The document discusses the transition from the temporary EHR certification program to the permanent certification program. The temporary program utilized ONC-ATCBs for both testing and certification, while the permanent program separates these functions with accredited testing labs (ONC-ATLs) and certification bodies (ONC-ACBs). It also provides timelines and requirements for the new structure to be fully implemented in 2012.

1. EHR Certification Programs
February 2012
Carol A. Bean
Doug Fridsma
Steve Posnack
Office of the National Coordinator for Health IT

2. BACKGROUND & CONTEXT
2

3. Outline
 Topics
 Background Information & Context
 Temporary Certification Program (TCP)
 Permanent Certification Program (PCP)
 ONC-Approved Test Procedures
 Speakers
 Carol Bean, Director of Certification Division
 Doug Fridsma, Director of Office of Standards &
Interoperability
 Steve Posnack, Director of Federal Policy Division
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4. Telling the HITECH Story – What, Why, and How?
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5. How do we achieve interoperable
healthcare information systems?
Enable Curate a
stakeholders to portfolio of
come up with standards, servic
simple, shared es, and policies
solutions to that accelerate
common information
information Team exchange
Accuracy &
exchange Compliance convened to
challenges solve problem
Solutions
& Usability
Enforce compliance with
validated information exchange
standards, services and policies
to assure interoperability
between validated systems

6. How do we achieve interoperable
healthcare information systems?
Example Patient Scenario
• A primary care doctor orders a lab test
and gets the test back from the lab. She
schedules the patient to be seen in the
office to discuss the results.
• Based on the results of the test, the
primary care doctor decides to send the
patient to a subspecialist. She sends a
summary of care record to the
subspecialist electronically with a
summary of the most recent visit.
• When the patient sees the subspecialist, it
becomes apparent that there is a missing
test that was done at a different hospital
that would be helpful in taking care of the
patient. Rather than repeating the
test, the doctor queries the outside
hospital for the lab test that she needs.

7. Interoperability: transport is necessary,
but not sufficient
Vocabulary & How should well-defined values be coded so that
Code Sets they are universally understood?
Content How should the message be formatted so that it
Structure is computable?
NwHIN Direct
and NwHIN
Transport How does the message move from A to B? Exchange
focus at these
levels
How do we ensure that messages are secure and
Security
private?
How do health information exchange
Services
participants find each other?
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8. Health Information Exchange
Turns A Corner
We have made huge strides in Stage 1, making certain that every certified EHR
can produce the standardized content that is the foundation for exchange and for
reporting quality measures and lab results.
The Nationwide Health Information Network (NwHIN) Direct Exchange Project
provides a simple, secure, standardized way to send encrypted health information
to trusted recipients over the Internet, enabling providers to meet Stage 1
Meaningful Use exchange requirements.
 To support better care coordination and advanced care processes, standards
development is focusing on NwHIN. Exchange requirements will become more
rigorous in Stage 2 of Meaningful Use.
Protecting the Privacy and Security of Personal Health Information is paramount
to advancing Health Information Exchange.
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9. The Nationwide Health Information Network
 The NwHIN is the portfolio of standards, services and polices that enable secure
health information exchange over the Internet.
 This portfolio of tools consists of modular “building blocks” that enable users to
tailor their NwHIN-based information exchange to their individual needs.
 In the next year, ONC will work with the communities to develop implementation
SOLUTIONS that describe how these building blocks work together to solve real-
world problems.
 Developing this portfolio is an ongoing endeavor, as new technologies, uses and
users will continue to emerge. ONC will continue to support these efforts to
support interoperable, standards-based health information exchange.

10. The Nationwide Health Information Network
 ONC has developed standards and specifications for Directed Exchange (secure
email) and Query-Based Exchange (web services.)
 The NwHIN Exchange Coordinating Committee is developing a business and
transition plan to guide the Exchange to a sustainable, scalable and efficient
public-private model.
 ONC is committed to supporting all forms of interoperable health information
exchange.
 Interoperability is not “one size fits all,” so we expect that multiple forms of health
information exchange will occur simultaneously. (Direct-based, web services-
based, etc.)

