Final Rules for EHRs: Incentives, Certification, Standards –Preliminary Roundup

Advancing the Future of Health Care with Electronic Health Records
Tuesday, July 13th, 2010 | Posted by: Dr. David Blumenthal on Health IT Buzz Blog and reposted here by e-Healthcare Marketing here.

Today, we’ve taken great steps forward in bringing America’s health records into the 21^st century. Widespread and meaningful use of fully functional electronic health record systems combined with a robust infrastructure for broad-based health information exchange can improve the quality, safety, and efficiency of health care for all Americans.

As more organizations adopt electronic health records, physicians will have greater access to patient information, allowing faster and more accurate diagnoses. Complete patient data helps ensure the best possible care.

Patients too will have access to their own information and will have the choice to share it with family members securely, over the Internet, to better coordinate care for themselves and their loved ones.

Digital medical records make it possible to improve quality of patient care in numerous ways. For example, doctors can make better clinical decisions with ready access to full medical histories for their patients—including new patients, returning patients, or patients who see several different providers. Laboratory tests or x-rays downloaded and stored in the patient’s electronic health record make it easier to track results. Automatic alerts built into the systems direct attention to possible drug interactions or warning signs of serious health conditions. E-prescribing lets doctors send prescriptions electronically to the pharmacy, so medications can be ready and waiting for the patient.

And while electronic health records require an initial investment of time and money, clinicians who have implemented them have reported saving money in the long term. With the efficiencies that electronic health records promise, their widespread use has the potential to result in significant cost savings across our health care system.

The future looks bright, but the vision can’t become reality without first laying a firm foundation.

Helping us in this endeavor are the providers, software developers, health care administrators, patients, and others on the frontlines of health care. We talked with them about their experiences and expectations of health IT. We heard their aspirations and their reservations. Our commitment to ensure privacy and security of electronic health records and health information exchange will remain at the forefront of all our efforts. We are confident that what we’ve learned from these ongoing conversations will lead to the development of a structure designed to support and improve health care in this country.

The final rules recently released are the blueprints for that structure. The standards and certification final rule, released on July 13, 2010, helps ensure that certified electronic health records will have the capabilities necessary to achieve our goals. And now, with the release of the final rule for the meaningful use of electronic health records, we have a plan for how those capabilities can lead to better health care.

These rules are not an end in and of themselves, but provide us with a plan for the future.

I recognize the challenges and obstacles before us. Fundamental changes are difficult to undertake but I saw the difference an EHR made in my practice and I can clearly see where meaningful use of health information technology can take us.

Now that we have the foundation in place and the blueprints in hand, I encourage you to continue your electronic health record adoption and implementation efforts so we can transform our vision into reality.

– Dr. David Blumenthal, National Coordinator for Health Information Technology
To comment directly on ONC’s Health IT Buzz Blog, click here.

See previous post on e-Healthcare Marketing for Final Rules PDFs, Press Release, Fact Sheets, and additional info.

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

CHIME Comments on Final Rule of Temporary EHR Certification

Posted on July 1, 2010 by Mike Squires

CHIME/College of Healthcare Information Management Executives issues Comments
Excerpted from CHIME Press Release July 1, 2010.
ANN ARBOR, MI, July 1, 2010 – The government’s certification program for health information technology will continue to evolve over time, according to a review of the recently released final rule for the temporary certification program, released last week.

The temporary program to certify electronic health record technology went into effect on June 24, and it will be replaced by the permanent certification program as soon as Dec. 31, 2011. However, the analysis by the College of Health Information Management Executives (CHIME) indicates that certification criteria will change, necessitating the ongoing need to certify HIT products for the foreseeable future.

CHIME found that the recently released final rule suggests that electronic health records (EHR) will need to be certified on an ongoing basis, and that meaningful use criteria are likely to evolve over time.

To receive stimulus funds, eligible hospitals and providers that implement electronic health records must demonstrate that they are using them to improve care delivery and clinical results. The plan originally proposed by the Centers for Medicare & Medicaid Services (CMS) would require providers to give evidence that their systems are achieving certain standards to show they’re using EHRs in meaningful ways. The original plan anticipated that the measures for demonstrating meaningful use would get tougher every two years over the three stages of the program. Providers can enter the program at any time over the next four years by meeting Stage 1 meaningful use criteria.

While the industry is uncertain about the final shape of the meaningful use objectives that CMS will choose, the temporary certification final rule suggests that Stage 1 criteria could become tougher over time.

“Regardless of the year and meaningful use stage at which an eligible professional or eligible hospital enters the Medicare or Medicaid EHR Incentive Program, the certified EHR technology that they would need to use would have to include the capabilities necessary to meet the most current certification criteria,” the temporary certification rule notes.

CHIME’s reading of the rule suggests that, although Stage 1 criteria will be finalized soon, it is possible future rule-making could include updates to the Stage 1 criteria, said Pamela McNutt, FCHIME, senior vice president and CIO at Dallas-based Methodist Health System and chair of CHIME’s Policy Steering Committee.

However, the final rules for temporary certification do provide some relief because they don’t require recertification for HIT product updates and “fixes” that don’t adversely affect meaningful use criteria. However, a product may be certified if there are any concerns about changes in an application that could affect its ability to achieve meaningful use objectives.

