eHealth Information: Federal eHealth Information: Federal Activities and Implications for Activities and Implications for
State PolicyState Policy
Susan M. ChristensenSusan M. ChristensenSenior AdvisorSenior Advisor
CSG Health Policy ForumCSG Health Policy Forum
On Mental Health Care and WellnessOn Mental Health Care and WellnessMay 31, 2006May 31, 2006
OverviewOverview
Terminology – Getting on the Same Terminology – Getting on the Same PagePage
Federal LandscapeFederal Landscape AHRQAHRQ Privacy and TrustPrivacy and Trust ResourcesResources Legal IssuesLegal Issues Appendix: Case Study – Legal IssuesAppendix: Case Study – Legal Issues
Terminology: HIE v. HITTerminology: HIE v. HIT
No longer just about putting electronic medical records No longer just about putting electronic medical records in hospitalsin hospitals Electric health information systems across Electric health information systems across allall care care
settings, as well as payers settings, as well as payers Linking them together – interoperability for Linking them together – interoperability for health health
information exchange (HIE)information exchange (HIE) For HIE, communities and states (and some regions) For HIE, communities and states (and some regions)
are developing networked systemsare developing networked systems To do this, it’s not just about investing in the To do this, it’s not just about investing in the
technology (HIT) technology (HIT) ; we must research how to do so in a ; we must research how to do so in a way thatway that Maximizes the value we hope to realize – clinically, Maximizes the value we hope to realize – clinically,
economically, and for population healtheconomically, and for population health Assures that security and privacy protections are Assures that security and privacy protections are
“baked into” HIE “baked into” HIE
HIE Policy IssuesHIE Policy Issues
In addition, a new market is being created, In addition, a new market is being created, with all the technical and policy issues that with all the technical and policy issues that entails, such asentails, such as Standards for data exchangeStandards for data exchange Assuring consumer participation and patient Assuring consumer participation and patient
protectionsprotections Security concernsSecurity concerns New business arrangements, new relationships New business arrangements, new relationships Disconnect between payment systems and new Disconnect between payment systems and new
relationships/care delivery modelsrelationships/care delivery models
What’s the situation?What’s the situation?
Federal LeadershipFederal Leadership
President’s Executive Order President’s Executive Order 13335 13335 (April 2004) (April 2004) – federal leadership for the development of a – federal leadership for the development of a nationwide interoperable electronic health nationwide interoperable electronic health information system:information system:
Created Office of the National Coordinator for Health Created Office of the National Coordinator for Health Information Technology in HHS (ONC)Information Technology in HHS (ONC)
ONC is required to develop a national strategic plan to support:ONC is required to develop a national strategic plan to support: Public-private collaboration to develop, adopt and implement Public-private collaboration to develop, adopt and implement
standardsstandards Evaluate benefits of HIT Evaluate benefits of HIT Address privacy and security issuesAddress privacy and security issues
ONC serves as principal advisor to Secretary on national HIT ONC serves as principal advisor to Secretary on national HIT policy, coordinates federal activities, and coordinates public-policy, coordinates federal activities, and coordinates public-private outreach and consultationprivate outreach and consultation
NOW
WORKGROUPS
COMMUNITY
ONC
INFRASTRUCTURE
20052004
FHA Strategic Plan
Health IT Policy Council Established
NHIN RFI Summary
Health IT Strategic Framework
JUL MAR SEP OCT JAN FEB MAR . . . DEC
Interoperable Electronic Healthcare
Records
Community Established
Review Workgroup Recommendations
2007 2014
2006 GOALS
Make Recommendations to the Community
Workgroups Established
Contracts Awarded
ONC Health IT Roadmap To-DateONC Health IT Roadmap To-Date
Recommendations for:• Biosurveillance• Consumer Empowerment• Chronic Care• Electronic Healthcare Records
• 2006 Strategic Plan
• NHIN Architectures• Standards Implementation Guidance• Ambulatory Care Certification Criteria
• Recommendations Report to the Secretary of HHS
Four Major HHS ContractsFour Major HHS Contracts
HHS has entered into four significant contracts: HHS has entered into four significant contracts: http://www.hhs.gov/healthit/contracts.htmlhttp://www.hhs.gov/healthit/contracts.html
