Transcript ethics-informatics-o.. - Buffalo Ontology Site

Ethics, Informatics and
Obamacare
Barry Smith
UB Clinical/Research Ethics Seminar
November 20, 2012
http://ontology.buffalo.edu/12/ethicsinformatics-obamacare.pptx
1
David Brailer
(first National Coordinator for Health Information Technology)
On saving money through Health IT
if patients’ information were shared across health
care settings so that personal health information
seamlessly followed any patient through various
settings of care—$77 billion would be saved
annually
“Economic Perspectives on Health Information Technology”, 2005
2
Obamacare: “The ‘no-brainer’ of health IT”
• A central pillar of [ARRA’s] mammoth, $800 billion
dollar legislation … is devoted to digitizing the
nation's medical records and rewiring healthcare for
the 21st century, via the $27 billion Health
Information Technology for Economic and Clinical
Health (HITECH) Act.
• health IT … has set the stage for broader healthcare
reform, … may just be the most lasting, bipartisan
and transformative piece of the stimulus bill.
Health IT News, TIME magazine correspondent Michael Grunwald, October 1, 2012
3
Electronic Health Records
• gaps and duplication in patient care delivery
can be reduced or eliminated through proven
technologies such as electronic health records,
e-prescribing, and telemedicine
• health information technology improves
quality by making needed clinical information
accessible to all appropriate providers and in
a more complete and timely fashion than
paper records
4
through interoperability, EHRs will save
money
David Brailer, again (from 2005):
• Currently, as soon as a patient arrives at a hospital, a
battery of tests is performed … because clinicians have
no way of knowing what has already been done.
• Eliminating this inefficiency and frustration through
interoperability represents a significant challenge. It
does not, however, require magical changes in the
business processes or culture of health care to be
realized. It is really about obtaining data by calling it
up on a computer system rather than waiting for
medical records to be delivered.
5
Brailer: what can go wrong?
“the policy challenge is to get a critical mass of
health IT adoption so that this nation can move
forward.
The reasoning is that once health IT adoption
reaches the 40 to 50 percent range, market
forces will take over, because health care IT will
become a requirement for doing business.”
6
Brailer: there are disincentives to early
adopters
• They “are like the first owners of fax machines. … there
is no infrastructure to which an EHR can connect. …
• there are 300 electronic health record products on the
market that I know of, and that does not include all the
home-grown products.
• Health care providers buy the wrong product virtually all
the time. There is no price transparency around
products, … .
• Physicians do not know how to contract for these
technologies, so they almost always take unnecessary
risks in their contracts. And they do not know how to
implement them. …
7
Why interoperability (combinability) is
so hard
• Different EHR vendors have financial incentives to
thwart interoperability
• Patients move between physicians and hospitals,
who use EHR systems deriving from different
vendors
• Even where hospitals or wards use the same EHR
vendor, their EHR data may not be interoperable
• Even where coders in the same hospital or ward
use the same EHR system, they may code in noninteroperable ways
• Interoperability standards are still slapdash
8
http://hl7-watch.blogspot.com/
9
HITECH Act: let’s bribe physicians to
adopt these EHRs quickly, and then
penalize them if they fail to do so
Eligible health care professionals and hospitals
can qualify for more than $27 billion in
Medicare and Medicaid incentive payments
available to eligible providers and hospitals
https://www.cms.gov/ehrincentiveprograms/.
10
EHR incentive payments to Medicare providers
2011
2012
2013
2014
2015
2016
2017
TOTAL
Adopt
2011
$18,000
$12,000
$8,000
$4,000
$2,000
$0
$0
$44,000
Adopt
2012
----------
$18,000
$12,000
$8,000
$4,000
$2,000
$0
$44,000
Adopt
2013
----------
-----------
$15,000
$12,000
$8,000
$4,000
$0
$39,000
Adopt
2014
----------
-----------
-----------
$12,000
$8,000
$4,000
$0
$24,000
Adopt
2015 +
----------
-----------
-----------
----------
$0
$0
$0
$0
After
~2018
penalties, in the form of reduced Medicare reimbursements
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• Question: Why do it so quickly,
when there are so few trained
personnel, and when EHR systems
are so bad, and when there are so
many systems, and when the
systems are not interoperable?
Answer: Magical thinking*
*What, after all, can go wrong?
12
Question: In the age of Wikileaks, how
do we ensure that success in achieving
health IT interoperability will not be
accompanied by massive threats to data
security?
