Final Rule on Meaningful Use, Certification, Standards Announced

Posted on July 13, 2010 by Mike Squires

SECRETARY SEBELIUS ANNOUNCES FINAL RULES TO SUPPORT MEANINGFUL USE OF ELECTRONIC HEALTH RECORDS
July 13, 2010 Press Release from Centers for Medicare and Medicaid Services
Plus PDFs of Final Rules, Joint ONC/CMS Fact Sheet,
ONC and CMS Fact Sheets and FAQs
Blumenthal article from NEJM with Summary Matrix
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KEY LINKS:
Summary of
The “Meaningful Use” Regulation for Electronic Health Records
By David Blumenthal, MD, MPP, National Coordinator for Health IT
and Marilyn Tavenner, RN, MHA, Principal Deputy Administrator of CMS
New England Journal of Medicine, July 13, 2010
Includes matrix with Summary Overview of Meaningful Use Objectives
HTML Version PDF Version

Finding My Way to Electronic Health Records
By Regina Benjamin, MD, MBA, Surgeonn General, US Public Health Service
New England Journal of Medicine, July 13, 2010
HTML Version PDF Version

FINAL RULES
Medicare and Medicaid Programs;
Electronic Health Record Incentive Program [PDF]
http://www.ofr.gov/OFRUpload/OFRData/2010-17207_PI.pdf

Health Information Technology:
Initial Set of Standards, Implementation Specifications,
and Certification Criteria
for Electronic Health Record Technology [PDF]
http://www.ofr.gov/OFRUpload/OFRData/2010-17210_PI.pdf
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July 13, 2010 Press Release from CMS:
WASHINGTON – U.S. Department of Health and Human Services Secretary Kathleen Sebelius today announced final rules to help improve Americans’ health, increase safety and reduce health care costs through expanded use of electronic health records (EHR).

HHS Secretary Kathleen Sebelius

“For years, health policy leaders on both sides of the aisle have urged adoption of electronic health records throughout our health care system to improve quality of care and ultimately lower costs,” Secretary Sebelius said. “Today, with the leadership of the President and the Congress, we are making that goal a reality.”

Under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, eligible health care professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt certified EHR technology and use it to achieve specified objectives. One of the two regulations announced today defines the “meaningful use” objectives that providers must meet to qualify for the bonus payments, and the other regulation identifies the technical capabilities required for certified EHR technology.

Announcement of today’s regulations marks the completion of multiple steps laying the groundwork for the incentive payments program. With “meaningful use” definitions in place, EHR system vendors can ensure that their systems deliver the required capabilities, providers can be assured that the system they acquire will support achievement of “meaningful use” objectives, and a concentrated five-year national initiative to adopt and use electronic records in health care can begin.

“This is a turning point for electronic health records in America , and for improved quality and effectiveness in health care,” said David Blumenthal, M.D., National Coordinator for Health Information Technology. “In delivering on the goals that Congress called for, we have sought to provide the leadership and coordination that are essential for a large, technology-based enterprise. At the same time, we have sought and received extensive input from the health care community, and we have drawn on their experience and wisdom to produce objectives that are both ambitious and achievable.”

Two companion final rules were announced today. One regulation, issued by the Centers for Medicare & Medicaid Services (CMS), defines the minimum requirements that providers must meet through their use of certified EHR technology in order to qualify for the payments. The other rule, issued by the Office of the National Coordinator for Health Information Technology (ONC), identifies the standards and certification criteria for the certification of EHR technology, so eligible professionals and hospitals may be assured that the systems they adopt are capable of performing the required functions.

As much as $27 billion may be expended in incentive payments over ten years. Eligible professionals may receive as much as $44,000 under Medicare and $63,750 under Medicaid, and hospitals may receive millions of dollars for implementation and meaningful use of certified EHRs under both Medicare and Medicaid.

The CMS rule announced today makes final a proposed rule issued on Jan, 13, 2010. The final rule includes modifications that address stakeholder concerns while retaining the intent and structure of the incentive programs. In particular, while the proposed rule called on eligible professionals to meet 25 requirements (23 for hospitals) in their use of EHRs, the final rules divides the requirements into a “core” group of requirements that must be met, plus an additional “menu” of procedures from which providers may choose. This “two track” approach ensures that the most basic elements of meaningful EHR use will be met by all providers qualifying for incentive payments, while at the same time allowing latitude in other areas to reflect providers’ needs and their individual path to full EHR use.

“CMS received more than 2,000 comments on our proposed rule,” said Marilyn Tavenner, Principal Deputy Administrator of CMS. “Many comments were from those who will be most immediately affected by EHR technology – health care providers and patients. We carefully considered every comment and the final meaningful use rules incorporate changes that are designed to make the requirements achievable while meeting the goals of the HITECH Act.”

Requirements for meaningful use incentive payments will be implemented over a multi-year period, phasing in additional requirements that will raise the bar for performance on IT and quality objectives in later years. The final CMS rule specifies initial criteria that eligible professionals (EPs) and eligible hospitals, including critical access hospitals (CAHs), must meet. The rule also includes the formula for the calculation of the incentive payment amounts; a schedule for payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs, eligible hospitals and CAHs that fail to demonstrate meaningful use of certified EHR technology by 2015; and other program participation requirements.

Key changes in the final CMS rule include:

Greater flexibility with respect to eligible professionals and hospitals in meeting and reporting certain objectives for demonstrating meaningful use. The final rule divides the objectives into a “core” group of required objectives and a “menu set” of procedures from which providers may choose any five to defer in 2011-2012. This gives providers latitude to pick their own path toward full EHR implementation and meaningful use.
An objective of providing condition-specific patient education resources for both EPs and eligible hospitals and the objective of recording advance directives for eligible hospitals, in line with recommendations from the Health Information Technology Policy Committee.
A definition of a hospital-based EP as one who performs substantially all of his or her services in an inpatient hospital setting or emergency room only, which conforms to the Continuing Extension Act of 2010
CAHs within the definition of acute care hospital for the purpose of incentive program eligibility under Medicaid.

CMS’ and ONC’s final rules complement two other recently issued HHS rules. On June 24, 2010, ONC published a final rule establishing a temporary certification program for health information technology. And on July 8, 2010 the Office for Civil Rights announced a proposed rule that would strengthen and expand privacy, security, and enforcement protections under the Health Insurance Portability and Accountability Act of 1996.

As part of this process, HHS is establishing a nationwide network of Regional Extension Centers to assist providers in adopting and using in a meaningful way certified EHR technology.

“Health care is finally making the technology advances that other sectors of our economy began to undertake years ago,” Dr. Blumenthal said. “These changes will be challenging for clinicians and hospitals, but the time has come to act. Adoption and meaningful use of EHRs will help providers deliver better and more effective care, and the benefits for patients and providers alike will grow rapidly over time.”

A CMS/ONC fact sheet on the rules is available at http://www.cms.gov/EHRIncentivePrograms/

Technical fact sheets on CMS’s final rule are available at http://www.cms.gov/EHRIncentivePrograms/

A technical fact sheet on ONC’s standards and certification criteria final rule is available at http://healthit.hhs.gov/standardsandcertification.

RULES:
Medicare and Medicaid Programs; Electronic Health Record Incentive Program [PDF]
http://www.ofr.gov/OFRUpload/OFRData/2010-17207_PI.pdf

Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology [PDF]http://www.ofr.gov/OFRUpload/OFRData/2010-17210_PI.pdf

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ONC: Electronic Health Records and Meaningful Use
Information for Providers
Information for Consumers

Information excerpted from ONC pages on July 13, 2010.
Electronic health records can provide many benefits for providers and their patients:

Complete and accurate information. With electronic health records, providers have the information they need to provide the best possible care.Providers will know more about their patients and their health history before they walk into the examination room.

Better access to information. Electronic health records facilitate greater access to the information providers need to diagnose health problems earlier and improve the health outcomes of their patients. Electronic health records also allow information to be shared more easily among doctors’ offices, hospitals, and across health systems, leading to better coordination of care.

Patient empowerment. Electronic health records will help empower patients to take a more active role in their health and in the health of their families. Patients can receive electronic copies of their medical records and share their health information securely over the Internet with their families.

Currently, most health care providers still use medical record systems based on paper. New government incentives and programs are helping health care providers across the country make the switch to electronic health records.

Why Electronic Health Records?
Electronic health records can improve care by enabling functions that paper medical records cannot deliver:

EHRs can make a patient’s health information available when and where it is needed – too often care has to wait because the chart is in one place and needed in another. EHRs enable clinicians secure access to information needed to support high quality and efficient care
EHRs can bring a patient’s total health information together to support better health care decisions, and more coordinated care
EHRs can support better follow-up information for patients – for example, after a clinical visit or hospital stay, instructions and information for the patient can be effortlessly provided; and reminders for other follow-up care can be sent easily or even automatically to the patient.
EHRs can improve patient and provider convenience – patients can have their prescriptions ordered and ready even before they leave the provider’s office, and insurance claims can be filed immediately from the provider’s office.

Background: Legislation and RegulationsThe Health Information Technology for Economic and Clinical Health (HITECH) Act provides HHS with the authority to establish programs to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT), including electronic health records and private and secure electronic health information exchange.Under HITECH, eligible health care professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt certified EHR technology and use it to achieve specified objectives. Two regulations have been released, one of which defines the “meaningful use” objectives that providers must meet to qualify for the bonus payments, and the other which identifies the technical capabilities required for certified EHR technology.

Incentive Program for Electronic Health Records: Issued by the Centers for Medicare & Medicaid Services (CMS), this final rule defines the minimum requirements that providers must meet through their use of certified EHR technology in order to qualify for the payments.
Standards and Certification Criteria for Electronic Health Records: Issued by the Office of the National Coordinator for Health Information Technology, this rule identifies the standards and certification criteria for the certification of EHR technology, so eligible professionals and hospitals may be assured that the systems they adopt are capable of performing the required functions.

JOINT ONC/CMS FACT SHEET
CMS AND ONC FINAL REGULATIONS DEFINE MEANINGFUL USE AND SET STANDARDS FOR ELECTRONIC HEALTH RECORD INCENTIVE PROGRAM
Excerpted from CMS site on July 13, 2010.
The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) today announced two complementary final rules to implement the electronic health records (EHR) incentive program under the Health Information Technology for Economic and Clinical Health (HITECH) Act.

Enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009, the HITECH Act supports the adoption of electronic health records by providing financial incentives under Medicare and Medicaid to hospitals and eligible professionals who implement and demonstrate “meaningful use” certified EHR technology. The CMS regulations announced today specify the objectives that providers must achieve in payment years 2011 and 2012 to qualify for incentive payments; the ONC regulations specify the technical capabilities that EHR technology must have to be certified and to support providers in achieving the “meaningful use” objectives.

The final CMS rule:

Specifies initial criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet to demonstrate meaningful use and qualify for incentive payments.
Includes both “core” criteria that all providers must meet to qualify for payments, while also allowing provider choice among a “menu set” of additional criteria.
Outlines a phased approach to implement the requirements for demonstrating meaningful use. This approach initially establishes criteria for meaningful use based on currently available technological capabilities and providers’ practice experience. CMS will establish graduated criteria for demonstrating meaningful use through future rulemaking, consistent with anticipated developments in technology and providers’ capabilities.

The CMS rule finalizes a Notice of Proposed Rulemaking published on Jan 13, 2010.

The final ONC rule:

Sets initial standards, implementation specifications, and certification criteria for EHR technology under the incentive program.
Coordinates the standards required of EHR systems with the meaningful use requirements for eligible professionals and hospitals
With these standards in place, providers can be assured that the certified EHR technology they adopt is capable of performing the required functions to comply with CMS’ meaningful use requirements and other administrative requirements of the Medicare and Medicaid EHR incentive programs.