Harmonize industry-wide health IT standards (ONC)Harmonize industry-wide health IT standards (ONC) Develop a conformance certification process for Develop a conformance certification process for
health IT (ONC)health IT (ONC) Assess and develop plans to address variations Assess and develop plans to address variations
business policies and state laws related to privacy and business policies and state laws related to privacy and security (AHRQ)security (AHRQ)
Four contracts to develop nationwide health Four contracts to develop nationwide health information network (NHIN) prototypes that can be information network (NHIN) prototypes that can be used to test specialized network functions, security used to test specialized network functions, security protections and monitoring, and demonstrate protections and monitoring, and demonstrate feasibility of scalable models (ONC)feasibility of scalable models (ONC)
Agency for Healthcare ResearchAgency for Healthcare Researchand Quality (AHRQ)and Quality (AHRQ)
MissionMission
To improve the quality, safety, To improve the quality, safety, efficiency, and effectiveness efficiency, and effectiveness
of health care for all of health care for all AmericansAmericans
Research at HHS:Research at HHS:Where Does AHRQ Fit In?Where Does AHRQ Fit In?
NIHNIH -- basic biomedical bench research and “efficacy” clinical trials -- basic biomedical bench research and “efficacy” clinical trials AHRQAHRQ -- “effectiveness” of healthcare services and the healthcare -- “effectiveness” of healthcare services and the healthcare
delivery systemdelivery system CDCCDC -- the public health system and community-based -- the public health system and community-based
interventionsinterventions
Other federal partners – Other federal partners – CMS CMS (Medicare and Medicaid)(Medicare and Medicaid), , HRSA HRSA (capital (capital and resources, workforce)and resources, workforce), and , and ONCONC (collaboration and (collaboration and coordination on health IT)coordination on health IT)
Intersection of Safety, Intersection of Safety, Quality and Health ITQuality and Health IT
AHRQ
Support diffusion of HIT to •41 states•40 million Americans
Improve medication safety•CMS e-prescribing demos
Provide HIT technical support to safety net
•Community health centers • Critical access hospitals• Public hospitals
Privacy and Security
Focus on Adoption of Health ITFocus on Adoption of Health IT
AHRQ’s work focuses on the AHRQ’s work focuses on the marriagemarriage of Health IT systems with of Health IT systems with the way work is done in health carethe way work is done in health care
Need to prepare for the impact of Need to prepare for the impact of new Health IT systemsnew Health IT systems Health IT is “Health IT is “oneone part technical, and part technical, and twotwo
parts culture and work process parts culture and work process change.” change.”
Opportunity to design new and better Opportunity to design new and better workflows – and review work workflows – and review work patterns that may never really have patterns that may never really have been examined. been examined.
State and Regional HIT State and Regional HIT DemonstrationsDemonstrations
Five-year state-based contracts: Five-year state-based contracts: Help states develop secure statewide networksHelp states develop secure statewide networks Ensure privacy of health informationEnsure privacy of health information Make an individuals’ health information more Make an individuals’ health information more
available to health care providers available to health care providers FY04: Five states awarded $1M/yearFY04: Five states awarded $1M/year
ColoradoColorado IndianaIndiana Rhode IslandRhode Island TennesseeTennessee UtahUtah Delaware added in FY05Delaware added in FY05
AHRQ National Resource Center for AHRQ National Resource Center for Health Information TechnologyHealth Information Technology
Provides technical and expert support to health IT Provides technical and expert support to health IT grantees, contractors, and selected other federal grantees, contractors, and selected other federal grantees (HRSA, CMS, IHS)grantees (HRSA, CMS, IHS)
Contract award to NORC (up to $18.5M over 5 years), Contract award to NORC (up to $18.5M over 5 years), in partnership with:in partnership with:
Vanderbilt UniversityVanderbilt University Center for IT Leadership (Partners) Center for IT Leadership (Partners) Indiana UniversityIndiana University Foundation for the eHealth InitiativeFoundation for the eHealth Initiative CSCCSC Burness CommunicationsBurness Communications
healthit.ahrq.govhealthit.ahrq.gov
Approaching the “Trust” Issue Approaching the “Trust” Issue
Why is this important to people? What are people thinking? Why is this important to people? What are people thinking? What is the “threat”? What is the “threat”?