Answer: HIPAA*
*Big locks on all the doors (which will also
make it hard to open the doors from the
inside)
13
through interoperability, EHRs will save
money
David Brailer, again (from 2005):
• Currently, as soon as a patient arrives at a hospital, a
battery of tests is performed … because clinicians have
no way of knowing what has already been done.
• Eliminating this inefficiency and frustration through
interoperability represents a significant challenge. It
does not, however, require magical changes in the
business processes or culture of health care to be
realized. It is really about obtaining data by calling it up
on a computer system rather than waiting for medical
records to be delivered.
14
Question: In the age of Wikileaks, how
do we ensure that success in achieving
health IT interoperability will not be
accompanied by massive threats to data
security?
Answer: HIPAA
*Big locks on all the doors
15
Question: How do we ensure that
physicians and software companies do
not game the system by creating
cheap Potemkin EHR systems and
sharing the subsidy dollars?
16
Question: How do we ensure that
physicians and software companies do
not game the system by creating
cheap Potemkin EHR systems and
sharing the subsidy dollars?
Answer: “Meaningful use”
17
CMS (Centers for Medicare & Medicaid Services)
Staged Approach to Meaningful Use
Stage 1: ~2011
1. Capturing health
information in a coded
format
2. Using the information to
track key clinical conditions
3. Communicating captured
information for care
coordination purposes
4. Reporting of clinical quality
measures and public health
information
Capture information
Stage 2: ~2013
1. Disease management, clinical
decision support
2. Medication management
3. Support for patient access to
their health information
4. Transitions in care
5. Quality measurement
6. Research
7. Bi-directional communication
with public health agencies
Report information
Stage 3: TBD
1. Achieving improvements in
quality, safety and
efficiency
2. Focusing on decision
support for national high
priority conditions
3. Patient access to selfmanagement tools
4. Access to comprehensive
patient data
5. Improving population health
outcomes
Leverage
information to
improve outcomes
CMS (Centers for Medicare & Medicaid Services)
Staged Approach to Meaningful Use
Stage 1: ~2011
Stage 2: ~2013
1. Disease management,
clinical decision support
2. Medication management
2. Using the information to track
3. Support for patient access
key clinical conditions
to their health information
3. Communicating captured
4. Transitions in care
information for care
5. Quality measurement
coordination purposes
6. Research
4. Reporting of clinical quality
7. Bi-directional
measures and public health
communication with public
health agencies
information
1. Capturing health information
in a coded format
Capture information
Report information
Stage 3: TBD
1. Achieving improvements in
quality, safety and
efficiency
2. Focusing on decision
support for national high
priority conditions
3. Patient access to selfmanagement tools
4. Access to comprehensive
patient data
5. Improving population health
outcomes
Leverage
information to
improve outcomes
Examples of Stage 1 Objectives
Maintain active medication allergy list
Measure
80%+ of patients
Record and chart changes in selected vital signs
(height, weight, BP, BMI, growth charts (2-20
yrs.)
50%+
of patients
Record smoking status for patients 13 years old
or older
50%+
of patients
Implement one clinical decision support rule along
with the ability to track compliance to that rule
1 rule
Report ambulatory quality measures to CMS or the
States
Aggregate
numerator/
denominator
20
J. Borman, Ethical Dimensions of
Meaningful Use
• “Projected quality and safety benefits from
MU could be so substantial that nonattainment may be egregious. … failure to
meet MU staged thresholds in a timely
manner might signify not only second-rate
status, but confer an air of third-world
competency.”
21
Stephen T. Miller and Alastair MacGregor:
Ethical Dimensions of Meaningful Use
Requirements for Electronic Health Records
“The need to bring clinical charting traditions into
the electronic format is obvious. Anyone who works
in a clinical setting knows that retrieving
information from an outdated or otherwise
separate chart is burdensome and inefficient.
Having that information in a structured, easily
retrievable format is a great boon to both health
care professionals and patients.”
22
from last week’s Congressional
Hearing on Interoperability
Subcommittee on Technology and Innovation, Nov 14, 2012
• Is "Meaningful Use" Delivering Meaningful
Results? An Examination of Health Information
Technology Standards and Interoperability
US House of Representatives, 2318 Rayburn House Office
Building Washington, DC 20515
23
Willa Fields, Healthcare Information and Management Systems
Society and Professor, School of Nursing, San Diego State University
Statement before the Technology and Innovation Subcommittee of
US House of Representatives
Interoperability Status
The impactfulness of electronic health record systems adoption
is highly dependent upon health information exchange (HIE),
since EHR data can most effectively be useful if it can be
exchanged across healthcare delivery systems, EHR vendors, and
health information exchanges. HITECH includes elements of
information exchange in the Meaningful Use criteria and
provides for state investment in health information exchange
infrastructure (referred to as HIEs) through the State Health
Information Exchange Cooperative Agreement Program.