ONC’s standards and certification criteria final rule completes the adoption of an initial set of standards, implementation specifications and certification criteria that was begun with publication of ONC’s on Jan. 13, 2010.

Timetable for Implementation
The HITECH Act states that payments for Medicare providers may begin no sooner than October 2010 for eligible hospitals and January 2011 for EPs. The final rule aligns the Medicare and Medicaid program start dates. Key steps in the implementation timeline include:

ONC began accepting applications from entities that seek approval as an ONC-Authorized Testing and Certification Body (ONC-ATCB) on July 1, 2010.

ONC projects that certified EHR software will be available for purchase by hospitals and eligible professionals by fall, 2010.

Registration by both EPs and eligible hospitals with CMS for the EHR incentive program will begin in January 2011. Registration for both the Medicare and Medicaid incentive programs will occur at one virtual location, managed by CMS.
For the Medicare program, attestations may be made starting in April 2011 for both EPs and eligible hospitals.
Medicare EHR incentive payments will begin in mid May 2011.
States will be initiating their incentive programs on a rolling basis, subject to CMS approval of the State Medicaid HIT plan, which details how each State will implement and oversee its incentive program.

The “Meaningful Use” Model
By focusing on the effective use of EHRs with certain capabilities, the HITECH Act makes clear that the adoption of records is not a goal in itself: it is the use of EHRs to achieve health and efficiency goals that matters. HITECH’s incentives and assistance programs seek to improve the health of Americans and the performance of their health care system through “meaningful use” of EHRs to achieve five health care goals:

To improve the quality, safety, and efficiency of care while reducing disparities;
To engage patients and families in their care;
To promote public and population health;
To improve care coordination; and
To promote the privacy and security of EHRs.

In the context of the EHR incentive programs, “demonstrating meaningful use” is the key to receiving the incentive payments. It means meeting a series of objectives that make use of EHRs’ potential and related to the improvement of quality, efficiency and patient safety in the healthcare system through the use of certified EHR technology.

Coordinated Approach to Support EHR Adoption
CMS’ and ONC’s final rules complement two other rules that were recently issued. On June 24, 2010, ONC published a final rule to establish a temporary certification program for health information technology. And on July 8, 2010, the Office for Civil Rights announced a proposed rule that would strengthen and expand privacy, security, and enforcement protections under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Together the four rules are key components of the regulatory structure needed to administer the EHR incentive program and to meet the goals of the HITECH Act:

The assurance of privacy protections is fundamental to the success of EHR adoption. The refinements and expansions of HIPAA provisions announced July 8 form an important base for EHR acceptance and use.

The temporary certification process published June 24 establishes a process through which organizations can be approved as certifying entities to which vendors may submit their EHR systems for review and certification.
The ONC rule announced today identifies the technical standards which must be met in the certification process, and coordinates those requirements with the meaningful use objectives.
Finally, the CMS rule announced today establishes guidelines and requirements on achieving meaningful use in clinical settings and qualifying for incentive payments based on this meaningful use.

Key Provisions of the Final Rule
CMS’s final meaningful use rule incorporates changes from the proposed rule on meaningful use that are designed to make the requirements more readily achievable while meeting the goals of the HITECH Act. For Stage 1, which begins in 2011, the criteria for meaningful use focus on electronically capturing health information in a coded format, using that information to track key clinical conditions, communicating that information for care coordination purposes, and initiating the reporting of clinical quality measures and public health information.

The final rule reflects significant changes to the proposed rule while retaining the intent and structure of the incentive programs. Key provisions in the final rule include:

For Stage 1, CMS’s proposed rule called on physicians and other eligible professionals to meet 25 objectives (23 for hospitals) in reporting their meaningful use of EHRs. The final rule divides the objectives into a “core” group of required objectives and a “menu set” of procedures from which providers can choose. This “two track” approach ensures that the most basic elements of meaningful EHR use will be met by all providers qualifying for incentive payments, while at the same time allowing latitude in other areas to reflect providers’ varying needs and their individual paths to full EHR use.
In line with recommendations of the Health Information Technology Policy Committee, the final rule includes the objective of providing patient-specific educational resources for both EPs and eligible hospitals and the objective of recording advance directives for eligible hospitals.
With respect to defining hospital-based physicians, the final rule conforms to the Continuing Extension Act of 2010. That law addressed provider concerns about hospital-based providers in ambulatory settings being unable to qualify for incentive payments by defining a hospital-based EP as performing substantially all of his or her services in an inpatient hospital setting or emergency room only.
The rule makes final a proposed rule definition that would make individual payments to eligible hospitals identified by their individual CMS Certification Number. The final rule retains the proposed definition of an eligible hospital because that is most consistent with policy precedents in how Medicare has historically applied the statutory definition of a ”subsection (d)” hospital under other hospital payment regulations.
Under Medicaid, the final rule includes critical access hospitals (CAHs) in the definition of acute care hospital for the purpose of incentive program eligibility.

The final rule’s economic analysis estimates that incentive payments under Medicare and Medicaid EHR programs for 2011 through 2019 will range from $9.7 billion to $27.4 billion.

Development of the Rules
CMS and ONC worked closely to develop the two rules and received input from hundreds of technical subject matters experts, health care providers, consumers, and other key stakeholders. Numerous public meetings to solicit public comment were held by three Federal advisory committees: the National Committee on Vital and Health Statistics (NCVHS), the HIT Policy Committee (HITPC), and the HIT Standards Committee (HITSC). HITSC presented its final recommendations to the National Coordinator in August 2009.

CMS published its proposed rule on Jan. 13, 2010. The agency actively solicited comments on its proposal and received more than 2,000 submissions by the close of the 60-day comment period. These comments, along with the input from advisory groups and outreach activities, were given careful consideration in developing the regulations announced today.
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ELECTRONIC HEALTH RECORDS AT A GLANCE
CMS FACT SHEET With Frequently Asked Questions
Excerpted from CMS site on July 14, 2010.

“Our recovery plan will invest in electronic health records and new technology that will reduce errors, bring down costs, ensure privacy and save lives.”
- President Obama, Address to Joint Session of Congress, February 2009

Background
As promised by the President, the American Recovery and Reinvestment Act of 2009 included under which, according to current estimates, as much as $27 billion over ten years will be expended to support adoption of electronic health records (EHRs). While there has been bipartisan support for EHR adoption for at least half a decade, this is the first substantial commitment of federal resources to support adoption and help providers identify the key functions that will support improved care delivery.

Under the Health Information Technology for Economic and Clinical Health Act (HITECH), federal incentive payments will be available to doctors and hospitals when they adopt EHRs and demonstrate use in ways that can improve quality, safety and effectiveness of care. Eligible professionals can receive as much as $44,000 over a five-year period through Medicare. For Medicaid, eligible professionals can receive as much as $63,750 over six years. Medicaid providers can receive their first year’s incentive payment for adopting, implementing and upgrading certified EHR technology but must demonstrate meaningful use in subsequent years in order to qualify for additional payments.

Since enactment of HITECH in February 2009, the Office of the National Coordinator for Health Information Technology (ONC), the Centers for Medicare & Medicaid Services (CMS) and other HHS agencies have been laying the groundwork for the massive national investment in EHRs:

Creation of Regional Extension Centers (RECs) to support providers in adopting EHRs
Developing workforce training programs
Identifying “Beacon Communities” that lead the way in adoption and use of EHRs
Developing capabilities for information exchange, including building toward a Nationwide Health Information Network
Improving privacy and security provisions of federal law, to bolster protection for electronic records
Creating a process to certify EHR technology, so providers can be assured that the EHR technology they acquire will perform as needed
Identifying standards for certification of products, tied to “meaningful use” of EHRs
Identifying the “meaningful use” objectives that providers must demonstrate to qualify for incentive payments.
Supporting State Medicaid Agencies in the planning and development of their Medicaid EHR Incentive programs with 90/10 matching funds.

Why EHRs?
Electronic health records improve care by enabling functions that paper records cannot deliver:

EHRs can make a patient’s health information available when and where it is needed – it is not locked away in one office or another.
EHRs can bring a patient’s total health information together in one place, and always be current – clinicians need not worry about not knowing the drugs or treatments prescribed by another provider, so care is better coordinated.
EHRs can support better follow-up information for patients – for example, after a clinical visit or hospital stay, instructions and information for the patient can be effortlessly provided; and reminders for other follow-up care can be sent easily or even automatically to the patient.
EHRs can improve patient and provider convenience – patients can have their prescriptions ordered and ready even before they leave the provider’s office, and insurance claims can be filed immediately from the provider’s office.
EHRs can link information with patient computers to point to additional resources – patients can be more informed and involved as EHRs are used to help identify additional web resources.
EHRs don’t just “contain” or transmit information, they also compute with it – for example, a qualified EHR will not merely contain a record of a patient’s medications or allergies, it will also automatically check for problems whenever a new medication is prescribed and alert the clinician to potential conflicts.
EHRs can improve safety through their capacity to bring all of a patient’s information together and automatically identify potential safety issues — providing “decision support” capability to assist clinicians.
EHRs can deliver more information in more directions, while reducing “paperwork” time for providers –for example, EHRs can be programmed for easy or automatic delivery of information that needs to be shared with public health agencies or quality measurement, saving clinician time.
EHRs can improve privacy and security – with proper training and effective policies, electronic records can be more secure than paper.
EHRs can reduce costs through reduced paperwork, improved safety, reduced duplication of testing, and most of all improved health through the delivery of more effective health care.

Why “meaningful use” requirements?
EHRs do not achieve these benefits merely by transferring information from paper form into digital form. EHRs can only deliver their benefits when the information and the EHR are standardized and “structured” in uniform ways, just as ATMs depend on uniformly structured data. Therefore, the “meaningful use” approach requires identification of standards for EHR systems. These are contained in the ONC Standards and Certification regulation announced on July 13, 2010.

Similarly, EHRs cannot achieve their full potential if providers don’t use the functions that deliver the most benefit – for example, exchanging information, and entering orders through the computer so that the “decision support” functions and other automated processes are activated. Therefore, the “meaningful use” approach requires that providers meet specified objectives in the use of EHRs, in order to qualify for the incentive payments. For example: basic information needs to be entered into the qualified EHR so that it exists in the “structured” format; information exchange needs to begin; security checks need to be routinely made; and medical orders need to be made using Computerized Provider Order Entry (CPOE). These requirements begin at lower levels in the first stage of meaningful use, and are expected to be phased in over five years. Some requirements are “core” needs, but providers are also given some choice in meeting additional criteria from a “menu set.”

Identification of the “meaningful use” goals and standards is the keystone to successful national adoption of EHRs. The announcement of final “meaningful use” regulations on July 13, 2010, marks the launch of the Nation’s push for EHR adoption and use.

Looking ahead
What is the timetable for approving the organizations that will certify EHR systems as qualifying for “meaningful use?”

ONC anticipates that the first entities will be authorized as ONC-ATCBs before the end of summer.

How soon can we expect certified EHR systems to be available?

We anticipate that certified EHR systems will be available later in the fall.

How will be the CMS EHR incentive program registration process work?

Medicare: Hospitals and eligible professionals can register for the program starting in January 2011. Once the programs begin, a link on the Registration web page on http://cms.gov/EHRIncentivePrograms/ will be available. Providers can use this central website to get information about the program and link to the programs’ online registration system.
Medicaid: The registration process will be the same for the Medicaid Incentive Program as for Medicare. A link on the Registration web page on http://cms.gov/EHrIncentivePrograms/ will be available when the program begins. Eligible Providers under the Medicaid Incentive Program can register at this site whether or not their state has initiated their program yet and CMS will pass their information on the state once the state initiates their program.

How will providers demonstrate that they have achieved the “meaningful use” objectives required by the regulation?

For 2011, CMS will accept provider attestations for demonstration of all the meaningful use measures, including clinical quality measures. Starting in 2012, CMS will continue attestation for most of the meaningful use objectives but plans to initiate the electronic submission of the clinical quality measures. States will also support attestation initially and then subsequent electronic submission of clinical quality measures for Medicaid providers’ demonstration of meaningful use.