Additionally, the authorized testing and certification bodies recognized by the Office of the National Coordinator for Healthcare IT (ONC-ATCBs) can not require that integrated bundled EHRs or EHR modules be certified to a higher set of standards than the certification criteria set by the ONC. CHIME views this clarification as a positive result of the commenting process that caused ONC to re-evaluate the proposed rule.

CHIME also positively views provisions in the final regulation that call for ONC-ATCBs to provide remote testing of applications.

Additionally, the regulations don’t require that an application must be live at a customer’s site before it is tested, opening the way for testing of applications at vendors’ facilities.

While the final regulations reflected resolutions of many of CHIME’s concerns and clarifies certain issues, the organization still is concerned that a product’s certification can be revoked for some “Type 1” violations by an ONC-ATCB that would prompt questions about the integrity of the certification of those products. If a product loses certification, a healthcare organization would have 120 days to secure a certified product, either by the vendor having its product re-certified by a different ATCB or installing another certified product.

While the loss of a product’s certification is unlikely, any such occurrence will probably affect hundreds of provider organizations and could place them under extreme stress to resolve the issue quickly, CHIME said.

About CHIME
The College of Healthcare Information Management Executives (CHIME) is an executive organization dedicated to serving chief information officers and other senior healthcare IT leaders. With more than 1,400 CIO members and over 70 healthcare IT vendors and professional services firms, CHIME provides a highly interactive, trusted environment enabling senior professional and industry leaders to collaborate; exchange best practices; address professional development needs; and advocate the effective use of information management to improve the health and healthcare in the communities they serve. For more information, please visit http://www.cio-chime.org/

ONC: Informational Calls on Temporary Certification Program + FAQs, Fact Sheet

Posted on June 28, 2010 by Mike Squires

June 30-July 2: Overview of Temporary Certification for Electronic Health Records
for Potential Applicants (ONC-ATCB), Health IT Developers/Vendors, Provider/Developers and Interested Provider
Notice emailed June 26, 2010, and excerpted below.
The Office of the National Coordinator for Health Information Technology (ONC) within the Department of Health and Human Services is hosting a series of informational calls the purpose of which is to provide an overview of the recently released final rule to establish a temporary certification program for electronic health record (EHR) technology. The temporary rule establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify EHR technology.

Participants will hear an overview of the final rule, and be able to ask questions.

Four informational calls are planned, targeting the information needs of specific audiences who may be impacted by the final rule:

1. For Potential Applicants Who Wish to Pursue Becoming an ONC-Authorized Testing and Certification Body (ONC-ATCB)

Date and Time: Wednesday, June 30, 2010, 4:00 p.m. – 5:00 p.m. EDT

Call-in Information:

Phone Number: 800-857-9600

Participant Passcode: 3533556

2. For Health IT Developers/Vendors

Date and Time: Thursday, July 1, 2010, 4:00 p.m. – 5:00 p.m. EDT

Call-in Information:

Phone Number: 800-619-0361

Participant Passcode: 3533556

3. For Providers Who are Also Health IT Developers (who may seek certification of systems developed in-house)

Date and Time: Friday, July 2, 2010, 10:00 a.m. – 11:00 a.m. EDT

Call-in Information:

Phone Number: 800-857-9600

Participant Passcode: 4129010

4. For Providers, Including Clinicians, Hospitals and Other Provider Organizations Interested in the Details of the Temporary Certification Program

Date and Time: Friday, July 2, 2010, 11:00 a.m. – 12:00 p.m. EDT

Call-in Information:

Phone Number: 800-769-9420

Participant Passcode: 3533556

Transcripts of each phone call will be made available on the ONC web site, within 48 hours of each call.

For more information about the temporary certification program and the final rule, please visit http://healthit.hhs.gov/certification.
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ONC Fact Sheet: HITECH Temporary Certification Program for EHR Technology
Excerpted from ONC site on 6/28/2010.
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-ATCBs are required to test and certify that certain types of EHR 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/tempcert
•   Medicare and Medicaid EHR incentive programs, visit http://www.cms.gov/EHRIncentivePrograms/
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Frequently Asked Questions:
Temporary Certification Program Final Rule

Excerpted from ONC site 6/28/2010.
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 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.

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.

###

ONC-ATCB? ONC-Authorized Testing and Certification Body

Posted on June 27, 2010 by Mike Squires

FINAL RULE Issued: Temporary Certification Program for Health IT
Published in Federal Register on June 24, 2010
AGENCY: Office of the National Coordinator for Health Information
Technology, Department of Health and Human Services.
45 CFR Part 170
“Establishment of the Temporary Certification Program for Health
Information Technology; Final Rule” was published in the Federal Register on June 24, 2010, with excerpts below and links to html and PDF versions. ONC now estimates there may be as many as five ONC-ATCBs, up from the three estimated in the interim rule and that they will certify ”at most, approximately 205 Complete EHRs and/or EHR Modules under the temporary certification program.” Organizations for ATCB status may start applying July 1, 2010.

