unique governance challenges posed by a learning health system, including changing privacy considerations and accommodating new sources of data, Ms. Adams suggests drawing on past successes and experiences while incorporating the widest array of viewpoints possible.

Theresa Mullin from the Food and Drug Administration describes ongoing efforts to implement a systematic strategy for data standards development and adoption. This process will address heterogeneity in new drug applications, improve regulatory efficiency, and contribute toward the agency’s public health mandate by facilitating exploration of safety and efficacy issues. Dr. Mullin suggests that, through the standardization of clinical data in electronic health records, this effort presents an opportunity to facilitate information exchange and analysis for learning, reducing costs, and reducing burdens on providers for adverse event reporting. Dr. Mullin also highlights some of the overarching governance principles driving this effort: an open, transparent, and inclusive process; and a requirement that the resulting requirements be practical, user-oriented, sensitive to costs, and sustainable.

Meeting patient expectations for privacy and security is central in developing a learning health system, explains Shawn Murphy from Partners HealthCare. He details how current limitations to privacy through de-identification could be overcome by a comprehensive security and privacy approach that does a better job of addressing patients’ chief concerns around health information protection—avoiding embarrassment and economic risk. Citing an example of research program–based restrictions on physician access to data—whose risk to patient privacy is negligible given their otherwise broad access to patient information—Dr. Murphy suggests that the certified trustworthiness of the recipient should be a component of access control. He goes on to note that this, coupled with appropriate de-identification and secure data storage, provides a balanced approach to security that better matches the expectations of the patient while facilitating access for approved data users.

Guidance for approaches to governing the digital health infrastructure can be drawn from examples of similar efforts. Harry Cayton of the National Information Governance Board (NIGB) for Health and Social Care in the United Kingdom describes the approach they have taken in dealing with information governance issues facing the National Health Service. Mr. Cayton details the role played by the NIGB as an independent statutory committee to advise the government on the use of patient-identifiable data for clinical audit and research. He describes their philosophy that information governance (or stewardship) is the responsibility of every organization involved and provides a list of principles developed by the committee to guide their work. Stating that the purpose of the NIGB is to deal with the “wicked questions” that arise around use of health information,

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