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Kairon: Granular Patient
Consent Management

The MITRE Corporation
Peter Mork, PhD




                                                                                                                     1
 Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
About MITRE Research


■ MITRE:
  –   Private, independent non-profit organization
  –   Chartered to work solely in the public interest
  –   Provide support to governmental sponsors
  –   Four Federally Funded Research and Development Centers

■ MITRE Research:
  –   Internal competition
  –   Approximately 6% of revenue (provided by FAR)
  –   Targeted to specific focus areas, including health care
  –   Advances technologies for transition to public and private sectors




                                                                                                                                2
                   Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
Consent Research


         Browser                                 Request Server




     Record Holder
                                                                              Consent Server
        Server


                Policy                                                                      Policy
               Enforcer                                                     Consent        Reasoner
   EHR
                                                                              DB

                                                                                                                                    3
             Approved for Public Release 11-0953. Distribution Unlimited.             © 2011 The MITRE Corporation. All rights Reserved.
Objective: Efficient Consent Management


  ■ Globally Accessible by:
    – Patients and
    – Record Holders
  ■ Intuitive User Interface
  ■ Platform Adaptable
  ■ Modular Design adapts to:
    – Technology or
    – Legal Changes




                                                                                                                         4
            Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
Consent Directive Analysis Model
                        Consent specifications
                        - allow/disallow action
                        -purpose of consent        Medical Record Reference
  Privacy Policy
                        -effective period          -Patient Identification
    Reference
                        -additional conditions     -Medical Record Identification



               Action Specification
- hierarchy of operations applied to information
                                                        Information Sender
        Health Information Affected                     -Organization
        -Related to a diagnosis                         Information Receiver
        -Data Sensitivity                               -Role
        -Coverage Type                                  -Identity
        -Type of information (e.g., lab, rx)
Consent Directive Form
Mobile App Interface




                                                                                                                        7
           Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
John Smith’s Privacy Preferences


  Recipient                             Purpose                                Allowed       Disallowed
                                                                               Types         Topics
  Primary Care                          Treatment                              Any           None
  Provider = Dr. Blass
  Drs. referred by                      Treatment                              Allergies,    Mental Health
  Dr. Blass                                                                    Medications
  Any                                   Research                               Not Imagery   PII, Mental
                                                                                             Health




                                                                                                                                           8
                Approved for Public Release 11-0953. Distribution Unlimited.                 © 2011 The MITRE Corporation. All rights Reserved.
Preference Simplification
(through Rule Minimization)                                                                                X = Primary
                                                                                                          Care Provider
                                                                              Direct Care
                                                                               Providers
                                                                                                          Referral from
            Dr. Walsh:                                                        Purpose =
                                                                                                          X to Recipient
                                                                              Treatment
            Purpose =                                                                       Medications
            Treatment                                                          Allowed
                                                                              Categories
                                                                                             Allergies
                                                                               ¬ Mental
                                                                                Health

                                                                              Purpose =
                          Allow                                               Treatment


                                                                              Dr. Blass


                                                                                                            Purpose =
     (Medications or Allergies) and not Mental Health                                                       Research


                                                                                                          Anonymized
                                                                              Research
                                                                                                            ¬ Imagery


                                                                                                             ¬ Mental
                                                                                                              Health

                                                                                                                                                   9
               Approved for Public Release 11-0953. Distribution Unlimited.                          © 2011 The MITRE Corporation. All rights Reserved.
Rewritten Preferences

                                     Blass                                      Walsh             Nelson
     Treatment                          Any                              (Allergies or              None
                                                                       Medications) and
                                                                      NOT Mental Health
     Research                        NOT Imagery, NOT PII and NOT Mental Health




   <AND>
     <OR>
       <String-is-in(‘medication’, Select(datatype))/>
       <String-is-in(‘allergy’, Select(datatype))/>
     </OR>
     <String-is-in(‘NOT-mental-health’, Select(topic)))/>
   </AND>

                                                                                                                                       10
                 Approved for Public Release 11-0953. Distribution Unlimited.             © 2011 The MITRE Corporation. All rights Reserved.
Consent Form  CDA Document




      • Produced by the
            form
      • Conforms to the
    Implementation Guide




          Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
Electronic Consent Directive:
CDA Document (rendered as HTML)




         Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
Sample Response




                                                                                                                     13
         Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
Contacts

  ■ Peter Mork, PhD
    – pmork@mitre.org
    – 703-983-1465
  ■ Jean Stanford
    – jstanford@mitre.org
    – 301-814-4934

  ■ Source Forge Site:
    – http://kaironconsents.sourceforge.net/




                                                                                                                           14
               Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
Backup Slides




                                                                                                                      15
          Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
Sample Consent Form




                                                                                                                      16
          Approved for Public Release 11-0953. Distribution Unlimited.   © 2011 The MITRE Corporation. All rights Reserved.
Constraints on Consent

 Legal                                                                                                       Trust
 • HIPAA / Privacy Act                                                                • Relationships
 • State Laws                                                                               • Delegation




