March 30, 2015

Patients Seeking Access to Data from Devices

By: On November 30, 2012

As the Wall Street Journal reports, more and more patients who are using implantable medical devices or health apps that collect medical data are seeking to get access to that data. However, the U.S. has strict laws that restrict access to patients’ medical records by anyone other than a medical professional. Now it appears that the convergence of personalized medicine, mobile health, and patient empowerment is driving a change to that paradigm.

Large medical device manufacturers are increasingly fielding requests from patients to get direct access to the data being collected on them. However, aside from the regulatory restrictions, raw data would be meaningless to patients. Even the reports provided to physicians could be misinterpreted if they were made available directly to patients.

So a new interface will be required if meaningful data is going to be made available to patients and the FDA would need to approve any tool that is developed, which could take years. Click here for the story in the Journal.