FCPA Compliance Report: AI, Data Compliance, and Ownership - A Conversation with Andrew Hopkins
Compliance into the Weeds: Unsexy Keys to Data Analytics for Compliance Programs
A Blueprint for Efficient SRRs: Mastering Your Subject Rights Workflow
A Less is More Strategy for Data Risk Mitigation
All in the Family: What’s Next for Cloud Attachments in eDiscovery?
Podcast - Bowling with Bumpers: Using a Privacy Framework to Set Your Company Up for a Strike
A Sneak Peek into Data Mapping: What Implementation Really Looks Like
It's Time to Think About Data Mapping Differently
Monumental Win in Data Breach Class Action: A Case Study — The Consumer Finance Podcast
[Webinar] AI and Data Privacy: Minimizing Risk and Maximizing Opportunity
Work This Way: A Labor & Employment Law Podcast | Episode 15: eDiscovery for Employers with Angela O’Neal, Nextra Solutions Director
Calculating eDiscovery Costs: Tips from Brett Burney
Work This Way: A Labor & Employment Law Podcast - Episode 6: Digital Forensics & Protecting Trade Secrets with Clark Walton
Managing Large Scale Review Efficiency: Tips From a GC
Record Retention and Information Governance
The Great Link Debate and the Future of Cloud Collaboration
Data Driven Compliance - Malcolm Hawker and Fit for Purpose Data
Review Analytics for a New Era
Data Governance for the BYOD Age
Podcast: Interoperability: Health Care's Next Disruptor Is openEHR - Diagnosing Health Care
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more
On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more
On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions (AI-DFS) final...more
As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more
In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most recently, AI has been used in the...more
Harnessing existing digital health solutions to improve chronic care management was a prominent topic at HIMMS this year (amongst many others, including AI and cybersecurity, both of which we will cover in upcoming blog...more