FORMATS: HTML , PDF , SUMMARY

“SUMMARY: This final rule establishes a temporary certification program
for the purposes of testing and certifying health information technology. This final rule is established under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The National Coordinator will utilize the temporary certification program to authorize organizations to test and certify Complete Electronic Health Records (EHRs) and/or EHR Modules, thereby making Certified EHR Technology available prior to the date on which health care providers seeking incentive payments available under the Medicare and Medicaid EHR Incentive Programs may begin demonstrating meaningful use of Certified EHR Technology.”

II. Overview of the Temporary Certification Program

“The temporary certification program provides a process by which an organization or organizations may become an ONC-Authorized Testing and Certification Body (ONC-ATCB) and be authorized by the National Coordinator to perform the testing and certification of Complete EHRs and/or EHR Modules.

“Under the temporary certification program, the National Coordinator will accept applications for ONC-ATCB status at any time. In order to become an ONC-ATCB, an organization or organizations must submit an application to the National Coordinator to demonstrate its competency and ability to test and certify Complete EHRs and/or EHR Modules. An
applicant will need to be able to both test and certify Complete EHRs and/or EHR Modules. We anticipate that only a few organizations will qualify and become ONC-ATCBs under the temporary certification program. These organizations will be required to remain in good standing by adhering to the Principles of Proper Conduct for ONC-ATCBs. ONC-ATCBs will also be required to follow the conditions and requirements applicable to the testing and certification of Complete EHRs and/or EHR Modules as specified in this final rule. The temporary certification program will sunset on December 31, 2011, or if the permanent certification program is not fully constituted at that time, then upon a subsequent date that is determined to be appropriate by the National Coordinator.”

Analysis and Response to Public Comments: Overview
”This section discusses the 84 timely received comments on the Proposed Rule’s proposed temporary certification program and our responses. We have structured this section of the final rule based on the proposed regulatory sections of the temporary certification program and discuss each regulatory section sequentially. For each discussion of the regulatory provision, we first restate or paraphrase the provision as proposed in the Proposed Rule as well as identify any
correlated issues for which we sought public comment. Second, we summarize the comments received. Lastly, we provide our response to the comments, including stating whether we will finalize the provision as proposed in the Proposed Rule or modify the proposed provision in
response to public comment. Comments on the incorporation of the “recognized certification body” process, “grandfathering” of certifications, the concept of “self-developed,” validity and expiration of certifications, general comments, and comments beyond the scope of this final rule are discussed towards the end of the preamble.”

Several Excerpts About Increase Estimate to Five ONC-ATCBs
Different Levels of Preparedness
“As stated in the collection of information section, we estimate that each ONC-ATCB will incur the same burden and, assuming that there are 5 ONC-ATCBs, will test and certify, at most, approximately 205 Complete EHRs and/or EHR Modules under the temporary certification program.”

“In the Proposed Rule, we stated that we anticipated that there would be no more than 3 applicants for ONC-ATCB status. Based on the comments received, we now believe that there may be up to 5 applicants for ONC-ATCB status. In addition, we believe that up to 2 of these applicants will not have the level of preparedness that we originally estimated for all potential applicants for ONC-ATCB status.”

“As part of the temporary certification program, an applicant will be required to submit an application and complete a proficiency exam. We do not believe that there will be an appreciable difference in the time commitment an applicant for ONC-ATCB status will have to make based on the type of authorization it seeks (i.e., we believe the application process and time commitment will be the same for applicants seeking authorization to conduct the testing and certification of
either Complete EHRs or EHR Modules). We do, however, believe that there will be a distinction between applicants based on their level of preparedness. For the purposes of estimating applicant costs, we have divided applicants into two categories, “conformant applicants” and
“partially conformant applicants.” We still believe, after reviewing comments, that there will be three “conformant applicants” and that these applicants will have reviewed the relevant requirements found in the ISO/IEC standards and will have a majority, if not all, of the documentation requested in the application already developed and available before applying for ONC-ATCB status. Therefore, with the exception of completing a proficiency examination, we believe “conformant applicants” will only spend time collecting and assembling already developed information to submit with their application. Conversely, we believe that there will be up to two “partially conformant applicants” and that these applicants will spend significantly more time establishing their compliance with Guide 65 and ISO 17025.”
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For several interesting points in the rule, see John Halamka’s June 25, 2010 post in his Life as a CIO blog. He credits Robin Raiford for bookmarking the site, to whom–in serial form–this blog give credit as well.

e-Healthcare Marketing published a post on June 19, 2010 on Final Rule with HSS press release, FAQs, overview, and ONC’s blog post from David Blumenthal.

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.

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”.

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

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.

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

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.

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

D. Comments on Proposed 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.

CMS: Final HIT rules moving from late spring to early summer?

Posted on June 10, 2010 by Mike Squires

NYTimes: Doctors and Hospitals Say Goals on Computerized Records Are Unrealistic; “Early summer” is the real story
“Final rules will be out in early summer,” according to Jonathan D. Blum, deputy administrator of the Centers for Medicare and Medicaid Services, as quoted in Robert Pear’s June 8, 2010 story in the New York Times, “Doctors and Hospitals Say Goals on Computerized Records Are Unrealistic.”

For several months, National Coordinator for Healthcare IT David Blumenthal has been saying that the final rules for certification of EHR systems (from ONC) and the final EHR incentives (from CMS) would come out in “late spring” 2010, which means prior to June 21. ONC and CMS have been working closely together on these two rules.

