The Office of the National Coordinator for Health IT and FDA should collaborate to regulate and certify home health care devices that are integrated with health IT systems, according to a report from the National Research Council, Modern Healthcare reports (Conn, Modern Healthcare, 7/18).
The report, titled "Health Care Comes Home: The Human Factors" was sponsored by the Agency for Healthcare Research and Quality (NRC release, 7/18).
The report notes that home health care devices frequently are used by people without medical training in non-clinical settings. It states, "If the demands of providing or self-administering health care exceed a person's capabilities, then the safety, efficacy and efficiency of that care will suffer."
The report calls for ONC and FDA to develop a certification process for home health devices that would require manufacturers to demonstrate that they have followed guidelines on accessibility and usability.
The report states, "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 health care proves to have beneficial or detrimental effects on people's lives."
The report also recommends that FDA:
- Make it easier for people to report problems with home health devices;
- Use the data collected to help determine the causes of adverse events linked to home health devices (Modern Healthcare, 7/18); and
- Help develop new standards for easy-to-understand labels and instructions for home health devices (NRC release, 7/18).