Building PCORnet as a Secure Platform for Outcomes Research
As we’ve begun the 18-month development of PCORnet, the National Patient-Centered Clinical Research Network, many people have expressed their excitement about the promise of this ambitious effort. After all, PCORnet aims to harness the potential of the vast amounts of health care data stored in electronic medical records—and the energy of activated patients—to transform outcomes research and speed answers to patients’ foremost health questions.
It’s an excitement shared by all of us here at PCORI, as well as by the hundreds of patients, patient advocates, researchers, physicians, nurses, health system leaders, and others involved in this effort. The initiative is increasingly gaining media attention. Just yesterday, a Washington Post article provided an overview of PCORnet's promise and challenges, saying “nothing of this scale has been built before, and researchers say the potential of the network to speed up research efforts and to answer questions that have long vexed scientists cannot be overstated.”
So, let me take this opportunity to provide you with an update on PCORnet, as we work to accelerate the pace of high-quality outcomes research in a way that stays focused on patients’ needs and concerns, engages them fully in how the system is built and operates, and protects the privacy of their personal health data.
Advancing Research to Help Patients and Clinicians Make Better-Informed Decisions
As we noted when we announced funding for PCORnet, vast amounts of valuable health information are created every day during patients’ interactions with clinicians, healthcare systems, and one another. The data generated through these real-world patient experiences are really the best way to find out what works best for patients in typical clinical care, given their individual circumstances and needs.
Opportunities to use this kind of health information are often missed, however. Most patients receive their care in more than one system. What’s more, the individual systems have lacked efficient ways to communicate or collaborate with each other; this impedes comprehensive follow-up as well as research. Finally, single systems usually can’t conduct studies that are large enough to provide reliable answers about what works for individual patients.
PCORnet is designed to address these issues. By integrating 18 Patient-Powered Research Networks and 11 health system–based Clinical Data Research Networks, it will facilitate the use of both patient-provided information and clinically derived data to support research. By folding research activities into clinical practice without interrupting the flow of care, PCORnet aims to facilitate comparative clinical effectiveness research and other kinds of studies on topics and questions most relevant to the needs of patients and those who care for them. The result will be a system that will enable researchers to ask clinical questions and derive results quickly and efficiently.
Tackling the Challenges: Data Security, Privacy, Interoperability
Of course, it will take significant work to connect PCORnet's 29 individual health data networks, with coverage spanning the entire country, and develop the structures, governance, and policies to ensure that the national network they form operates smoothly and securely. But building and leveraging the power of a large clinical data network and ensuring the security and privacy of sensitive personal information aren’t mutually exclusive.
Those of us involved in developing PCORnet are tackling head-on the many challenges inherent in a project like this—especially the need to provide robust data security measures and policies and procedures to guard patient privacy. Our Task Force on Data Privacy and Task Force on Data Standards, Security, and Network Infrastructure are working with each of the 29 partner networks on these key issues. The partner networks will have their own governance systems and maintain their own data, which will be securely protected by a firewall. Each partner network will develop security measures, policies, and procedures that are right for its members, as we develop general policies that will apply to PCORnet as a whole. A critical feature of this effort is that patients will be deeply involved in creating these policies.
As we develop overall governance policies for PCORnet and create the structures, methods, and means that will allow networks to operate together, we’ll provide specific information on how research teams can access the data and how queries will be handled, prioritized, and answered. We expect patient data provided in response to research requests will be stripped of personal identifying information, which will not leave the health system or original network, unless patients have explicitly consented to its release for a particular research purpose.
During the 18-month development phase, which ends September 2015, we will work continuously to improve the quality of the data and the efficiency of the PCORnet's capacity to support research. We are confident that each individual network will benefit from comparing approaches, and the most successful procedures and policies will be shared and refined. We predict that PCORnet will be a true game-changer in health research. We hope you’ll follow its progress with the same interest and excitement that we’re bringing to this initiative.
Selby is PCORI’s Executive Director