The United States has lagged behind other developed nations with respect to adoption of electronic health records (EHRs), especially in primary care, although that appears likely to change. The American Recovery and Reinvestment Act of 2009 will result in an investment of approximately US $19 billion toward the adoption of EHRs and, under the direction of the Office of the National Coordinator for Health Information Technology, an “initial set of standards, implementation specifications, and certification criteria” to enable the electronic exchange of health information [1]. With these developments in the United States, electronic sharing of health information—typically defined as the exchange of personal health information contained in the medical record between at least two different computer networks—is expected to increase exponentially over the next decade [2]. The expansion of electronic data sharing, also known as health information exchange (HIE), is heralded as a key solution to the problems of low quality and high cost of health care [3]. However, HIE has presented substantial challenges, not only in the United States but also in countries such as the United Kingdom [4], Australia [5], and Sweden [6].

The potential benefits of electronic health information exchange include improved health care quality, reduced medical errors and lower health care costs, as well as public health benefits, resulting from early detection of infectious disease and improved tracking of chronic disease management [7]. In the United States, regional health information organizations (RHIOs) have emerged as the leading model to facilitate the electronic exchange of patient-level clinical information between physicians’ offices and other health-care organizations that deliver care to patients [8,9]. The overarching goal of these RHIOs is to ensure that physicians and other health care providers have access to the best and most complete information about patients for whom they are caring when they need it most—in real time, when the patient is with them in the examination room, emergency department, or other clinical setting. Not only could awareness of a patient’s medical history, such as, for example, a current problem list or known allergies to medications, improve the quality of health care, but it could be, in some instances, life-saving [10]. The model of RHIOs is considerably different from that being used in other nations such as the United Kingdom, which has a single “spine” which is being implemented [11].

To date in the United States, however, the electronic exchange of health information has faced considerable challenges with respect to technical limitations and financial constraints (e.g., is there a sustainable business model?) [12]. Overcoming the lack of interoperability (i.e., the problem of systems on different platforms being unable to exchange information) and the question of who will pay for health information exchange have presented major impediments. In addition, concerns about the privacy and security of personal health information in these systems have also emerged [13,14]. As communities begin to overcome the technical and financial barriers to health information exchange, attention has turned to the importance of engaging community members—the patients—in the process. Specifically, policymakers have begun to focus on patients’ perspectives of electronic health information exchange, especially their concerns about confidentiality and data security, and their willingness to provide consent for health information exchange.

In preparation for launching community-wide electronic health information exchange in Massachusetts, we conducted formal and informal discussions among stakeholders to address key questions about the process: How well do patients understand the value of clinical data exchange? To what extent do they endorse the electronic transmission of clinical information among health care providers? What are their concerns and hesitations about the process? How should patients be informed about, and approached for, participation in a community’s HIE?

Exchanging health-related information electronically to improve clinical practice is central to maximizing the benefit of ongoing efforts to expand electronic health records to physicians’ offices everywhere [16]. Because health information exchange involves electronically exchanging patient-identified health information across geographically and commercially separate entities, it raises issues of patient privacy and data security which have resulted in heated debate [17,18]. However, little is known about patients’ attitudes toward health information exchange and their preferences for learning about it and giving consent for it. In this qualitative analysis of five focus groups within a community on the eve of launching a regional system of health information exchange, we found that most patients were willing to opt in to a system of health information exchange, although they had concerns about security and privacy and wanted assurances that they would be able to ask questions and obtain more information prior to consenting. Overwhelmingly, patients recognized the potential for the electronic exchange of health information to improve the quality of health care and prevent medical errors. This potential was the driving force behind many patients’ enthusiasm for participation.

Patients’ concerns about privacy and data security are not surprising, given the attention paid to these issues in both the medical and lay literature [19,20]. Furthermore, there have been some well-publicized breaches, such as an incident in the United Kingdom in which data from 25 million individuals were placed on CDs that were lost in the mail [21]. While some have pointed out that paper-based records systems have long been subject to breaches of privacy and security, the potential for large volumes of electronic data to be accessed in short amounts of time and the ease with which those data can be transmitted from user to user have elevated concerns about potential privacy violations and security breaches in computerized systems [22]. In addition, the high visibility of news stories which depict data loss and security breaches in a variety of business sectors [23], as well as in health care [24,25], seems to have sensitized the public to these concerns in the context of health information exchange. As countries intensify health information exchange efforts, concerns about privacy and data security are likely to increase, as well. For example, in the United Kingdom, where the National Health Service transmits more than 100 million clinical messages electronically every month [26], public concern has been particularly vocal and substantially hampered efforts to advance clinical information exchange programs [27,28]. It is reasonable to expect that public concern in other countries will increase correspondingly as the volume of data exchange expands to these levels.

