fully accommodate the diversity, strengths, and limitations of humans, both as care recipients and caregivers, and facilitate necessary improvements to the physical environments of homes.
The recommendations are organized into four areas: (1) health care technologies, including medical devices and health information technologies involved in health care in the home; (2) caregivers and care recipients; (3) residential environments for health care; and (4) research and development needs. 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.
U.S. government regulations that apply to devices and systems used in home health care have the potential to ensure that sound human factors principles are followed in the design and implementation of these technologies and thus to support the development of usable and accessible devices and systems.
Recommendation 1. The U.S. Food and Drug Administration and the Office of the National Coordinator for Health Information Technology should collaborate to regulate, certify, and monitor health care applications and systems that integrate medical devices and health information technologies. As part of the certification process, the agencies should require evidence that manufacturers have followed existing accessibility and usability guidelines and have applied user-centered design and validation methods during development of the product.