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VISION AND STRATEGY BACKGROUND

A VISION FOR A LEARNING HEALTH SYSTEM SHARING DATA FOR CONTINUOUS IMPROVEMENT

As a defining starting point, the steering committee developed a vision statement to describe the ideal state for data sharing, linkage, and use to facilitate continuous learning and care improvement.

STRATEGIC APPROACH

THE POTENTIAL OF ELECTRONIC HEALTH DATA

In recent decades, the amount of electronic health data generated by health systems and health plans, biopharmaceutical organizations, health care consumers, and a variety of organizations outside health care has rapidly expanded (IDC, 2014; Stanford Medicine, 2017). Many advances have enabled this electronic health data revolution, including the introduction of electronic health records in health systems and hospitals; systems interoperability and uniform reporting;

federal investments and incentives; the availability of transactional health care data; new biometric and genomic data; and the development of technologies and applications that allow individuals to assess their own health and well-being, upload health data to electronic repositories, and access their online medical records (Adler-Milstein et al., 2015; IOM, 2013; Raghupathi and Raghupathi, 2014; Sim, 2019). The data resulting from these advances have the potential to dramatically improve health, health care, and health equity among Americans. They make it possible to provide important information to patients, caregivers, clinicians, and health care organizations, resulting in improved decision making and outcomes.

The routine use of health data¹ is a central component of a continuously learning health care system in which, as the National Academy of Medicine has stated, “science, informatics, incentives, and culture are aligned for continuous improvement and innovation, with best practices seamlessly embedded in the care process, patients and families active participants in all elements, and new knowledge captured as an integral by-product of the delivery experience” (NAM, 2015). Another critical feature of a continuously learning health care system is that it is driven by its stakeholders. Patients and families, health care executives, researchers, clinicians, community members, and other stakeholders should be actively engaged in identifying deficiencies and opportunities in the system, prioritizing and designing efforts to address those deficiencies and opportunities, and ensuring that the information generated from those efforts is translated into meaningful system improvements.

EXISTING BARRIERS TO DATA SHARING, LINKAGE, AND USE

Despite recent efforts to improve the engagement of stakeholders in decision making about the appropriate use of electronic health data, many health care consumers are still unaware of how data are being used and how these data could be used more effectively to improve health care and outcomes (Kim and Helfand, 2018). They are more aware of news stories about major security breaches than they are of the potential for health data to improve health (Blumenthal, 2017).

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¹ Health data refer to all of the information that accumulates about a person or population that may affect health outcomes. This includes, but is not limited to, health data generated during clinical encounters and stored in electronic health records or other data systems; health insurance claims data; data gathered from clinical and health services research; genomic, proteomic, and immunomic data; data related to the social and environmental determinants of health collected during clinical encounters or outside of the health care system through community, state, and federal organizations; and patient-generated health data, which has been defined as health-related data created, recorded, or gathered by or from patients (or family members or other caregivers).As an understanding of health continues to evolve and the types of data that are routinely collected continue to expand, this list will continue to expand and evolve as well.

Some organizations have begun to leverage health data to improve outcomes and health system performance. However, these data have generally remained siloed, have so far had only marginal effects on health, and have had limited reliability. Generating robust information to support continuous improvement requires sharing and combining data so that differences in outcomes resulting from alternate health care interventions or approaches to delivering care can be efficiently detected and measured. Additionally, linking data from different sources can provide more complete information and allow for a greater number of questions to be addressed. Achieving the vision for a health system that shares data for continuous improvement requires breaking down silos, linking data among data holders, and using those data to maximum advantage in improving health.

Today, major ethical, regulatory, cultural, financial, and operational challenges limit the routine sharing and linking of data among data holders. Efforts are under way to address the technological challenges, which include a lack of interoperability and poor data quality, but resolving the technological challenges alone is not sufficient (Holmgren et al., 2017). The ethical, regulatory, financial, operational, and cultural challenges also need to be addressed. These include the absence of business models to support sharing data across organizations; barriers related to informed consent and privacy protections; the need for better ways of educating and engaging consumers about data transactions; and the creation of more widespread awareness about how electronic health data can improve individual, population, and systems outcomes.

GENERATING STAKEHOLDER SUPPORT AND DEMAND

Addressing these barriers requires the commitment and support of many important stakeholder groups, including patients and their families, clinicians, the research oversight community, and health care executives. Each of these groups has unique interests and concerns related to the sharing, linkage, and use of electronic health care data:

• Patients and families want more access to their health information, including the ability to seamlessly share information with others. Patients and families also want more transparency and control over how their electronic health data are used by others.
• Health systems, clinicians, health plans, public health agencies, and biopharmaceutical companies are well positioned to leverage data sharing for improved patient outcomes, clinician satisfaction, discovery, and overall system performance. However, to the extent that health data are seen as tools

of competitive advantage, creative thinking about how to incentivize data sharing will be necessary.