11. The Nationwide Health Information Network
CURATING
A portfolio of
services, standards and policies
that enable secure health
information exchange over the
Internet.
11

12. ONC EHR Certification Programs
The Division of Certification & Testing was established
Establishment to develop and oversee national programs for
certification of Health IT as required by HITECH
Providers and patients must be confident that the
electronic HIT products and systems they use are
secure, can maintain data confidentiality, can work
with other systems to share information, and can
perform a set of well-defined functions
Program Goals
The Certification Programs provide a defined
process to ensure that EHR technologies meet the
adopted standards, certification criteria, and other
technical requirements to achieve meaningful use of
those records in systems
12

13. How Does All This Work?
Vendors ONC- Certified Eligible EPs/EHs
create EHR ATCBs test EHR Providers collect
products and certify products (EPs) and incentive
that meet the are posted Eligible payments
the products to the CHPL Hospitals from CMS
standards based on (EHs) use
and those certified
certification criteria products in
criteria set a
by ONC meaningful
way
13

14. TEMPORARY CERTIFICATION
PROGRAM (TCP)
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15. TCP Program Achievements
Test
6 ONC-ATCBs
1,700+ procedures
have been
700+ vendors* have been
products* authorized to
have created developed in
have been test and certify
EHR products partnership
certified EHR
with NIST
technology
colleagues
Fostering Providing New Boosting
Competition Resources Business
Competition in the HIT
The CHPL has created a Certification has been a
certification market has
resource for providers to boost to small
offered vendors and
search for certified businesses
developers a wider
products to meet their
selection and has 100% of ONC-ATCBs are
meaningful use
lowered the overall cost small businesses
objectives
of certification.
M ore than 60% of CHPL
vendors are small
businesses
* As of 2/3/12
15

16. Temporary Program Growth
THEN – October 2010 NOW – February 2012
 3 ONC-ATCBs  6 ONC-ATCBs
 36 EHR vendors/developers  706 EHR vendors/developers
 54 certified EHR products  1,704 Certified EHR products
16

17. Meaningful Use Takes Off
Fifty-two percent of office-based physicians intend to take advantage of EHR
incentives.
The percentage of primary care providers who have adopted EHRs in their
practice
has doubled from 20 % to 40 % between 2009 to 2011.
 ONC’s Regional Extension Centers (RECs) have signed up more than 100,000
primary
care providers. This means that roughly one third of the nation’s primary care
providers have committed to meaningfully using EHRs by partnering with their
local
REC. Momentum is building!
Hospital adoption has more than doubled since 2009, increasing from 16 % to 35
%.
Most (85 %) of hospitals intend to attest to Meaningful Use by 2015.
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18. Medicare and Medicaid EHR Incentive
Payments – 100 K in 2012
500,000
400,000
300,000
200,000
Total registered:
100,000 172,972
2012 Goal:
143,637 professionals are
100,000
registered but not yet paid
paid
professional 0
s Total Paid: 29,335
Note: Figures reflect number of unique professionals Source: Number of professionals registered and
who have received a payment from either the Medicare paid are from CMS EHR Incentive Program Data
or Medicaid EHR Incentive Payment Programs. Figures as of 12/31/2011.
may be slightly different than the number of payments
that have been made to eligible professionals by the 18
programs.

19. Medicare or Medicaid EHR Incentive
Payment - Eligible Hospitals
5,000
4,000
3,000
Total registered: 3,077
2,000 1,714 hospitals are
registered but not yet paid
1,000
Total Paid: 1,363
0
Note: Figures reflect number of unique hospitals that have received a
Source: Number of hospitals registered and paid
payment from either the Medicare or Medicaid EHR Incentive Payment
are from CMS EHR Incentive Program Data as of
Programs. Figures are different than the number of payments that
12/31/2011.
have been made to eligible hospitals by the programs because
hospitals can receive payments under both programs.
Office of the National Coordinator for
2/19/2012 19
Health Information Technology

