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HITECH Act Clinical Trials

Hogan Lovells

A closer look: Remote monitoring terms in Clinical Trial Agreements require careful review

Hogan Lovells on

Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every...more

Bradley Arant Boult Cummings LLP

Lawmakers Propose CCPA Amendment to Further Except Healthcare and Research Information - Cybersecurity and Privacy Alert

A little more than a week after California’s groundbreaking California Consumer Protection and Privacy Act (CCPA) went into effect on January 1, the Senate Health Committee unanimously approved A.B. 713, introduced by...more

Hogan Lovells

California Consumer Privacy Act: The Challenge Ahead — Introduction to Hogan Lovells’ Blog Series

Hogan Lovells on

Groundbreaking. Watershed. Unprecedented. - We have heard the California Consumer Privacy Act of 2018 (CCPA) called all these things and more since its enactment on June 28, ?2018. Our experience to date has confirmed the...more

Dickinson Wright

Healthcare Legal News: Volume 7, Number 2

Dickinson Wright on

Where is your PHI Data Traveling Today? With most vendors offering and pushing cloud computing solutions and offsite data backup, or guaranteeing offsite backup of data they process for you, many HIPAA covered entities and...more

Morgan Lewis

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

Morgan Lewis on

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

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