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Director, Lister Hill National Center for Biomedical Communications
Phone Number: (
Expertise and Research Interests: 

Dr. McDonald's research focuses on clinical informatics; analyzing clinical data and providing feedback to clinicians; development and study of electronic medical record systems (EMRs) and personal health records (PHRs); automatic reminder systems; promoting the development, enhancement, and adoption of clinical messaging and vocabulary standards; and using huge clinical databases and de-identifying them for clinical research use.

He has led the development of the medical informatics standards necessary for transmitting patient data from source systems to electronic medical records and research databases. He was one of the founders of the Health Level 7 (HL7) message standards, used in all hospitals today, and he also developed the Logical Observation Identifier Names and Codes (LOINC) database of universal codes for clinical observations, including laboratory tests, clinical measurements and physician reports.

In 1972, Dr. McDonald developed one of the nation's first electronic medical record systems (EMRs), the Regenstrief Medical Record System (RMRS), and directed its use in clinical trials that have illuminated the ways in which electronic records can improve patient care. He published the first randomized trials showing the benefits of computer reminder systems and of physician order entry systems. He has written more than 275 peer-reviewed articles. Additionally, he implemented the Indiana Network for Patient Care, the first community-wide health information exchange, which now carries over 4 billion clinical observations from more than 70 hospitals, and is considered a national model for regional health information exchange.

His work at NIH continues this trend. Dr. McDonald collaborates in numerous efforts to facilitate industry adoption of standard vocabularies in electronic medical records and public health reporting, as required by meaningful use regulations. He has been working with numerous NIH Institutes to align research terminology with federally mandated clinical terminologies. He emphasizes the need for using the same standards where information content overlaps between clinical and research domains (e.g. laboratory testing, vital signs, and clinical survey instruments) that can be integrated with existing clinical LOINC variables to allow data sharing and interoperability.

Dr. McDonald served as the Scientific Director of the Lister Hill National Center for Biomedical Communications at NLM from 2006-2018, overseeing all LHNCBC research and development in biomedical informatics related to consumer health, clinical data, image processing and visualization, and natural language processing. Current research projects include biomedical data visualization, high resolution electron microscopy, imaging tools for cancer research, and 3D biomedical imaging research, openI (medical citations enriched by relevant images with capacity to search by image), and automated medical text indexing research. Dr. McDonald currently serves as the NLM Chief Health Data Standards Officer.

Dr. McDonald obtained his medical degree from the University of Illinois, and completed his internship in Internal Medicine at Boston City Hospital, Harvard Medical Service, and his residency in Internal Medicine at Cook County Hospital and University of Wisconsin. Before beginning his residency, he earned an MS in Biomedical Engineering from Northwestern University, and completed a fellowship at NIH, where he managed the development of the first clinical laboratory computer system at the Clinical Research Center.

Prior to joining NLM, Dr. McDonald was Regenstrief Professor of Medical Informatics and Distinguished Professor of Medicine at the Indiana University (IU) School of Medicine and Director of the Regenstrief Institute for Health Care.

Complete list of Clement McDonald's publications.


Professional Activities: 

Dr. McDonald is a member of the National Academies of Sciences, Engineering, and Medicine (formerly the Institute of Medicine) and was a founding member (elected in 1984) of the Fellows of the American College of Medical Informatics (FACMI).

He is a member of the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) for Health Information Technology (HIT) Standards Committee's Vocabulary Task Force and Clinical Operations Workgroup. He currently chairs the LOINC Committee.

Additionally, he is a member of the Electronic Laboratory Reporting (ELR) Task Force's Standards Working Group, which is a collaboration of the U.S. Centers for Disease Control and Prevention (CDC), the Council of State and Territorial Epidemiologists (CSTE), and the Association of Public Health Laboratories (APHL).

He served on the Board of the American College of Physicians (ACP) from 2003-2008. He was the second president the American Medical Informatics Association (AMIA), and a past member of the NLM Board of Regents.

