Work group says OK to some HIT safety regs

A federally chartered special work group with representatives from three federal agencies has submitted its draft recommendations on establishing a regulatory framework for health information technology. Chief among those recommendations is that health IT should not be subjected to pre-market federal regulation, but there were a few exceptions.

The exceptions under which there should be FDA regulation, according to the work group, include medical device accessories to be defined as such by the FDA; certain forms of “high risk” clinical decision support systems, such as “computer aided diagnostics,” also to be defined by the FDA; and some “higher risk software” use cases to be defined by the committee's own safety work group.

In addition, vendors should be required to list products that “are considered to represent at least some risk if a non-burdensome approach can be identified to doing so,” the work group suggested.

The group also recommended: developing a federally supported, post-market surveillance system for health IT products “to ensure safety-related decision support is in place,” creating a process for gathering information on safety issues, aggregated at the federal level and establishing a public process for “customer rating of HIT to enhance transparency.”

Dr. David Bates, chairman of the Food and Drug Administration Safety Innovation Act work group, presented the preliminary findings Wednesday at a meeting of HHS' Health Information Technology Policy Committee.

The work group, created in April, includes members from the FDA, the Office of the National Coordinator for Health Information Technology at HHS, and the Federal Communications Commission, which all have regulatory responsibilities in health IT.

Bates, a professor at Harvard Medical School, said the FDA and other agencies also need to take steps “to strongly discourage vendors from engaging in practices that discourage or limit the free flow of safety-related information.”

The current focus on IT systems and safety can be traced back to a 2011 report from the Institute of Medicine, "Health IT and Patient Safety: Building Safer Systems for Better Care (PDF)," that concluded there was a lack of objective research to determine the level of threat to patient safety the adoption of health IT systems poses.

On a parallel track to the work group's efforts, in July, the ONC released its 47-page Health Information Technology Patient Safety Action and Surveillance Plan.

Asked during a question and answer period following his presentation whether the committee had considered the liability implications of its recommendations, Bates said, “It's not something we discussed at length, but it's something we can discuss over the next month.”

The work group will continue to fine-tune its recommendations and bring a final version back to the HIT Policy Committee in September, Bates said. Under the 2012 FDASIA, Congress mandated the FDA to devise a regulatory framework for health IT by January 2014.

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