24
Currently only for VA? Also for military?
25
Staged Approach to Meaningful Use
Stage 1: ~2011
1. Capturing health
information in a
coded format
2. Using the information
to track key clinical
conditions
3. Communicating
captured information
for care coordination
purposes
4. Reporting of clinical
quality measures and
public health
information
Capture
Stage 2: ~2013
1. Disease management, clinical
decision support
2. Medication management
3. Support for patient access to
their health information
4. Transitions in care
5. Quality measurement
6. Research
7. Bi-directional communication
with public health agencies
Report information
Stage 3: TBD
1. Achieving improvements
in quality, safety and
efficiency
2. Focusing on decision
support for national high
priority conditions
3. Patient access to selfmanagement tools
4. Access to
comprehensive patient
data
5. Improving population
health outcomes
Leverage
information to
Stage 2 standards (130 pages)
https://www.federalregister.gov/articles/2012/09/04/2012-20982/health-informationtechnology-standards-implementation-specifications-and-certification-criteria-for
27
Example paragraph from the Stage 2
Final Rule
3. Scope of a Certification Criterion for Certification
In the Proposed Rule, based on our proposal to codify all the 2014 Edition
EHR certification criteria in § 170.314, we clarified that certification to the
certification criteria at § 170.314 would occur at the second paragraph
level of the regulatory section. We noted that the first paragraph level in
§ 170.314 organizes the certification criteria into categories. These
categories include: clinical (§ 170.314(a)); care coordination (§
170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security
(§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§
170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a
certification criterion in § 170.314 is at the second paragraph level and
would encompass all of the specific capabilities in the paragraph levels
below with, as noted in our discussion of “applicability,” an indication if
the certification criterion or the specific capabilities within the criterion
only apply to one setting (ambulatory or inpatient).
28
Example paragraph from Final Rule
3. Scope of a Certification Criterion for Certification
In the Proposed Rule, based on our proposal to codify all
the 2014 Edition EHR certification criteria in § 170.314,
we clarified that certification to the certification criteria
at § 170.314 would occur at the second paragraph level
of the regulatory section. We noted that the first paragraph level
in § 170.314 organizes the certification criteria into categories. These
categories include: clinical (§ 170.314(a)); care coordination (§
170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security
(§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§
170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a
certification criterion in § 170.314 is at the second paragraph level and
would encompass all of the specific capabilities in the paragraph levels below
with, as noted in our discussion of “applicability,” an indication if the certification
criterion or the specific capabilities within the criterion only apply to one setting29
Example paragraph from Final Rule
3. Scope of a Certification Criterion for Certification
In the Proposed Rule, based on our proposal to codify all
the 2014 Edition EHR certification criteria in § 170.314,
we clarified that certification to the certification criteria
at § 170.314 would occur at the second paragraph level
of the regulatory section. We noted that the first paragraph level
in § 170.314 organizes the certification criteria into categories. These
categories include: clinical (§ 170.314(a)); care coordination (§
170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security
(§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§
170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a
certification criterion in § 170.314 is at the second paragraph level and
would encompass all of the specific capabilities in the paragraph levels below
What can go wrong?
with, as noted in our discussion of “applicability,” an indication if the certification
criterion or the specific capabilities within the criterion only apply to one setting30
Pressure on hospitals to receive
meaningful use payments will cost lives
Sam Bierstock, MD: There is “enormous pressure by the
hospitals to force the physicians to use EHRs that are not
necessarily very user-friendly and therefore disruptive to their
work and to their efficiency,”
• hospital EHRs “are simply not yet adequately intuitive to
meet the needs of clinicians.”
• “Most EHRs result in a 20-30 percent decrease in efficiency
of emergency room doctors and an increase in the people
who leave without being seen due to extended wait times.
• “Providers also face mounting expenses as a result of
HITECH regulations, which … also strengthened security and
privacy requirements, “which are complex, costly to
implement and poorly understood by the majority of
providers”
31
Health IT and Patient Safety:
Building Safer Systems for Better Care
Institute of Medicine, November 10, 2011
Recommendations
Current market forces are not adequately addressing
the potential risks associated with use of health IT.