The quote by the deputy administrator of CMS appears to be setting the stage for finalization of rules to come June 21 (first day of summer) or later. Perhaps this New York Times story is actually setting the stage for some more flexibility in the final definitions and timing of “meaningful use” requirements. Folks from Intermountain, Kaiser, and Partners Healthcare System in Boston, are quoted as saying too much change is expected in too short a time, and these are people who are way ahead of the curve.

New AHRQ-Funded Report Provides Snapshot of Electronic Health Record (EHR) Vendor Usability Processes and Practices

Posted on May 27, 2010 by Mike Squires

New AHRQ-Funded Report Provides Snapshot of Electronic Health Record (EHR) Vendor Usability Processes and Practices

Received via email on May 27, 2010: “The Agency for Healthcare Research and Quality (AHRQ) has issued a new report that focuses on assessing and improving the state of usability in Electronic Health Record (EHR) systems. Key recommendations from the project’s expert panel include establishment of usability / information design of EHRs as an essential part of the certification requirements for EHRs, basing certification on a practical and fair process of usability evaluation, and designing certification programs for EHR usability in a way that focuses on objective and important aspects of system usability. Select to access the report and learn more about the panel’s recommendations.(PDF file).

“AHRQ is working closely with the National Institute of Standards and Technology (NIST) and the Office of the National Coordinator to address the recommendations identified in its research. In June, AHRQ plans to award a follow-on project for the development, testing and dissemination of an easy-to-use, objective and evidence-based toolkit that healthcare organizations can use to evaluate critical aspects of their EHR systems’ usability, accessibility and information design. In addition, NIST is currently seeking applications for development of an EHR usability evaluation framework at a meeting, titled “Health Care IT Usability: Strategy, Research, Implementation,” to be held in Gaithersburg, MD, on July 13, (2010).”

The report was written by Cheryl McDonnell, Kristen Werner, and Lauren Wendel; and was prepared by James Bell Associates and The Altarum Institute. Suggested citation: McDonnell C, Werner K, Wendel L. Electronic Health Record Usability: Vendor Practices and Perspectives. AHRQ Publication No. 09(10)-0091-3-EF. Rockville, MD: Agency for Healthcare Research and Quality. May 2010.

Excerpted from the pdf report:
Electronic Health Record Usability:
Vendor Practices and Perspectives
May 2010

Executive Summary

One of the key factors driving the adoption and appropriate utilization of electronic health record (EHR) systems is their usability. (1) However, a recent study funded by the Agency for Healthcare Research and Quality (AHRQ) identified information about current EHR vendor usability processes and practices during the different phases of product development and deployment as a key research gap. (2)To address this gap and identify actionable recommendations to move the field forward, AHRQ contracted with James Bell Associates and the Altarum Institute to conduct a series of structured discussions with selected certified EHR vendors and to solicit recommendations based on these findings from a panel of multidisciplinary experts in this area.

The objectives of the project were to understand processes and practices by these vendors with regard to:

• The existence and use of standards and “best practices” in designing, developing, and deploying products.

• Testing and evaluating usability throughout the product life cycle.

• Supporting postdeployment monitoring to ensure patient safety and effective use.

In addition, the project solicited the perspectives of certified EHR vendors with regard to the role of certification in evaluating and improving usability.

The key findings from the interviews are summarized below.

• All vendors expressed a deep commitment to the development and provision of usable EHR product(s) to the market.

• Although vendors described an array of usability engineering processes and the use of end users throughout the product life cycle, practices such as formal usability testing, the use of user-centered design processes, and specific resource personnel with expertise in usability engineering are not common.

• Specific best practices and standards of design, testing, and monitoring of the usability of EHR products are not readily available. Vendors reported use of general (software) and proprietary industry guidelines and best practices to support usability. Reported perspectives on critical issues such as allowable level of customization by customers varied dramatically.

• Many vendors did not initially address potential negative impacts of their products as a priority design issue. Vendors reported a variety of formal and informal processes for identifying, tracking, and addressing patient safety issues related to the usability of their products.

• Most vendors reported that they collect, but do not share, lists of incidents related to usability as a subset of user-reported “bugs” and product-enhancement requests. While all vendors described a process, procedures to classify and report usability issues of EHR products are not standardized across the industry.

• No vendors reported placing specific contractual restrictions on disclosures by system users of patient safety incidents that were potentially related to their products.

• Disagreement exists among vendors as to the ideal method for ensuring usability standards, and best practices are evaluated and communicated across the industry as well as to customers. Many view the inclusion of usability as part of product certification as part of a larger “game” for staying competitive, but also as potentially too complex or something that will “stifle innovation” in this area.

• Because nearly all vendors view usability as their chief competitive differentiator, collaboration among vendors with regard to usability is almost nonexistent.

• To overcome competitive pressures, many vendors expressed interest in an independent body guiding the development of voluntary usability standards for EHRs. This body could build on existing models of vendor collaboration, which are currently focused predominantly on issues of interoperability.

Based on the feedback gained from the interviews and from their experience with usability best practices in health care and other industries, the project expert panel made the following recommendations:

• Encourage vendors to address key shortcomings that exist in current processes and practices related to the usability of their products. Most critical among these are lack of adherence to formal user-design processes and a lack of diversity in end users involved in the testing and evaluation process.

