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HIT Policy Committee OKs Recommendations on Regulatory Framework for Health IT

September 4, 2013
by David Raths
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Sept. 4 marked the last Health IT Policy Committee meeting under the direction of Farzad Mostashari, M.D., as national coordinator of health IT. The meeting saw lively discussion on two fronts: first, recommendations regarding the development of a risk-based regulatory framework and strategy for health information technology; and second, progress on the meaningful use work group’s efforts to develop a framework for outcome-oriented measures as part of Stage 3 of meaningful use.

Mostashari led off the meeting noting that based on his discussions with providers working in accountable care settings, the regulatory shift toward outcomes aligns well with value-based purchasing approaches.

Providers talk about the importance of being able to understand and analyze the full, longitudinal history of the patient, he said. “As I think of what we have put in place, it is absolutely going in the right direction. We still have a long way to go. It is still too hard to use the certified EHR in the way providers want to. It is still too hard to get information out of the system into third-party applications should they chose to use them. So we have to keep pushing, and dig deeper to get to a common floor of capabilities across the country.”  Providers often feel they have very little negotiating power with vendors, he added. “We need to have common assumptions about what systems can do. We are on the right track.”

The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 calls for the HHS Secretary to post a report by January 2014 that contains a proposed strategy and recommendations on a risk-based regulatory framework pertaining to health IT, including mobile applications, that “promotes innovation, protects patient safety, and avoids regulatory duplication.”

David W. Bates, M.D., of Brigham and Women’s Hospital in Boston, chaired an FDAISA Committee that is making recommendations to FDA, ONC and the FCC.

At the Sept. 4 meeting, Bates outlined those recommendations and drew only enthusiastic comments from committee members about the thoroughness and thoughtfulness of the report. The main gist of the recommendations is that substantial additional regulation of health IT beyond what is currently in place is not needed and would not be helpful, except for:

• Medical device data systems;

• Medical device accessories; and

• Certain forms of high-risk clinical decision support.

But the committee does recommend that a patient safety risk framework should be used to develop a more robust and transparent framework, which would allow application of oversight by level of risk. Any new risk framework should support re-evaluation of what is currently regulated as well as new HIT, Bates said.

Paul Tang, M.D., chair of the meaningful use work group, described how his work group is focusing Stage 3 on outcomes rather than processes. Its current challenge is to link functional objective recommendations to the desired outcomes of improved health. A subgroup is working to develop recommendations for “HIT-sensitive,” outcomes-oriented electronic clinical quality measure (eCQM) concepts and specific measures that could be used for Stage 3.

The workgroup is also developing a “deeming pathway,” so that high-performing meaningful users (or significant improvers) who have already met all functional objectives in stages 1 and 2 could attest for MU by satisfying a subset of MU objectives. These providers could achieve high performance on two eCQMs in each of two high-priority categories and reduce disparity gaps in one area. The MU work group’s next steps will be to identify high-priority categories in which attesters must achieve high CQM performance and explore thresholds for participation. It will make final Stage 3 recommendations later in the fall.

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