Can we break it down? Is HIPAA compliance enough? Can we break it down? Is HIPAA compliance enough? Why not? Why not?
How to react?How to react? Who should be involved?Who should be involved? What message?What message? Guidance for leadership?Guidance for leadership?
““Trust” v. “Privacy” v. HIPAATrust” v. “Privacy” v. HIPAA
Clarify the issues:Clarify the issues: HIPAA – legal requirementHIPAA – legal requirement Additional legal privacy requirementsAdditional legal privacy requirements
FederalFederal StateState Contractual Contractual
Privacy – common law, ethics, good business, Privacy – common law, ethics, good business, protections beyond basic HIPAA complianceprotections beyond basic HIPAA compliance
Trust – broader public concern about security and Trust – broader public concern about security and reliabilityreliability
Privacy and Security ContractPrivacy and Security Contract In September 2005, AHRQ awarded “Privacy and Security In September 2005, AHRQ awarded “Privacy and Security
Solutions for Interoperable Health Information Exchange”Solutions for Interoperable Health Information Exchange” Overall contract managed by RTI International in partnership Overall contract managed by RTI International in partnership
with NGAwith NGA 18-month period; $11.5 million18-month period; $11.5 million RTI will subcontract with up to 40 states to: RTI will subcontract with up to 40 states to:
Identify within the state business practices that affect electronic health Identify within the state business practices that affect electronic health information exchangeinformation exchange
Propose solutions and implementation plansPropose solutions and implementation plans Collaborate on regional and national meetings to develop solutions Collaborate on regional and national meetings to develop solutions
with broader applicationwith broader application Provide final report on overall project outcomes and Provide final report on overall project outcomes and
recommendationsrecommendations
Contract PurposesContract Purposes Identify variations in organization-level business privacy and security Identify variations in organization-level business privacy and security
policies and practices that affect electronic clinical health information policies and practices that affect electronic clinical health information exchange (HIE)exchange (HIE) For those that are “best practices”, document and incorporate into For those that are “best practices”, document and incorporate into
proposed solutionsproposed solutions For those with a negative impact, identify source of the policy or For those with a negative impact, identify source of the policy or
practice and propose alternativespractice and propose alternatives
Preserve privacy and security protections as much as possible in a Preserve privacy and security protections as much as possible in a manner consistent with interoperable electronic health information manner consistent with interoperable electronic health information exchangeexchange
Incorporate state and community interests, and promote stakeholder Incorporate state and community interests, and promote stakeholder identification of practical solutions and implementation strategies identification of practical solutions and implementation strategies through an open and transparent consensus-building processthrough an open and transparent consensus-building process
Leave behind in states and communities a knowledge base about Leave behind in states and communities a knowledge base about privacy and security issues in electronic health information exchange privacy and security issues in electronic health information exchange that endures to inform future HIE activitiesthat endures to inform future HIE activities
Connecting for HealthConnecting for HealthCommon FrameworkCommon Framework
A set of free resources: 16 policy guides and technical documents A set of free resources: 16 policy guides and technical documents designed to advance HIE in a private and secure manner. designed to advance HIE in a private and secure manner. Technology neutral Technology neutral Includes model contract language for HIE agreements Includes model contract language for HIE agreements
The Common Framework puts forth a model of HIE that:The Common Framework puts forth a model of HIE that: Protects patient privacy by allowing health information to remain Protects patient privacy by allowing health information to remain
under local control – avoiding the need for a large, centralized under local control – avoiding the need for a large, centralized database or creation of a national patient IDdatabase or creation of a national patient ID
Avoids large-scale disruption and huge up-front capital investments Avoids large-scale disruption and huge up-front capital investments by making use of existing hardware and softwareby making use of existing hardware and software
