FDA Safety and Innovation Act of 2012 and Health Information Technology

Thursday, July 5, 2012

The FDA Safety and Innovation Act (aka FDA User Fee Agreement) was passed by the House on June 20th and by the Senate on June 26th. It has been presented to the President for his signature. The bill includes provisions to improve drug safety, bring breakthrough treatments to patients quicker, advance medical device innovations and prevent critical drug shortages. Section 618 of the compromise bill, addresses the regulatory structure for health information technology (HIT). The legislation calls upon the Food and Drug Administration (FDA), the Federal Communications Commission (FCC) and the Office of the National Coordinator for Health Information Technology (ONC) to post on their web sites, within 18 months, a strategy and recommendations for an “appropriate, risk based regulatory framework” for health IT, including mobile medical applications , that promotes innovation, protects patient safety, and avoids regulatory duplication. The bill also allows (does not require) the Secretary to convene an external working group to provide input into the strategy and recommendations. In effect, this provision allows HHS (including both ONC and the FDA) to continue to move toward Guidance – and, possibly – Regulations relating to mobile apps, if it chooses to.