Fast-Tracking Health Data Standards Development and Adoption in Real-World Settings: A Pilot Approach

Abstract

Background Pilot-testing is important in standards development because it facilitates agile navigation of the gap between needs for and use of standards in real-world settings and can reveal the practicalities of implementation. As the implementation and use of health data standards are usually more complicated than anticipated, the Office of the National Coordinator for Health Information Technology (ONC) routinely oversees and organizes relevant pilot projects.

Objectives This article provides an in-depth look into a sample of ONC's standards-focused pilot projects to (1) inform readers of the complexities of developing, implementing, and advancing standards and (2) guide those seeking to evaluate new standards through pilot projects.

Methods The ONC's approach to conducting pilot projects begins with identifying a clinical care need, research requirement, or policy outcome that is not well supported by existing standards through a landscape review. ONC then selects a testing approach based on the identified need and maturity of relevant standards. Next, ONC identifies use cases and sites to pilot-test the relevant standard. Once complete, ONC publishes a report that informs subsequent projects and standards development.

Results Pilot projects presented here are organized into three categories related to their demonstrated focus and related approach: (1) improving standards for presenting and sharing clinical genetic data, (2) accelerating the development and implementation of new standards, and (3) facilitating clinical data reuse. Each project illustrates the pilot approach from inception to next steps, capturing the role of collaboration among standards development organizations, stakeholders, and end-users to ensure standards are practical and fit for purpose.

Conclusion The ONC approach identifies implementation difficulties prior to broader adoption and use of standards, and provides insight into the steps needed to scale use of standards. The ONC's organization of pilot projects serves as a natural accelerator for building communities of practice, often providing a well-connected beneficiary of lessons learned.

Keywords

health information technology - Health Level 7 International - informatics - pilot projects - research - standards - implementation and deployment

Protection of Human and Animal Subjects

There were no human and/or animal subjects included in this project.

Note

The findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the U.S. Department of Veterans Affairs.

Authors' Contributions

A.F.D., T.Z.C., and P.J.W. led the conception of the article. All authors revised the article critically and provided intellectual content, and they approved the final version for submission. The order of authors listed in the manuscript has been approved by all authors.

