Patient control of medical records to radically change research for better (or for worse)
Experts call for attention and government action
April 17, 2008
As resources become available for patients to take control over the medical information in their health records, the dynamics of how clinical research is done will likely shift dramatically, Children's Hospital Boston researchers state in a Sounding Board article published in the April 17 issue of The New England Journal of Medicine. While the move to personally controlled health records (PCHRs) will provide patients and doctors with easier access to records during the clinical care process, it will also profoundly affect the biomedical research enterprise, the authors predict.
"Giving patients access and control over their medical records will unlock a whole new world where researchers will suddenly be able to recruit hundreds, thousands, possibly millions of patients from all over the world, and have access to all new data sets and populations," said Isaac Kohane, MD, PhD, of the Children's Hospital Informatics Program (CHIP) and co-author of the article. "Imagine the possibilities this will bring and the impact it will have on bringing research to the bedside."
It is expected that at some point in the future, personal or patient-controlled health records (PCHRs) will be universally available and used. With PCHRs, patients have web-based access to almost all the information in their medical records (currently only under the control of hospital personnel) and will be able to authorize anyone of their choosing to have access to that information, including lab tests, diagnosis, medications and clinical notes.
"While this is exciting indeed," says Kenneth Mandl, MD, MPH, also of CHIP and co-author of the article, "without forethought and regulation, the tremendous benefit of PCHRs - for research and clinically - could easily be overshadowed by problems that could arise from the unethical and uncontrolled use of a patient's valuable medical information."
Traditionally, academic medical centers, health maintenance organizations and health networks - all covered entities under the Health Insurance Portability and Accountability Act (HIPAA) - held institutional control over their patients' health records. With the emergence of PCHRs, companies new to health care have become more involved and may ultimately house and manage a patient's health care information, no longer putting hospitals and health care institutions in the control seat and exposing patients' data to entities not covered by HIPAA.
"Who will have access to the data, for what purposes, and under what sort of regulation? Can patients sell their information? How will we establish and protect their identity?" asks Mandl. "These are the kinds of questions - among many others - that we need to ask now and clarify before PCHRs become mainstream."
"While PCHRs may seem futuristic," Kohane continued, "they are here now and will be widely adopted in the not-so-distant future. Fortune 100 companies are already signing on to develop their own PCHRs for their employees. We can't afford to be asleep at the wheel. Before they hit prime-time, we need to think about what is at stake and what has to happen - including regulations and standards - if PCHRs are to be used to the full extent of their potential."
More than a decade ago Kohane, Mandl and the CHIP team developed the first PCHR, the Indivo system, which is web-based and enables patients to own complete, secure copies of their medical records. Indivo integrates health information across sites of care and over time and is built to public standards as an open-source application platform. Developed through grants from the National Library of Medicine and the Centers for Disease Control and Prevention, the system is currently being used worldwide and is a key part of Children's own informational patient portal. In a true testament to its innovation, Microsoft and Google each adapted the Indivo model as they built their PCHR platforms.
Founded in 1869 as a 20-bed hospital for children, Children's Hospital Boston today is the nation's leading pediatric medical center, the largest provider of health care to Massachusetts children, and the primary pediatric teaching hospital of Harvard Medical School. In addition to 397 pediatric and adolescent inpatient beds and comprehensive outpatient programs, Children's houses the world's largest research enterprise based at a pediatric medical center, where its discoveries benefit both children and adults. More than 500 scientists, including eight members of the National Academy of Sciences, 11 members of the Institute of Medicine and 12 members of the Howard Hughes Medical Institute comprise Children's research community. For more information about the hospital visit: www.childrenshospital.org/newsroom.