20. TCP Estimations vs. Realizations
Estimated Actual
1-2 ONC-ATCBs 6 ONC-ATCBS
200 certified 1,700+
products certified
products
$1,500,000,000 in $2,500,000,000+ in
Incentive Incentive
Payments** Payments*
*Includes Medicare and Medicaid
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21. CHPL Statistics
CHPL Stats Percent of Products
 1722 Certified EHR Products submitted by ONC-ATCB
Ambulatory Inpatient Total Drummond
CCHIT 32%
Complete 51%
EHR 743 137 880
Modular InfoGard
EHR 416 426 842 SLI ICSA 11%
2% 4%
Total 1159 563 1722
 712 EHR Vendors/Developers
*As of 2/3/2012
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22. Certified HIT and Vendor Trends
1800
1600
1400
1200
1000
800
Total Products
600 Total Vendors
400
200
0
*As of 2/3/2012
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23. CMS EHR Incentive Programs
Thousands of providers are
receiving incentive payments across
the country, totaling more than $2.5
Billion between Medicaid and
Medicare.
Quick Facts
 More than 176,000 active
registrations
 Both Medicare and Medicaid
have paid more than $2.5 Billion
to more than 15,000 providers
 43 states are participating
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24. Program Oversight & Monitoring
Purpose
To provide assurance to the community that the ONC
Certification Programs conducted oversight and
monitoring to evaluate ONC-ATCB operations.
Overall Feedback
 ONC-ATCBs are doing a fantastic job!
 Many ONC-ATCBs are exceeding expectations in how they handle
vendor testing
Areas for Improvement
 Creating a consistent vendor experience across the ONC-ATCBs
 Working to ensure that ONC-ATCBs respond to vendor complaints
in a timely fashion
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25. TCP Program Sunset
ONC issued an update to the Final Rule on November 3, 2011 to delay
the sunset of the TCP, originally scheduled for December 31, 2011. The
sunset will be tied to the effective date of the final rule that ONC intends
to issue in summer 2012.
Upon Sunset of the TCP
ONC-ATCBs are prohibited from
accepting new requests to certify
Complete EHRs or EHR Modules, but
are permitted up to six months after
the sunset date to complete all testing
and certification activities associated
with pending or current requests
received prior to the sunset date
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26. TCP Program Sunset Timeline
Dec. July
2011 2012
TCP (sunset in July)
TCP Wind Down Period
PCP Transition
ONC-AA Announcement ONC-ATLs and ONC-
ACB Announcements
PCP Fully Operational
26

27. TCP vs. PCP
Temporary Both Programs Permanent
Certification Certification
Program  Open application Program
process
 Organizations are
authorized to perform  Separate testing and
 Combined testing
the testing and/or certification
and certification
certification of  Testing Labs are
 Testing & certification
Complete EHRs, EHR accredited by NVLAP
bodies are
Modules, or both  Certification Bodies are
authorized by ONC
 ONC approves test accredited by the ONC-
procedures for use AA, ANSI
 Surveillance &
monitoring
27

28. PERMANENT CERTIFICATION
PROGRAM (PCP)
28

29. PCP Requirements Structure
ONC
Technical
Regulations
Requirements
ISO/IEC 17011
Accreditation
NVLAP Bodies
ANSI
ISO/IEC 17025
NIST 150 ISO/IEC Guide
65
NIST 150-31
ONC- ONC- Certifying
Test Labs ATL ACB Bodies
29

30. PCP Key Facts
Testing and certification
ANSI will be the ONC- activities are
ONC-ATCBs may apply separate, but a single
AA for ONC-ACBs and
NVLAP will accredit to be ONC-ACBs or organization can do
ONC-ATLs or both
ONC-ATLs both functions with a
firewall in place
Gap certification is Stage 2 Meaningful The PCP will be
available for new or Use is expected to be operational on or before
revised criteria implemented in 2013 the summer of 2012
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31. Improvement Plan for the PCP
CHPL Communications Test Procedures
• User interface • Website • MU Stage-2
• Search and filter • Social media recommendations for
• Data download and • Inbox management certification criteria
reporting • Outreach • Increase rigor and
• Education robustness
• New test
tools, procedures, players
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32. ANSI’s Role: ONC-AA
Key Responsibilities
 Maintain conformance with ISO/IEC 17011
 In accrediting certification bodies, verify conformance to, at minimum Guide 65 and ensure
the surveillance approaches used by ONC-ACBs include the use of
consistent, objective, valid and reliable methods
 Verify that ONC-ACBs are performing surveillance in accordance with their respective
annual plans
 Review ONC-ACB surveillance results to determine if the results indicate any substantive
non-conformance by ONC-ACBs with the conditions of their respect accreditations
 Selected every three years through a competitive process
Progress To Date
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33. ONC-ACBs: Certification
Overview
 Accredited by ANSI
 All interested organizations will have
to apply to ONC for ONC-ACB status
 Certify EHR products
Step 1: Step 2:
Note: ONC-ATCBs (authorized under Certification Certification
the Temporary Certification Program) Body receives Body applies to
accreditation ONC for ONC-
will not automatically become ONC- from ONC-AA ACB status
ACBs, as a CB must first be
accredited to be eligible for ONC-ACB
status.
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34. NVLAP: ONC-ATL Accreditor
Key Responsibilities
 Maintain conformance with ISO/IEC 17011
 In accrediting test labs, verify conformance to, at minimum, ISO/IEC 17025, NIST
150, NIST 150-31
 Ensure the approaches used by ONC-ATLs include the use of consistent, objective, valid
and reliable methods
 Verify that ONC-ATLs are performing testing in accordance with their
regulatory, technical, and other applicable requirements
 To determine if the results indicate any substantive non-conformance by ONC-ATLs with
the conditions of their respect accreditations
 Selected every three years through a competitive process
Progress To Date
34

