The Need for a Privacy Standard for Medical Devices That Transmit Protected Health Information Used in the Precision Medicine Initiative for Diabetes and Other Diseases.

Privacy is an important concern for the Precision Medicine Initiative (PMI) because success of this initiative will require the public to be willing to participate by contributing large amounts of genetic/genomic information and sensor data. This sensitive personal information is intended to be used only for specified research purposes. Public willingness to participate will depend on the public's level of trust that their information will be protected and kept private. Medical devices may constantly provide information. Therefore, assuring privacy for device-generated information may be essential for broad participation in the PMI. Privacy standards for devices should be an important early step in the development of the PMI.