caregivers and care recipients; (3) residential environments for health care; and (4) knowledge gaps that require additional research and development. Although many issues related to home health care could not be addressed, applications of human factors principles, knowledge, and research methods in these areas could make home health care safer and more effective and also contribute to reducing costs. The committee chose not to prioritize the recommendations, as they focus on various aspects of health care in the home and are of comparable importance to the different constituencies affected.

HEALTH CARE TECHNOLOGIES

Health care technologies include medical devices that are used in the home as well as information technologies related to home-based health care. The four recommendations in this area concern (1) regulating technologies for health care consumers, (2) developing guidance on the structure and usability of health information technologies, (3) developing guidance and standards for medical device labeling, and (4) improving adverse event reporting systems for medical devices. The adoption of these recommendations would improve the usability and effectiveness of technology systems and devices, support users in understanding and learning to use them, and improve feedback to government and industry that could be used to further improve technology for home care.

Regulation

Ensuring the safety of emerging technologies is a challenge, in part because it is not always clear which federal agency has regulatory authority and what regulations must be met. Currently, the U.S. Food and Drug Administration (FDA) has responsibility for devices, and the Office of the National Coordinator for Health Information Technology (ONC) has similar authority with respect to health information technology. However, the dividing line between medical devices and health information technology is blurring, and many new systems and applications are being developed that are a combination of the two, although regulatory oversight has remained divided. Because regulatory responsibility for them is unclear, these products may fall into the gap.

The committee did not find a preponderance of evidence that knowledge is lacking for the design of safe and effective devices and technologies for use in the home. Rather than discovering an inadequate evidence base, we were troubled by the insufficient attention directed at the development of devices that account, necessarily and properly, for users who are inadequately trained or not trained at all. Yet these new users often must



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