How and when will incentive payments be made?

CMS expects to initiate Medicare incentive payments nine months after the publication of the final rule. For Medicaid, States are determining their own deadlines for launching their Medicaid EHR Incentive programs but are required to make timely payments, per the CMS final rule. CMS expects that the majority of States will have launched their programs by the summer of 2011.

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Standards and Certification Criteria Final Rule:
Fact Sheet
Excerpted from ONC site on July 14, 2010

The Health Information Technology for Economic and Clinical Health (HITECH) Act provides HHS with the authority to establish programs to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT), including electronic health records (EHRs) and private and secure electronic health information exchange.

The HITECH Act directs the Office of the National Coordinator for Health Information Technology (ONC) to support and promote meaningful use of certified EHR technology nationwide through the adoption of standards, implementation specifications, and certification criteria as well as the establishment of certification programs for HIT.

About the Standards and Certification Criteria Final Rule
Two companion regulations were announced today. ONC’s final rule complements a final rule announced by the Centers for Medicare & Medicaid Services (CMS) that defines the minimum requirements that providers must meet through their use of EHRs in order to qualify for payments under the Medicare and Medicaid EHR incentive programs. The ONC rule establishes the required capabilities and related standards and implementation specifications that Certified EHR Technology will need to include to, at a minimum, support the achievement of meaningful use Stage 1 by eligible health care providers under the Medicare and Medicaid EHR Incentive Program regulations.

What Standards and Certification Criteria Mean for Health Care Providers
Both the Medicare and Medicaid EHR incentive programs include a requirement related to certified EHR technology. Under the Medicare EHR incentive program, eligible health care providers may receive incentive payments if they adopt and meaningfully use certified EHR technology (Complete EHR or EHR Modules that have been certified by an Office of the National Coordinator for Health Information Technology-Authorized Testing and Certification Body (ONC-ATCB)). Under the Medicaid EHR incentive program, eligible health care providers may first adopt, implement, or upgrade to certified EHR technology in their first year of the program and receive an incentive payment before having to meaningfully use certified EHR technology. The standards and certification criteria final rule specifies the necessary technological capabilities EHR technology will need to include, for the EHR technology to be certified by an ONC-ATCB. Additionally, it specifies how eligible health care providers will need to use the certified EHR technology to meet applicable meaningful use requirements.

What Standards and Certification Criteria Mean for Developers of EHR Technology
Developers of EHR technology who design their EHR technology in accordance with this final rule and subsequently get their EHR technology tested and certified by an ONC authorized testing and/or certified entity are assured that their EHR technology can be adopted by eligible health care providers who seek to achieve meaningful use Stage 1.For other questions related to the standards and certification criteria, please email onc.request@hhs.gov

Standards and Certification Criteria, visit http://healthit.hhs.gov/standardsandcertification
Medicare and Medicaid EHR incentive programs, visit http://www.cms.gov/EHRIncentivePrograms/

Standards and Certifications Criteria Final Rule:
Frequently Asked Questions
Excerpted from ONC site on July 14, 2010.

A. Background/GeneralKey Messages

Health Care Providers: Key Points
Both the Medicare and Medicaid electronic health record (EHR) incentive programs include a requirement related to certified EHR technology. Under the Medicare EHR incentive program, eligible health care providers must adopt and meaningfully use certified EHR technology (Complete EHR or EHR Modules that have been certified by an Office of the National Coordinator for Health Information Technology-Authorized Testing and Certification Body (ONC-ATCB)). Under the Medicaid EHR incentive program, eligible health care providers may first adopt, implement, or upgrade to certified EHR technology in their first year of the program and receive an incentive payment before having to meaningfully use certified EHR technology. The standards and certification criteria final rule specifies the necessary technological capabilities EHR technology will need to include in order be certified by an ONC-ATCB and subsequently used by eligible health care providers to meet applicable meaningful use requirements.

Developers of EHR Technology: Key Points
Developers of EHR technology who design their EHR technology in accordance with this final rule and subsequently get their EHR technology tested and certified by an ONC-ATCB are assured that their EHR technology can be adopted by eligible health care providers who seek to achieve meaningful use Stage 1.

B. Standards and Certification

B1. What is the standards and certification criteria final rule?
The final rule establishes the required capabilities and related standards and implementation specifications that Certified EHR Technology will need to include to, at a minimum, support the achievement of meaningful use Stage 1 by eligible health care providers under the Medicare and Medicaid EHR Incentive Programs.

B2. What are the major differences between the standards and certification interim final rule and the final rule?
In large part, the final rule is very similar to the interim final rule. However, in response to public comments, the final rule clarifies or revises certain standards and certification criteria. As noted in the final rule, some of the adopted certification criteria were revised to realign with changes to the Medicare and Medicaid EHR Incentive Programs final rule.

B3. What is the difference between a Complete EHR and an EHR Module?
Complete EHR refers to EHR technology that has been developed to meet, at a minimum, all applicable certification criteria adopted by the Secretary. For Complete EHRs designed for an ambulatory setting this means all of the certification criteria adopted at 45 CFR 170.302 and 45 CFR 170.304. For Complete EHRs designed for an inpatient setting this means all of the certification criteria adopted at 45 CFR 170.302 and 45 CFR 170.306. These certification criteria represent the minimum capabilities EHR technology needs to include and have properly implemented in order to achieve certification. They do not preclude Complete EHR developers from including additional capabilities that are not required for the purposes of certification.

EHR Module refers to any service, component, or combination thereof that meets at least one certification criterion adopted by the Secretary. EHR Modules, by definition, must provide a capability that can be tested and certified in accordance with at least one certification criterion adopted by the Secretary. Therefore, if an EHR Module does not provide a capability that can be tested and certified at the present time, it is not HIT that would meet the definition of EHR Module. We stress “at the present time,” because as new certification criteria are adopted by the Secretary, other HIT could be developed and then tested and certified in accordance with the new certification criteria as EHR Modules. An EHR Module could provide a single capability required by one certification criterion or it could provide all capabilities but one, required by the certification criteria for a Complete EHR. In other words, we would call HIT tested and certified to one certification criterion an “EHR Module” and HIT tested and certified to nine certification criteria an “EHR Module,” where ten certification criteria are required for a Complete EHR.

B4. CMS has specified a number of clinical quality measures for meaningful use. What clinical quality measures must EHR technology include in order to be certified?
In order to be certified, a Complete EHR or EHR Module designed for an ambulatory setting must be tested and certified as including at least nine clinical quality measures specified by CMS – all six of the core (three core and three alternate core) clinical quality measures specified, and at least three of the additional measures. Complete EHR and EHR Module developers may include as many clinical quality measures above that requirement as they see fit.A Complete EHR or EHR Module designed for an inpatient setting must include and will be required to be tested and certified to all of the clinical quality measures specified by CMS.

B5. Does EHR technology need to include administrative transactions capabilities?
No, we have removed these capabilities as conditions of certification for EHR technology in support of meaningful use Stage 1, but intend to revisit their inclusion for Stage 2.

C. Certification Process

C1. Where can I find out about the certification process?
For more information on the temporary certification program and the certification process, visit http://healthit.hhs.gov/tempcert.

D. Comments on the Interim Final Rule

D1. Where can I learn about how my comments on the interim final rule on standards and certification criteria, issued in January, were addressed in the final rule?
ONC staff carefully reviewed and considered each of the approximately 400 timely comments received on the standards and certification criteria interim final rule. Section III of the standards and certification criteria final rule discusses how the comments were addressed and incorporated into the final rule.

E. Related Rules

E1. How is this final rule related to the Medicare and Medicaid EHR Incentive Programs final rule?This final rule completes the adoption of an initial set of standards, implementation specifications, and certification criteria, and more closely aligns such standards, implementation specifications, and certification criteria with final meaningful use Stage 1 objectives and measures. Adopted certification criteria establish the required capabilities and specify the related standards and implementation specifications that certified EHR technology will need to include to, at a minimum, support the achievement of meaningful use Stage 1 by eligible professionals, eligible hospitals, and/or critical access hospitals.

HHS Press Briefing Webcast: Meaningful Use, Standards, Certification: July 13 10:00 AM ET

Posted on July 13, 2010 by Mike Squires

July 13, 2010 10:00 AM Live Webcast
“CMS and ONC will host a press briefing (on Tuesday, July 13, 2010 at 10:00 a.m. EDT) to announce the final rules on Meaningful Use and Standards and Certification under the HITECH Act’s Electronic Health Records (EHR) incentive program.”

See the e-Healthcare Marketing post published after the press briefing, with CMS Press Release, Joint ONC/CMS Fact Sheet; andtwo PDFs of new rules covering Meaningful Use, Incentives, Certification, and Standards. The Press briefing is below.

Presenters will include
Kathleen Sebelius
          Secretary, U.S. Department of Health and Human Services
Donald Berwick, M.D
          Administrator, Center for Medicare & Medicaid Services
David Blumenthal, M.D., M.P.P.
          National Coordinator for Health Information Technology
Regina Benjamin, M.D., M.B.A.
          Surgeon General

This video Webcast is also available on YouTube.

Related Links which we expect will be updated later today, July 13, 2010.
ONC Section on Meaningful Use
ONC Section on Standards & Certification
CMS Section on EHR Incentives
CMS Section on Meaningful Use
CMS Section on Certification

‘National Progress Report on eHealth’ Shows Significant Progress in Last 3 Years

Posted on July 4, 2010 by Mike Squires

eHealth Initiative Survey Identifies Challenges with Consumer Outreach and Understanding of Value
eHealth Initiative (eHI) issued the following press release on July 1, 2010.
WASHINGTON, DC – July 1, 2010 -Today, the eHealth Initiative (eHI) released the “National Progress Report on eHealth,” which tracks the progress of eHealth in the wake of the American Recovery and Reinvestment Act of 2009.

National Progress Report on eHealth 2010

The National Progress Report on eHealth includes a review of progress made over the last three years relative to strategies and actions proposed in a 2007 eHI report. Over one hundred individuals participated on committees charged with assessing progress in five focus areas: Aligning Incentives; Engaging Consumers; Improving Population Health; Managing Privacy, Security & Confidentiality; and, Transforming Care Delivery. The report highlights key trends, actions, and strategies that still need to be addressed.

The report reveals a number of high-level findings including:

Significant progress has been made over the last three years as a result of public and private sector initiatives. The American Recovery and Reinvestment Act (ARRA) was the key driver of progress.
Many providers are concerned about the lack of coordination across the government health and health information technology (HIT) initiatives.
More education and outreach to consumers about HIT and health information exchange (HIE) is required.
Knowledge and transparency of privacy and security policies will be the key to building consumer trust of HIT and HIE.

As part of the assessment process, eHI conducted an informal online survey to gauge perceptions of progress. The survey responses offer a snapshot about the eHealth landscape. Some findings include:

The majority of respondents believe significant progress has been made: 61 percent of respondents agree or strongly agree with the statement that significant progress has been made in the successful adoption and use of HIT since 2007.
The value of HIE is not clearly understood by the majority of respondents: 54.9 percent disagree or strongly disagree with the statement that the value of HIE is clearly understood.
The majority of respondents believe outreach to consumers about the value of EHRs and HIE is not effective: 66.6 percent disagree or strongly disagree with the statement that current outreach to consumers about the value of EHRs and HIE is effective.
The majority believe Regional Extension Centers and the National Health Information Technology Research Center (HITRC) will be vital to educating providers: 66.1 percent of respondents agree or strongly agree with the view that Regional Extension Centers and the HITRC will be vital to educating providers about adoption and meaningful use of HIT.

