The open patient movement
Patient advocacy groups lead efforts to make health data flow.

In August 2014, Steven Keating, a graduate student at the Massachusetts Institute of Technology (MIT), was diagnosed with a baseball-sized brain tumor. Besides having to go through surgery, chemotherapy and radiation, the experience gave Keating a close-up view of the dysfunctional nature of the U.S. healthcare data ecosystem and led him to become an advocate for open health data.

“I couldn’t believe that the hospitals are still using fax machines,” he said in a recent interview. “This is 2016 and they are sending sensitive documents with faxes. If I ask for my clinical data, which we all have a legal right to, it would come in the mail a week or two later on 20 compact discs. I don’t even have a CD reader. So I started asking why we couldn’t have a share button to make it easier for patients to share data.”

Keating believes patients should be able to collect their own data and easily share it with researchers and other patients. He has published all the data he has about his health on his personal website. His journey and his openness about his health have been inspirational to others, and he is featured in a new documentary film called The Open Patient.

But Keating is not alone; he is part of a broader movement. “Nothing about me without me.” That simple phrase has become the rallying cry for a new brand of activist—patients participating in a health data liberation movement. With health data becoming increasingly digital and as records are shared between large organizations for research and care coordination, patients are demanding that providers give them access to their own digital records so that they can track their health and contribute their data to research studies. There is also a push for greater access to government health data sets in de-identified form.

Progress is definitely being made, but questions about data formats, consent policies, regulations, security and privacy of data, proprietary data and business process transformation all stand as knowledge management challenges to the type of data liquidity those activists are seeking. Keating ran into several legal roadblocks in trying to get access to his tumor’s sequencing data.

Unleash the power

This movement has even spawned its own annual event in Washington, D.C., called the Health Datapalooza, whose tagline is “Unleashing the Power of Open Health Data.” Now in its seventh year, what started as a small gathering of government and public policy officials has grown exponentially to a three-day conference with thousands of attendees.

Through its electronic health record (EHR) incentive program, the federal government has required providers to make data available to patients in electronic format, and the Office for Civil Rights of the U.S. Department of Health & Human Services has established guidelines around timeliness and fair charges for copying records. Nevertheless, as several speakers at the 2016 Datapalooza made clear, many of the patient and family groups advocating in this space are impatient with how slow large healthcare organizations have been to provide data to patients in usable formats.

At last year’s 2015 Health Datapalooza, a “GetMyHealthData” initiative was launched to enlist people to ask health systems for their health data, with the idea that increasing consumer demand would help change business practices. But as Christine Bechtel, coordinator of the GetMyHealthData initiative, reported at this year’s conference, the first-year effort wasn’t promising. “We thought if we pulled on the rope, it would unravel the knots in the system,” she said. “What we found was that when we pulled, there was an elephant sitting on the other end of the rope.”

People who asked providers for their data got messages that they could have their data only if they asked “correctly” or they received response letters asking why they wanted their data. Not a single healthcare organization was able to send data to a health app at a patient’s request. People reported getting PDF files on CD-ROMs that they found unusable and were unable to share. Some were charged up to $600, with no estimate upfront about how much it would cost, she said. Some providers were even charging for access to patient portals that were subsidized by taxpayer dollars through the Meaningful Use EHR Incentive program.

Outdated technology

Last year patient advocate Bray Patrick-Lake posted a picture on Twitter of a pile of disks and two binders full of paper, which she titled “My 100 percent worthless longitudinal health record.” Speaking during a Datapalooza panel session, Patrick-Lake said, “I don’t even have a place where I can put a disk in a computer, and so even this disk they mailed to me, I don’t know what to do with it. A clinical trial I was in many years ago has the best data on me that I would probably ever have, and through extraordinary steps I was finally able to get it, but now I can’t do anything with it.”

In her work as director of stakeholder engagement at Duke University, Patrick-Lake supports efforts to actively engage participant partners in Duke’s research programs, as well as patient advocacy organizations and other stakeholders in Duke’s Clinical Trial Transformation Initiative. She also has been appointed one of three co-chairs of a working group helping to design President Obama’s Precision Medicine Initiative (PMI), which is seeking to enlist a million participants to donate their health data to research projects.

She said one goal of the Precision Medicine Initiative is to create a complete picture of patients, not just clinical health data from an EHR, but also bringing in sensor data, environmental data, behavioral and lifestyle data as well as genetic information. “The key to all this is frictionless participation,” Patrick-Lake said. “We should be able to direct how our data gets shared for research very easily rather than this backward construct of trying to get data back that should be ours. I always assumed as a patient that if I had a poor outcome or an adverse event, people were learning from it and that I didn’t have to take time-consuming and often frustrating action to share that data and make sure it is being used to help others.”

Because one of the goals of the Precision Medicine Initiative is to collect longitudinal health data on 1 million people, much of it directly from research participants themselves, work is underway to create mechanisms to allow individuals to gather and send their health data to PMI. The National Institutes of Health and the Office of the National Coordinator for Health IT (ONC) are developing a “Sync for Science” (S4S) application and protocol that would enable participants to acquire and review their EHR data.

The goals of the S4S pilot projects are to develop methods to facilitate individually controlled clinical data donations to the PMI Cohort and to accelerate and guide the national ecosystem for patient-mediated data access through application programming interfaces (APIs).