35. ONC-ATLs: Testing
Overview
 Accredited by NVLAP
 All interested organizations will have to apply
to ONC for ONC-ATL status
 Test EHR products
Step 2: Test
Step1: Test
Note: ONC-ATCBs (authorized under Lab applies
Lab receives
to ONC for
the temporary certification program) accreditation
ONC-ATL
will not automatically become ONC- from ONC-AA
status
ATLs, as a TL must first be accredited
to be eligible for ONC-ATL status.
35

36. Testing and Certification
A single organization can be both an ONC-ATL and an ONC-
ACB, serving as a “one-stop-shop” for testing and certification
A firewall must exist between the Testing and Certification branches of
the organization
ONC-ATL ONC-ACB
Performs testing Certifies tested
against Criteria products
36

37. ONC-APPROVED
TEST PROCEDURES
37

38. ONC Test Procedures
Test Procedures Process
The process below highlights how test procedures are developed.
Public comment is an important part of the process.
NPRM
includes initial NPRM Public
Comment Errata (if Final Test
set of test necessary) Final Rule Procedures
Period
procedures
Other Helpful Information:
 Meaningful Use and Test Procedures are separate, but related
 The Notice of Public Rulemaking for Meaningful Use Stage 2 and the EHR Incentive
Rule and Standards and Implementation Guidance and Certification Rule is
scheduled for spring 2012
 The Final Rule for both of these is scheduled for summer 2012
 Meaningful Use Stage 2 is scheduled to be implemented in 2013
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39. Test Procedure Consideration Process
To submit a test procedure for ONC consideration, complete the following
requirements:
 Identify the developer
 Specify the certification criterion/a that it addresses
 Explain how it would evaluate a Complete EHR’s or EHR Module’s compliance
with the applicable certification criterion/a
 Provide information describing the process used to develop it
 Demonstrate that it is clearly traceable to a certification criterion/a adopted by
the HHS Secretary
 Describe the public comment process used during the development of the test
tool and/or test procedure (including any opportunity for the public to comment
on the test tool and/or procedure and the degree to which public comments were
considered)
 Be sufficiently comprehensive to assess all required capabilities
 Guarantee provision of training, as required by ONC for the ONC-ATCBs and/or
ATLs
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40. A Track Record of Success
 More than 1,700 electronic health record
products from more than 700 vendors have
been certified
 CMS has paid more than $2.5 billion in
incentives to tens of thousands of providers
that “meaningfully used” certified EHR
technology
 Driving economic growth--100% of ATCBs
and 60% of vendors are small business
40

41. Come Stop by ONC’s Booth!
Learn more about the ONC Certification
Program by visiting the ONC Exhibit Hall booth:
BOOTHS 14624 & 14824
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42. Stay connected, communicate, and collaborate
•Browse the ONC website at: healthIT.gov
click the Facebook “Like” button to add us to your network
•Contact us at: onc.request@hhs.gov
•Subscribe, watch, and share:
 @ONC_HealthIT
 http://www.youtube.com/user/HHSONC
 Health IT and Electronic Health Records
 http://www.scribd.com/HealthIT/
Health IT Buzz Blog
 http://www.flickr.com/photos/healthit

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