The Food and Drug Administration would retain control over medical-device software it already regulates that could pose patient safety risks if glitches occur. Most health IT products, however, including complex systems such as computerized physician-order entry and medication management software, would fall under a lower-risk category, which, according to the proposed framework, would not be regulated by the FDA.
A central component of the plan is the establishment of a Health IT Safety Center, a clearinghouse for healthcare IT patient safety reports.
“We believe that the safety center has the potential to bring substantial value to the country,” said the HITPC work group's chairman, Dr. David Bates. He added that the safety center should be a government-supported, public-private partnership “outside of government.” Bates is the medical director of clinical and quality analysis, information systems at Partners HealthCare System, Boston. A final version of the federal regulatory framework isn't due until winter.
American Medical Association Executive Vice President and CEO Dr. James Madara said in a letter to the FDA that the AMA backs the plan's “risk-based framework for oversight and regulation.” The AMA also “strongly supports” the safety center, he wrote.
But some key groups are “extremely concerned with the feasibility of a three-category system under which all health IT will be regulated,” calling it, “a simplistic approach,” according to the mHealth Regulatory Coalition, whose members include medical devicemakers and application developers.
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