Professional Organizations: 
2010-Present Member, Clinical Operations Workgroup, U.S. Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) for Health Information Technology (HIT) Standards Committee
2010-Present Member, NIH National Center for Advancing Translational Science (NCATS) Office of Rare Diseases Research (ORDR) Global Rare Disease Registry (GRDR) Workgroup, Common Data Elements (CDE) Steering Committee
2010-Present Member, CDC/CSTE/APHL Electronic Laboratory Reporting (ELR) Task Force's Standards Working Group
2010 - 2011 Member, HHS Secretary's Advisory Committee on Heritable Disorders in Newborn and Children (SACHDNC) Health Information Technology Workgroup (HIT WG)
2009-Present Member, Vocabulary Task Force, U.S. Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) for Health Information Technology (HIT) Standards Committee
2009-Present Member, Healthcare Informatics Advisory Board, FNIH/FDA Observational Medical Outcomes Partnership (OMOP)
2008-Present Member, NIH Clinical And Translational Science Awards (CTSA) Informatics Key Function Committee (IKFC) Directors and Group Leads
2007-Present Member, Trans-NIH Biomedical Informatics Coordinating Committee (BMIC)
2007-Present Member, NIH Clinical Center Clinical Research Information System (CRIS) Steering Committee
2006 - 2006 Regent, National Library of Medicine (NLM) Board of Regents (BOR)
2005 - 2005 Member, Joint Commission’s Health Information Technology Advisory Panel (HITAP)
2005 - 2005 Member, Research Advisory Council (RAC), National Center for Quality Assurance (NCQA)
2004 - 2005 Member, American Medical Association (AMA) E-Medicine Advisory Committee (EMAC)
2003 - 2008 Regent, American College of Physicians (ACP)
2003 - 2006 Member, Annals of Internal Medicine’s Editorial Board
2002 - 2003 Member, Board of Directors, Clinical Data Interchange Standards Consortium (CDISC)
2001 - 2002 Member, Indiana University Cancer Center
2001 - 2003 Member, Board of Directors, Institute for Medical Knowledge Implementation (IMKI)
2000 - 2003 Committee Member, Robert Wood Johnson Foundation, Pursuing Perfection: Raising The Bar For Healthcare Performance Grant
2000 - 2002 Co-Chair HL7, HIPAA Attachment Special Interest Group (SIG)
1996 - 2004 Member, National Committee on Vital and Health Statistics (NCVHS)
1996 - 1997 Member, The Koop Foundation's Action Team and Leadership Council
1995 - 1997 Member, American Medical Association's Education Advisory Committee
1995 - 1999 Member, International Union of Pure and Applied Chemistry, Commission on Nomenclature, Properties and Units (VII.C.1)
1995 - 1997

Member, Joint Commission Council on Performance Measurement      

1995 - 1998 Member, VHA (Volunteer Hospital Association) Information Executive Council
1995 - 1996 Member, HCFA ICD-10-PCS Advisory Panel
1994-Present Chairman,  LOINC Committee
1994-Present Member, Association of American Physicians
1994 - 1996 Member, Editorial Advisory Board, Journal of Health Data Management
1994 - 1996 Member, European Committee for Standardization (CEN) TC251 WG3 (Healthcare Communications and Messages) PT3-022 Request and Report Messages for Diagnostic Service Departments
1994 - 1996 Chairman, Advisory Panel for the Information Technology and Health Care System, for the Office of Technology Assessment of the United States Congress
1992 - 1995 Chairman, American National Standards Institute (ANSI), Health Information Standards Planning Panel (HISPP)
1992 - 1995

Chairman, ANSI, Message Standards Developers Subcommittee (MSDS)

1992 - 1993 President, American Medical Informatics Association (AMIA)
1991 - 1997 Member, Board of Directors, InterStudy, Excelsior, Minnesota
1990 - 1993 Member, Dept. of Defense Peer Review Group, BATTELLE Corporation Health Care
1990 - 1992 Member, Committee on Clinical Practice Guidelines, Institute of Medicine (IOM)
1989 - 1990 Chairman, Medical Informatics Subcommittee, American College of Physicians (ACP)
1989 - 1990 Member, Educational Policy Subcommittee, American College of Physicians (ACP)
1989 - 2000

Associate Editor, MD Computing, a Springer-Verlag International Journal

1987 - 2003 Co-Chairman, Founding Chairman, Health Level-Seven, Orders/Observations Technical Committee
1985 - 1996 Chairman, ASTM E-31.11 Subcommittee for Developing Standards for Electronic Transmission of Clinical Data
1985 - 1988 Secretary, Executive Board, Symposium on Computer Applications in Medical Care
1984 - 1986 Member, Executive Board, American College of Medical Informatics
1983 - 1989 Founding Editor, MD Computing, a Springer-Verlag International Journal
1977 - 1981 Member, Technology Study Section, National Center for Health Services Research


Honors and Awards: 

Dr. McDonald is a recipient of the Morris F. Collen Award of Excellence from the American College of Medical Informatics (video tribute) (JAMIA article), and the NIH Director's Award, among many honors.

