Monthly Archives: March 2010

Certification Program Proposed by ONC

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Certification Program Proposed by ONC
Facts-At-Glance, FAQs Posted
The official Notice of Proposed Rulemaking (NPRM) on EHR Certification was posted on March 2, 2010 by the Office of National Coordinator for Health IT, in addition to the release of Letter #10 from National Coordinator David Blumenthal on the same subject.

ONC Page on EHR Certification Programs

  • Certification NPRM [PDF - 1.14 MB]
    Please note: This PDF file is the version submitted to the Federal Register.  The link will be replaced with an official version once it is published in the Federal Register. Persons with disabilities having problems accessing the above pdf file may call 202-690-7151 for assistance.
  • Facts-at-a-Glance
  • Frequently Asked Questions
  • Blumenthal’s Letter #10 on Certification

    • Facts-at-a-Glance
    excerpted from ONC site on Mar 2, 2010 

    • Section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, requires the National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, to keep or recognize a program or programs for the voluntary certification of health information technology (health IT)as being in compliance with applicable certification criteria.
    • Certification of EHR Technology will provide assurance to purchasers and other users of health IT that an EHR system offers the necessary technological capability, functionality, and security to meet meaningful use criteria.
    • Under this authority the Office of the National Coordinator for Health Information Technology (ONC) has issued a Notice of Proposed Rulemaking (NPRM) proposing the establishment of two certification programs for the purposes of testing and certifying health IT, one temporary and one permanent.
    • As required by statute, ONC has consulted with NIST on all aspects of developing the proposed certification programs, and will continue to consult and collaborate with NIST during the implementation and operational phases of both temporary and certification programs.  NIST is developing a test method and infrastructure that will be used by testing laboratories in the testing component of both certification programs.
    • Certified EHR technology is a requirement for providers to receive incentive payments for the adoption and meaningful use of EHRs under the Medicare & Medicaid Incentives Program. The development of these programs is also authorized by the HITECH Act and a separate proposed regulation has been published that outlines provisions governing the program.  The proposed rule may be viewed at http://edocket.access.gpo.gov/2010/E9-31217.htm.
    • An initial set of standards, implementation specifications, and certification criteria for Complete EHRs and EHR Modules was also published in a related Interim Final Rule. This rule may be viewed at http://edocket.access.gpo.gov/2010/E9-31216.htm.
    • The first proposal within the NPRM would establish a temporary certification program whereby the National Coordinator would authorize organizations to test and certify Complete EHRs and/or EHR Modules, thereby assuring the availability of Certified EHR Technology prior to the reporting period in which health care providers may seek the incentive payments available under the Medicare and Medicaid EHR Incentives Program demonstrating meaningful use of Certified EHR Technology. 
    • The second proposal within the Certification Programs NPRM would establish a permanent certification program to replace the temporary certification program.  The permanent certification program would separate the responsibilities for performing testing and certification, introduce accreditation requirements, establish requirements for certification bodies authorized by the National Coordinator to related to the surveillance of Certified EHR Technology, and would include the potential for certification bodies authorized by the National Coordinator to certify other types of health besides Complete EHRs and EHR Modules.
    • The temporary program would end once the permanent certification program is established and at least one certification body has been authorized by the National Coordinator.
    • The public comment period for the temporary certification program will be open for 30 days after publication. The public comment period for the permanent certification program will be open for 60 days after publication.   
    • While two certification programs are described in this proposed rule, ONC anticipates issuing separate final rules for each of the programs.
    • To inform the rulemaking processes, ONC received recommendations from the HIT Policy Committee (a Federal Advisory Committee), and input from technical subject matter experts, health care providers, and other stakeholders.                                                        

      FAQs as posted on ONC site 2010/03/02

    Blumenthal Letter #10: Proposed Rule for the Establishment of Certification Programs for Health IT

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    Blumenthal Letter #10:
    Proposed Rule for the Establishment of Certification Programs for Health Information Technology

    Dr. David Blumenthal


    Message  from Dr. David Blumenthal, National Coordinator for Health Information Technology
    March 2, 2010      (emailed message) 

    Today the Secretary of the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (NPRM) outlining the proposed approach for establishing a certification program to test and certify electronic health records (EHRs). The HITECH Act mandates the development of a certification program which will give purchasers and users of EHR technology assurances that the technology and products have the necessary functionality and security to help meet meaningful use criteria. While we are making significant strides toward modernizing our health care system, these efforts will only succeed if providers and patients are confident that their health information systems are safe and functional. 

    The proposed rule incorporates two phases of development for the certification program to ensure that eligible professionals and eligible hospitals are able to adopt and implement Certified EHR Technology in time to qualify for meaningful use incentive payments. The rulemaking process will take time, so this phased approach provides a bridge  to detailed guidelines to support an ongoing program of testing and certification of health IT. 

    The first proposed program creates a temporary certification process under which the National Coordinator would authorize organizations to assume many of the responsibilities that will eventually be fulfilled under the permanent certification program. For the permanent certification program, the rule proposes transitioning much of the responsibility for testing and certification to organizations in the private sector. 

    Publication of the proposed rule on the Establishment of Certification Programs for Health Information Technology is an important first step in bringing structure and cohesion to the evaluation of EHRs, EHR modules, and potentially other types of health IT.  The programs will help support end users of certified products, and ultimately serve the interests of each patient by ensuring that their information is securely managed and available where and when it is needed. 

    Your input is essential to bringing this important process to fruition.  We encourage your participation in the open public comment period.  

