In support of its mission to enable the effective electronic exchange and use of regulatory, scientific, and health information across FDA and with external stakeholders, the Office of Health Informatics (OHI) works to:

• Further regulatory science by providing easy access to FDA health information and collaborating with internal and external experts.

• Inform regulatory decision-making and research by developing standards to effectively exchange health information.

• Gain new insights from the integration and analysis of large and diverse health data sets.

To this end, OHI has partnered with external stakeholders under a Broad Agency Announcement to develop Healthy Citizen. This citizen-centric platform makes it possible for citizens and those who care for them, research organizations, and FDA to communicate and collaborate in a single, seamless environment to improve public health outcomes.

Healthy Citizen achieves this by engaging with citizens through their existing health care organizations and technologies. Once enrolled on the platform, a user can select the health topics and products that are important to her or him. With this information, Healthy Citizen will then provide the user with personalized notifications, messages, and information. Patients can also securely contribute their direct health experiences to FDA through the questionnaires they receive and obtain timely, personally relevant FDA alerts.

Bringing the health care support full circle, Healthy Citizen's cohort research platform enables FDA researchers to analyze the de-identified patient data and create cohorts with very large population pools. Once the cohort is set they will have the ability to reach back to patients for study inclusion.

Healthy Citizen bridges gaps between available health information on public government websites and that found in patient portals--and resolves their shortcomings. For example, currently, the vast volume of public information available on government websites is hard for patients and health care practitioners to consume because it's not in a standard format and is siloed. And although patient portals are valuable tools to collect health information from patients, it's often difficult for portals to offer current and customized information in an easily consumable format. Healthy Citizen aggregates information from many sources to provide current, relevant electronic information and tools to patient portals. These portals can then give this information more easily to patients and caregivers who use it.