Until the Food and Drug Administration provides further clarification on what types of applications would be viewed as clinical decision support, this software category will remain a regulatory gray area leaving developers unclear as to how to market these products. That is the consensus of stakeholders who met May 14 as part of a public meeting on a risk-based health IT regulatory framework proposed by federal agencies.
At Wednesdays meeting, stakeholders discussed the possible factors used to determine whether CDS should be regulated. William Maisel from FDA's Center for Devices and Radiological Health said the draft framework that FDA, ONC and FCC released April 3 defines CDS as providing healthcare professionals and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and healthcare. However, stakeholders expressed their confusion regarding regulatory oversight of CDS software.
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