Supports better informed policymaking around HIESupports better informed policymaking around HIE Establishes trust among collaborating organizations by applying Establishes trust among collaborating organizations by applying
well-vetted model contract language to fit their needswell-vetted model contract language to fit their needs
Series of activities to disseminate and provide education for how Series of activities to disseminate and provide education for how to use: AHRQ website, teleconferences, workshopsto use: AHRQ website, teleconferences, workshops
healthit.ahrq.gov and www.connectingforhealth.orghealthit.ahrq.gov and www.connectingforhealth.org
Vanderbilt Center for Better Vanderbilt Center for Better Health ModelHealth Model
Developed workshop design to explore trust issues, Developed workshop design to explore trust issues, come to consensus, and make recommendations or come to consensus, and make recommendations or develop workplan for moving forwarddevelop workplan for moving forward Goal: state/community controls the process and the outcomeGoal: state/community controls the process and the outcome Statewide: used principles in CFH model as kickoff for Statewide: used principles in CFH model as kickoff for
discussion about privacy and trust among stakeholders in discussion about privacy and trust among stakeholders in disparate HIEs across statedisparate HIEs across state
Another new statewide initiative: used workshop to do Another new statewide initiative: used workshop to do concrete planning for both technology and governance in new concrete planning for both technology and governance in new HIE HIE
http://www.volunteer-ehealth.org/AHRQ/12142005/http://www.volunteer-ehealth.org/AHRQ/12142005/index.htmindex.htm
http://www.mc.vanderbilt.edu/vcbh/ds/0606_privacy/http://www.mc.vanderbilt.edu/vcbh/ds/0606_privacy/ Working with AHRQ to make the workshop “portable”Working with AHRQ to make the workshop “portable”
Differing Approaches – Legal Differing Approaches – Legal IssuesIssues
Recognize that one approach, i.e., legislation, is not appropriate Recognize that one approach, i.e., legislation, is not appropriate for every issuefor every issue Federal legislation and mandatesFederal legislation and mandates National or regional consensusNational or regional consensus Model state lawsModel state laws State innovation through demonstrations or regulationState innovation through demonstrations or regulation Model contractsModel contracts Private agreementsPrivate agreements
Coordinate among initiatives; use them in combinationCoordinate among initiatives; use them in combination
SummarySummary
Communities can and should make their Communities can and should make their own choices about HIEown choices about HIE
The decision process on policies and The decision process on policies and implementation is as much a part of the implementation is as much a part of the solution as the technologysolution as the technology
Call on national initiatives for what they Call on national initiatives for what they can offer to save money and accelerate can offer to save money and accelerate the process the process
http://healthit.ahrq.govhttp://healthit.ahrq.gov
For additional information:For additional information:Susan ChristensenSusan Christensen
[email protected]@ahrq.hhs.gov
Case Study – One StateCase Study – One State
Workgroup of stakeholders assumed time frame two years Workgroup of stakeholders assumed time frame two years hencehence
Identified potential key legal, regulatory, and policy areas Identified potential key legal, regulatory, and policy areas that could still be of concern as regional health information that could still be of concern as regional health information exchange implementation progressesexchange implementation progresses
Stratified issues by national, regional, local or private in Stratified issues by national, regional, local or private in nature (i.e., best resolved at what level to be most nature (i.e., best resolved at what level to be most effective?), and split them into technical and non-technical effective?), and split them into technical and non-technical categoriescategories
Identified proposed approach: Identified proposed approach: legislationlegislation, , rule-makingrule-making, , consensusconsensus, , private agreementprivate agreement, or some combination, or some combination
Model legislation would be appropriate for many of the Model legislation would be appropriate for many of the consensusconsensus issue areas, except data and communication issue areas, except data and communication standardsstandards
Technical IssuesTechnical IssuesIssue AreaIssue Area NationalNational Regional/StateRegional/State PrivatePrivate
Data and communication Data and communication standardsstandards
Adopted at the national Adopted at the national levellevel; ; potential public/ potential public/ private collaboration for private collaboration for identificationidentification; ; mandatory mandatory for Medicare to drive for Medicare to drive take-up;take-up; common common standards identified for standards identified for MedicaidMedicaid
