Patient-Generated Health Data: FDA & PatientsLikeMe Collaboration Lighting the Way for Pharma


The recent partnership between the FDA and PatientsLikeMe is putting the concept of patient-generated health data front-and-center. An online patient-networking forum, PatientsLikeMe is likely the first iteration of other programs to come that leverage patient-reported information. In this case, the outcome of the partnership is to hopefully improve drug safety-monitoring efforts on the part of the FDA.

Pharma organizations should be watching this situation closely. Along with other initiatives like social media and data sharing, patient-generated health data has the potential to change the healthcare landscape, identifying potential adverse drug reactions, improving safety issues, and increasing organizational financial well-being, too.

Passive data collection has largely limited clinical trials, although the FDA, pharma manufacturers, and healthcare professionals have long relied on the restrained process. As a result, underreporting by patients is just one accepted constraint of the postmarketing surveillance system. The FDA-PatientsLikeMe partnership hopes to address this downside, along with identifying the true causes of adverse reactions.

By collecting patient-generated data in the forum, the FDA hopes to achieve the best of both worlds: collecting patient-generated health data and patient-reported outcomes, along with clinical trial data. While reported outcomes from the delivery system (or the clinical trial) includes valuable data like length of hospital stay, medications used, surgeries performed and complications, the missing factor in the process is and always has been the patient’s voice. Questions about patient data after procedures and hospital stays that occur during recovery at home has significant potential to inform future drug manufacturing decisions and financial drivers.

Regulations about data collection still lag, however, amidst questions about its delivery system, like which sources should be used (social media, wearables, etc.), whether pharma or regulators can follow up on the data/patients, and perhaps more significantly, how the volume of data will be distilled and sorted into useful insights.

Pharma organizations are largely proceeding with patient generated health data initiatives, convinced of the value that the patient’s perspective and patient engagement has for their financial health, not to mention the determination customer satisfaction and patient outcomes have for value-based reimbursement programs.

But there’s a problem. Lots of patient-generated health data – regardless of its sources – doesn’t automatically translate into meaningful data insights. In fact, patient-generated data is cumbersome, unmanageable and a challenge to digest, especially in the average 7-minute doctor-patient visit.

For health data generated by patients to prove useful to physicians, hospitals and pharma organizations, there lies a significant divide between experiencing data mayhem and acquiring actionable insights from data analytics. Harnessing the power of big data to drive new treatment strategies and better patient outcomes via EHRs, health information exchanges and data repositories requires that the FDA and the pharma industry at large employ a specialized data analytic solution.

As pharma and healthcare organizations prepare for the marathon of generating useful patient health data and creating national benchmarks, regulatory bodies must keep pace, developing national data standards and a consensus on how to deploy and use them. Since the industry at large has not been able to master manipulating big data that can be scaled for all users and analyzed to generate actionable insights in real-time and at-the-ready, perhaps patient-generated health data is the push it needs to reach the goal.

In theory, the future looks bright for patient-generated health data. If all goes well with harnessing and manipulating data for insights, success seems imminent. The ever-elusive trifecta that is patient-generated health data, big data and valuable insights may just be within pharma’s reach. As such, data discrepancies could become a thing of the past. In its place, pharma can construct a clear view of the patient and health condition, and a fully integrate it into the healthcare system – thought it’s still very much up to the industry and the FDA’s decisions.