Digital Infrastructure for the Learning Health System The Foundation for Continuous Improvement in Health and Health Care: Workshop Series Summary (2011) / Chapter Skim
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6 Stewardship and Governance in the Learning Health System
6 Stewardship and Governance in the Learning Health System
Pages 167-184
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From page 167... ...
Remaining pieces focus on the types of governance issues raised when considering a learning health system, including leveraging ongoing efforts to accelerate development and approaches to mitigating potentially conflicting interests among stakeholders. Drawing from her experiences -- including leading the establishment of the Rhode Island Health Information Exchange -- Laura Adams of the Rhode Island Quality Institute identifies and addresses fundamental questions posed in contemplating the governance of the digital health infrastructure.
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From page 168... ...
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.
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From page 169... ...
Rhode Island Quality Institute Establishing a governance structure for the learning health system calls for an open exploration that allows for emergence of structures perhaps not yet conceived, but advanced by consideration of several key factors to make it an effective and responsive function. Some important elements to be considered in establishing such a structure include the source and scope of authority; mission, purpose, and primary goals; operating procedures; the framework for evaluation and continual improvement; and the funding mechanism.
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From page 170... ...
. An emerging governance structure for the learning health system must also specify structures and relationships with other relevant entities.
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From page 171... ...
had relatively few problems with consent issues as they related to electronic health records, as people saw the value in moving away from paper records. The situation was different in Rhode Island, where from the beginning of the process of development of a statewide HIE, there was no contextual crisis, but a deep commitment to consumer engagement and addressing privacy concerns.
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From page 172... ...
Policy makers and researchers can use data collected from the emerging digital health infrastructure to address these questions, as well as many more. Development and widespread adoption of information standards is essential for the use of health data for knowledge generation and expedited application of new knowledge in clinical care.
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From page 173... ...
These standards will facilitate a more transparent and reliable review process for new products as well as advance the agency's public health mission by providing a platform for consistent, sciencebased regulatory decisions. Although premarket clinical research yields only a fraction of the volume of clinical data generated by care delivery, stakeholders such as the FDA, sponsors, and standard-setting bodies have an active interest in developing data standards for clinical and preclinical data.
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From page 174... ...
Fortunately, an increasing proportion of NDAs are being submitted electronically, and an increasing portion of the electronic submissions are being formatted according to the electronic Common Techical Document format. The bigger struggle with electronic submissions is the format and content of the clinical and preclinical data included to support claims of efficacy and safety.
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From page 175... ...
Although this process is motivated by the FDA's own public health mission, addressing the agency's need for more standardized clinical data may provide leverage to support the development of other learning systems. Clinical data form a critical part of the content for records in the care setting, and the clinical data standards developed to meet FDA regulatory requirements can serve and support a transition to more standardized clinical data in electronic health records (EHRs)
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From page 176... ...
This work may also accelerate the readiness of clinical data standards for use in EHRs. Systems interoperability coupled with common data standards would facilitate data pooling to address questions across both premarket clinical research and postmarket clinical care.
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From page 177... ...
. The patient names, dates, locations, and other potentially identifying information are removed by computer programs that search the text.
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What we actually tend to see is that people who are extremely trustworthy with data and pose little risk of harm to the patient are restricted from data in illogical ways. For example, handling genomic data tends to be extremely restrictive.
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From page 179... ...
Intended use of the data is not factored in heavily to this algorithm, as it does not affect the risk to the patient. The difference between this scenario and the current state is to consider every act of de-identification an achievement of balance between the level of data de-identification, the level of trustworthiness of the data recipients, and the level of security of the data location where it will reside.
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From page 180... ...
However, the introduction of a national electronic record system has presented new challenges to the application of both legal and ethical practice and required new applications of existing principles to ensure that information technology assists clinicians to provide better care. This short paper therefore deals primarily with the particular information governance issues facing the National Health Service (NHS)
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From page 181... ...
Whatever is decided by the new government in relation to the implementation of the components of electronic health care, its commitment to "an information society" is explicit. The National Information Governance Board for Health and Social Care The NIGB is an independent statutory committee established by Act of Parliament in 2008.
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From page 182... ...
• Professionals must work within legal and professional frameworks. We have also published two commitments to patients and the public: the NHS Care Record Guarantee and, more recently, a parallel document, the Social Care Record Guarantee.
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However we have learned a lot from it. Information governance exists in the space between people and technology.
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From page 184... ...
:637-641. NIGB (National Information Governance Board)
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