Transcript Key Requirements for Community Health Information

NCVHS Secondary Data Uses Work Group
Hyattsville, MD
July 19, 2007
Health Record Banks Enable
Secondary Data Use with
Privacy Protection
William A. Yasnoff, MD, PhD, FACMI
CEO, Health Record Banking Alliance
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Health Record Banking Alliance
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Virginia non-profit formed 6/06; first met 9/06
Purpose: promote the concept of health
record banks:
 Consumer-controlled independent
repositories of health records
Broad participation, no formal membership
 HIT vendors & organizations
 Health record bank organizations
 Consultants (HIT & health policy)
 Privacy advocates
 100+ on e-mail list
Monthly Meetings
Draft principles developed & posted on web
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1. Policies Needed to Achieve
Effective Secondary Data Use
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Strong public support of secondary use
 81% support use of electronic health
records for research [Markle
Foundation 9/05]
But public also wants control of their
information [Harris Interactive/WSJ 9/06]
 64% of adults said they would like to
have access to an electronic medical
record (EMR) to capture medical
information
 62% agree that "electronic medical
record use makes it more difficult to
ensure patient privacy.”
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1. Policies Needed for
Secondary Data Use (cont.)
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Policies needed:
 Individual right to medical privacy
 Individual may own a complete
copy of all their medical records
 Individual controls ALL use of their
medical information
 Consent required for any use
– May be provided in advance
– May be granted for person,
organization, specific study, etc.
– Specific to single purpose only
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2. Adequacy of Privacy
Protection Under Current Law
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HIPAA regulations are inadequate
 Treatment, payment, operations
(TPO) exceptions seem reasonable
 However TPO determination is
done by organization that has data
 No disclosure, reporting, or
effective oversight
 Not consistent with Fair Information
Practices (HHS, 1973)
No technical reason why individual
consent cannot be obtained
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3. Uses of Health Data with
Insufficient Protection
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All uses have insufficient protection
because HIPAA is inadequate
No disclosure of specific uses
Individuals cannot opt out of use of their
information
Individuals cannot find out what their
information is used
Individuals cannot prevent their information
from being used against them
“De-identification” is virtually never
absolute -- data can usually be re-identified
Violates Hippocratic Oath
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4. Other NHIN-related health
information use issues
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Requirements for Community Health
Information Infrastructure
Health Record Banking Model
Secondary Use Implications
Policy Recommendations
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Components of a
Community Health
Information Infrastructure
Stakeholder
cooperation
Complete
Electronic
Patient
Information
Financial
Sustainability
Public
Trust
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Complete
Electronic
Patient
Information
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Most information is already electronic: Labs,
Medications, Images, Hospital Records
Outpatient records are mostly paper
 Only 10-15% of physicians have EHRs
 Business case for outpatient EHRs weak
For outpatient information to be electronic, need
financial incentives to ensure that physicians acquire
and use EHRs
Requirement #1: Financial incentives to create good
business case for outpatient EHRs
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Complete
Electronic
Patient
Information
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Need single access point for electronic information
Option 1: Gather data when needed (scattered model)
 Pro: 1) data stays in current location; 2) no
duplication of storage
 Con: 1) all systems must be available for query
24/7/365; 2) each system incurs added costs of
queries (initial & ongoing); 3) slow response time;
4) searching not practical; 5) huge interoperability
challenge (entire U.S.); 6) records only complete if
every possible data source is operational
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Complete
Electronic
Patient
Information
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Need single access point for electronic information
Option 2: Central repository
 Pro: fast response time, no interoperability
between communities, easy searching, reliability
depends only on central system, security can be
controlled in one location, completeness of record
assured, low cost
 Con: public trust challenging, duplicate storage
(but storage is inexpensive)
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Complete
Electronic
Patient
Information
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Need single access point for electronic information
Requirement #2: Central repository for storage
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Stakeholder
cooperation
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Voluntary
Impractical
Financial incentives
 Where find $$$$$?
Mandates
 New
Impractical
 Existing
– HIPAA requires
information to be
provided on patient
request
Requirement #3: Patients
must request their own
information
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Financial
Sustainability
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Funding options
 Government
– Federal: unlikely
– State: unlikely
– Startup funds at best
 Healthcare Stakeholders
– Paid for giving care
– New investments or transaction
costs difficult
 Payers/Purchasers
– Skeptical about benefits
– Free rider/first mover effects
 Consumers
– 72% support electronic records
– 52% willing to pay >=$5/month
Requirement #4: Solution must appeal to
consumers so they will pay
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A. Public Trust = Patient
Control of Information
Public
Trust
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Requirement #5: Patients
must control all access to
their information
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Public
Trust
B. Trusted Institution
 Via regulation (like banks)
impractical ??
 Self-regulated
 Community-owned non-profit
 Board with all key stakeholders
 Independent privacy oversight
 Open & transparent
 Requirement #6: Governing institution
must be self-regulating communityowned non-profit
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Public
Trust
C. Trustworthy Technical Architecture
 Prevent large-scale information loss
 Searchable database offline
 Carefully screen all employees
 Prevent inappropriate access to
individual records
 State-of-the-art computer
security
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Strong authentication
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No searching capability
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Secure operating system
 Easier to secure central
repository: efforts focus on one
place
 Requirement #7: Technical architecture
must prevent information loss and
misuse
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Health Record Banking Model
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All information for a patient stored in Health
Record Bank (HRB) account
Patient (or designee) controls all access to
account information [copies of original
records held elsewhere]
Each HRB has three interfaces:
 Withdrawal window - record access
 Deposit window - receives new info
 Search window - authorized requests
When care received, new records sent to
HRB for deposit in patient’s account
All data sources contribute at patient request
(per HIPAA)
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Health Record Banking
Encounter
data sent to
Health
Record Bank
Clinician’s Bank
Patient data
delivered to
Clinician
Secure
patient
health data
files
Optional
payment
Clinician EHR
System
YES
Encounter Data
Entered in EHR
Patient
Permission?
NO
DATA NOT
SENT
Health Record Bank
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Clinical Encounter
Clinician
Inquiry
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Secondary Use Implications
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Privacy is protected through consumer control
 Each consumer customizes their own
privacy policy
Health record banks facilitate secondary use
 Searches over populations easy
– Not necessary to release data
– Counts of matches with demographics
normally sufficient
– Eliminates issues of “de-identification”
and reuse
 Can combine searches over multiple banks
 Banks can notify individuals without
knowledge of searchers (e.g. for clinical trial
recruitment, drug withdrawal from market)
 Banks collect fees to share with consumers
© 2007
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Policy Recommendations (1 of 2)
1.
2.
Consumer has complete legal ownership and
control of health record bank information
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No exceptions needed as copies of
information are elsewhere
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Information protected from
–
Change in ownership
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Failure of customer payment
–
Bankruptcy
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Consent for single-purpose access only
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No coerced consent
All holders of electronic medical information
required to provide it within 24 hours of
creation at no charge (on patient request)
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Policy Recommendations (2 of 2)
3.
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Include health record banks as
covered entities under HIPAA
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Cover personal health information
in all locations
Require independent privacy &
confidentiality audits of health
record banks
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Certification of auditing entities
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Public disclosure of audits
Require security procedures
sufficient to enforce privacy &
confidentiality policies
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Questions?
For more information:
www.healthbanking.org
www.yasnoff.com
William A. Yasnoff, MD, PhD, FACMI
[email protected]
703/527-5678
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