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

Project Overview Purpose/Type of Data Project Features Results Challenges
Biomarkers Consortium. Public/private biomedical
research partnership managed by Foundation for NIH.
Identifies, develops, funds and executes projects that
develop and qualify biomarkers to accelerate
development of new drugs and improve care. Founded
by FNIH, NIH, FDA, PhRMA and CMS and has 28 other
stakeholder members. Aimed at precompetitive
research/development combining public health benefit
with practical impact on drug development, regulatory
decision-making, clinical practice.
Tennessee Health Information Exchange Cooperative
Agreement Program. State Office of eHealth and other
state agencies working to ensure that providers have
affordable, functional options to meet HIE requirements
of Meaningful Use. Support patient-centered
healthcare; continuous improvements in quality, safety,
and efficiency of care; public health. Funded by state,
ONC state HIE Cooperative Agreement, CMS. 11
AMIA Invitational Health Policy Meeting 2012
Page 39 12/10/2012
Data from biomedical
research studies:
collect/pool data to power
Consortium efforts and
disseminate data in findings
and/or repositories of
samples, and raw data made
publicly available. Data
comes from literature
searches, observational
studies and clinical trials.
Help providers adopt Direct
Messaging to jumpstart
statewide electronic
exchange of health
information. No data
collected/ aggregated
except to use Direct HIE to
submit reportable public
health data, e.g.,
Immunization Registry,
Cancer Registry, etc.
Data collection enabled by
Consortium and FINH’s role
as trusted 3 rd party or ‘safe
harbor’ for collaborative
research. Data not stored
in centralized infrastructure
but remain stored with
partners.
Support private sector
providers, build awareness
of “Direct based” HIE
capabilities through
extending operations of the
Tennessee Regional
Extension Center, and
pilots. Encourage marketbased
provision of Direct
HIE services to providers
15 launched projects to date,
2 fully completed; 2 in the
pipeline. $47 million raised
from private sector. 3 major
FDA guidances: accelerated
approval pathway for breast
cancer drugs; new clinical
endpoints for therapeutic
trials in community-acquired
bacterial pneumonia and
acute skin infection. 14
journal/book publications.
Formulation of plans and
strategies is underway.
� Patient confidentiality,
informed consent, privacy
constraints
� Need clear research aim
that fits precompetitive
mission while attracting
private sector funding
� Private sector reluctant to
share data: competitive or
medico-legal risks
� Concerns about objectivity
of shared data analyses
� Investigators reluctant to
share data due to
incentives for research
credit/authorship
None noted