News & Analysis as of July 2, 2025

Cybersecurity › Clinical Trials › Data Privacy

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

Life Sciences Law Update - Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

Hogan Lovells on 1/22/2025

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Health Care Compliance Association (HCCA) on 8/8/2023

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

New FDA electronic records guidance prioritizes Digital Health Technology oversight

Hogan Lovells on 3/28/2023

On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...more

The DOJ’s Focus on Clinical Trial Enforcement: An Ounce of Prevention Is Better Than an Enforcement Action Cure

Orrick, Herrington & Sutcliffe LLP on 4/27/2022

In early April, the U.S. Department of Justice (DOJ) Civil Division’s Consumer Protection Branch (CPB) published its first-ever “Recent Highlights” report. The report provides background on the CPB, highlights from its recent...more

A closer look: Remote monitoring terms in Clinical Trial Agreements require careful review

Hogan Lovells on 4/22/2022

Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every...more

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on 2/17/2022

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

FDA Addresses the Role of Digital Health Technology in Clinical Trials

Foley & Lardner LLP on 1/12/2022

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

CCPA Amendment Further Harmonizes with HIPAA and Provides Additional Exemptions

Troutman Pepper Locke on 10/2/2020

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

COVID-19 Exit Strategy: A Global Privacy and Cybersecurity Guide - May 2020

Hogan Lovells on 5/21/2020

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

[Event] Regional Compliance & Ethics Conference - February 27th - 28th, Anchorage, AK

Society of Corporate Compliance and Ethics... on 2/6/2020

This two-day Regional Compliance and Ethics Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

California Consumer Privacy Act: The Challenge Ahead – Four Key Considerations For Health And Life Sciences Companies

Hogan Lovells on 10/8/2018

This is the sixth installment in Hogan Lovells’ series on the California Consumer Privacy Act. The California Consumer Privacy Act of 2018 (CCPA) adds another set of privacy requirements for health and life sciences...more

California Consumer Privacy Act: The Challenge Ahead — Introduction to Hogan Lovells’ Blog Series

Hogan Lovells on 9/13/2018

Groundbreaking. Watershed. Unprecedented. - We have heard the California Consumer Privacy Act of 2018 (CCPA) called all these things and more since its enactment on June 28, ?2018. Our experience to date has confirmed the...more

FDA Establishes Electronic Privacy, Security, and Reliability Criteria for Clinical Trial Records

Jones Day on 8/2/2017

In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more

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