• The research oversight community is concerned with ensuring that electronic health data are shared and used in ways that appropriately balance population-level interests in generating new knowledge for current and future patients with the need to protect individuals and groups from risks, such as those that might arise from privacy intrusions and data misuse.

Reflecting the distinct interests and concerns of stakeholder groups, conversations among these groups have been limited, as have efforts to facilitate conversations among these groups to foster a shared understanding of opportunities, approaches, and common principles. Improving communication and engagement both within and across stakeholders is critical to building support and demand for responsible sharing, linkage, and use of electronic health data.

KEY POLICY AND CULTURAL LEVERS TO FACILITATE PROGRESS

Several crosscutting policy and cultural levers could facilitate progress toward achieving the vision of a health system that employs data to support continuous improvement, including the following:

• Routinely and systematically engaging stakeholders across the health care system in conversations about how electronic health data may be used to support health and health care improvements. Health care consumers, clinicians, health care leaders, and policy makers need to be engaged in conversations about the practical uses and benefits of electronic health data as well as the risks of harm and how those have been mitigated. Such data may be used to support informed decision making when patients are considering different treatment options. This engagement should consider each stakeholder’s relationship to the broader health care ecosystem as well as the cost–benefit considerations relevant to that stakeholder in achieving the stated vision. Effective approaches to engagement must involve clear guidelines to resolve conflicts when disagreements arise regarding policies or approaches to support data sharing. While some engagement efforts are under way, particularly in clinical research, discussions about electronic data sharing need to be much more extensive.
• Implementing systematic approaches for demonstrating value that results from the use of electronic health data. Engendering support

for data sharing will require greater awareness of how the use of electronic health care data has led to improved outcomes for patients, higher levels of patient and clinician satisfaction, reduced health care costs, better access to necessary services, and other benefits. Achieving this goal requires that patients, caregivers, and providers have access to information generated from data-sharing efforts at the point of care and in formats that allow them to use that information to support health-related decision making. These approaches should also create incentives for innovation and competition within and across the organizations that comprise the U.S. health care system.

• Developing and maintaining a trustworthy data-sharing environment. A trustworthy data-sharing environment must ensure ethical uses of health data. It must demonstrate respect for individual data sharing and linkage preferences through the adoption of appropriate oversight, disclosure, and consent practices; maintain a commitment to data security; and ensure privacy at every step of the data management life cycle, from data collection, to their use in a primary care setting, to their analysis and sharing in secondary settings. Policies for electronic health data sharing must explicitly prohibit the use of those data for discriminatory purposes as well as the re-identification of anonymized data. Developing and maintaining trust also will require informing health care consumers of federal, state, and other system-specific policies related to data collection, sharing, and use so that consumers understand when and how their data are protected. Finally, the health care system should work to engender trust by preventing the use of electronic health care data to gain competitive advantage.
• Addressing structural incentives that discourage electronic data sharing. The dominant fee-for-service payment model in the U.S. health care system provides little incentive to share information. To facilitate change, outcomes and payments need to be aligned in the delivery of value-based care. In addition, resources need to be available to maintain data integrity, reliability, and access, such as a state-of-the-art data security framework and data governance and use policies. Resources are also needed to support the hiring and training of staff with the appropriate expertise to maintain data-sharing efforts and to function on investigative teams within health care organizations.

CONCLUSION

The health care system faces a momentous challenge that is linked to an unprecedented opportunity. The current system has unacceptable shortcomings

and unsustainable costs. At the same time, it has an opportunity to apply new tools and technologies to help solve these problems. Working together, key stakeholders could capture this opportunity by better sharing, linking, and using electronic health data. Transforming the U.S. health care system into one that continuously learns and improves requires addressing ethical, regulatory, operational, financial, and cultural barriers. Technological barriers also exist and have been analyzed in many other locations—this Special Publication focuses on the other barriers. Such a transformation could result in a health care system in which the generation of new knowledge is embedded into and an expected goal of care delivery.

The current initiative aims to engage patients and family members, health care leaders and health plan executives, and the research and research oversight community in a coordinated effort to identify the critical issues, overcome the barriers to resolving those issues, and build demand for the routine sharing and use of data to improve health.