Federal Regulation of HIT Embedded in New Law

Published
  • July 11 2012, 12:06pm EDT

President Obama has signed the Food and Drug Administration Safety and Innovation Act, which includes language to establish federal regulation of the safety and functionality of health information technology applications, including mobile apps. The bill now is Public Law 112-144.

The new law has many changes for the FDA, including updated user fees that pay for regulatory programs, new policies to better manage drug shortages, and mandated establishment of unique medical device identifiers.

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