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Data Collection Data Privacy Food and Drug Administration (FDA)

Hogan Lovells

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

Hogan Lovells on

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

Mintz - Health Care Viewpoints

OHRP Workshop Highlights Artificial Intelligence Uses, Concerns in Human Research

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice”...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

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Volume 3, Issue 16

CHIPS and Science Act Will Lower Costs, Create Jobs, Strengthen Supply Chains, and Counter China "Spurred by the passage of the CHIPS and Science Act of 2022, companies have announced nearly $50 billion in additional...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 3, Issue 5

The Cryptocurrency Revolution and President Biden's Formal Recognition - Out of the ashes of the 2008 financial crisis, Bitcoin sprang up like an insurgency, targeting both the unbridled activity of large financial...more

King & Spalding

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

King & Spalding on

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

Foley & Lardner LLP

FDA Addresses the Role of Digital Health Technology in Clinical Trials

Foley & Lardner LLP on

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

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

Proskauer - The Patent Playbook

Synthetic Data Gets Real

As we mentioned in the early days of the pandemic, COVID-19 has been accompanied by a rise in cyberattacks worldwide. At the same time, the global response to the pandemic has accelerated interest in the collection, analysis,...more

McDermott Will & Emery

[Webinar] Around the Corner: Evolving Opportunities and Challenges for Real-World Evidence and Data-Powered Solutions - August...

McDermott Will & Emery on

Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - January 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug Practice....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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