The National Research Council believes that home health device manufacturers don't give enough consideration to human factors like ease of use when creating their technology, according to a report released this week. The report, commissioned by the Agency for Healthcare Research and Quality, also calls on government agencies, in particular the U.S. Food and Drug Administration and the Office of the National Coordinator for Health IT, to work together more closely in regulating such devices, as well as any accompanying applications.
Patients and caregivers should be able to use such devices easily and also should have a mechanism for providing feedback on their design flaws, the report notes. At a time when hospitals and healthcare systems are placing increased emphasis on post-acute care, the report's recommendations highlight wide gaps that currently exist in home care regulations.
Among the study's specific recommendations:
- ONC, AHRQ and the National Institute of Standards and Technology "should establish design guidelines and standards...for content, accessibility, functionality, and usability guidelines" for information technology used in home care, such as personal health records and patient portals.
- To improve FDA's understanding of user difficulties with home health devices, the agency should improve its adverse events reporting system so that it can collect data from both "lay users" and professionals.
- The FDA, in conjunction with device manufacturers, should develop a database to guide physicians in prescribing home health devices appropriately.
- Caregivers should be well-trained in home care and in using home health devices.
NRC's announcement was made one day before the FDA released its draft guidance for mobile medical applications.
To learn more:
- read the NRC press release
- see the NRC report