On June 9, 2016, the US Food and Drug Administration (FDA) published draft guidance outlining considerations for the “appropriate and responsible” dissemination of individualized data from medical devices from device manufacturers to patients.
In the draft guidance, FDA clarifies that medical device manufacturers may share “patient-specific information” from legally marketed medical devices with patients at the patients’ request without additional premarket review by the agency, provided such dissemination falls within the lawful scope for which the manufacturer may market the device. For purposes of the draft guidance, “patient-specific information” is any information that is unique to an individual patient or unique to that patient’s treatment or diagnosis that, consistent with the intended use of the device, may be recorded, stored, processed, retrieved and/or derived from that device. Examples of patient-specific information include recorded patient data, device usage/output statistics, provider inputs, alarms and/or records of device malfunctions. Patient-specific information does not, however, include any interpretation of such data aside from interpretations normally reported by the device to the patient or the patient’s healthcare provider.
When sharing patient-specific information with patients, FDA recommends that manufacturers consider the following factors to ensure that such information is usable by patients and to avoid the disclosure of confusing or unclear information:
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Content of information provided. The information provided to patients should be comprehensive and up-to-date, and manufacturers should take measures to ensure that such information is easily understood and useful to the patient. Depending on the type and scope of information being shared, the manufacturer should provide supplementary instructions, materials or references to help patients understand the data. In deciding what measures may be necessary, the manufacturer should be sure to consider whether any characteristics of the intended recipient audience (e.g., mental capacity) may affect the interpretability of the information.
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Context in which information should be understood. Manufacturers should provide the information in context to avoid situations where the information may be misinterpreted, leading to invalid or inappropriate conclusions.
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Necessity of access to follow-up information. Manufacturers should consider what, if any, information they should include about whom to contact for follow-up information. At minimum, manufacturers should advise patients to contact their health care providers with any questions about their data. Manufacturers should also consider providing their own contact information to facilitate response to patient questions about the device.
The draft guidance is the latest in a line of documents in which FDA has attempted to clarify its expectations for—and in many cases, allay the concerns of—developers of mobile health products. Though short on specifics, developers should find the guidance helpful insofar as they have questions regarding the extent to which they can disseminate medical device data to patients. Notably, however, the FDA does not address how manufacturers should proceed with respect to the dissemination of many patient-specific analyses, likely because the agency intends to address such issues in its long-awaited guidance on clinical decision support software.
