Patients Suffer Under Archaic Clinical Trial Interoperability Woes

Meredith Karney, MS, MHA, Vice President for Health Economics, Center for Medical Interoperability

Meredith Karney, MS, MHA, Vice President for Health Economics, Center for Medical Interoperability

“Most people’s experience with healthcare is similar and it’s frustrating,” says Meredith Karney, speaking from direct experience. As a 36-year-old with a history of Hodgkin’s lymphoma since 2002, she’s had an estimated 450 unique medical encounters, been part of several clinical trials, seen more than 20 primary and specialist physicians, interacted with more than 25 provider networks, and dealt with more than 40 distinct electronic health record (EHR), radiology, and billing systems.  “It doesn’t need to exist this way,” she says.

Unlike some, however, she’s in a position to do something about it. “Every other industry has decided to solve this [interoperability] problem, and they have come together to do it in much the same approach that we’re taking at the Center for Medical Interoperability (CMI)” says Karney, MS, MHA, vice president for health economics and value at CMI.

CMI is a 501(c)(3) cooperative research and development lab founded by health systems to simplify and advance data sharing among medical technologies and systems. It provides a centralized, vendor-neutral approach to performing technical work aimed at enabling person-centered care, testing and certifying of devices and systems, and promoting the adoption of scalable solutions. The organization is looking for like-minded professionals to get involved, too, Karney says.

The industry must come together to fix things, she says. If it fails, the consequences are dire. “What does that mean in terms of its impact on patients? It’s killing about a jet load of patients a day, like a 747-load full of people a day [who] are experiencing adverse events or death as a result of just the lack of interoperability among technologies,” Karney says. It also contributes to “clinician fatigue [and] wastes billions of dollars each year” across the entire healthcare spectrum.

The barriers are formidable, she admits. Today, there’s “no interoperability among vendor systems, institutional systems, and enterprises, [and] transferring information from one health [information technology] system to another frequently results in the distortion or loss of information, blocking of critical details, or introduction of erroneous data,” Karney says.

Problems include “semantic incompatibility” and “trust and security” issues, according to Karney. For example, clinicians capture too much information as free text in ways unique to the clinician and thus difficult to collect across systems. In addition, the Health Insurance Portability and Accountability Act is outdated, and there’s no overarching “legal and governance structure which controls and protects patient data sharing for use in a modern technology ecosystem,” she adds.

“Achieving true data liquidity requires health data to flow from the person, within an episode of care, across care settings” in a way “accessible to an innovation marketplace,” Karney says.

As any guru worth his or her own salt will tell you, to achieve a dream, one must first visualize it. For clinical trial veteran Karney, it’s simple, yet complicated. Here’s her ideal future state for clinical trials:

  • Patients know about and can easily access clinical trials.
  • Patients feel in control of their digital health data and where it is shared.
  • Clinical trials data can be integrated with EHRs, medical devices, and other software and technology through a trusted infrastructure.
  • Providers spend less time entering data and more time analyzing data insights and knowledge.
  • New opportunities exit to harness the power and utility of digital health data in clinical trials as a care option.

Broadly speaking, the drug development industry has not kept pace with mobile technology adoption, Karney says. Citing studies showing nearly 40% of millennials engage their primary care physicians virtually or through ambulatory clinics, she notes, “Integrating technology into clinical research as a care option will be a game changer in achieving greater participation in clinical research and decreasing overall time for trial completion.”

Author: Michael Causey