Adopted for Medicaid by Adopted for Medicaid by state programsstate programs
Participation in Participation in identification and identification and incorporation into productincorporation into product
Safety standards for Safety standards for items like drugs and items like drugs and devicesdevices
SameSame SameSame SameSame
Standards enforcementStandards enforcement Enforcement by regional Enforcement by regional exchanges as exchanges as requirement for userequirement for use; ; possibly mandatory for possibly mandatory for Medicaid Medicaid
CertificationCertification Requirements and Requirements and administration/enforcemeadministration/enforcement at regional levelnt at regional level; ; possibly mandatory for possibly mandatory for Medicaid Medicaid
Bioterrorism/ defense Bioterrorism/ defense systemssystems
Developed and funded Developed and funded federallyfederally
Portions developed and Portions developed and funded at state/regional funded at state/regional level in collaboration with level in collaboration with federal effortsfederal efforts
Non-Technical IssuesNon-Technical Issues
Issue AreaIssue Area NationalNational Regional/StateRegional/State PrivatePrivate
Research on HIT policy, Research on HIT policy, standards and valuestandards and value
Funding,Funding, dissemination dissemination and oversight; and oversight; demonstrationsdemonstrations
Funding and Funding and adoptionadoption Funding and adoptionFunding and adoption
Payment reformsPayment reforms Medicare payment Medicare payment reformreform; ; Medicaid reform; Medicaid reform; FEHBP contractsFEHBP contracts
Adopt Medicaid reforms; Adopt Medicaid reforms; SCHIPSCHIP and and employee employee coverage reformscoverage reforms
Pay for performance and Pay for performance and IT utilizationIT utilization
Startup fundingStartup funding Tax incentives, loans, Tax incentives, loans, grantsgrants, and , and demonstrationsdemonstrations
Licensure for health Licensure for health professionalsprofessionals
Leader in developing Leader in developing standardized content that standardized content that supports information supports information exchangeexchange
Adoption and Adoption and enforcement of licensure enforcement of licensure rules rules
Professional organization Professional organization and payer support of and payer support of “model” rules“model” rules
Liability protections/ Liability protections/ accountabilityaccountability
Leader in developing Leader in developing standardized contentstandardized content
Adoption and Adoption and enforcementenforcement
Underserved populations Underserved populations Model legislation that Model legislation that supports interoperability supports interoperability
Outreach, funding and Outreach, funding and enforcementenforcement
HIE StructureHIE Structure
Issue AreaIssue Area NationalNational Regional/StateRegional/State PrivatePrivate
Governance/ structureGovernance/ structure Leadership in developing Leadership in developing standardized options that standardized options that support regional health support regional health information exchangeinformation exchange
State option to adopt by State option to adopt by statutestatute or or rulemakingrulemaking
Private agreements can Private agreements can supplement or reflect supplement or reflect state option, or may be state option, or may be stand-alone in absence stand-alone in absence of state actionof state action
Responsibility/ Responsibility/ accountabilityaccountability
Leadership in developing Leadership in developing standardized options that standardized options that support regional health support regional health information exchange information exchange and interoperability and interoperability
State option to adopt by State option to adopt by statutestatute or or rulemakingrulemaking
Taxing authorityTaxing authority Leadership in developing Leadership in developing options that support options that support regional health regional health information exchangeinformation exchange
State option to adopt by State option to adopt by statutestatute
Funding authorityFunding authority Leadership in developing Leadership in developing options that support options that support regional health regional health information exchangeinformation exchange
State option to adopt by State option to adopt by statutestatute or or rulemakingrulemaking
Private agreements can Private agreements can supplement or reflect supplement or reflect state option, or may be state option, or may be stand-alone in absence stand-alone in absence of state actionof state action
LiabilityLiability Leadership in developing Leadership in developing standardized content to standardized content to support interoperability support interoperability
State option to adopt by State option to adopt by statutestatute