We get Privacy for work — Episode 7: What Is a WISP and Why Your Organization Must Have One
Under the Radar: DOJ's Data Security Rules and Their Impact on Payments Companies — Payments Pros – The Payments Law Podcast
Podcast - Regulating AI in Healthcare: The Road Ahead
No Password Required: Former Lead Attorney at U.S. Cyber Command, Cyber Law Strategist, and Appreciator of ‘Mad Men’ Hats
We get Privacy for work – Episode 6: The Potential Privacy Risks Inherent to Mergers and Acquisitions
Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
FCPA Compliance Report: Ethical Challenges in AI, Data Protection, and Sports with Andre Paris
We get Privacy for work: The Privacy Pitfalls of a Remote Workforce
No Password Required: From AOL to Award-Winning Cuisine to High-Stakes Hacking
Everything Compliance: Episode 156, To Document or Not Edition
AI on the Job: How to Stay Ahead of Employment and Data Privacy Risks
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — Regulatory Oversight Podcast
Constangy Clips Ep. 10 - 3 Ways the GDPR Is Evolving with Today’s Tech Landscape
The Privacy Insider Podcast Episode 14: The Pig Around the Corner: Privacy and Trade with Constantine Karbaliotis of nNovation LLP
FCPA Compliance Report: AI, Data Compliance, and Ownership - A Conversation with Andrew Hopkins
A Less is More Strategy for Data Risk Mitigation
Weathering the 2025 Whirlwind: How to Keep Calm & Carry On
Approach to Responsible AI
Why Privacy Matters to Your Business and What's in Store for 2025
No Password Required Podcast: Senior Security Researcher at Nokia and Guardian of Secure AI Networks
No Safe Harbor: New DOJ Data Export Rule Restricts Deidentified Data Transfer - This article outlines new requirements from the Department of Justice regarding “bulk sensitive data”, including de-identified, anonymized,...more
On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...more
The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more
Life sciences companies have long been outside the scope of US national security regulations and benefited from significant exemptions under US privacy laws. ...more
Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more
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
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials (Draft Guidance). It provides sponsors and others involved in clinical trial...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more
The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
Some weeks ago, we described the highlights of the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance" (CoC) and the impact on data...more
A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the initial version, dated back to 2016, was missing some key provisions...more
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
Last week we raised our hands to inform you about the Spanish Data Protection Authority’s approval of the "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well...more
Research and development, innovation, product and service improvement, AI design and deployment...these are key commercial drivers for the successful modern business. They also underpin technological, medicinal, and other...more
The Spanish Data Protection Authority published on Friday on its website the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance"...more
On 31 January 2022, the EU Clinical Trial Regulation (CTR) will come into application, almost 8 years after its adoption by the European Parliament and the Council of the EU. The CTR will radically change the regulatory...more
Multinational pharmaceutical companies, by nature of their business, handle a great deal of data, often transferred across borders, whether based on research, clinical trial data, and employee personal data....more
Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...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
Given the challenges of conducting clinical trials during the COVID-19 pandemic, many countries — including France — have allowed for some use of remote quality controls. In response to guidelines issued recently by European...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