Publication History

Received: 20 February 2021

Accepted: 20 May 2021

Article published online:
11 August 2021

• References

• 1 Henry J, Pylypchuk Y, Searcy T. et al. Adoption of electronic health record systems among U.S. non-federal acute care hospitals: 2008–2015. Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/briefs/2015_hospital_adoption_db_v17.pdf
• 2 Office of the National Coordinator for Health Information Technology. Office-based physician electronic health record adoption, health IT QUICK-STAT #50. Accessed February 8, 2021 at: https://dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php
• 3 Kruse CS, Beane A. Health information technology continues to show positive effect on medical outcomes: systematic review. J Med Internet Res 2018; 20 (02) e41
• 4 McCullough JS, Casey M, Moscovice I, Prasad S. The effect of health information technology on quality in U.S. hospitals. Health Aff (Millwood) 2010; 29 (04) 647-654
• 5 Agha L. The effects of health information technology on the costs and quality of medical care. J Health Econ 2014; 34: 19-30
• 6 Jones SS, Rudin RS, Perry T, Shekelle PG. Health information technology: an updated systematic review with a focus on meaningful use. Ann Intern Med 2014; 160 (01) 48-54
• 7 Alotaibi YK, Federico F. The impact of health information technology on patient safety. Saudi Med J 2017; 38 (12) 1173-1180
• 8 Chaudhry B, Wang J, Wu S. et al. Systematic review: impact of health information technology on quality, efficiency, and costs of medical care. Ann Intern Med 2006; 144 (10) 742-752
• 9 Sadoughi F, Nasiri S, Ahmadi H. The impact of health information exchange on healthcare quality and cost-effectiveness: a systematic literature review. Comput Methods Programs Biomed 2018; 161: 209-232
• 10 Hersh WR, Totten AM, Eden KB. et al. Outcomes from health information exchange: systematic review and future research needs. JMIR Med Inform 2015; 3 (04) e39
• 11 Lehne M, Sass J, Essenwanger A, Schepers J, Thun S. Why digital medicine depends on interoperability. NPJ Digit Med 2019; 2: 79
• 12 Perlin JB. Health information technology interoperability and use for better care and evidence. JAMA 2016; 316 (16) 1667-1668
• 13 Interoperability in Healthcare. Accessed April 19, 2021 at: https://www.himss.org/resources/interoperability-healthcare
• 14 Haug PJ, Narus SP, Bledsoe J, Huff S. Promoting national and international standards to build interoperable clinical applications. AMIA Annu Symp Proc 2018; 2018: 555-563
• 15 Chen ES, Melton GB, Sarkar IN. Translating standards into practice: experiences and lessons learned in biomedicine and health care. J Biomed Inform 2012; 45 (04) 609-612
• 16 Office of the National Coordinator for Health Information Technology. About ONC (February 14, 2019). Accessed February 8, 2021 at: https://www.healthit.gov/topic/about-onc
• 17 Office of the National Coordinator for Health Information Technology. Scientific initiatives. (September 25, 2020). Accessed February 8, 2021 at: https://www.healthit.gov/topic/scientific-initiatives
• 18 Zayas-Cabán T, Chaney KJ, Rucker DW. National health information technology priorities for research: a policy and development agenda. J Am Med Inform Assoc 2020; 27 (04) 652-657
• 19 Zayas-Cabán T, Abernethy AP, Brennan PF. et al. Leveraging the health information technology infrastructure to advance federal research priorities. J Am Med Inform Assoc 2020; 27 (04) 647-651
• 20 Office of the National Coordinator for Health Information Technology. National health IT priorities for research. (January 15, 2020). Accessed February 8, 2021 at: https://healthit.gov/research-agenda
• 21 Zayas-Cabán T, Wald JS. Opportunities for the use of health information technology to support research. JAMIA Open 2020; 3: 321-325
• 22 Richesson RL, Krischer J. Data standards in clinical research: gaps, overlaps, challenges and future directions. J Am Med Inform Assoc 2007; 14 (06) 687-696
• 23 Bouhaddou O, Cromwell T, Davis M. et al. Translating standards into practice: experience and lessons learned at the Department of Veterans Affairs. J Biomed Inform 2012; 45 (04) 813-823
• 24 Rozwell C, Kush R, Helton E. Saving time and money. Appl Clin Trials 2007; 16: 70-74
• 25 Goldzweig CL, Towfigh A, Maglione M, Shekelle PG. Costs and benefits of health information technology: new trends from the literature. Health Aff (Millwood) 2009; 28 (02) w282-w293
• 26 Bassi J, Lau F. Measuring value for money: a scoping review on economic evaluation of health information systems. J Am Med Inform Assoc 2013; 20 (04) 792-801
• 27 International Organization for Standardization. Economic benefits of standards. Accessed April 7, 2021 at: https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/ebs_case_studies_factsheets.pdf
• 28 Kilbourne AM, Goodrich DE, Miake-Lye I, Braganza MZ, Bowersox NW. Quality enhancement research initiative implementation roadmap: toward sustainability of evidence-based practices in a learning health system. Med Care 2019; 57 (10, Suppl 10 Suppl 3): S286-S293
• 29 Kötter T, Blozik E, Scherer M. Methods for the guideline-based development of quality indicators--a systematic review. Implement Sci 2012; 7: 21
• 30 Ratwani R, Fairbanks T, Savage E. et al. Mind the Gap. A systematic review to identify usability and safety challenges and practices during electronic health record implementation. Appl Clin Inform 2016; 7 (04) 1069-1087
