Compliance Tip of the Day: Crowd Sourcing Risk Intelligence
AI in eDiscovery Today: An Open Conversation
Tenant Tales and Reseller Realities: Inside the FCRA Arena With Eric Ellman — FCRA Focus Podcast
Early Returns Podcast - Oliver Roberts: AI and the Law, and an Education
Driven by Data: Auto Finance Trends Uncovered - Moving the Metal: The Auto Finance Podcast
The Privacy Insider Podcast Episode 13: Preserving Privacy and Social Connection with Christine Rosen of the American Enterprise Institute
Innovations in Compliance: Data Collection & Cybersecurity with ModeOne’s Matt Rasmussen and Ryan Frye
Early Days of the Trump Administration: Impact on the CFPB — The Consumer Finance Podcast
CFPB's Inquiry Into Payments Privacy — Payments Pros – The Payments Law Podcast
Innovation in Second Requests: Data is Your Greatest Asset
Podcast: How Delaying Third Party Discovery Can End Up Costing You Dearly
No Password Required: Director and Cybersecurity Adviser at KPMG and Rain Culture Authority
Podcast - Bowling with Bumpers: Using a Privacy Framework to Set Your Company Up for a Strike
The Presumption of Innocence Podcast: Episode 48 - Digital Boundaries: Fourth Amendment Protections in a Connected World
eDiscovery Needs Digital Forensics for a Mobile World
A Sneak Peek into Data Mapping: What Implementation Really Looks Like
It's Time to Think About Data Mapping Differently
EEO-1 Filing After June 4: What to Do Now, and How to Prepare for Next Year - Employment Law This Week®
Navigating State Privacy Laws
[Webinar] You Are Here: First Steps in Data Mapping
The U.K. Government has announced the creation of a new U.K-wide Health Data Research Service that will provide a secure single access point to national-scale data sets. The Wellcome Trust and the Government will invest up to...more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more
The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document entitled, “Collection of Race and Ethnicity...more
In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more
The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more
In a notable step toward more equitable healthcare, the U.S. Food and Drug Administration (FDA) introduced new draft guidance on August 10, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical...more
Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more
In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more
With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more
On July 1, 2019, the Administrative Regulations on Human Genetic Resources (人类遗传资源管理条例) (the “Regulations”) issued by the State Council of the People’s Republic of China (the “PRC”) came into effect. On October 17, 2020, the...more
The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. DHT can take the form of hardware and...more
n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more
Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more
On September 28, California Governor Gavin Newsom signed AB-713 into law, which relaxes some of the California Consumer Privacy Act (CCPA) compliance challenges faced by the health care and life science industries — more...more
Digital health technologies have brought a number of significant breakthroughs to clinical trial programs, including faster patient recruitment, more efficient data collection, and better tracking of biometric information....more
Typically, if you hear “technology-assisted review” echoing in a room, you’re probably in a courtroom. Surprisingly, that may no longer be the case. Maura Grossman and Gordon Cormack are taking technology-assisted review...more
As the world focuses its efforts on the right strategy to beat the coronavirus and make normal life safe again, businesses are devising and implementing a variety of measures to deal with the COVID-19 crisis which rely on the...more
The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials...more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more
Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more
On January 23, 2019, the European Data Protection Board (“EDPB”) issued an interesting opinion about personal data processed in relation to clinical trials. The main role of the EDPB – which succeeded the Article 29...more
On January 23, 2019, the European Data Protection Board (“EDPB”), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, adopted an Advisory Opinion...more
The European Medicines Agency (EMA) has published a draft qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU....more