A growing group of patients is beginning to demand more from their medical devices, calling on medtech manufacturers and physicians to grant them access to the data gathered from their medical implants and other devices.
As medical technologies and the patients using them are growing more tech- and web-savvy, the information gathered by a device such as a cardiac implant or a sleep apnea machine is becoming tricky ground for patients, device makers, physicians and regulators.
A patient movement has been growing over time, including calls from computer programmers who want access to the code that keeps them alive.
Other patients are looking for data on the working of their own bodies, including patient data access advocate Hugo Campos who has campaigned for years to win direct access to the heart rhythm data gathered by his cardiac implant.
Campos went so far as to reach out to medtech giant Medtronic (NYSE:MDT), eventually winning a compromise in which the data his implant gathers, which gets routed through the manufacturer and then to Campos’ doctor, then gets forwarded to Campos by his physician’s office.
The data accumulated by implanted medical devices exists in a regulatory loophole just outside of current FDA rules and HIPPA patient protection guidelines, the Wall Street Journal reported.
Existing laws grant patients access to health data held by healthcare providers, but because the information gathered by a medical device generally goes directly to the device maker, which then provides a cleaned up version for doctors and hospitals, patients don’t have the right to demand the raw information gathered by their own devices.
Some device makers seem uninterested in pioneering the new landscape, but Medtronic is keeping its eye on the growing patient movement.
"This is the direction where things are going," Medtronic cardiac rhythm division vice president Tim Samsel told the Journal, adding that the raw data sent by an implant to a manufacturer would need to be cleaned up and the end product organized into a format approved by FDA regulators.
"In the current format, the data collected from implantable cardiac devices should be relayed through the physician to ensure proper interpretation and explanation," FDA spokeswoman Erica Jefferson told the paper.
Ultimately the argument comes down to one of utility and safety – the data currently gathered by the devices may not be of much use to patients who aren’t trained to make sense of it.
Campos told the Journal that he took a $2,000 course generally reserved for device technicians in order to better understand the information gathered by his cardiac implant, but some doctors worry that the average patient could be confused or misled by medical device data if it’s not put into context by a healthcare provider.
