FDA, FCC, ONC Release Risk-Based HIT Regulatory Framework

by GREG SLABODKIN  NEW DEVELOPMENT: Clinical decision support software now in the regulatory crosshairs The report on a risk-based health IT framework, which was due to Congress by January, includes mobile medical applications--a technology area previously addressed by the FDA's September 2013 final guidance on mobile medical apps. However, one area that wasn't covered in the final guidance but is included in the FDASIA-mandated report to Congress is the topic of clinical decision support software. In the proposed regulatory strategy for health IT released today, the report states that "most clinical decision support (CDS) functionalities can be categorized as health management health IT and that the "FDA does not intend to focus its oversight on CDS with health management health IT functionality. After months of delays, the Food and Drug Administration, Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology today released a proposed strategy and recommendations for a risk-based regulatory framework ... READ MORE »