Policy Committee Endorses Creating a Health IT Safety Center

July 9, 2014 in News

On Tuesday, the Health IT Policy Committee voted to endorse a workgroup’s recommendation to create a Health IT Safety Center, Modern Healthcare reports (Tahir [1], Modern Healthcare, 7/8).


As directed by the Food and Drug Administration Safety and Innovation Act, HHS in April released a draft report that included a proposed strategy and recommendations for creating a risk-based health IT regulatory framework.

The draft report was developed by FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission.

Among other things, the proposed framework calls on ONC to work with FDA, FCC, the Agency for Healthcare Research and Quality and other stakeholders to create a public-private Health IT Safety Center. The center would be tasked with developing best practices and providing an avenue for sharing information and ideas related to patient safety (iHealthBeat, 6/11).

Details of Workgroup Recommendation

David Bates — chair of the workgroup and senior vice president for quality and safety at Brigham and Women’s Hospital — told the Policy Committee that the Health IT Safety Center’s main focus should be on the “three Es”:

  • Education, which could include gathering information and sharing it with the community;
  • Engagement with consumers, providers and vendors; and
  • Evidence, which could include identifying broad safety trends in the health IT sector (Tahir [2], Modern Healthcare, 7/5).

Further, Bates said the workgroup recommended that the Safety Center be supported by a large board composed of consumers, doctors and vendors. However, he said a smaller executive board — made up of 10 to 12 members — should be in charge of decision-making for the center.

Safety Center Challenges

Bates said that current data flows could be a challenge to developing the Safety Center, as data from patient-safety organizations are “limited” and the industry has “not been terribly forthcoming.”

One way the Safety Center can address this issue is by providing value to its constituents, Bates said.

He also noted that funding — both public and private — will be an ongoing issue for the center. Several Republicans from the House Energy and Commerce Committee already have questioned whether private funding for the center is mandatory, Modern Healthcare reports.

Next Steps

ONC said the workgroup’s recommendations will be presented to the head of the agency, but there is no specific timeline for next steps, Modern Healthcare reports.

However, the agency did include the Safety Center as a line item in its most recent budget (Tahir [1], Modern Healthcare, 7/8).

Comments on Safety Center, Health IT Regulatory Draft Framework

In related news, comments on both the health IT regulatory draft framework and the Safety Center have flooded in, Modern Healthcare reports (Tahir [3], Modern Healthcare, 7/8).

Meanwhile, the Healthcare Information and Management Systems Society said that the Safety Center “should operate within the scope outlined in the draft report — not as a regulatory or oversight body, but rather focus on gaining evidence and knowledge without specific implementation responsibility.”

HIMSS also suggested that the Safety Center “operate transparently, with clear roles for public and private sector participants, open meetings and potential opportunities to review drafts of policies” (Walsh, Clinical Innovation Technology, 7/8).

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