7th Annual AMIA Invitational Health Policy Meeting December 12-13 ...

Agency or
Organization
Food and Drug
Administration (FDA)
Coordinating Council for
Comparative
Effectiveness Research
Government
Accountability Office
(GAO)
Institute of Medicine (IOM)
AMIA Invitational Health Policy Meeting 2012
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Data Use Programs and Policies (selected)
� Mini-Sentinel is a pilot FDA project to create the Sentinel System to monitor the safety of FDA-regulated medical products.
Mini-Sentinel uses pre-existing electronic healthcare data from multiple sources. Collaborating institutions provide access to
data as well as scientific and organizational expertise. See http://mini-sentinel.org/
� Federal Coordinating Council for Comparative Effectiveness Research, (created by ARRA to foster optimum coordination of CER
conducted or supported by Federal departments and agencies) issued a 2009 report to the President and the Congress. The
Federal Coordinating Council was ended by the Affordable Care Act. See
http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf
� 2001 report: Record Linkage and Privacy: Issues in Creating New Federal Research and Statistical Information. Washington, DC: US General
Accounting Office. http://www.gao.gov/new.items/d01126sp.pdf
� 2009 Report: Electronic Personal Health Information Exchange: Health Care Entities’ Reported Disclosure Practices and Effects on Quality of
Care http://www.gao.gov/new.items/d10361.pdf
� 2009 Report: Challenges Remain for VA's Sharing of Electronic Health Records with DOD GAO-09-427T, Mar 12, 2009
http://www.gao.gov/assets/130/121872.pdf
� IOM: Sharing Clinical Research Data: A Workshop. Pharmaceutical companies, academics, and government agencies such as the Food and
Drug Administration and the National Institutes of Health have large quantities of clinical research data. Data sharing within each sector and
across sectors could facilitate scientific and public health advances and could enhance analysis of safety and efficacy. Much of this
information, however, is never published. This workshop will explore barriers to sharing of clinical research data, specifically clinical trial
data, and strategies for enhancing sharing within sectors and among sectors to facilitate research and development of effective, safe, and
needed products. http://www.iom.edu/Activities/Research/SharingClinicalResearchData/2012-OCT-04.aspx
� IOM: Digital Data Improvement Priorities for Continuous Learning in Health and Health Care - Workshop Summary. Digital health data are
the lifeblood of a continuous learning health system. A steady flow of reliable data is necessary to coordinate and monitor patient care,
analyze and improve systems of care, conduct research to develop new products and approaches, assess the effectiveness of medical
interventions, and advance population health. The totality of available health data is a crucial resource that should be considered an
invaluable public asset in the pursuit of better care, improved health, and lower health care costs.
http://www.iom.edu/Reports/2012/Digital-Data-Improvement-Priorities-for-Continuous-Learning-in-Health-and-Health-Care.aspx
� IOM: Informatics Needs and Challenges in Cancer Research - Workshop Summary Released: July 16, 2012 x Informatics tools – which help
collect, organize, and analyze data – are essential to biomedical and health research and development. The field of cancer research is facing
an overwhelming deluge of data, heightening the national urgency to find solutions to support and sustain the cancer informatics ecosystem.
The IOM’s National Cancer Policy Forum held a workshop February 27-28, 2012, to further examine informatics needs and challenges for
21st century biomedical research. http://www.iom.edu/Reports/2012/Informatics-Needs-and-Challenges-in-Cancer-Research.asp
� IOM: Communicating with Patients on Health Care Evidence, released September 2012, accessible at Research was conducted in three
phases (environmental scan, qualitative research/focus groups and quantitative/survey analysis) to determine strategies to raise awareness
of and increase demand for medical evidence among patients, providers, healthcare organizations and policy makers.
http://www.iom.edu/Global/Perspectives/2012/~/media/Files/Perspectives-Files/2012/Discussion-Papers/VSRT-Evidence.pdf