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 patient access to information in electronic health records. The lack of guidance in this area, particularly related to the requirements in the home care setting, makes it difficult for developers of personal health records and patient portals to design systems that fully address the needs of consumers.

Recommendation 2. The Office of the National Coordinator for Health Information Technology, in collaboration with the National Institute of Standards and Technology and the Agency for Healthcare Research and Quality, should establish design guidelines and standards, based on existing accessibility and usability guidelines, for content, accessibility, functionality, and usability of consumer health information technologies related to home-based health care.

The committee found a serious lack of adequate standards and guidance for the labeling of medical devices operated by lay users. Furthermore, we found that the approval processes of the U.S. Food and Drug Administration (FDA) for changing these materials are burdensome and inflexible.

Recommendation 3. The U.S. Food and Drug Administration (FDA) should promote development (by standards development organizations, such as the International Electrotechnical Commission, the International Organization for Standardization, the American National Standards Institute, and the Association for the Advancement of Medical Instrumentation) of new standards based on the most recent human factors research for the labeling of and ensuing instructional materials for medical devices designed for home use by lay users. The FDA should also tailor and streamline its approval processes to facilitate and encourage regular improvements of these materials by manufacturers.

Adverse Event Reporting Systems

The committee notes that the FDA’s adverse event reporting systems, used to report problems with medical devices, are not user-friendly, especially for lay users, who generally are not aware of the systems, unaware that they can use them to report problems, and uneducated about how to do so. Improving these systems would increase the FDA’s knowledge of



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