• Include in the design and testing process, and collect feedback from, a variety of end-user contingents throughout the product life cycle. Potentially undersampled populations include end users from nonacademic backgrounds with limited past experience with health information technology and those with disabilities.

• Support an independent body for vendor collaboration and standards development to overcome market forces that discourage collaboration, development of best practices, and standards harmonization in this area.

• Develop standards and best practices in use of customization during EHR deployment.

• Encourage formal usability testing early in the design and development phase as a best practice, and discourage dependence on postdeployment review supporting usability assessments.

• Support research and development of tools that evaluate and report EHR ease of learning, effectiveness, and satisfaction both qualitatively and quantitatively.

• Increase research and development of best practices supporting designing for patient safety.

• Design certification programs for EHR usability in a way that focuses on objective and

important aspects of system usability.

Background

Encouraged by Federal leadership, significant investments in health information technology (IT) are being made across the country. While the influx of capital into the electronic health record (EHR)/health information exchange (HIE) market will undoubtedly stimulate innovation, there is the corresponding recognition that this may present an exceptional opportunity to guide that innovation in ways that benefit a significant majority of potential health IT users.

One of the key factors driving the adoption and appropriate utilization of EHR systems is their usability. (1) While recognized as critical, usability has not historically received the same level of attention as software features, functions, and technical standards. A recent analysis funded by the Agency for Healthcare Research and Quality (AHRQ) found that very little systematic evidence has been gathered on the usability of EHRs in practice. Further review established a foundation of EHR user-interface design considerations, and an action agenda was proposed for the application of information design principles to the use of health IT in primary care settings. (2), (3)

In response to these recommendations, AHRQ contracted with James Bell Associates and the Altarum Institute to evaluate current vendor-based practices for integrating usability during the entire life cycle of the product, including the design, testing, and postdeployment phases of EHR development. A selected group of EHR vendors, identified through the support of the Certification Commission for Health Information Technology (CCHIT) and AHRQ, participated in semistructured interviews. The discussions explored current standards and practices for ensuring the usability and safety of EHR products and assessed the vendors’ perspectives on how EHR usability and information design should be certified, measured, and addressed by the government, the EHR industry, and its customers. Summary interview findings were then distributed to experts in the field to gather implications and recommendations resulting from these discussions.

Vendor Profiles

The vendors interviewed were specifically chosen to represent a wide distribution of providers of ambulatory EHR products. There was a representation of small-sized businesses (less than 100 employees), medium-sized businesses (100-500 employees), and large-sized businesses (greater than 500 employees). The number of clinician users per company varied from 1,000 to over 7,000, and revenue ranged from $1 million to over $10 billion per year. The EHR products discussed came on the market in some form in the time period from the mid-1990s to 2007. All vendors except one had developed their EHR internally from the ground up, with the remaining one internally developing major enhancements for an acquired product. Many of these products were initially designed and developed based on a founding physician’s practice and/or established clinical processes. All companies reported that they are currently engaged in groundup development of new products and/or enhancements of their existing ambulatory products. Many enhancements of ambulatory products center on updates or improvements in usability. Examples of new developments include changes in products from client-based to Web-based EHRs; general changes to improve the overall usability and look and feel of the product; and the integration of new technologies such as patient portals, personal health records, and tablet devices.

The full list of vendors interviewed and a description of their key ambulatory EHR products are provided in Appendixes I and II. The following discussion provides a summary of the themes encountered in these interviews.

Standards in Design and Development

End-User InvolvementAll vendors reported actively involving their intended end users throughout the entirendesign and development process. Many vendors also have a staff member with clinical experience involved in the design and development process; for some companies the clinician was a founding member of the organization.nWorkgroups and advisory panels are the most common sources of feedback, with some vendors utilizing a more comprehensive participatory design approach, incorporating feedback from all stakeholders throughout the design process. Vendors seek this information to develop initial product requirements, as well as to define workflows, evaluate wireframes and prototypes, and participate in initial beta testing. When identifying users for workgroups, advisory panels, or beta sites, vendors look for clinicians who have a strong interest in technology, the ability to evaluate usability, and the patience to provide regular feedback. Clinicians meeting these requirements are most often found in academic medical centers. When the design concerns an enhancement to thencurrent product, vendors often look toward users familiar with the existing EHR to provide thismfeedback.

“We want to engage with leadership-level poartners as well as end users from all venues that may be impacted by out product.”

Design Standards and Best Practices

A reliance on end-user input and observation for ground-up development is seen as a requirement in the area of EHR design, where specific design standards and best practices are not yet well defined. Vendors indicated that appropriate and comprehensive standards were lacking for EHRspecific functionalities, and therefore they rely on general software design best practices to inform design, development, and usability. While these software design principles help to guide their processes, they must be adjusted to fit specific end-user needs within a health care setting. In addition to following existing general design guidelines such as Microsoft Common User Access, Windows User Interface, Nielsen Norman Group, human factors best practices, and releases from user interface (UI) and usability professional organizations, many vendors consult with Web sites, blogs, and professional organizations related to health IT to keep up to date with specific industry trends. Supplementing these outside resources, many vendors are actively developing internal documentation as their products grow and mature, with several reporting organized efforts to create internal documentation supporting product-specific standards and best practices that can be applied through future product updates and releases.

