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Data Protection Data Privacy Clinical Trials

Goodwin

Life Sciences Companies Must Navigate the DOJ Data Rule

Goodwin on

Life sciences companies have long been outside the scope of US national security regulations and benefited from significant exemptions under US privacy laws. ...more

Hogan Lovells

DOJ restricts data transfers to protect national security; research exemptions expanded in final rule

Hogan Lovells on

The U.S. Department of Justice (DOJ) has finalized its rule on “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” which restricts data brokerage...more

Hogan Lovells

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

Hogan Lovells on

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

Troutman Pepper Locke

CCPA Amendment Further Harmonizes with HIPAA and Provides Additional Exemptions

Troutman Pepper Locke on

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

Hogan Lovells

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

Hogan Lovells on

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

Society of Corporate Compliance and Ethics...

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

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

Hogan Lovells

Medical Research Council Advises on How to Anonymise Information for Research Purposes

Hogan Lovells on

Anonymisation has always been (and still is) a real challenge for those carrying out clinical research. To shed some light on this matter, the Medical Research Council (MCR) – which is part of UK Research and Innovation – has...more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

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

Hogan Lovells on

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

Morgan Lewis

Clinical Trial Data: The New Regime

Morgan Lewis on

The European Medicines Agency moves to increase EU clinical trial transparency. The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results, moving from...more

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