Institute of Medicine

Electronic Infrastructure for the Learning

Healthcare System: The Road To Continuous
Improvement In Health And Health Care
Workshop # 1: Opportunities, Challenges,
Priorities
Session 5: Stewardship and governance in the learning health
system

Meryl Bloomrosen
Vice President Public Policy and Government Relations, AMIA

July 28, 2010

 Establishing and Advancing the
Framework for Use of Health Data
• Technological capabilities to collect and exchange
data are outpacing existing policies, procedures,
and processes
• Need for additional attention and leadership at
the national and state levels
• Recognized the need for and proposed a
framework for data stewardship components and
principle
• Valuable opportunities and benefits are offered
by the aggregation of health information into very
large data sets and repositories
• Patients are becoming active partners in their
care and in making treatment decisions
• Need for greater acceptance of patient
participation by researchers and providers

Toward a National Framework for the Secondary Use of Health Data”. Safran C, Bloomrosen
M, Hammond WE, Labkoff S, Markel-Fox S, Tang PC, Detmer DE, Expert Panel. J Am Med
Inform Assoc. 2007 Jan-Feb;14(1):1-9. Epub 2006 Oct 31.; and
Bloomrosen M, Detmer D. Advancing the framework: use of health data--a report of a
working conference of the American Medical Informatics Association. J Am Med Inform
Assoc. 2008 Nov-Dec; 15(6):715-22. Epub 2008 Aug 28
Bloomrosen M,  Detmer DE. Informatics, evidence-based care, and research; implications for
national policy: a report of an American Medical Informatics Association health policy
conference.  J Am Med Inform Assoc. 2010 Mar-Apr;17(2):115-23
 AMIA Recommendations for a National
Framework
• Establish transparent principles, policies and
practices for the use of health data
• Focus on control (stewardship) rather than
ownership
• Raise public understanding, knowledge and
awareness
• Refine definitions of data users and data uses
• Enhance national leadership
 Data Stewardship
• Data stewardship encompasses the responsibilities and
accountabilities associated with managing, collecting,
viewing, storing, sharing, disclosing, or otherwise
making use of personal health information
• Principles of data stewardship apply to all the
personnel, systems and processes engaging in health
information storage and exchange within and across
organizations
• Provides guidance for all discussions about data use
and lays the groundwork for the principles
 Data Stewardship Principles
• Provide the rationale and safeguards for legitimate
data users and uses
• Describe the governance and enforcement mechanisms
that provide reassurance of appropriate use
• Describe the benefit to the field of having “trusted
data stewards” who adhere to these principles
― Stewards would potentially be able to share data
without having to create ad hoc data handling
guidelines for each transaction
 General Comments
• Clarify societal, public policy, legal, organizational, ethical, technical,
and technological issues
― Environment is dynamic and fluid
― Issues are complex and ongoing study is needed
― Blurring technological lines of distinction
• Consider data quality issues
― Robust, representative, accurate; reproducible; complete; timely;
credible
― Address data sources and potential data limitations
• Confirm level of understanding and knowledge of the general public
― Terms and terminology (electronic infrastructure; learning healthcare
system; evidenced- based medicine; comparative effectiveness)
― Enhanced and increasing role of patients (and their caregivers) in
decision making, care, treatment, and research
― Value of personal health information for legitimate biomedical and
health services research
 Personal Reflections
• Consumer, family, patient-centered care, learning, research

• Timing counts

• Multiple, changing, context driven roles and perspectives

 Selected Relevant AMIA
Publications
• Safran C, Bloomrosen M, Hammond WE, Labkoff S, Markel-Fox S, Tang PC, Detmer
DE, Expert Panel. Toward a national framework for the secondary use of health
data: an American Medical Informatics Association White Paper. J Am Med
Inform Assoc. 2007 Jan-Feb;14(1):1-9. Epub 2006 Oct 31
• Bloomrosen M, Detmer D. Advancing the framework: use of health data--a report
of a working conference of the American Medical Informatics Association. J Am
Med Inform Assoc. 2008 Nov-Dec; 15(6):715-22. Epub 2008 Aug 28
• Bloomrosen M,  Detmer DE. Informatics, evidence-based care, and research;
implications for national policy: a report of an American Medical Informatics
Association health policy conference.  J Am Med Inform Assoc. 2010 Mar-
Apr;17(2):115-23
• Bloomrosen, et.al. Anticipating and Addressing Unintended Consequences of HIT
and Policy: a report of an American Medical Informatics Association health
policy conference (publication pending)
 THANK YOU

Meryl Bloomrosen
American Medical Informatics Association
4915 St. Elmo Avenue Suite 401
Bethesda, Maryland 20814
301 657-1291

www.amia.org
meryl@amia.org