Dr. Richard Culbertson, professor and program director of health policy and systems management at the LSU Health School of Public Health, authored an article entitled “The Ethics of Big Data” for the November/December issue of Healthcare Executive.
The article chronicles healthcare’s “small-data world of paper charts and limited electronic data storage” to the emergence of the first major “application of big data” in the 2008 Flu Trends project by Google. Although Google greatly overestimated specific regions and states’ rates of flu incidence in its predictions, its use of multiple databases and search terms garnered the interest of many researchers.
Dr. Culbertson explained how “patient specific clinical information” became ubiquitous with the introduction of electronic health records, prompting the “comparability of massive amounts of clinical data in real time.” Heretofore, such magnitudes of data sets were unimaginable.
In 2010 the Patient-Centered Outcomes Research Institute (PCORI) was established “to oversee the conduct of pragmatic clinical trials with information obtained from health records of large numbers of patients – ideally, one million or more lives in a comparison network.” Subsequently large numbers of healthcare systems joined “PCORI-funded networks”, making huge quantities of “patient data available for study purposes.”
In 2013 the University of California-San Francisco Health eHeart study attracted private venture capitalist funding to study one million participants throughout the world “to be followed through questionnaires and remote monitoring.” The study’s PI, Dr. Jeffrey Olgin, claimed his work constituted “a whole new science” – one that allowed for “analyses of large populations versus small expensive traditional clinical trials.”
This “new science” captured the attention of scholars who “identified the ethical dilemmas… (of) informed consent; patient engagement; privacy and confidentiality; and data sharing.” Patient privacy traditionally has been sacrosanct in the healthcare world. Other than obtaining “blanket consents (from millions of patients) that do not provide the specificity we now demand” the healthcare executive is facing the conundrum of protecting privacy at the cost of supporting studies that may benefit a broader population.
Another concern posed by the use of big data is whether “analytic uses for this information may not yet have been devised.” Hence, the studies’ beneficence to the general population is questionable.
These combined issues prompted the American College of Healthcare Executives (ACHE) to issue the Ethical Policy Statement “Health Information Confidentiality, which requires that executives protect patient privacy and the confidentiality of their medical records, “unless the circumstances warrant an exception.”
In light of big data emergence, requests for exceptions have proliferated.
There is no simple response to this development, stated Dr. Culbertson “(since) leading ethicists disagree on the primacy of the respect for a person’s principle and strict adherence to our traditional view of consent versus the beneficence that might result from the identification of superior forms of treatment…”
The ACHE policy statement requires the (health care) “executive to participate in public dialogue” on each request for exception, and whether a patient’s privacy should be waived.