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Electronically Stored Information Medical Devices

Array

This Week in eDiscovery: Data Growth Survey Findings | EDNY Refuses “Discovery on Discovery” | Cooperative eDiscovery

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Every week, the Array team reviews the latest news and analysis about the evolving field of eDiscovery to bring you the topics and trends you need to know. This week’s post covers the period of December 1-7. Here’s what’s...more

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

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Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

Ankura on

The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

Hanzo

Complying With the FDA’s Advertising Regulations: Why You Need an Interactive Website Archive

Hanzo on

Pharmaceutical advertising is big business. In 2020, pharmaceutical companies spent more than $6.5 billion on advertising. The Food and Drug Administration (FDA) regulates advertisements of prescription drugs, but it...more

Reveal

There Are More Challenges in Managing Discovery in Healthcare Than You Probably Realize

Reveal on

A few months ago on this blog, I wrote about using Artificial Intelligence (AI) to keep up with the “alphabet soup” of compliance. An important area to address from a compliance standpoint is health data and at least two of...more

Faegre Drinker Biddle & Reath LLP

FDA Relaxes Modification Restrictions for Non-Invasive Remote Monitoring Devices During COVID-19 Public Health Emergency

On March 20, 2020, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued a new guidance document for industry and FDA staff, attempting to “help expand the availability and capability...more

Hanzo

How a Multifaceted Lawyer Takes on Multidistrict Litigation

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Sean Burke, Partner at Duane Morris, fills us in on the challenges of multidistrict litigation, the advantages of social media evidence, and new medical device technology. Sean Burke, a partner at Duane Morris LLP,...more

The Volkov Law Group

E-Mail Communications: The Devil is on the Server

The Volkov Law Group on

It is hard to imagine how prosecutors were able to bring cases before there was email communications. When I was a prosecutor, we looked for evidence in a lot of other sources, internal memos, calendars and other places where...more

Polsinelli

FDA Releases Final Cybersecurity Guidance for Medical Devices

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Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more

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