FDA Reaffirms Patient’s Critical Role in Healthcare
February 11, 2015
By Bettina Experton MD, MPH

Late last week, the FDA finalized guidance on data transmission, reaffirming that it doesn’t intend to regulate software that receives, transmits, stores or displays data from medical devices “due to the low risk to patients and the importance in advancing digital health.”  This is great news for everyone and is another step in reinforcing the critical new role the patient plays in driving their own care.

Patient-generated data from wearables and self-monitoring devices (digital blood pressure monitors, digital scales, etc.) are critically important for healthcare to be rendered accurately and effectively.  This FDA ruling reinforces the fact that patients are no longer passive, but to the contrary, participating actors in their own care to truly transform the quality and efficiency of healthcare.

Wearables are becoming incredibly common – with Juniper Research predicting more than 18 million smart wearable devices will be in use by year’s end. However, as James Moar, an analyst with Juniper told FierceMobileHealthcare: “The key is making the devices provide meaning as well as data.”  So while the possibilities for wearable health and fitness devices are very interesting, things start to get powerful for an individual health perspective when the data from these devices is put in context with your individual medical health history coming from your electronic health records.

Imagine patients living with hypertension, who can self measure and record their blood pressure over time with their own monitoring device and see not only a record of their personal blood pressure (BP) readings, but also gets alerts on specific medications affecting their BP, or how on or off target they are with regards to their weight, exercise level, or salt intake, which all contribute to BP management. With all of this information in one place, the patient and their physician can see what elements of the treatment plan are working, measure the impact of lifestyle modifications and medication compliance, and over time, best manage a chronic condition.

Many of us in the health IT industry are working tirelessly to make the patient the central information hub and lead communicator among his multiple care providers over time. This latest development is another step in the patient-centered data revolution taking place in healthcare today!

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