HHS' Office of the National Coordinator for Health Information Technology and the U.S. Food and Drug Administration should work together "to regulate, certify and monitor healthcare applications and systems" that integrate home medical devices such as blood-pressure monitors and health information technology systems used by clinicians, according to a report from the National Research Council.
Report calls for usability standards for home health devices
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.
"In the future, individuals will play a greater role in managing their own healthcare needs and those of their family members at home and in the community," according to the report. "The extent to which human-factors research is incorporated into home-based devices, technologies and practices will have a big influence on whether greater reliance on home healthcare proves to have beneficial or detrimental effects on people's lives.”
With more care being performed out of a clinical setting, both professional caregivers and laypeople sometimes are faced with performing difficult tasks using unfamiliar equipment "in environments not designed to support these activities," the authors wrote. "All of these factors need to be addressed, and among the most critical are the human-systems interactions, also known as human factors. If the demands of providing or self-administering healthcare exceed a person's capabilities, then the safety, efficacy, and efficiency of that care will suffer.”
The report recommends that the ONC and the FDA require, as part of a certification process for home-health devices and systems, that manufacturers demonstrate they have followed accessibility and usability guidelines and applied "user-centered" design in developing the products.
The council also recommends that the FDA make it easier for laypeople to report problems with their home medical devices and then use the data collected to help determine root causes of any adverse events linked to use of the devices.
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