• 31 Office of the National Coordinator for Health Information Technology. ONC change package for improving EHR usability (February 2018). Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/playbook/pdf/usability-change-plan.pdf
• 32 DeBar LLJJ, Tuzzio L, Vazquez MA. Assessing feasibility: spotlight on demonstration projects. Accessed February 8, 2021 at: https://rethinkingclinicaltrials.org/chapters/conduct/assessing-feasibility/spotlight-on-four-demonstration-projects
• 33 Fiordalisi C, Borsky A, Chang S, Guise JM. AHRQ EPC series on improving translation of evidence into practice for the learning health system: introduction. Jt Comm J Qual Patient Saf 2019; 45 (08) 558-565
• 34 Guterman S, Davis K, Stremikis K, Drake H. Innovation in Medicare and Medicaid will be central to health reform's success. Health Aff (Millwood) 2010; 29 (06) 1188-1193
• 35 Nevedal AL, Reardon CM, Jackson GL. et al. Implementation and sustainment of diverse practices in a large integrated health system: a mixed methods study. Implement Sci Commun 2020; 1: 61
• 36 Forrow S, Campion DM, Herrinton LJ. et al. The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program. Pharmacoepidemiol Drug Saf 2012; 21 (Suppl. 01) 12-17
• 37 Kilbourne AM, Jones PL, Atkins D. Accelerating implementation of research in learning health systems: lessons learned from VA health services research and NCATS clinical science translation award programs. J Clin Transl Sci 2020; 4 (03) 195-200
• 38 Matney SA, Heale B, Hasley S. et al. Lessons Learned in creating interoperable fast healthcare interoperability resources profiles for large-scale public health programs. Appl Clin Inform 2019; 10 (01) 87-95
• 39 Office of the National Coordinator for Health Information Technology. Precision medicine. (June 23, 2020) Accessed February 8, 2021 at: https://www.healthit.gov/topic/scientific-initiatives/precision-medicine
• 40 Office of the National Coordinator for Health Information Technology. Building data infrastructure to support patient-centered outcomes research (PCOR) (March 31, 2020). Accessed February 8, 2021 at: https://www.healthit.gov/pcor
• 41 Zayas-Cabán T, Chaney KJ, Rogers CC, Denny JC, White PJ. Meeting the challenge: Health information technology's essential role in achieving precision medicine. J Am Med Inform Assoc 2021; ocab032
• 42 Office of the National Coordinator for Health Information Technology. Health IT playbook. Accessed February 8, 2021 at: https://www.healthit.gov/playbook/sdo-education/chapter-2/
• 43 Connectathon IHE. A unique testing opportunity. Accessed April 7, 2021 at: https://www.ihe.net/participate/connectathon/
• 44 HL7 FHIR Connectathon FAQs. Accessed February 8, 2021 at: https://confluence.hl7.org/display/FHIR/HL7+FHIR+Connectathon+FAQs
• 45 Schulz S, Stegwee R, Chronaki C. Standards in Healthcare Data. In: Kubben P, Dumontier M, Dekker A. eds. Fundamentals of Clinical Data Science. Cham, Switzerland: 2019: 19-36
• 46 Proctor E, Silmere H, Raghavan R. et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health 2011; 38 (02) 65-76
• 47 Office of the National Coordinator for Health Information Technology. Sync for genes. . (January 7, 2021). Accessed February 8, 2021 at: https://www.healthit.gov/topic/sync-genes
• 48 White PJ, Halamka J. Precision medicine task force transmittal letter. (September 25, 2015). Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/facas/PMTF_Transmittal_Letter_2015-09-25_v2.pdf
• 49 Gallagher L, Malec A. Health information technology standards committee transmittal letter. (July 22, 2016). Accessed April 20, 2021 at: https://www.healthit.gov/sites/default/files/facas/HITSC_PMI_Phase2_Recs_2016-07-22.pdf
• 50 Denny JC, Rutter JL, Goldstein DB. et al; All of Us Research Program Investigators. The “all of us” research program. N Engl J Med 2019; 381 (07) 668-676
• 51 Office of the National Coordinator for Health Information Technology. Sync for genes: enabling clinical genomics for precision medicine via HL7®fast healthcare interoperability resources®. (November 28, 2017). Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/sync_for_genes_report_november_2017.pdf
• 52 Genetic Reporting Implementation Guide. (July 25, 2018). Accessed February 8, 2021 at: http://hl7.org/fhir/uv/genomics-reporting/
• 53 HL7 domain analysis model: clinical genomics, release1. Accessed February 8, 2021 at: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=479
• 54 Office of the National Coordinator for Health Information Technology. Sync for genes phase 2 project: exploring approaches to make clinical genomics available at the point-of-care final report. (April 2020). Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/page/2020-04/Sync%20for%20Genes%202%20Final%20Report.pdf
• 55 Office of the National Coordinator for Health Information Technology. Sync for genes phase 3 engaging laboratories final report. (January 2021). Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/page/2021-01/Sync-for-Genes-Phase-3-Engaging-Laboratories.pdf
• 56 Garcia SJ, Zayas-Cabán T, Freimuth RR. Sync for genes: making clinical genomics available for precision medicine at the point-of-care. Appl Clin Inform 2020; 11 (02) 295-302
• 57 U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006; 4: 79
• 58 Office of the National Coordinator for Health Information Technology. Advancing the collection and use of patient-reported outcomes through health information technology. (March 2020). Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/page/2020-03/ONCPROFinalReportFinal.pdf