All stakeholders must coordinate efforts to identify
and understand patient safety risks associated with
health IT by … creating a reporting and investigating
system for health IT-related deaths, serious injuries,
or unsafe conditions
32
Disasters: Australia
The Age (Victoria, Australia), January 24, 2011:
• THE state government is considering abandoning Victoria's
trouble-plagued $360 million health technology program,
• … The HealthSMART program - five years late and $35
million over budget - is supposed to link computer systems
in hospitals and introduce processes such as electronic
prescribing.
• But clinical applications are only partially running in just
four hospitals, and doctors say patient safety is
compromised by inadequate procedures that causes them
to duplicate paperwork, chase test results and compete
for access to computer terminals.
For more details see: http://www.systemswiki.org/index.php?title=An_Overview_of_Health_Information_Technology_and_Health_Informatics
34
Disasters: United Kingdom
The UK National Program for Health IT (NPfIT)
Conceived in 1998 to bring:
• Lifelong electronic health records for every person in the
country.
• Round-the-clock on-line access to patient records and
information about best clinical practice, for all NHS clinicians.
• Genuinely seamless care for patients through GPs, hospitals
and community services sharing information across the NHS
information highway.
• Fast and convenient public access to information and care
through on-line information services and telemedicine
• The effective use of NHS resources by providing health
planners and managers with the information they need.
35
Disasters: United Kingdom (some
headlines)
• U.K. Scrapping National Health IT Network
after $18.7 billion in wasted expenditure
• NPfIT stunted NHS IT market
• Rotherham: NPfIT has put us back 10 yrs
• NPfIT failures have left NHS IT “stuck”
• NPfIT ‘pushed the NHS into disarray’
• So good, they abolished it twice
36
first reason for the NPfIT disaster: lack
of patient privacy safeguards
Two Big Brother Awards
– 2000 The NHS Executive—award for Most
Heinous Government Organisation
– 2004 NFPIT - award for Most Appalling
Project because of its plans to computerise
patient records without putting in place
adequate privacy safeguards.
37
38
second reason for disaster: lack of
working standards
over-optimism on the part of Tony Blair and
others as concerns the quality of available
standards. “If we use international standards,
sanctioned by ISO, what, after all, can go
wrong?”
39
Evidence to UK House of Commons
Select Committee on Health in 2007:
from Richard Granger (Head of NPfIT program):
• “there was some mythology in the Health Informatics
Community that the standards existed, HL7 was
mature, and so forth. That was completely untrue.”
from UK Computing Research Committee:
• “many of the technologies are new and have not been
tested.
• Of the two standards at the heart of the EPR – HL7 v3
and SNOMED-CT – “neither has ever been
implemented anywhere on a large scale on their own,
let alone together. Both have been criticized as
seriously flawed.”
40
Why national eHealth programs need dead philosophers:
Wittgensteinian reflections on policymakers' reluctance to learn from
history.
41
The Milbank Quarterly: Multidisciplinary Journal of Population Health and Health Policy, 2011, 89(4), 533-63
Why national eHealth programs need
dead philosophers
Findings
National eHealth programs unfold as they do partly
because no one fully understands what is going on.
They fail when this lack of understanding becomes
critical to the programs’ mission.
View NPfiT as an “n of 1” case study
But those in charge of national eHealth programs
appear reluctant to learn from such studies.
42
Components
patient
PAYER
Secondary
users
portal
Allied
health
other
provider
HILS
Imaging lab
PAS
DSS
UPDATE
QUERY
Enterprise
Msg gateway
Patient
Record
EHR
Online
Demographic
registries
Interactions DS
Local
modelling
Online drug,
Interactions DB
4.43
Clinical
models
Multimedia
genetics
LAB
workflow
realtime
gateway
demographics
Clinical
ref data
Path lab
notifications
Comprehensive Basic
identity
ECG etc
billing
terms
guidelines
protocols
Online
terminology
Online
archetypes
telemedicine
The problem
The content of EHR systems (and of terminology
standards such as SNOMED) develops too slowly to
meet the needs of clinical researchers
1. They are functionally outdated
2. They do not allow vital distinctions to be made
(for example between disease and diagnosis)
3. They are run by large committees / business
managers
45
The Buffalo solution
• To find out what it takes to capture the reality on
the side of the patient in a rigorous and effective
way
• We will try to work out what is needed to bring
about a radical overhaul of these systems,
including creation of rigorous and up-to-date
ontologies for specific disease domains
• which we will violently test in real-world
scenarios until we know they work
•
46
Ethical conclusion
Meaningful use regulations will certainly push
things forward; they will give rise, in the short
term, to much that is good.
The question is, whether they will create a path
for the longer term future that will bring lasting
value for the wider public.
47
END
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