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Health care providers and information technology vendors told a federal advisory panel March 28 that solving the challenges of making medical devices interoperable with electronic health records and other devices would do much to improve quality, safety, and efficiency in the health care delivery system.
However, most medical devices do not communicate well with EHRs and other devices and do not do a good job transmitting patient data from devices to providers' clinical information systems, panelists told the Health Information Technology Standards Committee clinical operations workgroup, an advisory group to the Office of the National Coordinator for Health IT.
Chief among the problems in making medical devices interoperable is there are no universally accepted or enforced technical standards for ensuring devices communicate in the same ways with EHRs and other clinical information systems, the panelists said.
Julian M. Goldman, an anesthesiologist at Massachusetts General Hospital and medical director of biomedical engineering for Partners HealthCare System, said that in the current environment, when medical device integration with other devices or electronic health records and information systems is required, customized interfaces are required, often at a high cost, long development time, and with incomplete functionalities.
“Furthermore, medical device interoperability is necessary to lay a foundation for the more comprehensive improvements in patient safety and quality that can arise from point-of-care clinical systems integration incorporating rich data from medical devices,” Goldman said.
Similarly, R. Scott Evans, senior medical informaticist at Intermountain Healthcare, said that one of the main problems his firm has encountered in collecting patient data from medical devices is that “unique middle layer software” often has to be developed to connect health information systems to each device from which patient data could be obtained.
“This is due to the fact that there are currently no standard interfaces being used by the medical device manufacturers,” Evans said. “Standards for output port types, data protocols, and frequency and methods of acquiring data would be helpful.”
In addition, Evans noted, medical device makers do not use a standard coding language. And, even if they use common messaging formats--such as HL7 or XML--there still can be variations that prohibit interoperability.
Courtney R. Lyles, a researcher with Group Health Research Institute at the University of Washington in Seattle, called the development of medical device interoperability standards “essential” to meeting patient needs and expectations.
“Patients need interoperability, not only between electronic records and consumer devices, but also between devices themselves, such as glucose meters and mobile phones,” Lyles said.
Lyles said medical devices--such as glucose meters--that can be used by patients in their homes or other settings outside of medical clinics and hospitals improve patient and clinician management of chronic conditions.
However, medical devices often are not designed to transmit data over varying channels (wired and wireless connections, for example) and into varying types of data networks using varying operating systems, raising frustrations for patients and providers, said Robert Havasy, customer operations manager at the Center for Connected Health.
“Together, providers and patients would like to simply choose the devices which are medically necessary and have them just work, regardless of the communications network to which the patient has access,” Havasy said.
Havasy also said that the “first mission” of interoperability efforts should be to “encourage the broadest possible compatibility with the existing communication networks” to meet patient needs and expectations.
Workgroup members questioned researchers on one panel about whether patients expressed concern about their personal health data being collected via medical devices, then transmitted to an EHR or other clinical information system.
“That was actually not a large concern,” Lyles responded, referring to a population of diabetes patients in a study using glucose meters with which she was involved. “This was not a barrier.”
Havasy also said patients typically were not concerned about the privacy of data sent to their doctors via their medical devices.
“They trust the people in the white coats regardless of the technology,” he told the workgroup.
Nevertheless, Havasy said protecting patient privacy was important and that existing federal requirements, under the Health Insurance Portability and Accountability Act, caused medical device development to move slowly, but doing so ensured protections were put in place.
Robert Jarrin, co-chair of the Continua Health Alliance U.S. Policy Working Group and senior director of government affairs at Qualcomm Inc., said that patients' physiological data captured by medical devices, sensors, and other health IT products were vital to the continuum of care and that greater emphasis should be placed at the federal level on how data are captured, derived, and transmitted via interoperable devices.
As such, Jarrin said ONC should be more aggressive in promoting the inclusion of “meaningful use” objectives for engaging patients in their care at an earlier stage in the EHR incentive program.
“The incentive program needs to be expanded to include electronic self-management tools for patients with high priority health conditions while offering the capability to upload and incorporate patient-generated data such as electronically collected patient survey data, biometric home monitoring data, patient suggestions of corrections to EHRs and clinician workflow,” Jarrin said.
Several panelists noted that the currently envisioned Stage 3 of the meaningful use program would begin to require providers to engage patients more in their care, but some, like Jarrin, said that patient engagement should happen sooner.
Others, including Lyles, said that the currently envisioned staging of patient engagement in the meaningful use program was appropriate, noting that the medical device industry needed time to “tackle some of the usability challenges in home monitoring systems,” and said patient concerns should be among top considerations.
“Although home monitoring for conditions such as blood glucose levels and blood pressures are important uses of electronic health records, they will be meaningful only if we can keep the needs and preferences of patients first,” Lyles said.
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