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A The Learning Health System and the Digital Health Utility 251

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Foundational Elements 252 Learning Health System Characteristics Data utility: data stewarded and Digital technology: the Trust fabric: strong, protected,Leadership: multi- used for the common good engine for continuous and actively nurtured focal, networked, improvement and dynamic Care: starting with the best practice, Health information: Outcomes and costs: transparent Knowledge: every time a reliable, secure, and and constantly assessed ongoing, seamless reusable resource product of services and research Culture: participatory, team-based, transparent, Design and processes: Patients and public: fully and Decisions: improving patient-anchored and tested actively engaged informed, facilitated, shared, and coordinated Meaningful Use Requirementsa Core structured personal data (age, sex, Core list of active problems Core structured Clinical decision Care coordination ethnicity) clinical data support support/ (VS, meds, interoperability [labs]) Outpatient medicines electronically Automated medication safeguard/ Visit-specific Automated patient e-Record patient prescribed econciliation information reminders access (copy or to patients patient portal) Embedded clinical quality measures Security safeguards [Condition- [Public health [Advance specific data reporting directives for retrieval (reportable ages >65] capacity] conditions)]

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Next-Generation Digital Infrastructure LHS Digital Health Utility Strategy Elements Stakeholder Next generation requirements Activities that advance: Responsibilitiesb Technical Ultra-large-scale system perspective Ultra-large-scale system ONC works with NIST, other Progress Distributed, local data maintenance perspective agencies and IT community to Virtual interoperability Functionality focus advance interoperability and Reliable use and system security System specifications/ security protocols protocols interoperability NSF works with ONC/NIH on test Standards vehicles for setting/ Workflow and usability beds for digital infrastructure revising, metadata, vocabulary, Security and privacy safeguards component technologies data transport, common core System innovation including ULS system approach datasets, sentinel indicators, access Interoperability agreements authorization/authentication, data among delivery systems utilizing quality review protocols EHRs CMS develops test beds for digital infrastructure application in care coordination/delivery model innovation Knowledge Core clinical data elements available Shared learning environment NIH, NSF, AHRQ, and FDA work Generation/Use for quality improvement and Point of decision support and on innovative approaches to research guidance research insights from clinical Channels and protocols for integrating Research-ready records for data data clinical and public health data reuse CDC develops templates/protocols Capacity and protocols for query- Patient-generated data for integrating population and driven data use in quality and Integration/use of data across clinical data research and monitoring of sentinel sources Healthcare organizations form indicators Distributed data repositories research collaboratives Novel statistical and database tools for Sentinel indicators reliable new insights Query capacity Analytical tools and methods innovation 253 continued

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Patient/Population 254 Engagement “New norm” for patient involvement Value proposition and patient AHRQ, FDA, NIH, and ONC use Facilitated personal record interface confidence established links with patient Clinician–patient electronic Shared learning culture community to foster active partnership Patient–clinician outcome embracing of the digital health Patient information access/control partnerships utility Updated best practices delivered at Person-centric, lay-oriented Patient and clinician groups point of decision health information mediate public engagement Active patient support for data use in Closing the disparity gap and facilitate dialogue among care improvement Continuous evaluation stakeholders to develop shared Clinician–public health e-partnership learning culture/trust Governance Progressively evolving requirements, The vision ONC works with other agencies, specifications, process protocols Guiding principles the HIT community, and for exchange, interoperability, and Participant roles and patient/clinician groups to foster research responsibilities development of a governance Cross-national harmonization to foster Process and protocol mechanism that encourages the global e-health utility stewardship dynamic entrepreneurial growth Broad ongoing evaluation capacity Implementation phasing while safeguarding personal Continuous evaluation security and the common good a Optional elements denoted with [ ]. See Appendix B for details. b Sample list, neither definitive nor complete. See page xxiii for list of acronyms.