“There are no standards most of the time, and when there are standards, there is no enforcement of them. The software industry has plenty of guidelines and good best practices, but in health IT, there are none.”

Industry Collaboration

As these standards and best practices are being developed, they are not being disseminated throughout the industry. Vendors receive some information through professional organizations and conferences, but they would like to see a stronger push toward an independent body, either governmental or research based, to establish some of these standards. The independent body would be required, as all vendors reported usability as a key competitive differentiator for their product;this creates a strong disincentive for industrywide collaboration. While all were eager to take advantage of any resources commonly applied across the industry, few were comfortable with sharing their internally developed designs or best practices for fear of losing a major component of their product’s competitiveness. Some vendors did report they collaborate informally within the health IT industry, particularly through professional societies, trade conferences, and serving on committees. For example, several vendors mentioned participation in the Electronic Health Record Association (EHRA), sponsored by the Healthcare Information and Management Systems Society (HIMSS), but noted that the focus of this group is on clinical vocabulary modeling rather than the usability of EHRs. Some interviewees expressed a desire to collaborate on standards issues that impact usability and patient safety through independent venues such as government or research agencies.

“The field is competitive so there is little sharing of best practices in the community. The industry should not look toward vendors to create these best practices. Other entities must step up and define [them] and let the industry adapt.”

Customization

In addition to the initial design and development process, vendors commonly work with end users to customize or configure specific parts of the EHR. Vendors differed in the extent to which they allowed and facilitated customization and noted the potential for introducing errors when customization is pursued. Most customizations involve setting security rules based on roles within a clinic and the creation of document templates that fit a clinic’s specific workflow. Many vendors view this process as a critical step toward a successful implementation and try to assist users to an extent in developing these items. While some vendors track these customizations as insight for future product design, they do not view the customizations as something that can be generalized to their entire user base, as so many are context specific. The level of customization varies according to vendor since vendors have different views about the extent to which their product can or should be customized. Vendors do not routinely make changes to the code or underlying interface based on a user request; however, the level to which end users can modify templates, workflows, and other interface-related characteristics varies greatly by vendor offering.

“You cannot possibly adapt technology to everyone’s workflow. You must provide the most optimum way of doing something which [users] can adapt.”

Usability Testing and Evaluation

Informal Usability Assessments

Formal usability assessments, such as task-centered user tests, heuristic evaluations, cognitive walkthroughs, and card sorts, are not a common activity during the design and development process for the majority of vendors. Lack of time, personnel, and budget resources were cited as reasons for this absence; however, the majority expressed a desire to increase these types of formal assessments. There was a common perception among the vendors that usability assessments are expensive and time consuming to implement during the design and development phase. The level of formal usability testing appeared to vary by vendor size, with larger companies having more staff and resources dedicated to usability testing while smaller vendors relied heavily on informal methods (e.g., observations, interviews), which were more integrated into the general development process. Although some reported that they conduct a full gamut of both formal and informal usability assessments for some parts of the design process, most reported restricting their use of formal methods to key points in the process (e.g., during the final design phase or for evaluation of specific critical features during development).

“Due to time and resource constraints, we do not do as much as we would like to do. It is an area in which we are looking to do more.”

Measurement

Functions are selected for usability testing according to several criteria: frequency of use, task criticality and complexity, customer feedback, difficult design areas, risk and liability, effects on revenue, compliance issues (e.g., Military Health System HIPAA [Health Insurance Portability and Accountability Act], and the American Recovery and Reinvestment Act) and potential impacts on patient safety. The most common or frequent tasks and tasks identified as inherently complex are specifically prioritized for usability testing. Neither benchmarks and standards for performance nor formalized measurements of these tasks are common in the industry. While some vendors do measure number of clicks and amount of time to complete a task, as well as error rates, most do not collect data on factors directly related to the usability of the product, such as ease of learning, effectiveness, and satisfaction. Many vendors reported that the amount of data collected does not allow for quantitative analysis, so instead they rely on more anecdotal and informal methods to ensure that their product works more effectively than paper-based methods and to inform their continuous improvements with up rades and releases.

“Testing is focused more on functionality rather than usability.”

Observation

Observation is the “gold standard” among all vendors for learning how users interact with their EHR. These observations usually take place within the user’s own medical practice, either in person or with software such as TechSmith’s Morae. (4) Vendors will occasionally solicit feedback on rototypes from user conferences in an informal lablike Sstting. These observations are typically used to gather information on clinical workflows or process flows, which are incorporated into the product design, particularly if the vendor is developing a new enhancement or entire product.

“[Methods with] low time and resource efforts are the best [to gather feedback]; wherever users are present, we will gather data.”

Changing Landscape

While informal methods of usability testing seem to be common across most vendors, the landscape appears to be changing toward increasing the importance of usability as a design necessity. Multiple vendors reported the current or recent development of formal in-house observation laboratories where usability testing could be more effectively conducted. Others reported the recent completion of policies and standards directly related to integrating usability more formally into the design process, and one reported a current contract with a third-party vendor to improve usability practices. While it is yet to be seen if these changes will materialize, it appeared that most respondents recognized the value of usability testing in the design process and were taking active steps to improve their practices.

