Healthcare Research

Promoting and enhancing the use of established data repositories for EHR data, with appropriate controls in place, supports the sharing of individual-level human and other sensitive data, and promotes efficiencies in costs and resources. Moreover, it reduces the burden of negotiations and investments by multiple ICs to access data from the same EHR sources. Data sharing agreements between EHR systems should not add restrictions that arbitrarily limit sharing and use. Data repositories should maximize appropriate sharing, including eliminating investments in data that cannot eventually be made accessible for research purposes, and invest in new capabilities that cut costs, promote efficiencies, and enhance the scientific value of the repositories. A key piece of optimal data sharing and maximum collaborative synergy is promoting the sharing of NIH-supported established data repositories among NIH ICOs. Furthermore, facilitating access to clinical data for research, when feasible, including by not limiting access to only those institutions, organizations or systems that collected the data, will democratize capacity to conduct this type of research. Advancing inter-agency coordination on cross-agency accessibility to EHR data and facilitating development of cost-sharing models is a desirable future goal with the potential to benefit both research and downstream clinical care and healthcare operations.

NIH should demonstrate respect for persons by taking steps to make them aware of, and provide support for making decisions about, sharing and using their EHR and other clinical data for research purposes. There are a variety of viewpoints held by people regarding how broadly their clinical data should be shared for research purposes, as well as approaches to request permission for research uses. Demonstrating respect for persons includes being mindful of the full range of those viewpoints and taking steps, to the greatest extent possible, to enact measures to address them.

Data used in research warrant privacy considerations regardless of whether the data are collected from non-research settings that may be subject to different privacy standards than traditionally applied to research data. To that end, NIH should encourage investigators to proactively assess the protections needed for collecting, using, and sharing data from individuals regardless of whether the data meet technical and/or legal definitions of “de-identified” and can legally be shared without additional protections. Assessments should consider risks to individuals, their families, groups, and populations. Fostering and maintaining public trust necessitates that NIH protect the privacy and confidentiality of every individual. Taking proactive measures to address necessary requirements up front allows for accurate communication with the public about how data will be used and maximizes researchers’ ability to responsibly share data after collection.

Science and health can be advanced through access to and use of clinical data for research and for decision making. Access to and use of these data can foster collaborations (e.g., create larger datasets for scientific value) and form mutually beneficial partnerships involving researchers, the community, and healthcare providers (e.g., to address community-specific health disparities). Considerations should be given to the needs and interests of the communities from which the data are generated (e.g., urban communities, rural communities, Tribal policies and regulations, etc.) and appropriate measures should be enacted to ensure respectful use.

Promoting awareness among the public that EHRs and clinical data are being used for valuable research is important for establishing public trust. Embracing transparency with regards to research uses for clinical data demonstrates respect for persons and is a necessary component of requesting permission from persons for use of such data in research. Transparency is critical to building and maintaining public trust in the research enterprise whereas its omission threatens to erode any progress made. Communication of research value is also a critical component of transparency. People should receive information about the knowledge aimed to be gained as well as potential risks, just as they do in the clinical care realm. Communicating secondary uses of clinical data, including risks and benefits, and conveying the potential utility of research findings at the individual, community, and population level allows people to make informed decisions, increases trust, and sets the expectation for accountability and integrity.

When viewed through a research “lens,” clinical data may be incomplete, inaccurate, or lack harmonization. Additionally, outcomes data, which are useful, and at times foundational, for both clinical and research purposes, are hard to extract from EHRs. For the use of these data to be beneficial to all, clinical data collected into the EHR, to the extent possible, should be representative of the population, accurate and consistent across personnel and systems, and informed by different types of research and clinical use needs. For many research participants, part of the value of participating in a research study is the utility of their research data to inform and improve their clinical care, thus it may be beneficial to also promote ways in which research data can be used in the clinical care environment.

Detailed, large-scale clinical data can be utilized for research purposes to allow discoveries to be made significantly sooner and for a fraction of the cost of a traditional study design. While recognizing that the use of clinical data for research is an important complementary component of a robust research and innovation ecosystem, when deciding whether to use clinical data for research purposes, there is an ongoing need to consider the importance of the knowledge to be gained, and the potential risks to the individuals, families, and communities from which the data were collected. Decision-making about research uses for clinical data needs to evaluate benefits and risks, while carefully considering these NIH guiding principles, and existing laws, policies, and regulations, including applicable Tribal laws, ordinances and research protocols. Future policies should likewise consider these factors.

Rapid advancements in data science and technology will continue to expand opportunities to utilize clinical data for research. These advancements may also introduce new challenges to protecting privacy, communicating benefits and risks to the public, and ensuring broad representation of individuals, families, and communities contributing clinical data for research. NIH should work to empower staff, researchers, and their institutions, to develop frameworks and tools to understand the risks of utilizing clinical data for research, anticipating advances in technological capabilities, and understanding community perspectives. Establishing periodic assessments for NIH policy development and for institutional determinations will be needed to understand and respond to changes in risk introduced by new technologies, including impacts on sensitivity of specific data types and data linkage capacity.