“Contributors to the report found that, while considerable progress has been made over the past three years, challenges remain,” noted Jennifer Covich Bordenick, eHealth Initiative’s Chief Executive Officer. “Coordinating public and private sector efforts, and communicating the true value of HIT and HIE to consumers will be critical as we move forward.”

As part of its work, the eHealth Initiative collected information on dozens of existing and new HIT initiatives occurring across the country. An online version of the current activities is available in the report and online.

The National Progress Report on eHealth was supported by the Commonwealth Fund, a private foundation supporting independent research on health policy reform and a high performance health system.

The report is available on the eHI website at: http://www.ehealthinitiative.org/

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About eHealth Initiative
The eHealth Initiative (eHI) is an independent, non-profit, multi-stakeholder organization whose mission is to drive improvements in the quality, safety, and efficiency of healthcare through information and information technology (IT). eHI is the only organization that represents all of the stakeholders in the healthcare industry. eHI advocates for the use of HIT that is practical, sustainable and addresses stakeholder needs, particularly those of patients. For more information, visit http://www.ehealthinitiative.org/
# # #

Jennifer Lubell, HITS staff writer, reported July 2, 2010 in ModernHealthcare.com on National Progress Report,
“Electronic healthcare initiatives have made headway over the last several years, but health information technology remains an undervalued tool, a new report concludes.”

Toward Enhanced Information Capacities for Health: Achieving the Promise: NCVHS

Posted on June 26, 2010 by Mike Squires

NCVHS Concept Paper Looks How to Achieve the
Promise of Health Reform and Electronic Health Records
The National Committee on Vital and Health Statistics (NCVHS) met June 16-17, 2010 in Washington, DC, and used the NCVHS concept paper “Toward Enhanced Information Capacities for Health” as the basis of discussions for their 6oth Anniversary Symposium of the committee. The paper, issued May 26, 2010, focuses on policies HHS could establish to maximize the benefits that could be acheived through the appropriate use of the tremendous amount of health data that will be generated with Electronic Health Records.

The committee advises the Secretary of HHS on policies toward health data, statistics, privacy, national health information policy, and Administrative Simplication of HIPAA.

NCVHS Concept Paper
“Toward Enhanced Information Capabilities for Health”
PDF FORMAT
The text of the 11-page paper is reproduced in whole below.

EXECUTIVE SUMMARYHealth care reform and federal stimulus legislation have created an unprecedented opportunity to improve health and health care in the United States. The nation’s ability to seize this opportunity will depend greatly on the existence of robust health information capacities. The National Committee on Vital and Health Statistics (NCVHS) is the statutory advisory body on health information policy to the Department of Health and Human Services. On the occasion of the Committee’s 60th anniversary, this concept paper outlines its current thinking about the necessary information capacities and how NCVHS can help the Department guide their development.

We are entering a new chapter in the health and health care of Americans. The expansion of health care coverage, the infusion of new funds and adoption of standards for electronic health records (EHRs), and increased administrative simplification offer us the potential to use the enriched data generated to better address our country’s health and health care challenges. Having better information with which to measure and understand the processes, episodes, and outcomes of care as well as the determinants of health can bring considerable health benefits, not only to individuals but also to the population as a whole.

To be able to achieve the promise of these new developments, we need to be attentive to the underpinnings of the data, ensuring that they are easy to generate and use at the front lines as well as easy to reuse, manipulate, link, and learn from within a mantle of privacy and security. It is important to remember that the new data sources are not necessarily a replacement for traditional sources such as administrative and survey data, which play a key role in our infrastructure. Rather, the new sources present an opportunity to augment and enrich traditional sources. While efficiency may be gained by replacing some survey and administrative data with newer EHR data, we must continue to nourish and sustain the traditional data sources that offer unique and irreplaceable information for both clinical and population health purposes.

National health information capacities must enable not just better clinical care but also population health and the many synergies between the two. More specifically, health information policy should foster improved access to affordable, efficient, quality health care; enhanced clinical care delivery; greater patient safety; empowered and engaged patients and consumers; patient trust in the protection of their health information; continuous improvement in population health and the elimination of health disparities; and support of clinical and health services research. A major priority of health information policy should be to enable the multiple uses of data, drawn from the full range of sources, while minimizing burden. Most sources have primary uses for which they were designed; however, with adequate standardization, privacy protections, and technology, the data from many sources can be used for multiple purposes. Realizing the collective potential of all information sources is what will allow the U.S. to maximize the return on its investments in system reform and health IT for the benefit of all Americans.

As information capacities expand, it is critical that the information be comprehensive, timely, efficiently retrievable, and usable, with full individual privacy protections in place. “Comprehensive” refers to the inclusion not just of traditional health-related data, but also of data on the full array of determinants of health, including community attributes and cultural context. Usability of the data—whether for initial use or reuse―requires a well-coordinated effort to assure the accessibility and availability of information as well as its standardization.

NCVHS will continue to use its consultative and deliberative processes, working collaboratively with other HHS advisory committees, to help the Department meet these opportunities and challenges. Given the rapidity of the changes now under way, we cannot over-emphasize the urgency of this endeavor and the need to move ahead with deliberate speed.

INTRODUCTION

Health care reform and federal stimulus legislation have created an unprecedented opportunity to improve health and health care in the United States. The nation’s ability to seize this opportunity will depend greatly on the existence of robust health information capacities. 1 To maximize the return on these enormous investments and make it possible to evaluate their impact, health information capacities must be carefully developed with an eye to their uses for improving health care and health for all Americans. New investments in EHRs and health information exchanges are important contributors, especially for clinical care, but the benefits from these investments will be limited unless the synergies with other types of health information are recognized and used. Population-level data from vital statistics systems, surveys, and public health surveillance and health care administrative data are equally important information sources. Assuring that all these sources are adequately developed and supported and can be integrated appropriately is essential to developing the information capacities the nation needs.

The National Committee on Vital and Health Statistics, the Department’s statutory advisory body on health information policy, has long assisted the Department in the development of national health information policy, providing thought leadership and expert advice in the areas of population health, privacy, standards, the NHII/NHIN, health care quality, and more. Nearly ten years ago, NCVHS put forward a vision for a national health information infrastructure in its 2001 report, Information for Health,2 followed in 2002 by a vision for 21st century health statistics.3 Today, as data and communication capacities explode and health care coverage expands, new thinking and visioning are needed to clarify the information capacities that will make it possible to meet our national goals for better health and health care for all Americans. On the occasion of the Committee’s 60th anniversary, this concept paper outlines its current thinking about the required capacities and their development.

In 2009, as course-altering legislation was unfolding, NCVHS began to consider how it could assist the Department’s development of the necessary information capacities.4 All four NCVHS subcommittees have contributed to the early thinking on this subject, and all plan further work

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1 We use the term capacities in the sense of the ability to perform or produce. That is, information capacities are understood in relation to specific needs, purposes, and functions of information.
2 NCVHS, Information for Health: A Strategy for Building the National Health Information Infrastructure, November 2001.
3 NCVHS, Shaping a Health Statistics Vision for the 21st Century, November 2002.
4 As part of this process, NCVHS in 2009 commissioned two authors of the 2002 health statistics vision report to help the Committee consolidate and update its recommendations. Their report to the Committee is posted on the NCVHS website. < http://www.ncvhs.hhs.gov/090922p3.pdf >
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in their respective domains, as described below. 5 The Committee has crafted a highly effective process for bringing multiple points of view and areas of expertise to bear as it develops recommendations to the Secretary, and this process is well suited to the work that lies ahead. NCVHS will continue to use its consultative process to create venues for dialog, eliciting input and perspectives from stakeholders and experts regarding critical challenges, potential opportunities, and next steps. It will use this external input and its own broad expertise to help the Department develop health information policies that are commensurate with new opportunities and needs. Given the rapidity of the changes now under way, we cannot over- emphasize the urgency of this endeavor and the need to move ahead with deliberate speed.

INFORMATION CAPACITIES FOR HEALTH AND HEALTH CAREPublic sector involvement in health information has a long history. State, local, and federal agencies have gathered information through vital records, hospital and ambulatory data sets, public health surveillance, population surveys, and other sources to monitor health trends, identify threats, and guide interventions to protect and promote health. Congress initiated a new type of government involvement in 1996 when the Health Information Portability and Accountability Act (HIPAA) recognized the importance of protecting individuals’ health care information while improving the efficiency of health care delivery through standardized electronic administrative transactions. Most recently, the American Recovery and Reinvestment Act of 2009 (ARRA) began another type of intervention, providing financial incentives for health IT adoption in the nation’s hospitals and physician offices as well as funding for infrastructure support.

While much current attention is focused on the ARRA funding of health IT and critical associated tasks such as defining and implementing “meaningful use” of EHRs, a broader perspective is required to take full advantage of evolving opportunities. Widespread use of optimally configured, standardized EHRs will greatly expand the information available on health care services, users, and providers. However, promoting the health and wellness of the population also requires information about those who have not received health care services, among other things, as well as information on other determinants of health beyond traditional health care, including environmental, social, and economic factors.6

In short, national health information capacities must support a broad array of uses and purposes that include improving access to affordable and efficient quality health care, supporting clinicians in delivering care, empowering and engaging patients and consumers in their care,
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5 At present, NCVHS has subcommittees on population health, standards, quality, and privacy/confidentiality/security.
6 See the NCVHS-developed graphic of the determinants of health on page 9 of its report on a vision for 21st century health statistics (see note 3).
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ensuring patient safety, promoting patient trust, eliminating health disparities, monitoring and improving population health, and supporting health services and clinical research. As these capacities are developed, it is critical that the information being collected be comprehensive, timely, efficiently retrievable, and usable, and that individual privacy be protected.

In the Committee’s view, this requires a well-coordinated effort that assures the following:

1. Accessibility and availability of information. The availability of sufficient, timely information from relevant sources must be assured to meet the priority needs of diverse users (including clinicians, consumers, purchasers, payors, researchers, public health officials, regulators, and policymakers) for taking action and evaluating outcomes. To minimize burden, wherever possible data should be collected once, for multiple appropriate uses by authorized users. Where appropriate, the capacity to connect data from multiple sources should be provided.

2. Standardization. Standardization is necessary to enable interoperability for the efficient collection and timely sharing of information among all types of users. Robust standards should be assured through the definition, application, and adoption of terminologies, codes, and messaging in the areas of reimbursement, public health, regulation, statistical use, clinical use, e-prescribing, and clinical documents.

3. Privacy, confidentiality, and security protections. With the increasing adoption of interoperable electronic health records technology, along with the move toward global access to health data and emerging new uses of data, methods of access and information availability raise significant new and unique privacy and security concerns. Appropriate privacy, confidentiality, and security protections; data stewardship; governance; and an understanding of shared responsibility for the proper collection, management, sharing, and use of health data are critical to addressing these concerns.

Each is briefly discussed below.

1. ACCESSIBILITY AND AVAILABILITY OF INFORMATION

In today’s world, the boundaries between health care, population health, and even individual personal health management are permeable, and information exchange is increasingly multi- directional. The domains traditionally called “public health” and “health care” are increasingly intertwined, often sharing broad, common information sources and capacities. For example, promoting the health and wellness of individuals and the population requires attention to health determinants including not only the treatment and prevention of disease and the nature of community health resources but also environmental, housing, educational, nutritional, economic, and other influences. Continuously improving the quality, value, and safety of health care involves, among other things, research and knowledge management, meaningful performance measurement, education and workforce development, and support for personal and family health management. Finally, improving health and health care on a national scale requires monitoring and eliminating health disparities and assessing the health status of all Americans, including vulnerable sub-populations.

A major priority of health information policy should be to facilitate these interconnections and enable the multiple uses of information for current and emerging data needs. With health IT, complemented by the necessary privacy protections and data stewardship and facilitated by well designed standards, data can be combined to create richer information and used to address a broad array of current and emerging health and health care issues. Realizing the collective potential of all information sources is what will allow the U.S. to maximize the return on its investments in system reform and health IT for the benefit of all Americans.