 Compliance                                                                         Authentication
 • Auditing                                                                               • Credentials
 • Enforcement                                                                  • Identity Management
                                                                                                                                    17
                 Approved for Public Release 11-0953. Distribution Unlimited.          © 2011 The MITRE Corporation. All rights Reserved.
Implementation Landscape
      High




                                  Automated                                      Integrate with                                Intelligent
                                 Enforcement                                    State Mandates                                 Redaction
Technical Complexity




                                                 Eliciting Patient                                            Integrate Care
                                                   Preferences                                                Relationships                                         Implemented



                                                                                                                                                                       Under
                                                                                                                                                                    Development

                                            Patient Review
                                                                                                                                                                       Grand
                                              & Approve                                                                                                              Challenges




                                  Preemptory                                                                                   Credential
                                                                           Audit                                               Matching
                                    Access
  Low




                       Accepted Practices                                     Policy Maturity                                                    Inchoate


                                                                                                                                                                                 18
                                               Approved for Public Release 11-0953. Distribution Unlimited.                         © 2011 The MITRE Corporation. All rights Reserved.

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11 0953 kairon - slide deck for source forge final 2 11

  • 1. Kairon: Granular Patient Consent Management The MITRE Corporation Peter Mork, PhD 1 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 2. About MITRE Research ■ MITRE: – Private, independent non-profit organization – Chartered to work solely in the public interest – Provide support to governmental sponsors – Four Federally Funded Research and Development Centers ■ MITRE Research: – Internal competition – Approximately 6% of revenue (provided by FAR) – Targeted to specific focus areas, including health care – Advances technologies for transition to public and private sectors 2 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 3. Consent Research Browser Request Server Record Holder Consent Server Server Policy Policy Enforcer Consent Reasoner EHR DB 3 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 4. Objective: Efficient Consent Management ■ Globally Accessible by: – Patients and – Record Holders ■ Intuitive User Interface ■ Platform Adaptable ■ Modular Design adapts to: – Technology or – Legal Changes 4 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 5. Consent Directive Analysis Model Consent specifications - allow/disallow action -purpose of consent Medical Record Reference Privacy Policy -effective period -Patient Identification Reference -additional conditions -Medical Record Identification Action Specification - hierarchy of operations applied to information Information Sender Health Information Affected -Organization -Related to a diagnosis Information Receiver -Data Sensitivity -Role -Coverage Type -Identity -Type of information (e.g., lab, rx)
  • 7. Mobile App Interface 7 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 8. John Smith’s Privacy Preferences Recipient Purpose Allowed Disallowed Types Topics Primary Care Treatment Any None Provider = Dr. Blass Drs. referred by Treatment Allergies, Mental Health Dr. Blass Medications Any Research Not Imagery PII, Mental Health 8 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 9. Preference Simplification (through Rule Minimization) X = Primary Care Provider Direct Care Providers Referral from Dr. Walsh: Purpose = X to Recipient Treatment Purpose = Medications Treatment Allowed Categories Allergies ¬ Mental Health Purpose = Allow Treatment Dr. Blass Purpose = (Medications or Allergies) and not Mental Health Research Anonymized Research ¬ Imagery ¬ Mental Health 9 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 10. Rewritten Preferences Blass Walsh Nelson Treatment Any (Allergies or None Medications) and NOT Mental Health Research NOT Imagery, NOT PII and NOT Mental Health <AND> <OR> <String-is-in(‘medication’, Select(datatype))/> <String-is-in(‘allergy’, Select(datatype))/> </OR> <String-is-in(‘NOT-mental-health’, Select(topic)))/> </AND> 10 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 11. Consent Form  CDA Document • Produced by the form • Conforms to the Implementation Guide Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 12. Electronic Consent Directive: CDA Document (rendered as HTML) Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 13. Sample Response 13 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 14. Contacts ■ Peter Mork, PhD – pmork@mitre.org – 703-983-1465 ■ Jean Stanford – jstanford@mitre.org – 301-814-4934 ■ Source Forge Site: – http://kaironconsents.sourceforge.net/ 14 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 15. Backup Slides 15 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 16. Sample Consent Form 16 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 17. Constraints on Consent Legal Trust • HIPAA / Privacy Act • Relationships • State Laws • Delegation Compliance Authentication • Auditing • Credentials • Enforcement • Identity Management 17 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.
  • 18. Implementation Landscape High Automated Integrate with Intelligent Enforcement State Mandates Redaction Technical Complexity Eliciting Patient Integrate Care Preferences Relationships Implemented Under Development Patient Review Grand & Approve Challenges Preemptory Credential Audit Matching Access Low Accepted Practices Policy Maturity Inchoate 18 Approved for Public Release 11-0953. Distribution Unlimited. © 2011 The MITRE Corporation. All rights Reserved.

Hinweis der Redaktion

  1. FAR = Federal Acquisitions Regulations
  2. Slide courtesy of Ioana Singureanu, Eversolve, LLC.
  3. Slide courtesy of Ioana Singureanu, Eversolve, LLC.
  4. Slide courtesy of Ioana Singureanu, Eversolve, LLC.
  5. Slide courtesy of Ioana Singureanu, Eversolve, LLC.