News & Analysis as of

EHR New Guidance

King & Spalding

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

King & Spalding on

In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

Holland & Knight LLP

New HIPAA Guidance for Medical App Developers

Holland & Knight LLP on

The federal Department of Health and Human Services' Office for Civil Rights, which enforces HIPAA, maintains a website with very helpful "frequently asked questions" (FAQs) regarding the HIPAA Privacy Rule and Security Rule....more

Bricker Graydon LLP

FDA issues guidance on use of EHR data in clinical research

Bricker Graydon LLP on

Many hospitals and health systems conduct sponsored clinical research at their facilities, and clinical trial agreements typically require that sponsors and clinical investigators have access to certain data regarding the...more

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