Proposed HIT Safety Center Likely To Have Light Touch

By Christine Kern, contributing writer

Health IT Safety Center would monitor the safety of health IT products, but it is already being called ‘outdated’ by critics.

The ONC’s policy advisory committee has endorsed recommendations from a workgroup for a proposed Health IT Safety Center – a concept introduced in April in a draft framework from the FDA, FCC, and ONC – and intended to serve as a place to monitor the safety of health IT products. But that broad brief left many details undefined, leaving it to a workgroup convened by ONC to add flesh to the bones.

David Bates, chairman of the workgroup and senior vice president for quality and safety at Brigham and Women’s Hospital, said the workgroup recommends that the overall focus of the center should be on the “three Es”: engagement with providers, vendors and consumers; evidence, i.e., finding what broad safety trends are occurring in the sector; and education, including taking what’s learned, and educating the community on the best way to proceed.

So what does this mean for providers? Ultimately, it seems, those healthcare providers that heavily invested in health information technology will likely feel only a light regulatory touch from federal agencies seeking to devise a framework for patient-safety oversight and monitoring of those systems, recent developments indicate.

Although a final version of a federal regulatory position statement isn't due until winter, a preliminary draft completed its 90-day public comment period this week, gaining acceptance with most stakeholders while also garnering some criticism, according to Modern Healthcare.

Under the plan, the FDA would add nothing new to its regulatory portfolio, but would retain control over software for the medical devices it’s already regulating, such as bedside monitor alarms, that could pose relatively high risks to patient safety 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.

Support for the basic concept of a proposed Safety Center came from the Electronic Health Record Association, a vendors’ trade group affiliated with HIMSS, in a letter to FDA Commissioner Dr. Margaret Hamburg. “Speaking for our nearly 40 member companies, we support many of the concepts proposed in the health IT framework and look forward to working with key stakeholders to move these important concepts forward.”

The EHR vendors’ group said, for the sake of clarity, they would like to see in the final guidance more examples of the three risk categories outlined in the draft plan. They also want to see the role of the Safety Center clarified as not including oversight or regulatory functions.

The 34-page draft report, released in April, came in response to a mandate by Congress as part of the Food and Drug Administration Safety and Innovation Act of 2012 to look into patient safety while avoiding regulatory duplication.

ONC spokesman Peter Ashkenaz said the next steps are for the policy committee to review the workgroup’s recommendations and comments made during a meeting Tuesday and then forward the recommendations to the ONC. Then it, the FCC, and FDA will review all the public comments and produce a final report by the end of the year, or early next year. The proposed FDASIA framework isn’t the only health IT patient-safety plan federal regulators have under consideration.

Last July, the ONC released its own 50-page “Health Information Technology Patient Safety Action & Surveillance Plan.” It called for establishing a Health IT Patient Safety Program with data collection capabilities within the ONC.

A $5 million appropriation request exists to fund the first year of the safety center in the HHS section of President Barack Obama’s fiscal 2015 budget now before Congress, Ashkenaz said. Whether the patient safety center will be within the ONC, as its plan envisioned, or established outside the government as the FDASIA workgroup recommended, is as yet “undetermined,” Ashkenaz said.