rules on post-trial motions. A 4-day trial took place between November 9-13, 2015. The disputed product is generic forms of plerixafor, which is...more

Top Takeaways from Fenwick’s Fifth Annual Digital Health Investor Summit

Fenwick’s fifth annual Digital Health Investor Summit brought together investors who are active in the digital health space to discuss the evolving digital health sector and their investment outlook for the year...more

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