M. Cleat Szczepaniak, Michael M. Wagner, Judith Hutman and Sherry Daswani RODS Laboratory, Center for Biomedical Informatics, University of Pittsburgh, Pittsburgh, Pennsylvania
Kenneth W. Goodman University of Miami, Miami, Florida
Many organizations are involved in biosurveillance; they are encouraged to cooperate by laws, regulations, money, altruism, and mutual benefit (or self-interest). For example, state, local, and federal health departments have a long tradition of voluntary and regulated interoperation. The healthcare system interoperates with governmental public health for reasons that include regulatory compliance and altruism.
As in most spheres of human activity, laws and regulations tend to lag behind real-world needs. This situation is especially true of late in biosurveillance because of the rapid changes in the types of data that are now perceived as necessary for early detection of outbreaks. Little precedent, less regulation, and yet less law, are available to guide organizations that are attempting to exchange newer types of biosurveillance data. Until regulatory and legal frameworks catch up with emerging requirements, the ability of biosurveillance organizations to implement desired new practices will depend largely on their ability to negotiate agreements with other organizations
In this chapter, we first concentrate on negotiating data use agreements (DUAs). Documents of this type can be called by other names than "data use agreements," but regardless of the name, they are documents that legally govern use, care, and confidentiality of data. DUA negotiations are set in the general context of existing laws and regulations (which may not explicitly require the desired data or service); thus, negotiators oftentimes find themselves considering fundamental ethical principles related to privacy and confidentiality in reaching agreements. For this reason, we discuss ethical principles that constrain negotiations. We provide a brief discussion at the end of this chapter on service agreements, which are expanded DUAs that may specify reliability of provisioning of data and services such as testing of patients.
2. AGREEMENTS TO PROVIDE OR EXCHANGE DATA_
Biosurveillance depends on data about the health of people and animals, as well as the microbiological status of the environment.
It also depends on data related to the production of food, drugs, drinkable water, and the movement of people.
Many organizations hold the requisite data. The number of organizations in any region that hold these data is large, and existing legal or customary practices only govern a fraction of the data and organizations. Any other exchanges of data are subject to mutual voluntarily agreement of both parties, as well as prevailing community standards of privacy and confidentiality, general law and regulations. As discussed in Chapter 5, in the United States each state has its own provisions about disease reporting, and health departments must therefore develop their surveillance systems with regard to the data they can collect in accordance with their particular state's provisions (Broome et al., 2003).
For clarity, we will use the term data requester to refer to an organization that is asking another organization to provide data. We will similarly use the term data provider to refer to the organization that is being asked to provide data. Our discussion will be from the perspective of the data requester. We recognize that the goal of a negotiation may be a mutual exchange of data and the principles that we discuss apply to that situation as well.
This section discusses general principles, specific strategies, and documents that we have found useful when negotiating agreements for data exchange. In our discussion, we assume that a decision is already made to pursue a specific type of data (for the types of data that might be useful in biosurveillance and what organizations have the data, see Parts II and IV). We address the issues that come up in negotiations and how they can be addressed. We emphasize the need for flexibility in handling the issues, which means that the data requester must be willing to adjust to and accommodate the needs of a data provider.
2.1. General Principles
A DUA is the end result of a negotiation that begins with an initial approach by one organization to another. Some general
Handbook of Biosurveillance ISBN 0-12-369378-0
Elsevier Inc. All rights reserved.
principles apply to the entire process of negotiation, which begins with an initial contact and ideally results in an exchange of data.
The support of governmental organizations that may have legal authority to acquire, hold, or receive the data in question is essential in most negotiations. Not only will these organizations utilize the data, but also most potential data providers, such as hospitals, recognize the authority of these organizations and likely have existing relationships with them.
Departments of health are quite active in both supporting and initiating data exchanges. Many employ a "biosurveillance coordinator" or "director of biosurveillance" who is charged to develop the biosurveillance capabilities of the department. These individuals understand the need for data, and their involvement in data use negotiations is highly desirable.
Governmental and other organizations may have been approached, are working with, or may approach the same data provider during your negotiation. Knowing both the history of previous and concurrent approaches is important. A data provider will be confused if your request overlaps or is inconsistent with other approaches. If another organization is unaware of your request and approaches the data provider during your negotiation, it may undermine or slow your discussion. Multiple uncoordinated requests are a recipe for failure.
Although an agreement must meet the needs of both parties, it is especially important to consider the needs of the data provider. Flexibility on the part of the data requester is a key to eliciting participation. A data requester must understand that it is generally not the primary mission of many data providers to supply data to biosurveillance organizations. A hospital's mission, for example, is to treat its patients; a laboratory's mission is to process and report the results of tests that will facilitate the proper treatment of patients; and the mission of a commercial company is to achieve profitability for the company and its shareholders.
Minor problems and questions frequently arise during a negotiation. There may be questions and disagreements over the language in a DUA, unanticipated problems in designing the technical mechanism for data transfer, or costs involved in setup. Each step in the process must be closely monitored on a daily or weekly basis to ensure success and all problems are satisfactorily and quickly resolved.
Establishing data exchange for biosurveillance is a rather complex process, involving technical, business, ethical, and legal dimensions. The parties involved in a negotiation must have a working understanding of relevant technology, laws, regulations, and work flows in both organizations. A negotiation typically involves individuals with different backgrounds, which may include medicine, technology, law, and business, and typically some individuals who do not understand some of the relevant dimensions. This lack of shared understanding of the problem will be a barrier to progress unless one can educate all individuals involved in the negotiation.
Early in the negotiation, the data requester should provide two fact sheets. One fact sheet should provide basic information about the biosurveillance system and convey its purpose (Figure 34.1).Another should "make the business case," which means to convey why the organization should provide the requested data and describe the benefits to the data provider for participating in the project (Figure 34.2).The business case should be presented from the perspective of the potential data provider and make selling points that will resonate with the organization. These fact sheets should address the information needs of high-level decisions makers. It is likely that the organization will pass the documents up and down a chain of command.
The data requester should also offer a document describing the information technology (IT) specifications for the system (e.g., Appendix F).This document must be detailed enough to allow the IT staff (oftentimes the chief information officer) of the data provider to estimate the time, effort, and cost required to make any IT modifications necessary to transfer data. The IT-specifications document must clearly describe what is required of the data provider, provide specific step-by-step instructions, and use illustrations and graphics wherever possible. Making the process as clear, simple, and efficient as possible demonstrates professionalism of the organization requesting the data.
Concerns about data security arise frequently. The data requester should have available a document devoted exclusively to the topic of data security, including how the data are protected, if they are encrypted, who will use the data, and how the organization guarantees secure handling and use of the data (Figure 34.3).
The decision makers at potential data providers organizations are highly educated and will weigh the costs and benefits of participating in any project. In many cases (especially with hospital and pharmacies), the decision makers have extensive domain knowledge and general familiarity with the goals of public health surveillance or biosurveillance. They often want scientific evidence that the data you request is of value. One or more scientific publications showing that the data are capable of contributing to biosurveillance is perhaps the most efficient way to satisfy the decision makers. We often provide decisions makers with a research publication on syndrome
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