  • 2011 Honorary Degree in Science, Indiana University
  • 2010 NIH Director's Award
  • 2009 Indiana Univesity President’s Medal for Excellence
  • 2006 Glenn W. Irwin, Jr., MD Research Scholar Award
  • 2005 Honoree, Hoosier Heritage Lifetime Achievement Award
  • 2004 Morris Collen Award, MedInfo
  • 2004 American Medical Informatics Association (AMIA) President's Award
  • 2003 Indiana Business Journal Health Care Heroes Award
  • 2002 American Medical Informatics Association (AMIA) Presidents’ Award
  • 2002 Who’s Who in Health Care, Indianapolis Business Journal
  • 2002 Association of Medical Directors of Information Systems, AMDIS Achievement Award
  • 2001 Outstanding Researcher Award, GIM/Geriatrics Division Awards for 2001, Indiana University School of Medicine
  • 2000 Hickam Lecturer, Central Society for Clinical Research
  • 1994-Present Member, National Academy of Science's Institute of Medicine
  • 1994-Present Member, Council of the Association of American Physicians
  • 1993 American Health Informatics Management Association, Distinguished Service Award
  • 1993 Blue & Company/Hudson Institute, Horizon Award
  • 1993 Fellow, American Institute for Medical and Biological Engineering
  • 1992 Distinguished Professor of Medicine, Indiana University
  • 1991 Computers in Health Care, Pioneer Award
  • 1991 Hospital Information Management Systems Society (HIMSS), Award for Outstanding Achievement
  • 1984 Fellow, American College of Physicians
  • 1984 Founding Fellow, American College of Medical Informatics (FACMI)
Publications/Tools by Clem McDonald: 
Zhang XA, Yates A, Vasilevsky N, Gourdine JP, Callahan TJ, Carmody LC, Danis D, Joachimiak MP, Ravanmehr V, Pfaff ER, Champion J, Robasky K, Xu H, Fecho K, Walton NA, Zhu RL, Ramsdill J, Mungall CJ, Kohler S, Haendel MA, McDonald CJ, Vreeman DJ, Peden DB, Bennett TD, Feinstein JA, Martin B, Stefanski AL, Hunter LE, Chute CG, Robinson PN. Semantic integration of clinical laboratory tests from electronic health records for deep phenotyping and biomarker discovery. NPJ Digit Med. 2019;2. pii: 32. doi: 10.1038/s41746-019-0110-4. Epub 2019 May 2.
Dhoot R, Humphrey JM, O'Meara P, Gardner A, McDonald CJ, Ogot K, Antani SK, Abuya J, Kohli M. Implementing a mobile diagnostic unit to increase access to imaging and laboratory services in western Kenya. BMJ Glob Health. 2018 Oct 8;3(5):e000947. doi: 10.1136/bmjgh-2018-000947. eCollection 2018.
McDonald CJ, Maglott D, Abhyankar S, Goodwin RM, Kanduru A, Lu S, Lynch P, Vreeman D, Wang Y, Wood G. US Realm, Chapter 5, Use Case – Clinical Genomics Results Reporting in HL7 Version 2.5.1 Implementation Guide: Lab Results Interface (LRI), DTSU3. HL7 International (Ann Arbor).
McDonald CJ, Maglott D, Abhyankar S, Goodwin RM, Kanduru A, Lu S, Lynch P, Vreeman D, Wang Y, Wood G. US Realm, Chapter 14, Use Case – Clinical Genomics Code Systems. in HL7 Version 2.5.1 Implementation Guide: Lab Results Interface (LRI), DTSU3. HL7 International (Ann Arbor).
McDonald CJ. Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Test; Guidance for Industry and Food and Drug Administration Staff. Silver Spring, Md: Center for Devices and Radiological Health, FDA, 2018.
Vreeman DJ, Abhyankar S, McDonald CJ. Re: Unit conversions between LOINC codes Published June 19, 2017 [Letter]. J Am Med Inform Assoc. 2018 May 1;25(5):614-615. doi: 10.1093/jamia/ocx087.
Tang P, McDonald CJ. Computer-Based Patient-Record Systems - Chapter 9. In Shortliffe E, Perreault L, eds. Medical Informatics. New York: springer. 2001:327-358. DOI: 10.1007/978-0-387-21721-5_9.
McDonald CJ. FHIR Overview Presentation by Clement J. McDonald, MD
Lynch P, Wang Y, Kanduru A, Luan X, Mericle L, Lu S, McDonald CJ. On-the-Fly Data Capture Tooling for FHIR/HL7 V2 HL7 January 2018 Working Group Meeting, New Orleans, LA
Lynch P, Wang Y, Kanduru A, Luan X, Mericle L, Lu S, McDonald CJ. On‐the‐Fly Data Capture Tooling for FHIR/HL7 V2 HL7 January 2018 Working Group Meeting, New Orleans, LA February 1st, 2018.