Postdeployment Monitoring and Patient Safety

Feedback Solicitation

Vendors are beginning to incorporate more user feedback into earlier stages of product design and development; however, most of this feedback comes during the postdeployment phase. As all vendors interviewed are currently engaged in either the development of enhancements of current products or the creation of new products, the focus on incorporating feedback from intended end users at all stages of development has increased. Many of the EHRs have been on the market for over 10 years; as a result, many vendors rely heavily on this postdeployment feedback to evaluate product use and inform future product enhancements and designs. Maintaining contact with current users is of high priority to all EHR vendors interviewed and in many ways appeared to represent the most important source of product evaluation and improvement. Feedback is gathered through a variety of sources, including informal comments received by product staff, help desk support calls, training and implementation staff, sales personnel, online user communities, beta clients, advisory panels, and user conferences. With all of these avenues established, vendors appear to attempt to make it as easy as possible for current users to report potential issues as well as seek guidance from other users and the vendor alike.

“A lot of feedback and questions are often turned into enhancements, as they speak to the user experience of the product.”

Review and Response

Once the vendors receive both internal and external feedback, they organize it through a formal escalation process that ranks the severity of the issue based on factors such as number of users impacted, type of functionality involved, patient safety implications, effects on workflow, financial impact to client, regulation compliance, and the source of the problem, either implementation based or product based. In general, safety issues are given a high-priority tag. Based on this escalation process, priorities are set, resources within the organization are assigned, and timelines are created for directly addressing the reported issue. Multiple responses are possible depending on the problem. Responses can include additional user training, software updates included in the next product release, or the creation and release of immediate software patches to correct high-priority issues throughout the customer base.

“Every suggestion is not a good suggestion; some things do not help all users because not all workflows are the same.”

Patient Safety

Adoption of health IT has the potential for introducing beneficial outcomes along many dimensions. It is well recognized, however, that the actual results achieved vary from setting to setting, (5) and numerous studies have reported health IT implementations that introduced unintended adverse consequences detrimental to patient care practice. (6) Surprisingly, in many interviews patient safety was not initially verbalized as a priority issue. Initial comments focused on creating a useful, usable EHR product, not one that addresses potential negative impacts on patient safety. Vendors rely heavily on physcians to notice potential hazards and report these hazards to them through their initial design and development advisory panels and postdeployment feedback mechanisms. After further questioning specific to adverse events, however, most vendors did describe having processes in place for monitoring potential safety issues on a variety of fronts. Some vendors become aware of patient safety issues through user feedback collected from patient safety offices and field visits; others educate support staff as well as users on how to identify potential patient safety risks and properly notify those who can address the issue. Once patient safety issues are identified, vendors address them in various ways, including tracking and reporting potential issues online, using patient safety review boards to quantify risk, and engaging cognitive engineers to uncover root causes.

When asked about client contracts, no vendors reported placing specific contractual restrictions on disclosures by system users of patient safety incidents that were potentially related to the EHR products, sharing patient safety incidents with other customers or other clinicians, or publishing research on how the EHR system affects patient safety or their clinical operations.

“Physicians are very acutely aware of how technology is going to impact patient safety; that’s their focus and motivation.”Role of Certification in Evaluating Usability

Current Certification Strategies

The issue of certification is one that elicited strong opinions from most vendors. Certification of any type represents an investment of time and money to meet standards originating outside the organization. For many vendors, particularly the smaller ones, this investment was seen as burdensome. Vendors commonly described the current CCHIT certification process as part of a larger “game” they must play in order to remain viable in the marketplace, not as a way to improve theirnproduct(s). Accounts of functions added specifically for certification but not used by customers were common, as well as specific
instances where vendors felt meeting certification guidelines actually reduced aspects of their product’s quality. As one vendor noted, sometimes providing the functionality for “checking the box” to meet a certification requirement involves a backward step and a lowering of a potentially innovative internal standard. As meaningful use has entered the picture, however, vendors are striving to provide their customers with products that will comply with this definition and plan to participate in any associated certifications.

“We don’t want to get dinged for an innovative standard that we’ve developed and [that] tested well with users because it doesn’t fit the criteria.”

Subjectivity

Interviewees held mixed opinions on whether the certification process can effectively evaluate the usability aspect of EHR performance. Without exception, participating vendors had concerns about the inherent subjectivity of evaluation of usability, which can be strongly affected by the past EHR experience of the user, the context in which the product is used, and even the education and background of the evaluator. Methods for overcoming these types of bias issues included suggestions such as certifying workflows rather than attempting to measure usability, comparing objective product performance (time and error rates) for specific tasks, or measuring usability based on end-user surveys instead of juror analysis.

“Some products may be strong, but due to the familiarity of jurors of a product or technology, some products may be overrated or underrated.”

Innovation

Several interviewees also expressed concern about the effect of usability certification on innovation within the EHR marketplace. This seemed to stem from experience with CCHIT’s feature- and function-based criteria. It was noted that in the developing EHR marketplace, current systems are striving to make significant changes in the way physicians practice care, which has inherent negative implications for perceived usability early in the product’s release. Guidelines or ratings that are too prescriptive may have the effect of forcing vendors to create technologies that more directly mirror current practices, a strategy that could limit innovation and the overall effectiveness of EHRs.

