rely on equipment without ready knowledge about limitations, maintenance requirements, and problems with adaptation to their particular home settings.

The increased prominence of the use of technology in the health care arena poses predictable challenges for many lay users, especially people with low health literacy, cognitive impairment, or limited technology experience. For example, remote health care management may be more effective when it is supported by technology, and various electronic health care (“e-health”) applications have been developed for this purpose. With the spectrum of caregivers ranging from individuals caring for themselves or other family members to highly experienced professional caregivers, computer-based care management systems could offer varying levels of guidance, reminding, and alerting, depending on the sophistication of the operator and the criticality of the message. However, if these technologies or applications are difficult to understand or use, they may be ignored or misused, with potentially deleterious effects on care recipient health and safety. Applying existing accessibility and usability guidelines and employing user-centered design and validation methods in the development of health technology products designed for use in the home would help ensure that they are safe and effective for their targeted user populations. In this effort, it is important to recognize how the line between medical devices and health information technologies has become blurred while regulatory oversight has remained distinct, and it is not always clear into which domain a product falls.

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.

Guidance and Standards

Developers of information technologies related to home-based health care, as yet, have inadequate or incomplete guidance regarding product content, structure, accessibility, and usability to inform innovation or evolution of personal health records or of care recipient access to information in electronic health records.

The ONC, in the initial announcement of its health information technology certification program, stated that requirements would be forthcom-

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