• 59 Patient Reported Outcomes FHIR Implementation Guide. (Aug 31, 2018). Accessed February 8, 2021 at: http://www.hl7.org/fhir/us/patient-reported-outcomes/2018Sep/
• 60 Office of the National Coordinator for Health Information Technology. Patient-reported outcomes through health IT project. (March 27, 2020). Accessed February 8, 2021 at: https://www.healthit.gov/topic/scientific-initiatives/pcor/patient-reported-outcomes-through-healthit-pro
• 61 Sayeed R, Gottlieb D, Mandl KD. SMART Markers: collecting patient-generated health data as a standardized property of health information technology. NPJ Digit Med 2020; 3: 9
• 62 Office of the National Coordinator for Health Information Technology. Advancing standards for precision medicine. (January 26, 2021). Accessed February 8, 2021 at: https://www.healthit.gov/topic/advancing-standards-precision-medicine
• 63 Office of the National Coordinator for Health Information Technology. Advancing standards for precision medicine final report. (January 2021). Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/page/2021-01/Advancing-Standards-in-Precision-Medicine.pdf
• 64 Application Data Exchange Assessment Framework and Functional Requirements for Mobile Health. (February 18, 2020). Accessed February 8, 2021 at: https://hl7.github.io/fhir-project-mhealth/index.html
• 65 IHE Patient Care Coordination Technical Framework Supplement – Assessment Curation and Data Collection (ACDC). (March 24, 2020). Accessed February 8, 2021 at: https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_Suppl_ACDC.pdf
• 66 Office of the National Coordinator for Health Information Technology. Coordinated Registry Network for Women's Health Technologies. (June 14, 2020). Accessed February 8, 2021 at: https://www.healthit.gov/topic/scientific-initiatives/pcor/coordinated-registry-network-womens-health-technologies-crn
• 67 Office of the National Coordinator for Health Information Technology. Developing a strategically coordinated registry network (CRN) for women's health technologies final report. (June 2020). Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/page/2020-06/Strategically-CRN-for-Womens-Health-Technologies.pdf
• 68 Blumenthal S. The use of clinical registries in the united states: a landscape survey. EGEMS (Wash DC) 2017; 5 (01) 26
• 69 U.S. Food and Drug Administration. FDA facts: postmarket patient registry ensures access to safe and effective devices. (December 21, 2017). Accessed February 8, 2021 at: https://www.fda.gov/about-fda/innovation-fda/fda-facts-postmarket-patient-registry-ensures-access-safe-and-effective-devices
• 70 Agency for Healthcare Research and Quality. Registries for evaluating patient outcomes: a user's guide. (February 2018). Accessed February 8, 2021 at: https://effectivehealthcare.ahrq.gov/sites/default/files/registries-guide-3rd-ed-addendum-research-2018.pdf
• 71 Workman TA. Engaging Patients in Information Sharing and Data Collection: The Role of Patient-Powered Registries and Research Networks [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013. Sep. Report No.: AHRQ 13-EHC124-EF. PMID: 24156118
• 72 Women's Health Technologies (WHT) Coordinated Registry Network. (CRN) FHIR implementation guide. (March 26, 2019). Accessed February 8, 2021 at: https://build.fhir.org/ig/HL7/coordinated-registry-network/
• 73 Office of the National Coordinator for Health Information Technology. Sync for science. (November 12, 2020). Accessed February 8, 2021 at: https://www.healthit.gov/topic/sync-science
• 74 Office of the National Coordinator for Health Information Technology. Sync for science pilot project: participants' experiences. (November 2020). Accessed February 8, 2021 at: https://www.healthit.gov/sites/default/files/page/2020-11/Sync%20for%20Science%20Pilot%20Project_Participants%20Experiences.pdf
• 75 Office of the National Coordinator for Health Information Technology, Department of Health and Human Services, 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications. 45 C.F.R §170. Accessed February 8, 2021 at: https://pubmed.ncbi.nlm.nih.gov/26477063/
• 76 Office of the National Coordinator for Health Information Technology. 2015 edition common clinical data set (CCDS) reference document. (February 22, 2018). Accessed April 19, 2021 at: https://www.healthit.gov/sites/default/files/ccds_reference_document_v1_1.pdf
• 77 Health Resources and Services Administration. Fiscal Year 2018 Advancing Precision Medicine Supplemental Funding Opportunity (APM). Accessed February 8, 2021 at: https://allofus.nih.gov/sites/default/files/final_hrsa-18-126_apm_supplement.pdf
• 78 Health Resources and Services Administration. FY 2018 Advancing precision medicine (APM) supplemental awards. (May 2020). Accessed February 8, 2021 at: https://bphc.hrsa.gov/program-opportunities/advancing-precision-medicine-fy2018-awards
• 79 About the Argonaut Project. (August 31, 2020). Accessed April 19, 2021 at: https://argonautwiki.hl7.org/Main_Page
• 80 Office of the National Coordinator for Health Information Technology. Interoperability standards advisory structure. Accessed April 7, 2021 at: https://www.healthit.gov/isa/isa-structure
• 81 Jones D, Garcia S, Ruiz-Schultz N. et al. A strong start: enhancing newborn screening for precision public health. (October 13, 2020). Accessed February 8, 2021 at: https://blogs.cdc.gov/genomics/2020/10/13/a-strong-start/
• 82 FHIR at Scale Taskforce (FAST). (December 22, 2020). Accessed February 8, 2021 at: https://oncprojectracking.healthit.gov/wiki/pages/viewpage.action?pageId=43614268