News & Analysis as of

Healthcare Data Integrity

Butler Snow LLP

Empowering Healthcare with AI and Wearables: Smarter Data, Better Care … Or Not

Butler Snow LLP on

The advancement of artificial intelligence (AI) in healthcare information management is an unpredictable journey, both thrilling and daunting, akin to the wild west. Healthcare accounts for over 30% of the world’s data...more

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

Alston & Bird on

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

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