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HHS, FCC form patient-safety advisory work group


By Joseph Conn
Posted: April 19, 2013 - 3:15 pm ET
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HHS and the Federal Communications Commission have formed a joint advisory panel to improve patient safety and promote innovation in health information technology.

The panel also will seek to promote regulatory efficiency, according to an HHS news release. It will report to the Health IT Policy Committee, itself a federal advisory body created under the American Recovery and Reinvestment Act of 2009. The committee advises the Office of the National Coordinator for Health Information Technology at HHS on policy matters.

At 29 voting and three ex-officio members, the new patient-safety workgroup is one of the largest of the 13 workgroups and subcommittees of the 24-member IT committee.

The new group's members include representatives of providers, academia, health IT developers, health plans, venture capital investors, telecommunications companies, trade groups, government and a law firm and have been appointed by both HHS and the Federal Communication Commission.

The Food and Drug Administration Safety and Innovation Act of 2012 directed HHS through the FDA commissioner, the ONC and the chairman of the FCC, to develop “a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including medical mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication,” the HHS statement said.

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“As the FDA thinks about regulation, the phrase they talked about is 'a risk-based approach,'” said Dr. Paul Tang, vice-chairman of the Health IT Policy Committee, in a phone interview. “You don't want to treat every piece of software the same.”

“You don't want to impede innovation,” Tang said, but then again, as more and more medical devices move to mobile and other forms of computer technology, patients and the public will still need regulatory protection to ensure safety and protect them from harm.

“The problem is, where do you draw regulatory lines,” Tang said. “How do you define the risk? That's probably one of the things the group will work through.”

"New technologies can revolutionize healthcare, helping to improve patient outcomes, while expanding access, creating convenience and lowering healthcare costs for millions of Americans," said FCC Chairman Julius Genachowski in the news release. "We anticipate that this talented group of leaders from their respective fields of discipline will help to bring fresh ideas to the table with an eye towards ensuring patient safety.”

Noted health IT researcher Dr. David Bates, a member of the Health IT Policy Committee and several other of its workgroups, will chair the new patient safety panel. Bates is a professor at Harvard Medical School and serves as the executive director of the Center for Patient Safety Research and Practice based at Harvard and the Brigham and Women's Hospital in Boston.

The group's first meeting is scheduled for April 29.

Follow Joseph Conn on Twitter: @MHJConn


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