At present, the major sources of data on health are:

       Surveys (interview and examination) and Censuses    Public health surveillance data (e.g., notifiable disease reporting, medical device reporting)        Health care data (EHRs, HIEs, registries, and other such as prescription history, labs, imaging)
      Administrative data (claims, hospital discharge data, vital records)
      Research data (community-based studies, clinical trials, research data repositories)

Another essential set of sources for understanding health is the information on influences on health (including transportation, housing, air and water quality, land use, education, and economic factors) managed by various public and private sector agencies. In addition to all these well-established sources, new ones such as personal health records and computerized personal health monitoring devices are emerging with the potential to contribute to understanding health at individual and population levels. Social networking content has the potential to provide yet another new and novel resource.

Most data sources have primary uses for which they were designed. However, given adequate standardization, privacy protections, and informatics technology, these sources have great potential to be used for multiple purposes. For example, EHR data elements are collected to document and manage clinical care, but also can be used for public health reporting (such as communicable diseases and medication safety) and to evaluate population health and conduct health services research. Surveys are principally for population-level analysis, but survey information also contributes to clinical care. Vital records not only provide information about births and deaths, but also serve as the “bookends” of population health data. Administrative data (ICD-9-CM disease codes and CPT-4/HCPS procedure codes) were initially used for management and reimbursement, but today play a critical role in quality assessment and public health monitoring (e.g., quality and safety indicators and disease prevalence evaluation). As we look to the future, the goal is to leverage all these sources, when appropriate, and expand their utility for understanding personal and population health and their determinants while carefully protecting the confidentiality of the data they contain.

To bring about the needed improvements and efficiencies and draw all possible benefit from the large and growing investment in health IT, the emerging information capacities must enable both more effective and cost-effective clinical services and population health promotion, and their many synergies. This can be facilitated through multi-directional data sharing and linkages to generate information that is comprehensive and broadly representative. It will be critical to break down the silos that now make it difficult to share and connect data. This requires addressing the policy, institutional, technical, and other barriers that contribute to the existing silos. A workforce trained to take advantage of the broader data and informatics capacities is also essential. Detailed local data are needed to enable understanding of health and health care at local neighborhood, community, sub-population, and other levels of aggregation. Key decisions about health and health care are made at the local level, and we envision the potential to meet these needs in ways not previously possible. Finally, a critical use of population health data, especially with the advent of health care reform, is to assess the effectiveness, comparative effectiveness, and equity of health care.

Because resources are limited and burden must be minimized, information policy must set priorities regarding which data are most important in order to target investments in data collection. As noted, burden can be minimized by collecting data once for multiple uses. At least in the near term, provided that data can be put in the hands of trusted stewards, enhanced administrative data may be a powerful component that reduces the burden of multiple collections. As new capacities come on line, it may be possible to curtail or redirect some current collection activities.

An important criterion is that information, whatever its source, must be meaningful to users. Experience has demonstrated that having relevant data and information available does not ensure that it is accessible in a timely manner and useful form to the full range of potential users. Delays may be created by approval processes or regulatory requirements, as well as by the lack of data handling and analysis capacities that could enable a user to pose a question, indentify relevant data sources, and request a report that is understandable and protects the privacy of data sources. Ensuring access to useful information is a critical part of the challenge. An overarching goal of all these endeavors is to assure that data can be converted into information and ultimately into knowledge that can answer the priority questions about personal and population health in the U.S. and enable effective decisions and actions to improve them.

2. STANDARDS FOR INTEROPERABILITY, USABILITY, QUALITY, SAFETY, AND EFFICIENCY

The purposes of health information standards are to ensure the efficient, secure, safe, and effective delivery of high quality health care and population health services; to support the information exchange needs of health care, public health, and research; and to empower consumers to improve their health.

The impending implementation of the next generation of HIPAA standards, the enactment of The Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, and the recent signing of health reform into law are creating an unprecedented convergence of driving forces, foundational components, technology advances and capabilities, and regulatory requirements. Together, these assets can help create a common national pathway toward achieving the vision and policy priorities of a 21st century health system that relies on a strong health information and health information technology foundation. The past five years have seen a remarkable transformation in the adoption and use of standards for electronic exchange of health information. The transformation encompasses privacy and security standards, standards for administrative and financial transactions, the establishment of unique identifiers, and more recently the adoption of standards for codifying, packaging, and transmitting clinical information between and across health care organizations. This rapidly evolving transformation is moving us closer to the ideal of a fully interoperable electronic health information collection and exchange environment that supports all functions and needs of the country’s health and health care ecosystem, as discussed in the previous pages.

Data standards provide a key architectural building block that supports the collection, use, and exchange of health information. Health information standards have been developed and are being adopted and implemented in many different areas. Capturing information in codified format through standard representations such as clinical vocabularies and terminologies, code sets, classification systems, and definitions is a key strategy for achieving semantic interoperability. The inclusion of standardized metadata, which describe characteristics of the data such as provenance, increases the potential for assessing the reliability and validity of the data for aggregation, research, and other uses. Organizing and packaging data through defined electronic message and document standards to be accessed and exchanged via standardized electronic transport mechanisms and protocols achieves access and exchange of health information. The availability and integrity of health information is protected and ensured through the deployment of security standards, thus guaranteeing confidentiality and privacy of protected health information. Finally, the certification of health information technology for Meaningful Use depends on the wise deployment and use of health information standards.

3. PRIVACY, CONFIDENTIALITY, SECURITY

With the move toward the management of health data in electronic form, there is a significant opportunity to enhance health data access, utility in patient care, and important secondary uses. The opportunity is further enhanced through the emergence of new methods to exchange health data, both on a regional and national basis. However, the ability to realize the potential of electronic health data depends greatly on ensuring that uses are appropriate and individuals’ reasonable privacy, confidentiality, and security expectations are met.

Individuals should have the right to understand how their health data may be used, and to provide consent where appropriate. Often, consent is difficult, as not all uses are known at the time the health data are collected. Further, standards do not yet exist to track an individual’s consent as data are exchanged. Although many of the population health uses described in this concept paper involve aggregated or de-identified health data, legitimate concerns exist about group harms and possible re-identification. In addition, the possibility of using health data from emerging information sources, such as personal health record systems, raises unique privacy concerns.

NCVHS has discussed many of these privacy challenges in numerous reports and letters to the Secretary. Most notably, NCVHS published two reports, a Primer on health data stewardship 7 and Recommendations on Privacy and Confidentiality, 2006-2008. Both are available on the NVCHS website.8

Further work is necessary to develop the privacy, confidentiality, and security standards that should apply as these data uses continue to evolve. In addition, work is needed to establish governance structures to provide the proper oversight of entities that exchange and use health data. In essence, governance is the accountability for ensuring that proper data stewardship (as described in the NCVHS Primer cited above) is practiced. To differentiate between governance and data stewardship, data stewardship is focused on the internal practices of the entity that uses health data, whereas governance is focused on the oversight of such entities to ensure that their data stewardship practices are adequate. Such oversight includes initially approving entities that have access to data, ensuring that such entities appropriately use and protect data, and ensuring that entities that misuse data are appropriately sanctioned.

THE WAY FORWARDTaken together, today’s emerging policy opportunities and the nation’s longstanding health challenges create a situation of considerable urgency for the United States. The openness to bold new approaches offered by recent legislation will disappear quickly. Given that the U.S. lags behind most other industrialized countries in the health status of its citizens, we must seize the opportunities to maximize the health benefits and begin to assess whether the huge investments are indeed having the desired impact.

This paper has noted the critical federal role in devising health information policy to support national health goals. Federal leadership is more needed than ever to create the comprehensive approaches that will guide the development of information capacities and coordinate efforts by actors in the public and private sectors. Whatever progress is made in the critical transition to electronic health records, clinical data alone will not suffice; broad information capacities that

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7 An NCVHS Primer: Health Data Stewardship―What, Why, Who, How, December 2009.
8 http://www.ncvhs.hhs.gov
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draw on all the sources and serve all the purposes discussed in this paper will be necessary. This will require shoring up the data resources for public functions such as surveys, safety surveillance, and vital records, along with strategic thinking to determine what capacities will be needed in the future and how to guide their development. Many issues require research and demonstration as part of a prioritized, adequately funded research agenda. In addition, further investments in a trained workforce are needed, to ensure the availability of professionals and leaders who can properly use information resources for analysis and decision-making.

As it develops policies and strategies, the Department has always invited input from experts and stakeholders; and NCVHS has long helped to facilitate this dialogue and distill the key messages and lessons. NCVHS will continue to use its consultative and deliberative processes, working collaboratively with other HHS advisory committees, to help the Department meet the current opportunities and challenges. As noted, all NCVHS subcommittees plan to be involved in this effort; this report is an early installment on subcommittee and full Committee work plans for the coming 18 months or more. NCVHS expects to develop recommendations on a research agenda, which may be the focus of one or more hearings. Each of the subcommittees is identifying the key issues in its domain, to be pursued through workshops, hearings, and internal deliberations as NCVHS develops recommendations for the Secretary. The subcommittees’ preliminary thinking is outlined below.

SUBCOMMITTEE ON QUALITY

Over the next two years, the NCVHS Subcommittee on Quality will focus on supporting the development of meaningful measures, leveraging both existing and emerging data sources (e.g., patient-generated data, remote monitoring, personal health records), and in particular identifying significant opportunities and gaps. Critical to meaningful measurement is the availability of relevant data elements that could be easily captured using certified EHR technology and functionality, among other tools. The Subcommittee on Quality will identify emerging health data needs for a health system where the individual engages in his or her health and health care. As a near-term priority, the Subcommittee will address the data needs of person-centered health and health care, emphasizing coordination and continuity of care across a continuum of services. A longer term goal is to develop a national strategy to leverage clinically rich health data to address important national questions about determinants of health and disease.

SUBCOMMITTEE ON PRIVACY, CONFIDENTIALITY AND SECURITY

The NCVHS Subcommittee on Privacy, Confidentiality and Security will focus its efforts on providing recommendations that support national priorities, in coordination with such groups as the ONC HIT Policy Committee’s Privacy and Security Workgroup. In the next year, the Subcommittee plans to develop recommendations regarding governance as well as a framework for the identification and appropriate management of sensitive data. The Subcommittee will also consider transparency and the role of patient consent. In addition, it will continue to review and make recommendations regarding new privacy, confidentiality, and security regulations; compliance with these regulations; and strategies for effective enforcement.

SUBCOMMITTEE ON STANDARDS

Health care reform legislation now provides a new opportunity to continue the administrative simplification that began under HIPAA―a process in which NCVHS will remain heavily involved. The NCVHS Subcommittee on Standards will continue to meet its responsibilities related to HIPAA; will implement the many administrative simplification responsibilities assigned by the Health Reform Act of 2010; and will meet new requests for recommendations on the use of standards to enhance interoperability of the transmission and semantics of health data as they arise. As we look to the future, several goals stand out with respect to standards. The Subcommittee will seek to ensure a comprehensive framework and roadmap for health information standards that support the national health IT strategic framework, vision and policy priorities; the public health policy agenda; the NCVHS proposed data stewardship framework; a national research agenda that includes comparative effectiveness; and the needs of all data users.

SUBCOMMITTEE ON POPULATION HEALTH

Understanding the population’s health and its determinants relies on multiple data sources, including population surveys, clinical data, administrative data (notably, birth and death records and billing data on use of health services), and public health and environmental reporting systems. At the national level, Federal agencies such as the National Center for Health Statistics are charged with developing methods, assessing validity, and reporting national population health information. As we envision building a comparable capacity for communities and states across America, the quality of information and its timeliness will be central to success. The Subcommittee on Population Health will focus on facilitators and barriers to data linkage at state and local levels as a critical part of health information infrastructure, specifically linking EHR data with existing administrative and local survey data. Fundamental to understanding population health is describing the underlying population, which also comprises those who have not seen a doctor recently or have refused to respond to a survey. The work of the Subcommittee will focus on methods to ensure that linked data sources provide valid health information, including methods to adjust for missing data and methods to protect privacy.

