Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more
On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
On September 15, 2021, the Federal Trade Commission (FTC) voted 3–2 along party lines (with Republican commissioners dissenting) to issue a policy statement announcing an expansive interpretation of the FTC’s Health Breach...more
9/21/2021
/ Breach Notification Rule ,
Cybersecurity ,
Data Privacy ,
Data Security ,
Digital Health ,
Enforcement ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Mobile Health Apps ,
Personally Identifiable Information ,
PHI