PGHD: the Next Wave in Pharma Data?

Lately, I’ve been writing a lot about Big Data, electronic health records, the ACA and their impact on the pharmaceutical industry.  While these influences are definitely directly “in our windshield,” (particularly with Meaningful Use Stage 2 in process through 2016), it’s worth taking a slightly longer-term view to see what lies further ahead.

Meaningful Use Stage 3 is set to begin in 2017 and while the detailed, technical guidelines aren’t expected until the fall of 2014, the high level objectives have already been set.  These include “access to comprehensive patient data through patient-centered health information exchange.”  So, what exactly does this mean and how can the pharmaceutical industry prepare?  I posit that PGHD (Patient Generated Health Data) will be a radical, new set of information that will add tremendous benefit to not only the industry, but change the way patients interact with the healthcare system in totally new ways.

What exactly is PGHD?

In the past, pharma has sought to learn as much as possible about patients and populations across the spectrum of available data – from the traditional chart audits and prescription data to today’s nascent EHR population data.  One piece, however, has been left out of patient care: the actual voice and experience of the patient.  With PGHD, that model will change.  Patient Generated Health Data can broadly be thought of as voluntarily patient provided health information.  On the surface this may not seem like much, but having the ability, in real-time, to know about and interact with a patient is something the healthcare system has never really experienced up until now.

More narrowly defined, PGHD can be broken down into various groupings that include “wearables” (e.g., Fitbits and Jawbones), medical devices (e.g., Bluetooth glucose meters), surveys (e.g., pre-physical or health risk assessments), and even patient lifestyle tracker mechanisms (such as weight or diet trackers, be it paper, online or app based).

Technology is enabling this shift.  For example, some companies have created ingestible sensors that attach to a pill so that you (or your care provider) can monitor medication intake – and provide a reminder when necessary.  Others are creating mobile tools that help patients receive support that enable healthier lifestyles, such as weight loss programs targeted specifically to those at risk of type 2 diabetes.  Recently, a fun survey mirroring the NCAA “Sweet 16” basketball tournament came out pitting one wearable device against each other.  The overall winner was a new life vest for patients at risk for sudden cardiac heart arrest.  The vest allows active physician cardiac monitoring and even provides a shock to restore heart rhythm should a problem be detected.  Imagine that – remote monitoring and lifesaving treatment, all from afar.

Not all technologies will be winners.  Crowdsourcing is funding everything from connected toothbrushes to posture assistance devices.  Time will tell, but it is an exciting period nonetheless.

mHealth (mobile health) is one of the key enablers of PGHD.  The Pew Research Health Fact Sheet tells us that 58% of U.S. adults own a smart phone and that 52% of us have used our smart phones to look up health or medical related information.  And, 19% have already downloaded an app to help track or manage health – an impressive number in such a new industry.

Pew also reports that 7 in 10 U.S. adults have tracked a health indicator for themselves or for someone else. Of those, 34% share their health tracking records or notes with another person or group.  So, even without Meaningful Use Stage 3 in place, people are clearly eager to experience these types of services and share PGHD.

Is the Pharmaceutical Industry Prepared?

In an industry that has been slow to shift to an outcomes/value model and has yet to fully engage in EHR integration and population data, it remains to be seen if it is ready for this next wave of information.  Granted, PGHD’s full potential has yet to be developed and the technical standards are not yet in place.  Still, should pioneering companies start thinking about ways to engage with PGHD?  Strategies might include partnering to get population data from wearable device manufacturers and marrying that data with EHRs to get a better sense how patients live their lives outside of the physician’s office and what happens during the actual physician visit.  Or, tracking the experience of patients on a particular drug vs. lifestyle choices – and supporting them with mHealth apps that enable positive outcomes.

As these technologies expand, pharma companies will have the ability to truly understand and meet the needs of the patient, be it in strategically developing the commercial pipeline towards unmet needs or improving outcomes through mHealth support.  PGHD might lead to that Holy Grail that everyone seeks – a 360 degree view of the patient, fully integrated into the healthcare system.