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Connecting for Health Common Framework:
the Model Contract for Health Information Exchange
Gerry Hinkley gerryhinkley@dwt. com
July 18, 2006
Davis Wright Tremaine LLP
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Background
Connecting for Health Collaboration of 100+ stakeholders Founded and supported by Markle Foundation with additional
support from Robert Wood Johnson Foundation Policy Subcommittee: 40 members representing law, health privacy
and ethics, health care delivery, administration, technology, local network development
Common Framework Policy Guides Technical Guides Model Contract
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Overview
Model Contract for Health Information Exchange Topic List Model Contract Language
Objectives Assist SNOs to prepare participation agreements Provide 60-40 solution Identify issues and alternatives, raise questions
Scope SNO participation agreement Data use agreement Technology service/license agreement
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Overview
Structure and Context Common Framework adopted by standards and policy entity (SPE) Terms and Conditions adopted by each SNO, tailored to that
SNO’s needs Registration Agreements between each SNO and its participants
Definitions Sub-network organization (SNO), includes RHIOs and others Participant
Data Provider Data Recipient
Authorized User (individual)
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Essential Components
Address the broad scope of agreements that may be required – may be implemented in separate documents
Incorporate applicable terms of Common Framework Policies and Procedures
Provide specific terms that the SNO determines are appropriate for its unique needs
Include mechanism for making and implementing changes Development and adoption of Common Framework Changes in public perception and acceptance Legal and other regulatory developments Developing technology Subsequent events Operational requirements
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Structural Considerations
Manage resources in negotiating participation agreements Multilateral nature of the agreement Acknowledge advantages and disadvantages of traditional
relationships and contracting strategies Standard terms that apply to all parties Flexibility to negotiate unique agreements with specific parties
Simplify process for negotiating agreements with large numbers of Participants
Simplify process for making changes Stress importance of role played by stakeholders’ representatives (e.g.,
Management Committee) to assure document structure and process is and remains reasonable
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Structural Devices
Incorporation by reference Participant’s Registration Agreement incorporates SNO Terms and
Conditions SNO Terms and Conditions incorporates Common Framework
Policies and Procedures Structure seeks to limit number of subjects each Registration
Agreement addresses in unique terms Application for registration Mechanism for making changes
Changes required by law may be implemented unilaterally upon notice
Changes affecting material rights or obligations may be implemented if Participant does not object and terminate Registration Agreement within specified period of time following notice
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Common Framework
Policies and procedures promoting health information exchange among SNOs
Common Framework Policies and Procedures not yet adopted among SNOs, and should be expected to change over time
Subjects Permissible terms of user agreements Categories of participants Patient participation Technical standards Minimum privacy and security standards Permitted and prohibited uses of health information Minimum standards regarding liability and indemnification Minimum standards, generally
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Model SNO Terms and Conditions
Addresses unique needs of each SNO State and local laws Specific services Specific technology Operational considerations Community needs SNO governance
Model assumes SNO will Operate record locator service-based peer to peer network Provide (or provide access to) software necessary to use SNO’s
network
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Terms and Conditions: Topic List
Nature and scope of SNO’s system (i.e., technology) and services Selection of Participants Mechanism for amendments Responsibility for certification and supervision of individual Authorized
Users; security measures Nature and scope of Participants’ rights to use data obtained through
the Network; permitted and prohibited uses Nature and scope of Participants’ obligations to provide data Compliance with applicable agreements, e.g., vendor agreements,
software licenses, etc. Operational issues
Measures required to protect Network, Responsibility for training and support, etc.
Reporting obligations
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Terms and Conditions: Topic List
Services and/or technology provided by SNO, Participant, others Economics
SNO system and services NHIN Participants
Preservation of intellectual property rights Liability, warranties and indemnification Parties’ roles as business associates of other Participants Parties’ rights regarding termination General provisions
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Use of the Model
Current initiatives, recent experience Issues that have received particular attention
Selection of Participants Process Standards
Economics Model assumes Participants will pay service fees Tying payment obligations to receipt of benefits Arranging economics on another basis
Responsibilities for training and security Liability, disclaimers of liability and indemnification Patient opt-in vs opt-out
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Common Framework Resources
All materials are available without charge at www.connectingforhealth.org
Discussion forum for registered users is available at www.healthit.ahrq.gov
Software code available from regional sites: Regenstrief, MAShare, OpenHRE
E-mail to [email protected] to [email protected]