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# Dissemination of Patient-Specific Information Guidance
- URL: https://www.fdaweb.com/dissemination-of-patient-specific-information-guidance/
- Published: 2016-08-16T12:00:00.000Z
- Updated: 2026-09-14T21:24:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136526

Commenting on an FDA draft guidance on dissemination of patient-specific information from medical devices, the Patient, Consumer, and Public Health coalition [says](https://www.regulations.gov/document?D=FDA-2016-D-1264-0007&ref=fdaweb.com) that information communicated to patients should be done in a manner that is easy for them to understand. The coalition also says it agrees with the agency that patient-specific information shared with patients should be “comprehensive and contemporary,” and expresses concern that “comprehensive” not become a useless “data dump.”

“We generally support this brief draft guidance,” the letter signed by nine advocacy groups says, “but the HIPAA section needs clarity, and the Content section needs more details on how device makers can avoid disseminating confusing or unclear information to patients.”

In its letter, Novartis says that the guidance’s scope should be restricted to medical devices that have an intended use for patient self-diagnosis or disease monitoring. “Without a change in scope,” it cautions, “institutional, clinical, or office-based equipment providing patient data that may only transmit directly to a patient record, be seen on screen for recording, or provide information not aimed toward a lay user would need to be redesigned in order to comply.” The company also requests more information on expectations for market applications, associated verification and validation testing requirements, needs for testing of human factors elements of both the information provided and the instructions for access to the data. Novartis also requests a timeline for older medical devices already on the market to be in compliance.

AdvaMed [suggests](https://www.regulations.gov/document?D=FDA-2016-D-1264-0009&ref=fdaweb.com) that the guidance more clearly state that its information on content and context are suggestions, not requirements, and should be implemented when feasible. “Because most patient-specific information is developed for the healthcare provider or manufacturer, reconfiguring it and restating it can be difficult and burdensome,” the company says. “The most desirable way to communicate patient-specific information to a patient is via the patient’s healthcare provider. This line of communication should be emphasized and more clearly stated as the primary means for providing patient-specific information.”

Finally, Hospira [says](https://www.regulations.gov/document?D=FDA-2016-D-1264-0005&ref=fdaweb.com) the guidance “appears to presume that all medical device manufacturers have access to patient-specific data from medical devices that are already in the field. There may be a small population of manufacturers who provide this service for specific devices.”