National Coordinator for Health Information Technology Karen DeSalvo, M.D., this morning kicked off a three-day public meeting to get industry comment on the federal government's proposed strategy for regulating health IT.
"We are here today to work with you all to understand your feedback and your thoughts," DeSalvo told the audience. "We look forward to that being candid, as I know many of you always are."
The May 13-15 meeting, hosted by the Food and Drug Administration, Office of the National Coordinator for Health IT and Federal Communications Commission, is meant to solicit public comment on the agencies draft strategy released April 3 which divides health IT products into three categories--administrative health IT functions, health management health IT functions, and medical device health IT functions--based on functionality and risk. The proposed risk-based regulatory framework for health IT, mandated by the FDA Safety and Innovation Act, focuses on what a product does regardless of the platform on which it operates.
Bakul Patel, senior policy advisor for the FDA's Center for Devices and Radiological Health, described the framework as a "platform agnostic" approach. In the first panel session of the day, stakeholders were generally supportive of the FDASIA health IT report's emphasis on functionality.
"We think your approach is on track. We would suggest that it needs a lot more specificity around it. I think that's one of the goals of why we are here today," said Joel White, executive director of the Health IT Now Coalition. "We have advocated for a risk-based framework. And so, we like a lot of the aspects of the report. We think that any effective regulatory approach that is risk based would accommodate a number of different pathways to market. And, we think the risk-based approach is most effective when we use a functional-based definition of the technologies."
Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, emphasized that the agencies have recommended a "limited, narrowly tailored" regulatory approach that "relies primarily on ONC-coordinated activities and leverages private sector capabilities and experience" and that "no new extensive regulation is needed."
The meeting, held at the National Institute of Standards and Technology in Gaithersburg, Md., will address the proposed federal Health IT report's four strategic priority areas: promoting use of quality management principles; identifying, developing and adopting standards and best practices; leveraging conformity assessment tools; and creating an environment of learning and continual improvement. Six panels will take place at the meeting over the next three days, with each panel discussing two assigned topics.
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