Privacy and Security Tiger Team: Jun 29 Consumer Choice Tech Hearing

Posted on June 21, 2010 by Mike Squires

Consumer Choice Technology Hearing June 29, 2010
Plus Tiger Team Archives
Privacy and Security “Tiger Team” Announces Consumer Choice Technology Hearing
Friday, June 18th, 2010 | Posted Originally on FACA Blog by Deven McGraw and reposted by e-Healthcare Marketing in full.

The HIT Policy Committee (HITPC) invites you to attend the Privacy and Security Tiger Team’s upcoming hearing on consumer choice technology. The Tiger Team is a workgroup which has been assigned the task of analyzing and providing recommendations on privacy and security issues on an expedited basis to the HITPC, and ultimately to the Office of the National Coordinator for Health Information Technology. Many consumers and consumer groups have expressed concern about the ability of patients to control the disclosure of their health information as providers transition to electronic health records and electronic health information exchange. The protection of information related to “sensitive” health conditions such as substance abuse, mental health and sexually transmitted disease is of particular concern. Currently, some state and federal laws require patient consent to share this information. In the paper based exchange, control is maintained either by sharing the record only with patient consent or by redacting certain information from the record prior to sharing. Some experts have said there is no technology to support these consent requirements in an electronic environment. Others have stated that some technology supports these consent requirements.

The purpose of the hearing is to learn more about the capabilities of existing consumer choice technology and the potential for future development in this area. The morning session will focus on consumer choice technology in use today in health information exchange. A user of the technology will speak about their specific implementation of the technology, accompanied by a demonstration. The afternoon session will take a look at consumer choice technologies that are in the development stages for use within health information exchange. These developers have been invited to demonstrate either a prototype of the technology or its current use, and discuss its potential for further development within health information exchange.

After each session, a panel of discussants, along with the members of the Tiger Team, will pose questions to the users and developers about the technological approaches presented. The goal of the panel is to probe the presenters for further information regarding the implementation of the consumer choice solutions and potential for technological development. There will be an opportunity for public testimony both in the morning and the afternoon.

We look forward to learning from the users and developers of these technologies as well as the various stakeholders for electronic health information exchange.

Privacy and Security Tiger Team Hearing Details:
Tuesday, June 29, 2010
8:00 a.m. – 5:15 p.m.

Grand Hyatt Hotel
1000 H Street NW
Washington, DC 20001
Meeting Location: Constitution Ballroom, Constitution Level

Registration Information and Agenda (pdf)
# # #

AGENDA (pdf)
8:15am Opening remarks by Tiger Team co-chairs
–Deven McGraw, Center for Democracy & Technology
–Paul Egerman, Software Entrepreneur
8:15am Opening remarks by David Blumenthal, MD
National Coordinator for Health IT
8:30am Consumer Choice Technology in Use Today — Panel 1
–Intersystems HealthShar
–CMBHS
9:30am Break
9:45am Consumer Choice Technology in Use Today–Panel 2
–E-MD E-Chart
–TBD
10:45am Consumer Choice Technology in Use Panel Discussion
–Deborah Peer, MD
–Melissa Goldstein, JD, MA
–Iona Singureanu
–David Kibbe, MD
11:30am Tiger Team Discussion
12: 15pm Lunch
1:15pm Cutting-edge Consumer Choice Technology–Panel 3
–Tolven Institute
–Private Access
2:15pm Break
2:30pm Cutting-edge Consumer Choice Technoloogy–Panel 4
–DOD/VA VLER
–HIPAAT
3:30pm Cutting-edge Consumer Choice Technology Panel Discussion
–Deborah Peer, MD
–Melissa Goldstein, JD, MA
–Iona Singureanu
–David Kibbe, MD
4:15pm Tiger Team Discussion
5:00pm Public Discussion
5:15pm Adjourn

Privacy and Security Tiger Team Section on ONC site

Tiger Team Meetings Archive
June 15, 2010 Meeting
Agenda [PDF - 36 KB]
Recommendations [PDF 16 KB]
Meeting Audio [MP3 - 24 MB]

June 11, 2010 Meeting
Agenda [PDF - 13 KB]
Point to Point Exchange Risk Levels [PDF - 72 KB]
Meeting Audio [MP3 - 24 MB]

June 10, 2010
Agenda [PDF - 19 KB]
NHIN Policy and Technology Framework [PDF - 124 KB]
Meeting Audio [MP3 - 14 MB]

ONC Rules on Temp EHR Certification: Press Release, FAQs, Overview, Blumenthal Blogs

Posted on June 19, 2010 by Mike Squires

ONC Issues Final Rule to Establish the Temporary Certification Program for Electronic Health Record Technology

HHS Press Release June 18, 2010
The Office of the National Coordinator for Health Information Technology (ONC) today issued a final rule to establish a temporary certification program for electronic health record (EHR) technology. The temporary certification program establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify EHR technology.

Use of “certified EHR technology” is a core requirement for providers who seek to qualify to receive incentive payments under the Medicare and Medicaid Electronic Health Record Incentive Programs provisions authorized in the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH was enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009. The Centers for Medicare & Medicaid Services will soon issue final regulations to implement the EHR incentive programs.

Certification is used to provide assurance and confidence that a product or service will work as expected and will include the capabilities for which it was purchased. EHR technology certification does just that: It assures health care providers that the EHR technology they adopt has been tested and includes the required capabilities they need in order to use the technology in a meaningful way to improve the quality of care provided to their patients.

On March 10, 2010, the U.S. Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (NPRM) entitled Proposed Establishment of Certification Programs for Health Information Technology. The NPRM proposed the establishment of two certification programs for purposes of testing and certifying EHRs —one temporary and one permanent. The temporary certification program final rule issued today will become effective upon publication in the Federal Register. The final rule for the permanent certification program is expected to be published this fall.

“By purchasing certified EHR technology, hospitals and eligible professionals and hospitals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system,” said David Blumenthal, M.D., M.P.P., national coordinator for health information technology. “We hope that all HIT stakeholders view this rule as the federal government’s commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs.”

This final rule is issued under the authority provided to the National Coordinator for Health Information Technology in section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the HITECH Act.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification.

For more information about other HHS Recovery Act Health Information Technology funding and programs, see http://www.hhs.gov/recovery/programs/index.html#Health.

Picture picked up from ONC home page, June 19, 2010.
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Overview: Temporary Certification Program
Excerpted from ONC site June 19, 2010

The Office of the National Coordinator for Health Information Technology (ONC) has established a temporary certification program for health information technology (health IT). The program provides a way for organizations to become authorized by the National Coordinator to test and certify electronic health record (EHR) technology.

Certification assures health care providers that the EHR technology they adopt includes the capabilities they will need to participate in the Medicare and Medicaid EHR incentive programs.

Use of certified EHR technology is a core requirement for health care providers to become “meaningful users” and eligible for payment under Medicare and Medicaid EHR incentive programs.

To become an ONC-Authorized Testing and Certification Body (ONC-ATCB), an organization must submit an application to ONC to demonstrate its competency and ability to test and certify Complete EHRs and/or EHR Modules.

Applicants are required to request, in writing, an application for ONC-ATCB status from the National Coordinator at ATCBapplication@hhs.gov. The application has two parts:

Part I: Provide general identifying and contact information; complete and submit the results of self-audits to all sections of ISO/IEC Guide 65:1996 (Guide 65) and ISO/IEC 17025:2005 (ISO 17025); submit additional documentation related to Guide 65 and ISO 17025; and agree to adhere to the Principles of Proper Conduct for ONC-ATCBs.

Part II: Successfully complete a proficiency examination.

Applicants are required to complete and submit both parts of the application to the National Coordinator for the application to be considered complete. Please review Section III of the final rule for more details about the application and application review processes.

Learn more about the Temporary Certification Program:

CMS MU NPRM

Standards/Certification IFR

For other questions relating to the Temporary Certification Program, email ONC.Certification@hhs.gov.

ONC FACT SHEET ON
HITECH Temporary Certification Program for EHR Technology
Excerpted from ONC site June 19, 2010
The Health Information Technology for Economic and Clinical Health (HITECH) Act provides HHS with the authority to establish programs to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT), including electronic health records (EHRs) and private and secure electronic health information exchange.

The HITECH legislation directs the Office of the National Coordinator for Health Information Technology (ONC) to support and promote meaningful use of certified electronic health record (EHR) technology nationwide through the adoption of standards, implementation specifications, and certification criteria as well as the establishment of certification programs for HIT, such as EHR technology..

About the Temporary Certification Program and ONC-ATCBs
To provide assurance to eligible professionals, eligible hospitals and critical access hospitals (CAHs) that the EHR technology they adopt will assist their achievement of meaningful use, the Department of Health and Human Services (HHS) issued a final rule to establish a temporary certification program for EHR technology on June 18, 2010. The rule outlines how organizations can become ONC-Authorized Testing and Certification Bodies (ONC-ATCBs). Authorized by the National Coordinator, ONC-ATCB are required to test and certify that certain types of her technology (Complete EHRs and EHR Modules) are compliant with the standards, implementation specifications, and certification criteria adopted by the HHS Secretary and meet the definition of “certified EHR technology”.

About the Standards, Implementation Specifications, and Certification Criteria
On January 13, 2010, the Secretary published in the Federal Register an interim final rule that adopted standards, implementation specifications, and certification criteria for HIT. A final rule, which will realign with the Medicare and Medicaid EHR Incentive Programs final rule, is expected to be released in the near future.

What Certification Means for Health Care Providers
EHR technology, certified by an ONC-ATCB must be used in order to qualify for incentive payments. The temporary certification program provides assurance that the EHR technology health care providers adopt is technically capable of supporting their efforts to achieve meaningful use.

What Certification Means for Developers of EHR Technology
The temporary certification program provides a way for developers of EHR technology to have their HIT tested and certified so that it can be subsequently adopted by eligible professionals, eligible hospitals and CAHs who seek to achieve meaningful use.

For other questions related to the Temporary Certification program, please email ONC.Certification@hhs.gov.

• Temporary Certification Program, visit http://healthit.hhs.gov/certification
• Medicare and Medicaid EHR incentive programs, visit http://www.cms.gov/EHRIncentivePrograms/

Frequently Asked Questions:
Temporary Certification Program Final Rule
Excerpted June 19, 2010 from ONC site. Please check ONC site for latest updates.

A. Background/General

Key Messages

Health Care Providers: Key Points
In order to qualify for Medicare and Medicaid EHR incentive payments, providers must use EHR technology that has been certified by an Office of the National Coordinator for Health Information Technology-Authorized Testing and Certification Body (ONC-ATCB, or ATCB). The temporary certification program provides assurances that the EHR technology adopted by health care providers is technically capable of supporting their efforts to achieve meaningful use.

Developers of EHR Technology: Key Points
The temporary certification program provides a way for developers of EHR Technology to have their EHR technology tested and certified so that it can be subsequently adopted by health care providers who seek to achieve meaningful use.

A1. What is the temporary certification program final rule?
The Secretary of Health and Human Services (the Secretary) issued the temporary certification program final rule to establish a process through which organizations may become ONC-ATCBs. An ONC-ATCB is authorized by the National Coordinator to test and certify EHR technology (Complete EHRs and/or EHR Modules).

A2. What is the purpose of the temporary certification program?
The temporary certification program is the first part of ONC’s two-part approach to establish a transparent and objective certification process. The temporary certification program was established to ensure that “Certified EHR Technology” will be available for adoption by health care providers who seek to qualify for the Medicare and Medicaid EHR incentive payments beginning in 2011. ONC-ATCBs will be required to test and certify EHR technology (Complete EHRs and/or EHR Modules) as being in compliance with the standards, implementation specifications, and certification criteria to be adopted by the Secretary in a forthcoming final rule.