    Additional information on both of these programs and how you can comment can be found through the HHS news release issued today and at the http://HealthIT.HHS.Gov website. 

    The vision of the HITECH Act is unfolding rapidly, and all of us at ONC look forward to continuing to work with you to achieve the meaningful use of EHRs. 

    Sincerely,
    David Blumenthal, M.D., M.P.P.
    National Coordinator for Health Information Technology
    U.S. Department of Health & Human Services 

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    ONC Listening Session at HIMSS10–Tue, Mar 2; follows ONC Town Hall

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    Tomorrow’s Technology Challenges — Listening Session by ONC
    Tuesday, March 2, 4:00 pm
    Office of National Coordinator (ONC) will host a  listening session at HIMSS10 Atlanta on Tuesday afternoon, March 2 from 4:00 pm to 5:00 pm. Session will be moderated by ONC Chief Scientific Officer Charles Friedman, who until recently was the ONC Deputy Director, and Wil Yu from the Office of Chief Scientist. Meeting will be held in Georgia Ballroom 3 in Building C of the Georgia World Congress Center.  This follows the ONC Town Hall

    ONC Town Hall @HIMSS10: Implementing HITECH :
    Next Steps to Adoption and Meaningful Use of Health IT
    Tuesday, March 2, 2:15 am
    2:15 pm to 3:45 pm: Georgia Ballroom 3 in Building C of GWCC
    Moderator: Farzad Mostashari, Senior Advisor to National Coordinator
    Panel:    
    –Charles Friedman, PhD, Chief Scientific Officer
    –Chris Muir, Senior Program Analyst
    –Ned Ellington, Program Manager, Health IT Research Center
    –Doug Fridsma, MD, Acting Director, Office of Standards & Interoperability
    –Jodi Daniel, DIrector, Office of Policy and Planning

    ONC‘s Listing of their events at HIMSS10

    ONC to Announce NHIN Direct at HIMSS

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    ONC to Announce NHIN, Demonstrate Communities CONNECTing to NHIN
    These announcements about events at HIMSS10 Atlanta were posted on ONC Health IT BUzz Blog on March 1, 2010.
    “NHIN Direct will be announced at HIMSS. Be sure to attend the Education Session ‘Nationwide Health Information Network – 2010′ on Wednesday, March 3 at 1pm in Georgia Ballroom 3. Doug Fridsma, Acting Director, Office of Standards and Interoperating will unveil an expanded and new vision for NHIN. Also, we have a brief presentation in the Interoperability Showcase Tuesday at 11:30 and others in showcase that would also be of interest.”

    ONC at HIMSS: Communities CONNECTing to the NHIN
    “This week, the Office of the National Coordinator for Health IT (ONC) is sponsoring a series of demonstrations at the HIMSS Interoperability Showcase that illustrate innovative efforts to achieve progress toward secure, nationwide health information exchange across providers and jurisdictions.

    “The ONC and the Federal Health Architecture (FHA) showcase will feature 25 demonstrations that involve 42 organizations. These organizations illustrate broad uses of the Nationwide Health Information Network (NHIN), a set of standards, services, and policies that enable the secure exchange of health information over the internet.  The demonstrations also highlight the use of CONNECT, an open source NHIN gateway that was developed by the FHA program for organizations wanting to securely exchange health information using NHIN constructs.  Demonstrations are grouped into four areas that align with key health outcome policy priorities:

    • Improving Quality, Safety, Efficiency and Reducing Health Disparities
    • Improving Care Coordination
    • Engaging Patients and Families in their Health Care
    • Improving Population and Public Health

    “Examples of demonstrations include:

    • Enhancing Wounded Warrior Care — a demo supported by the Department of Defense, the Veteran’s Health Administration and Kaiser Permanente. The organizations illustrate how data exchange using the NHIN can support continuity of care for wounded warriors.
    • Supporting Midwestern Grandparents on Vacation — a demo supported by three health information exchanges (HIEs):   HealthBridge (a large urban Cincinnati HIE), Thayer County Health Services (a southeast Nebraska community HIE), and Redwood MedNet (a rural California HIE). Together, the HIEs exhibit how they’ve used the CONNECT toolkit to enable the exchange of electronic medication and diagnostic health data for grandparents from Nebraska as they travel across the country to visit their grandchildren in Ohio and California.

    “The ONC-FHA showcase will also feature 32 mini educational presentations about the demonstration programs and related topics.  Please join us!”

    ONC at HIMSS10 in Atlanta: Posts Schedule

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    ONC at HIMSS10 Atlanta: Health IT Buzz Blog
    On February 27, 2010, ONC posted  schedule on its Health IT Buzz Blog of where their people would be participating at the HIMSS10 Annual Meeting in Atlanta from February 28 to March 3. This is excerpted from the blog.

    “Health IT professionals from around the country will be convening in Atlanta at the beginning of March for the Healthcare Information and Management Systems Society’s (HIMSS) Annual Conference. HIMSS will provide a unique opportunity for ONC to speak to, learn from and interact with 27,000 leaders in the health IT field. This year’s theme — change is everywhere, opportunity is here — aptly sets the tone for ONC’s participation and related presentations that will highlight the administration’s efforts to support the adoption of health IT and the promotion of secure, nationwide health information exchange. Here are some of the events we will be participating in at the conference:

    “ONC hopes to engage a diverse range of health IT stakeholders in dialogue and discuss the work that needs to be done over the coming year to transform our healthcare system through the use of IT.”