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FDA site encourages patient feedback on medical devices, processes

The Food and Drug Administration took a step toward greater patient engagement with the development of a website aimed at receiving patient feedback on prescription drugs and medical devices. The site also offers resources on the drug development process, from federal approval to regulating the safety of each drug once they’re publicly available. On the FDA site, patients also can apply to be patient representatives and serve on FDA advisory committees.

Margaret Hamburg, M.D., FDA commissioner, announced the agency’s patient engagement site and said she hoped it would allow for feedback from a wider audience. “We hope, with the launch of this new Web site, to expand the role of patients beyond the select group of patient representatives and to engage a wider audience of patients in new and broader ways,” she wrote.

The FDA has other spaces for manufacturers, device users and patients to report problems with devices and use feedback to study adverse events but the new site marks a greater focus on receiving patient input. A study in the Journal of AHIMA said that involving patients in their care can prove beneficial. The study discovered that patients can improve overall data integrity by confirming the validity of their individual patient data and patient portals are one way for providers to allow patients to do so. Providers must be prepared for patient responses before implementing a portal. They should designate an employee to review and address patient feedback.

Giving patients access to their own personal health records is another way to get them involved in their care. A study from 2011 noted that less than 10% of Americans had a PHR. Web-based PHRs, like the discontinued Google Health, haven’t been as widely adopted as provider-offered PHR options. Some PHRs are becoming more versatile, allowing patients to monitor their vital signs through smartphone apps. Giving patients the chance to monitor their own health has benefits, but some physicians are hesitant to include self-monitoring data in formal patient evaluations.

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