A3. When will the temporary certification program end?
The temporary certification program will be in effect until the permanent certification program is in place. We anticipate that certifications issued under the permanent certification program will occur no earlier than January 1, 2012.

A4. How will ONC work with the National Institute of Standards and Technology (NIST) in regard to certification and standards?
ONC will work with NIST to ensure the availability of relevant test methods and other resources for the temporary certification program. ONC will continue to work with NIST in developing the permanent certification program.

B. Application Process
B1. How does an organization become an ONC-ATCB?
An organization must submit an application to the National Coordinator to demonstrate its competency and ability to test and certify EHR technology (Complete EHRs and/or EHR Modules). Once authorized, ONC-ATCBs are required to comply with the principles and conditions applicable to the testing and certification of EHR technology as specified in the temporary certification program final rule.

B2. Can you provide an overview of the application process?
Applicants are required to request, in writing, an application for ONC-ATCB status from the National Coordinator at ATCBapplication@hhs.gov. The application has two parts:

Part II: Successfully complete a proficiency examination.

B3. When will ONC begin accepting applications, and when will applicants be informed if they have received ONC-ATCB status?
The National Coordinator will begin accepting applications on July 1st and any time thereafter while the temporary certification program is operating. Because the final rule is effective immediately, the National Coordinator will review, process, and make determinations regarding submitted applications as soon as possible.

B4. Will ONC limit the number applicants who apply for ONC-ATCB status?
ONC will not restrict the number of applicants who may apply for ONC-ATCB status. Having available more organizations with ONC-ATCB status will give developers of EHR technology more options for testing and certification.

C. Certification Process

C1. I have an EHR technology ready for market. Is there anything I can do to get the technology certified now so that I can start marketing to hospitals and physicians?
Until organizations are authorized by the National Coordinator to perform testing and certification, EHR technology cannot be tested and certified in accordance with the temporary certification program final rule. At this time, no organizations are currently authorized to test and certify EHR technology under the temporary certification program established by HHS, but when organizations attain ONC-ATCB status ONC will make it publicly known and post their names on our website. ONC will work with ATCBs to encourage them to begin certifying EHR technology as soon as possible after they are authorized to do so.

C2. When will ONC-ATCBs be up and running?
ONC-ATCBs are permitted to start testing and certifying EHR technology consistent with the scope of their authorization as soon as it is received. Some ONC-ATCBs may need more time to establish their processes than others; however, we anticipate that ONC-ATCBs would be ready to test and certify EHR technology within a few weeks of attaining their authorization.

C3. How long will it take for an EHR technology to be certified?
This will vary according to the process used by the ONC-ATCB.

C4. What does a developer of EHR technology need to do to get its EHR technology tested and certified?
A developer of EHR technology will need to (1) select an ONC-ATCB that is authorized to test and certify its EHR technology (Complete EHR or EHR Module), and (2) demonstrate in accordance with the ONC-ATCB’s processes that the EHR technology provides the capabilities required by all applicable certification criteria adopted by the Secretary.

C5. Where can I find out information about EHR technology that has been certified?
ONC will maintain on its website a Certified HIT Products List (CHPL) as a single, aggregate source of all certified Complete EHRs and EHR Modules reported by ONC-ATCBs to the National Coordinator. The CHPL will comprise all of the certified Complete EHRs and EHR Modules that could be used to meet the definition of Certified EHR Technology. It will also include the other pertinent information we require ONC-ATCBs to report to the National Coordinator, such as a certified Complete EHR’s version number. Eligible professionals and eligible hospitals that elect to use a combination of certified EHR Modules may also use the CHPL webpage to validate whether the EHR Modules they have selected satisfy all of the applicable certification criteria that are necessary to meet the definition of Certified EHR Technology.

C6. Will EHR technology previously certified under any other programs or organizations automatically be certified by this new process?
No. In order to meet regulatory requirements implementing the HITECH Act, including the definition of “Certified EHR Technology,” EHR technology (Complete EHRs and/or EHR Modules) must be tested and certified by an ONC-ATCB. Any other certifications issued by an organization that is not an ONC-ATCB at the time of issuance will be invalid for purposes of meeting the definition of Certified EHR Technology and cannot be used to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs. Unless reissued in accordance with the requirements of the temporary certification program, certifications previously issued by an organization that has subsequently become an ONC-ATCB will also be invalid for purposes of satisfying the definition of “Certified EHR Technology,” because such certifications were issued prior to the organization achieving ONC-ATCB status.

Certification by an ONC-ATCB means that EHR technology meets the specific standards, implementation specifications, and certification criteria established for the temporary certification program. (HHS issued an interim final rule outlining specific standards and certification criteria on December 30, 2009, and a final rule is expected to be issued in the near future.)

EHR technology must be tested and certified by an organization authorized by ONC as an ONC-ATCB, using currently adopted standards and certification criteria. Once ONC has authorized testing and certification organizations as ONC-ATCBs, the follow actions are appropriate:

Developers of EHR technology who wish to have their EHR technology tested and certified should contact an ONC-ATCB
Health care providers who are eligible under the Medicare and Medicaid EHR Incentive Programs should contact their vendors to ensure their EHR technology is tested and certified by an ONC-ATCB under the temporary certification program requirements

C7. Will EHR technology certified under the temporary certification program be automatically certified under the permanent certification program?
EHR technology tested and certified by an ONC-ATCB under the temporary certification program will remain certified once the permanent certification program replaces the temporary certification program. The change in certification programs will not affect the certified status of EHR technology at the time of change. However, we anticipate that new or modified certification criteria will be adopted by the Secretary to support future stages of meaningful use, and as a result, certifications issued by ONC-ATCBs will presumably no longer indicate or represent that a Complete EHR or EHR Module can provide all of the capabilities necessary for an eligible professional or eligible hospital to achieve a future stage of meaningful use.

C8. Whose responsibility is it to make sure that EHR technology gets tested and certified as required to meet the certification criteria adopted to support meaningful use?
In most cases it will be the responsibility of developers of EHR technology that sell EHR technology. However, a health care provider that has developed its own EHR technology and is eligible under Medicare and Medicaid EHR Incentive Programs likely will be responsible for getting it tested and certified.

C9. If I buy an EHR technology that is tested and certified, does that qualify me for the Medicare or Medicaid EHR incentive payments?
Having EHR technology that is certified by an ONC-ATCB is an essential part of qualifying for the EHR incentive payments. For details on the Medicare and Medicaid EHR Incentive Programs, please visit http://www.cms.gov/Recovery/11_HealthIT.asp

C10. I already use EHR technology. If it gets certified, will I qualify for the Medicare or Medicaid EHR incentive payments?
If the EHR technology you currently use is certified in the HHS temporary certification program, you may be eligible for incentive payments. For details on the Medicare and Medicaid EHR Incentive Programs, please visit http://www.cms.gov/Recovery/11_HealthIT.asp

D. Comments on Proposed Rule

D1. Where can I learn about how my comments on the proposed rule on the Establishment of Certification Programs for Health Information Technology issued in March were addressed in the temporary certification program final rule?
ONC staff carefully reviewed and considered each comment received on the proposed rule. Section III of the temporary certification program final rule includes a discussion of how the comments were incorporated into the temporary certification program final rule.

E. Related Rules

E1. How does this final rule relate to the Medicare and Medicaid EHR Incentive Programs Proposed Rule?
The National Coordinator will use the temporary certification program to authorize organizations to test and certify EHR technology (Complete EHRs and/or EHR Modules). Once tested and certified, these types of HIT may be used to meet the regulatory definition of “Certified EHR Technology.” Health care providers who are eligible to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required to use Certified EHR Technology, as promulgated in the CMS final rule.
HHS expects to issue final rules related to the initial set of standards, implementation specifications, and certification criteria and to the Medicare and Medicaid EHR Incentive Programs in the near future.

E2. When will the permanent certification program final rule be published?
We anticipate that a final rule for the permanent certification program will be issued by fall 2010 and that the permanent program will be in place in 2012.

For other questions related to the Temporary Certification program, please email ONC.Certification@hhs.gov.

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ONC Health IT Buzz Blog Post by Dr.David Blumenthal
Temporary Certification Program
Originally posted on June 18, 2010 on Health IT Buzz Blog by Dr. David Blumenthal
A surgeon can’t operate without the proper equipment. A clinician can’t achieve meaningful use of electronic health records without an EHR that is designed to improve patient care and practice efficiency.

The Secretary of the Department of Health and Human Services announces today a big step in ensuring that clinicians can easily identify EHRs and EHR modules that have the capabilities needed to achieve meaningful use and thereby reap the financial incentives offered by Medicare and Medicaid. The temporary certification program lays out a path by which organizations can become authorized to test and certify EHR products. Certification can give physicians confidence that the EHR product they choose has the capabilities to help their practices achieve meaningful use.

However, it does not mean that choosing an EHR will be a simple decision, or that certification of an EHR guarantees the provider using it will accomplish meaningful use. Certification is another example of how ONC supports the nation’s clinicians in the move towards a fully functional, secure health information exchange system. Combined with the technical advice and support of Regional Extension Centers, certification helps level the playing field and enables practices large and small to make educated choices that will lead to meaningful use.

Updates on ONC’s SHARP — Strategic Healthcare IT Advanced Research Projects

Posted on June 7, 2010 by Mike Squires

SHARP Awards for Health IT Establish Web Sites
Web sites have been launched for each of the four advanced research projects announced April 2, 2010 by the Office of the National Coordinator (ONC) for Health IT. The program called Strategic Healthcare IT Advanced Research Projects (SHARP), totalling $60 million over four years, taps into four consortia of leading reseach and academic institutions each led by a major research institution. “The research projects supported by the SHARP program will focus on solving current and expected future challenges that represent barriers to adoption and meaningful use of health IT. These projects will focus on areas where ‘breakthrough’ advances are needed to realize the full potential of health IT.” This chart was taken from the Mayo Clinic College of Medicine Wiki site for its project.

: SHARP Organization

1. Security of Health IT
http://sharps.org
University of Illinois at Urbana-Champaign
Strategic Healthcare IT Advanced Research Projects on Security (SHARPS)
SHARPS is accociated with the Center for Health Information Privacy and Security in the Information Trust Institute at the University of Illinois at Urbana-Champaign
In their research overview, SHARPS describes the structure of their project, “SHARPS is organized around three major environments: Electronic Health Records (EHRs), Health Information Exchanges (HIEs), and Telemedicine (TEL), with Personal Health Records (PHRs) included as a major subtopic. SHARPS research projects in these strategic areas are interconnected through three cross-cutting themes: conceptual and policy foundations, service models, and open validation.”
People
Research
Jobs
Publications
Links

2. Patient-Centered Congnitive Support
http://sharpc.org
The University of Texas Health Science Center at Houston
National Center for Cognitive Informatics and Decision Making in Healthcare (NCCD)
Alternative URL: http://www.uthouston.edu/nccd
Mission: “The mission of the NCCD is to bring together a collaborative, interdisciplinary team of researchers from across the nation; with the highest level of expertise in patient-centered cognitive support research from biomedical and health informatics, cognitive science, clinical sciences, industrial and systems engineering, and health services research. Additionally, the NCCD will conduct short-term research that addresses the urgent usability , workflow, and cognitive support issues of Health Information Technology ( HIT) as well as long-term, breakthrough research that can fundamentally remove the key cognitive barriers to HIT adoption and meaningful use. The center will translate research findings to the real world through a cooperative program involving researchers, patients, providers, HIT vendors, and other stakeholders.”

