I am sure I am not alone in feeling vindicated at the spate of activity and news around patient generated health data (PGHD). From Beth Israel deciding to allow patients to add their own notes to their medical records to Walgreens integrating crowd-sourced data from PatientsLikeMe in to their patient portal, the dawn of the PGHD revolution is upon us.
Historically, patient generated data was considered only of value to the patient and there was no place for it to be included into the clinical decision making process or within patient records. Patients have used methods ranging from paper-and-pencil, spreadsheets, or more recently, mobile applications to record their own condition-specific data including things like diet, activity, symptoms, triggers, drug-related events and notes. While this data contained a treasure trove of information that could potentially help fulfill the promise of personalized medicine, without confirmation of patient diagnoses or validity, it was not considered trustworthy enough to be used by the clinical complex.
The more recent proliferation of home-use medical devices and monitors adds new legitimacy to this data source. Still considered patient generated, remote monitoring data allows a clinician to collect vital physiological parameters with much greater frequency while the patient is in the comfort of their own home. This represents a great opportunity for healthcare organizations trying to cut down overall costs and deliver optimal care. The examples at Beth Israel and Walgreens (with PatientsLikeMe) represent a turn in the tide where patient self-reported data is now allowed to live side-by-side with clinical data.
With increasing costs across the healthcare ecosystem, the Federal Drug Administration (FDA) is looking to expedite the drug and device approval process. As part of the 21st Century Cures initiative, the FDA is being asked to keep up with the times. Given that the FDA’s last major update occurred in 1997 when the internet was largely texted based, it is imperative that they adopt a 21st century regulatory framework. A key driver for this updated framework is continued innovation in data collection and analysis methods that include data on efficacy of therapies as reported by patients themselves, saving time and money for providers, physicians, and patients. At Klio, we are certainly at the forefront of this revolution and are glad that patient-generated health data is finally having its day in the sun.