Acting on mandates of the FDA Safety and Innovation Act ("FDASIA"), FDA, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology continue to focus on developing a common, risk-based regulatory framework for addressing health information technology ("health IT"). At a three-day workshop last month, representatives from these agencies met with consumer and industry stakeholders, including the American Medical Association, who urged regulators to act soon in developing a central program to provide guidelines on health IT safety. Promoting continual improvement and evidence-based care in health IT were key themes of the discussion. In April, the three agencies released a report calling for the creation of a Health IT Safety Center, and their joint policy committee plans to meet in July to hammer out details of the Center's governance, function, and data-collection activities. The public comment period on the proposed risk-based regulatory framework closes July 7.
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