About NCCD
Org Chart
Projects
Key Personnel

Project Advisory Committee
Sharp C Wiki (not up and running as of 6/7/2010)

Projects	Project Title
Project 1	Work-Centered Design of Care Process Improvements in HIT
Project 2A	Cognitive Foundations for Decision Making: Implications for Decision Support
Project 2B	Modeling of Setting-Specific Factors to Enhance Clinical Decision Support Adaptation
Project 3	Automated Model-based Clinical Summarization of Key Patient Data
Project 4	Cognitive Information Design and Visualization: Enhancing Accessibility and Understanding of Patient Data
Project 5	Improving Communication in Distributed Team Environment

3. Health Application and Network Platform Architectures
http://www.smartplatforms.org
Harvard University
Substitutable Medical Apps, reusable technologies

“A platform with substitutable apps constructed around core services is a promising approach to driving down healthcare costs, supporting standards evolution, accommodating differences in care workflow, fostering competition in the market, and accelerating innovation.”

The March 26, 2009 essay by Kenneth D. Mandl, MD, MPH, and Isaac S. Kohane, MD, PhD, in New England Journal of Medicine “No Small Change for the Health Information Economy”. They wrote “A health care system adapting to the effects of an aging population,growing expenditures, and a diminishing primary care workforceneeds the support of a flexible information infrastructure thatfacilitates innovation in wellness, health care, and publichealth.” They reference the flexbility of applications and the stable platform provided by the iPhone.

HTML: http://content.nejm.org/cgi/content/full/360/13/1278
PDF: http://content.nejm.org/cgi/reprint/360/13/1278.pdf

Ten principles were developed at a subsuquent workshop setup on May 13, 2009 by the”Informatics Program at Children’s Hospital Boston (CHIP) “of leading experts in health, innovation and technology to define ten core principles of a platform that would support healthcare information technology.” See “Ten Principles for Fostering Development of an ‘iPhone-like’ Platform for Healthcare Information Technology”

4. Secondary Use of EHR Data
http://sharpn.org
Mayo Clinic College of Medicine
Per Mayo Clinic College of Medicine Wiki: “We propose research that will generate a framework of open-source services that can be dynamically configured to transform EHR data into standards-conforming, comparable information suitable for large-scale analyses, inferencing, and integration of disparate health data. We will apply these services to phenotype recognition (disease, risk factor, eligibility, or adverse event) in medical centers and population-based settings. Finally, we will examine data quality and repair strategies with real-world evaluations of their behavior in Clinical and Translational Science Awards (CTSAs), health information exchanges (HIEs), and National Health Information Network (NHIN) connections.

“We have assembled a federated informatics research community committed to open-source resources that can industrially scale to address barriers to the broad-based, facile, and ethical use of EHR data for secondary purposes. We will collaborate to create, evaluate, and refine informatics artifacts that advance the capacity to efficiently leverage EHR data to improve care, generate new knowledge, and address population needs. Our goal is to make these artifacts available to the community of secondary EHR data users, manifest as open-source tools, services, and scalable software. In addition, we have partnered with industry developers who can make these resources available with commercial deployment. We propose to assemble modular services and agents from existing open-source software to improve the utilization of EHR data for a spectrum of use-cases and focus on three themes: Normalization, Phenotypes, and Data Quality/Evaluation. Our six projects span one or more of these themes, though together constitute a coherent ensemble of related research and development. Finally, these services will have open-source deployments as well as commercially supported implementations.

“There are six strongly intertwined, mutually dependent projects, including: 1) Semantic and Syntactic Normalization; 2) Natural Language Processing (NLP); 3) Phenotype Applications; 4) Performance Optimization; 5) Data Quality Metrics; and 6) Evaluation Frameworks. The first two projects align with our Data Normalization theme, while Phenotype Applications and Performance Optimization span themes 1 and 2 (Normalization and Phenotyping); while the last two projects correspond to our third theme.”

SHARP Program Organization
SHARP Area 4: Themes & Projects
Project Initiation Meeting Slides PDF

For more recent post about SHARP Program on e-Healthcare Marketing, click here.

Regenstrief Updates LOINC for Electronic Health Info Exchange

Posted on June 5, 2010 by Mike Squires

June 7 Release for Updated Lingua Franca for Electronic Health Info Exchange
Press Release from Indiana University School of Medicine on June 3, 2010:
INDIANAPOLIS — As the practice, regulation and reimbursement of health care become more complicated, and as the demand for electronic medical records and health information exchange grows, a universal method of identifying test results and other clinical measurement is essential.

The standardized medical terminology system called Logical Observation Identifiers Names and Codes, known as LOINC®, with a 57,000 term code vocabulary meets that need. LOINC provides the lingua franca needed for the creation of an electronic medical record and for health information to be electronically exchanged. The latest version of LOINC will be released on June 7.

LOINC has been developed by Regenstrief Institute investigators so that results of the same test – cholesterol level, or the same clinical observation – blood pressure reading, for example, can be compared by different institutions for the purposes of patient care, research, quality assessment or outcomes management. It is these codes that also are critical to computerized transmission of medical information.

“Our fragmented health-care system makes it difficult to deliver the best care possible because we lack complete, accurate information about our patients. Interconnected electronic record systems are beginning to overcome some of these challenges. As we move toward a national information infrastructure, LOINC fills a crucial role as a common vocabulary that allows clinical results from different sources to be electronically aggregated in systems for providers when and where they need it” said Regenstrief investigator Daniel Vreeman, PT, DPT, assistant research professor at the Indiana University School of Medicine and director of the LOINC development activities at Regenstrief.

LOINC began in the mid 1990’s when Regenstrief investigators, using their decades of experience with electronic medical records, began the Indiana Network for Patient Care, the nation’s first citywide health information exchange. The researcher clinicians found they could receive data from various INPC member institutions but that the clinical content was difficult to interpret because each used a different code for the same test or observation so it was like receiving messages in French, Spanish and Italian when all they could understand was English.

They decided to develop a lingua franca and LOINC was born. From the beginning it has been a free and open system, encouraging additions, comments and feedback. Two new versions of LOINC are issued annually, with more than 2,000 new terms for tests or clinical observations per release. These new additions are based on requests from end users.

Over the past seven years, more than 130 health-care organizations around the world, including the Centers for Disease Control, the U.S. departments of defense and veterans affairs and individual hospitals have made submissions. In the past two years, users from 131 different countries downloaded the standard more than 23,000 times. LOINC encourages and supports translation of terms and documentation into foreign languages. Currently, portions of the database have been translated into Simplified Chinese, Spanish, French, and Italian and both German and Estonian versions of the documentation also exist.

“With support from the U.S. government and other organizations, the Regenstrief Institute continues to develop LOINC as an open, freely available standard. LOINC’s growing worldwide adoption is a testament to both the need for a common language and the success of this open approach,” said Dr. Vreeman.

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LOINC development is performed under the auspices of the Regenstrief Institute, Inc. and is currently supported in part by Regenstrief Institute, Inc., the National Library of Medicine, the HHS Assistant Secretary for Planning and Evaluation, and the Centers for Medicare and Medicaid Services. Present federal funding totals $3.7 million through 2013, with 75 percent of annual support from federal funding and 25 percent from non-federal sources.

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LOINC Web site
Regenstrief Institute Web site
University of Indiana School of Medicine

ONC Plans new Privacy and Security Task Force

Posted on May 28, 2010 by Mike Squires

Chief Privacy Officer for Health IT Joy Pritts
announces new Privacy & Security Task Force
Per slide (ppt slide set) from May 26, 2010 Privacy and Security Workgroup of Health IT Standards Committee, ONC Chief Privacy Officer “Joy Pritts (had) talked to Workgroup about ONC’s plan to create a Privacy and Security Task Force, under HITPC (HIT Policy Committee), to work intensively over the summer to define privacy and security policy to be applied consistently across ONC projects and programs.”
“–Workgroup encouraged involvement of technical experts in Task Force and offered support.
“–Privacy and Security Workgroup efforts to consider and recommend standards, implementation specifications, and certification criteria will abate pending policy decisions from the new Task Force.”

Howard Anderson, Managing Editor of HealthcareInfoSecurity.com reported ” ‘it became quite apparent that a number of workgroups were working on little pieces of this at the same time, and the issues were overlapping, and we didn’t really want to proceed in that fashion very much longer,’ Pritts told a meeting of ONC’s Health Information Technology Policy Committee on May 26.”

Boston Health IT/HIE Conferences meets goals center stage and off stage

Posted on May 2, 2010 by Mike Squires

Blumenthal, governor put health IT center stage in Boston;
Off stage state HIE, Medicaid and other officials network
Guided by the deft hand of Massacussetts Secretary of Health and Human Services JudyAnn Bigby through a series

Blumenthal: Live, Projected, Streaming

of scheduling shifts, the Boston-based national conference on Health IT with 600 participants from 30 states on April 29-30, 2010, included inspirational keynotes from National Coordinator for Health IT David Blumenthal and Surgeon General Regina Benjamin, as well as an enthusiastic welcome from host Governor Deval Patrick who moderated a panel as well.

Off stage state HIE and Medicaid directors and leaders took the opportunity to network and compare notes, as well as take advantage of the smaller workshops where session leaders focused on encouraging discussion and bringing up issues that needed to be addressed in the accelerating Health IT federal-state initiative.

Bernie Monegain reported for Healthcare IT on April 30, 2010, “The government will announce ‘soon – it should be very, very soon’ which 15 communities of the 130 that applied will be awarded Beacon Community grants, National Coordinator for Health IT David Blumenthal, MD, said.” In addition to supporting improved electronic health record implementation and information exchange in communities that have already demonstrated great strengths in those capabilities, these Beacon communities will share lessons learned and best practices in achieving measurable outcomes in health care quality, safety, efficiency, and population health with communities across the country, according to the Office of the National Coordinator site.

CMIO.net story by Jeff Byers on April 29, 2010 was headlined “CMIO Blumenthal gets personal, calls for teamwork among health IT pros.” Seeing younger colleagues using electronic health records, Blumenthal noted, per Byers reporting, “I was not going to be the only one in my physician group of ten not using it.” Blumenthal’s message is increasingly appealing to physicians’ sense of professionalism and focus on delivering the best patient care.

Byers futher reported April 29, 2010 in CMIO.net on a discussion of the role of consumers and patients in Health IT by a ”Panel: How do HIEs, EMRs affect patient-physician experience?,” and provides the viewpoint of each of the panelists.

ComputerWorld’s article by Lucas Mearian on April 30, 2010 reported “Health IT funding to create 50,000 jobs; Sixty regional IT help centers will help health care facilities implement electronic medical records.”

In addition to regional collaboration meetings among state officials grouped according to CMS regions, Workshops included “Achieving Sustainable Success,” Making a Difference–Health IT and Clinical Quality Improvement,” “State Initiatives in Healthcare Reform,” “Successful HIEs–How They Did It and How Ii Helps,” “Jobs, Jobs, Jobs–Health IT and State Economic Development Policy,” Creating Effective Public/Private Partnerships,” “EHR Early Adopters–How They Did It and How It Helps,” and “Health IT, HIE, and Public Health.”

One key panel, providing a sweeping overview of Health IT policies and standards, was moderated by Internet publisher pioneer Tim O’Reilly of O”Reilly Communications.

State HIE Directors are reportedly meeting with the ONC next week, and this conference acted as a bit of a warmup, with relatively new officials getting to connect, and others catch up.

See previous post on conference on e-Healthcare Marketing.

NOTE: As Jackie Slivko pointed out on LinkedIn on May 3, 2010, “Local and regional healthcare leaders as well as key vendors were also present and had an unprecedented opportunity to connect, learn from each other and network. Kudos to Mass Health Data Consortium http://www.mahealthdata.org/ , and the eHealth Initiative at the Mass Technology Collaborative http://www.maehi.org/ , both of whom continue to provide related forums and seminars. For live video and more from the conference, see http://mahit.us/ .”

e-Healthcare Marketing

Health Information Exchange, Electronic Health Records and Personal Health Records

Category Archives: Standards