Over the past 18 months, the Office of the National Coordinator of Health IT (ONC) has tried to fill this gap by developing educational materials and forms to give patients a "meaningful choice" on HIE use of their personal health information. On Oct. 22, ONC launched a month-long field test of these materials and the use of computer tablets to obtain electronic consent from patients. ONC officials described details of the pilot in an exclusive interview with InformationWeek Healthcare.
The test is taking place in the Buffalo, N.Y., area. Participating in the pilot are the HealtheLink HIE and four physician offices, including two primary care and two specialty care sites in urban, suburban and rural areas. Among the practices involved are Trinity Medical, Buffalo Cardiology and Pulmonary Associates, Family Health Medical Services, and Rheumatology Consultants of Western New York.
The tablets in the practice sites are loaded with an ONC video and educational materials tailored to HealtheLink and each practice's participation in the HIE. After viewing the content, patients are asked whether they want to "opt in" to allow the HIE to use their data for purposes other than direct exchanges between treating providers, which are permitted under HIPAA regulations.
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"Patients will use the tablet to review interactive educational material, and they can electronically choose whether to allow their information to be used in health information exchange," said Kathryn Marchesini, a senior analyst and advisor to ONC's chief privacy officer.
The patients' choices are stored remotely on HealtheLink's server, so no personal health information resides on the tablet in the physician office, she explained. Providers who are seeking information on the patient can see what the patient's preference is through the HIE, which also notifies the patient's own physician about whether the patient has opted in or not.
The purposes of the test are to see how well patients understand the educational content and how well the technology enables the e-consent process. ONC expects to have the results by next spring. After that, Marchesini said, ONC plans to disseminate the materials to providers and HIEs, including the statewide HIEs that have received ONC grants.
"Ideally, we're hoping to provide an open source tool that we can publicly make available for anyone to download and use in their environment," Marchesini said. "We realize that each HIE is unique, and there are some special local and state laws that may vary, and some nuances of wording may have to be worked through. But we hope that the materials we piloted can be leveraged by HIEs across the country."
ONC has issued an official guidance to the statewide HIE grantees about how to obtain "meaningful" consent, which can be done through either the opt-in or opt-out models. To be meaningful, the document says, the choice must be:
--Made with advance knowledge/time
--Not used for discriminatory purposes or as a condition for receiving medical treatment
--Made with full transparency and education
--Commensurate with circumstances for why IIHI is exchanged
--Consistent with patient expectations
--Revocable at any time.
Marchesini emphasized that having patients sign a "boilerplate form" or relying on them going to a website is not meaningful choice. "We're focusing on engaging the patient in an interactive manner so they understand the options they have."
She added that using paper forms is not an efficient way to obtain patient consent in the context of electronic information exchange.
The issue of meaningful consent in HIEs has become a front-burner issue for many healthcare organizations. John Halamka, the CIO of Beth Israel Deaconess Medical Center in Boston, recently told InformationWeek Healthcare that BIDMC had decided to have its 1,800 ambulatory care providers ask their patients to opt in for data sharing among the clinicians coordinating their care.
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