1. Patient Consent:
A Vision for the Future
Presentation at HIMSS 13
March 6, 2013
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

2. |2|
Purpose
Enable a discussion
around patient consent
management
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

3. |3|
Current Environment
 Patient choices currently limited
– “Static,” paper-based
– To extent offered, separately administered
by each provider/entity
– “All” or “nothing”
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

4. |4|
Vision for the Future (1 of 2)
 Patient indicates preference levels for sharing
– What personal data should/should not be shared
– Who can send/receive, when, and for what purpose
– Framework translates complexities into actionable,
easily understood choices
– Choice options supported by just in time, context
sensitive education to ensure meaningful choice
 Generalized and Centralized
– Web-based, one-stop shopping for the patient
– One set of choices can be used to specify different
consents for different providers
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

5. |5|
Vision for the Future (2 of 2)
 Flexible
– Granular choices go beyond simple “yes” and “no;” “all”
or “nothing” options
– Choices easily updated
– Extendable to allow inclusion of additional criteria
 Available
– Open source
– Web-based
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

6. |6|
SAMHSA & MITRE Initiatives
 Substance Abuse and Mental Health Service Administration
(SAMHSA) involved extensively in HL-7 standards and ONC S&I
DS4P implementation guide development
 MITRE, as a federally funded research and development center,
invested funding in research on a nationwide consent
management approach
 SAMHSA engaged MITRE to leverage research for development
of a User Interface to express patient consent preferences
– Interoperable with DS4P S&I Initiative Pilot
 Visit the Interoperability Showcase
– Investigate meaningful choice
 Represent and educate on trade-offs among sharing options
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

7. |7|
User Interface for Patient Consent Management
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

8. |8|
Consent Management (Notional)
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

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User Interface Core Ideas
Law enforcement
Behavioral Health
Providers
Clinical Health
Providers
Schools
Centralized Choices
Trade-Offs
Choices
Pharmacies
Educate
Hospitals
Human Services
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

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Establishing the Patient Policy
The reason the information is needed
WHY Purpose of Use (Treatment, Emergency, Research, Public Health, etc.)
Overall Setting Default setting
What topics may need different obligations
Sensitive Areas (Mental Health, Substance Abuse, etc)
Sensitive Area 1 Setting Setting for specific topics
WHAT
Sensitive Area 2 Setting
Sensitive Area 3 Setting
…
What is the relationship with the provider requesting
WHO Provider information?
(closer, more integral to care requires more information)
WHEN Date Ranges What is the date range for this consent?
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

11. | 11 |
Trade Offs
 Limited sharing => Not available for clinical decisions
– Certain information is more sensitive to this risk
 Example: Patient prescription for methadone
– Sharing may disclose treatment for substance abuse and related privacy risks
– Not sharing may increase risk of adverse drug interactions in an emergency
situation
– Granular choices may allow patients to balance risks
Least Sharing Most Sharing
Mostly Mostly
Restrict Share
Shared
Privacy Risk Medical Safety Risk
Minimized Minimized
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

12. | 12 |
Slider Concept for Expressing Choices
Mostly Mostly
Share
Restrict Shared
Share Share
Share Share All
Nothing immunizations,
immunizations
allergies, meds
& allergies
& procedures
• Ask the patient their willingness to share
• Pair: Recipient and Topic for specific Purpose of Use
• System does the work
• Show policy generated
• Goal to show patient effect on their record
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

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Education
Mostly Mostly
Share
Restrict Shared
Restrict: Provider Mostly restrict: The Mostly share: Share: All
does not need your provider’s decisions Provider needs most information will be
medical record to treat are less important to of your medical shared with my care
you effectively. If the your overall health information and you team.
provider may prescribe and/or you are less are comfortable with
medications, consider comfortable with sharing.
selecting another sharing.
option that allows
sharing of medication
history and allergies.
Dentist A referred provider PCP or Specialist for
by your Primary chronic condition
Care Provider
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

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Provide Education to the User
 Links to eConsent educational material
– ONC funded project to “Educate and inform individuals of
their option to give individual choice (e.g. automate informed
consent process, patient-centered decision making process)
in a clinical setting to share their health information
electronically.”
http://healthit.hhs.gov/pdf/E-
consent%20Trial%20statement%20of%20work.pdf
 Contextual help
– Definitions
– Trade-off alerts
– Recommendations
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

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User Interface Dashboard
Why
When
What
Who
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Demo
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Login
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Choices for Treatment
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Choices for Highly Sensitive Information
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Choice for Emergencies
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

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Choice for Research
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

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Some of the Challenges
 Effective education on trade-offs
– Understanding how preferences affect the release of
information in a given situation
– Understanding the risks associated with sharing or
protecting information
 Infrastructure to support this type of approach
– DS4P pilots
– SAMHSA’s open source ACS service (in development)
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.

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Areas for Discussion
 Patient Consent User Interface feedback
 What policy or actions would facilitate empowering
the patient?
 What needs to be in place for providers to accept and
use generic patient consents?
 Does a granular approach to health record data
introduce additional questions?
 How do current events influence how this should be
approached?
© 2013 The MITRE Corporation. All rights reserved. Approved for Public Release - 13-1050.