News & Analysis as of

Data Privacy Clinical Trials Medical Devices

Hogan Lovells

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

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Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug prices; France adopts standard CTA clauses; UK easing clinical trials; Devices:...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

A&O Shearman on

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Hogan Lovells

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

Hogan Lovells on

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

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Hogan Lovells

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

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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

McDermott Will & Emery

Special Report: Developments in UK Life Sciences – Spring Update 2022

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MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

Health Care Compliance Association (HCCA)

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

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

King & Spalding

A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

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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

Sheppard Mullin Richter & Hampton LLP

FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

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

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Latham & Watkins LLP

EU-UK Trade and Cooperation Agreement: Implications for Life Sciences Companies

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The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more

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