In the United States, most early data exchange efforts have been at the community level. In this study, the concerns about privacy and security ranged from non-specific, “gut-level” worries to sophisticated, reasoned acknowledgements of the risks in both electronic and paper-based systems. Without question, though, patients across the community in our study expected privacy and security to be addressed and adequately assured.

Among community members, there was unanimous acceptance of the notion that health information exchange would lead to improvements in the quality and safety of health care. Patients cited their own experiences with misplaced paper charts, for example. They easily recognized the potential value of having their health information, such as medication lists or allergies, immediately accessible to clinicians in practice settings where they are not customarily available. In this study, no one expressed any skepticism about the potential for health information exchange to improve care, and in fact many patients linked this potential benefit to their willingness to provide consent for participation. The promise of improved quality and safety of health care seemed to outweigh patients’ deep-seated concerns about confidentiality and data security, as long as the system explicitly and adequately addressed the latter.

Participants in this study also articulated a consistent message that community members must receive clear and concise materials describing the system of health information exchange and have opportunities to ask questions about it before they would be willing to opt in. While nearly all participants indicated that they would provide consent for inclusion in the exchange system, many expressed a need to have information about it, and especially assurances of privacy and security, available for review and consideration well in advance of being asked to “sign on the dotted line”. This finding indicates that enrolling a community in health information exchange may take considerable time, as patients want to be able to read and reflect on materials, discuss them with family members, and ask clarifying questions before committing to it. Patients’ interest in making an informed decision also likely reflects the fact that they expect to have control over whether their information is included in the system.

The input from the focus group discussions led to considerable revision of the consent form (See Multimedia Appendix 3), the educational / informational brochure (See Multimedia Appendix 4), and the fact sheet (See Multimedia Appendix 5) that were ultimately produced and distributed within the community. In the initial materials and during the discussions, for example, the health information exchange was referred to as a community health record or a shared health record. Focus group discussions suggested that “e-health summary” was a more appealing and meaningful description. In addition, feedback from patients led program leaders to craft a schematic diagram of the multiple sources of information that would populate the e-health summary (See Multimedia Appendix 4, page 5).

Perhaps the most noteworthy outcome of the focus group discussions was the decision to make health information exchange an “opt-in”, rather than and “opt-out”, experience. At the time of the focus group discussions, regional policymakers had considered establishing the health information exchange system such that the records of all patients of all participating physicians would be included unless the patient actively opted out. However, patients’ robust preferences for retaining the authority to provide consent—and their near unanimous expressions of willingness to provide that consent—led to the establishment of an “opt-in” system.

A few prior studies from the United States have explored patients’ attitudes toward the use and protection of health information [29-31]. Little is known about how best to approach the process of engaging community members in health information exchange in the United States and abroad. One of the first regional health information exchange systems in the United States, the Santa Barbara County Care Data Exchange, recognized that privacy issues need to be addressed explicitly and early in the process [32]. Santa Barbara leaders also realized the value of engaging community members in the development of policies intended to educate consenting patients before they participated in the health information exchange [33]. These observations are consistent with and reinforced by the salient themes that emerged from our study.

Interestingly, some experts have suggested the potential for streamlining the consent process for health information exchange through electronic communication [34]. While our study did not directly assess the acceptability of an e-consent process, we did find that community members expect information to be presented clearly and concisely, with time provided between the presentation of information and the need to consent in order for there to be opportunities to ask for more or clarified information. To the extent that electronic consent processes can incorporate these community needs, they may enable communities to streamline the enrollment process, though access to paper materials and human information sources will likely remain essential.

The findings of this analysis need to be considered in the context of the study design. We conducted five focus groups in one community in Massachusetts, and the attitudes and preferences of patients in communities elsewhere may differ. On the other hand, the purpose of this study was to identify the breadth of attitudes among community members about consent for health information exchange and, as such, it is likely to have identified the relevant domains of concern for many other communities embarking on similar efforts.

This study provides insight into the ways that patients perceive electronic health information exchange and their willingness to provide consent for participation. Others have already recognized the value of sharing experiences and lessons learned from community implementation of health information technology, including the electronic exchange of health information [9,35]. Future studies should test differing strategies for educating community members about health information exchange and for securing their consent for participation. While there will likely be variability across communities and nations, as well as a need for local programs and policies, each community embarking on the implementation of clinical data exchange should not need to “reinvent the wheel” in terms of engaging patients in the process.