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April 17, 2014

Big-Data Backlash: Medical Database Raises Privacy Concerns

George Leopold

A controversial big data initiative designed to create a huge U.S. database of medical records intended to help patients and their doctors make better health care decisions is raising privacy and other ethical concerns.

The initiative, Patient-Centered Outcomes Research Institute, or PCORI, was formed as a non-profit organization in Washington, D.C., under the 2010 Affordable Care Act. The institute was created to coordinate research on the “comparative effectiveness” of drugs, devices, and treatments.

PCORI’s formation also coincided with the rise of big data and data analytics, areas that Obama administration science officials have been stressing as tools of economic growth and technology innovation.

“Both the opportunity and the anxiety are pretty electrifying,” Francis Collins, director of the National Institutes of Health, told the Washington Post.

Critics worry that patients will lose even more control over their electronic medical records if they end up in a huge medical research database. PCORI’s database is expected to launch as early as September 2015.

“The promise of big data in medicine has been only a promise,” said one critic, Dr. Deborah Peel, founder of the group Patient Privacy Rights.

Peel noted that congress is responding to growing complaints about the patient privacy by focusing on data brokers. She claimed some data brokers collect up to 1,500 data points on individual patients, then sell the information.

In an interview with C-SPAN, Peel claimed the one data broker disclosed in a government filing that “they buy our health information, electronic health records, prescriptions, claims data, and they also put in information about our health from social media.” These “longitudinal” health profiles are then sold to thousand of clients, including the federal government.

“This kind of use of health information, our electronic health information, when we can’t even get it, is absolutely appalling,” Peel asserted.

Nevertheless, the use of data analytics in health care continues to grow. For example, the medical technology startup Ambient Clinical Analytics founded by Mayo Clinic researcher recently launched a “bedside analytics” application. The startup is backed by Silicon Valley investors.

Meanwhile, the PCORI health care database would pool patient data collected by hospitals, clinics and health insurers. Personal data would be removed before patient records are entered into the database.

The impetus behind the initiative is to provide medical researchers a much larger sample of data about the relative effectiveness of treatments. Conventional clinical trials generate valuable data but lack the breadth needed to address real-world medical situations.

Partly in response to growing privacy concerns, the health care research institute stressed in an April 17 update that its PCORnet database now in development would be a “secure platform for [patient] outcomes research.”

PCORI Executive Director Dr. Joe Selby also acknowledged in a statement that “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,” Selby said.

The group announced last December that it had approved $93.5 million to support 29 health data networks that will serve as the backbone for the national health research database. “PCORnet will join together networks operated by both patient communities and health systems and will require patients’ and other stakeholders’ involvement in all aspects of the collection and use of the data,” the group said in announcing the funding.