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Data Collection Data Security Food and Drug Administration (FDA)

Foley & Lardner LLP

FDA Clinical Investigations: New Guidance on Electronic Systems

Foley & Lardner LLP on

On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - April 2022

In this month’s Privacy & Cybersecurity Update, we examine the FTC chair’s comments suggesting a potential shift in its approach to data privacy regulation, the European Data Protection Board’s request for comment on its...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 17

China Passes Major Data Protection Law as Regulatory Scrutiny on Tech Sector Intensifies - A final version of the law has not been published but a previous draft included rules around requiring consent for data protection...more

K&L Gates LLP

K&L Gates Triage: FDA & Health Care Update: The Use of Real-World Data and Real-World Evidence in Medical Product Development

K&L Gates LLP on

In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and...more

Arnall Golden Gregory LLP

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

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