NRC wants teamwork for home-health regs
Anot-for-profit group is calling on two federal agencies to work together to regulate and certify home-health devices that incorporate health information technology systems. In a report released last week, the National Research Council, an arm of the National Academies of Science, seeks a joint effort by HHS’ Office of the National Coordinator for Health Information Technology and the U.S. Food and Drug Administration to fill in regulatory gaps and help ensure that IT-reliant home-health tools are user-friendly.
The 203-page report, “Health Care Comes Home: The Human Factors,” is based on a study sponsored by the Agency for Healthcare Research and Quality and conducted by the council’s Committee on the Role of Human Factors in Home Health Care.
“As it is now, the ONC has the responsibility for the credentialing and oversight for health information technology and the FDA over devices,” committee chairman David Wegman said. “The gap is when those devices are interconnected.” For its part, the FDA this week issued draft guidance for developers of mobile health applications that in part addresses this NRC recommendation (see sidebar), one of 11 in the council’s report.
The council also recommends that the ONC work with the National Institute of Standards and Technology and the AHRQ to set design guidelines and standards for home health devices based on existing guidelines “for content, accessibility, functionality and usability.”
“The issue is how well are those systems designed for use in the home,” said Weg- man, professor emeritus of work environment at the University of Massachusetts at Lowell’s School of Health and Environment. Given that the systems are used not only by professional home caregivers but also by not-medically trained consumers, they may be more likely to be misused or not maintained, he said.
Mobile and home-health tools hold important potential to boost individuals’ overall well-being by letting them better monitor personal health metrics between physician and hospital visits, said Mike Critellis, CEO of Dossia, a not-for-profit consortium launched in 2006 by a group of large U.S. employers, including AT&T, Cardinal Health, Intel and Wal-Mart, to promote health and wellness. Dossia uses a Web-based technology platform that hosts a personal health-record system and offers health-related game and incentive programs as well as information “to support wellness and healthcare decision-making,” according to a recent Dossia news release.
For hypertensive patients, for example, Critellis said, there’s decision-making value in being able to track swings in blood pressure