“Products are picked on the amount of things they do, not how well they do them. CCHIT perpetuates this cycle; if a product contains certain functions, it is placed among the elite. That has nothing to do with usability.”

Recognized Need

Despite these concerns, vendors recognized the role certification could play both as an indicator to support customers in selecting EHRs and as a method through which established standards could be disseminated across the industry. While there is unease about the details of the conduct of certification, many vendors thought that some form of certification or evaluation had the potential to serve as a complement to what is now a predominantly market-driven issue. While each vendor viewed itself as a leader in the development of usable EHR systems and supported the role of consumer demand in continuing to improve product usability, vendors recognized that there could be utility to more standardized testing that could be evenly applied throughout the industry.

“Being aware of standards and guidelines is very important, but we also want to make sure we are not hamstrung by them.”

Conclusion

All vendors interviewed expressed a deep commitment to the continued development and provision of usable EHR product(s) to the market. Vendors believe that as features and functions become more standardized across the industry, industry leaders will begin to differentiate themselves from the rest of the market based on usability. Current best practices and standards of design, testing, and monitoring EHR product(s), particularly for usability, are varied and not well disseminated. While models for vendor collaboration for issues such as interoperability currently exist through EHRA and IHE (Integrating the Healthcare Enterprise), collaboration among vendors with regard to usability is almost nonexistent. Given the current move toward the adoption and meaningful use of health IT, and the role usability plays in realizing intended benefits, a transition from the current environment seems likely. This could be driven by many sources, including standards developed by academic research, certification required by government entities, collaboration through a nonprofit association such as EHRA or IHE, or simply market pressures demanding more usable offerings. Vendors recognize these pressures and the importance of usability to the continued success of their products. Disagreement exists as to the ideal method for ensuring that usability is evaluated and communicated across the industry as well as to customers. This disagreement exists even within companies, as well as across vendors. Regardless of this uncertainty, there is agreement that end users need to remain a central component within the development process, innovation needs to be encouraged, and usability needs to be a critical driver of efficient, effective, and safe EHRs.

Implications and Recommendations

The summary interview findings were distributed to selected experts in the field, who provided additional thoughts on the implications of these discussions and developed recommendations based on the discussions. A summary of these suggestions follows.

Standards in Design and Development

Increase diversity of users surveyed for pre-deployment feedback. While the use of subject-matter experts and inclusion of end-user feedback in the design and development process are beneficial and important approaches, the end-user selection process currently in use has a potential for bias. Vendors noted extensive use of volunteered feedback. Clinicians with a strong interest in technology, the ability to evaluate usability, and the patience to provide regular feedback are not indicative of the typical end user. Additionally, as these types of clinicians are commonly found in academic medical centers, they may rely on residents or other trainees to do most of the work involving the EHR. Similar issues exist when soliciting input from users familiar with the existing EHR; these users have potentially learned, sometimes unconsciously, to work around or ignore many of the usability problems of the current system. To some extent, vendors must utilize this “coalition of the willing” to gather feedback, given the extremely busy schedules of most practicing clinicians. However, steps must be taken both in the vendor community and by independent bodies to encourage inclusion of a more diverse range of users in all stages of the design process. This more inclusive approach will ultimately support a more usable end product.

Support an independent body for vendor collaboration and standards development. Lack of vendor collaboration resulting from attempts to protect intellectual property and uphold a competitive edge is understandable. However, with the accelerated adoption timeframe encouraged by recent legislation and increasing demand, letting the market act as a primary driver to dictate usability standards may not ensure that appropriate standards are adopted. The user base currently has relatively limited abilities to accurately determine product usability before purchase and, if dissatisfied after purchase, may incur significant expense to explore more usable products. Simply deeming an EHR usable or not usable does not create or disseminate standards and best practices for design. The market can provide direction, but more must be done to document trends and best practices, create new standards for design, and regulate implementation across the industry.

Develop standards and best practices in use of customization during EHR deployment. Customization is often a key to successful implementation within a site, as it can enable users to document the clinical visit in a way that accommodates their usual methods and existing workflow. However, customization may also serve to hide existing usability issues within an EHR, prevent users from interacting with advanced functions, or even create unintended consequences that negatively impact patient safety. There is an additional concern that customization may negatively impact future interoperability and consistency in design across the industry. Customer demand for customization exists and some level of customization can be beneficial to supporting individual workflows; however, more work must be done to evaluate the level of customization that maximizes the EHR’s benefits and limits its risks.

Usability Testing and Evaluation

Encourage formal usability testing early in the design and development phase as a best practice. Usability assessments can be resource intensive; however, it has been demonstrated that including them in the design and development phase is more effective and less expensive than responding to and correcting items after market release.7 Identifying and correcting issues before release also reduce help desk support and training costs. Vendors indicated an awareness of this tradeoff and a move toward investment in usability assessment up front. Further monitoring will be required to evaluate how the vendor community incorporates formal usability testing within future design and development practices.

Evaluate ease of learning, effectiveness, and satisfaction qualitatively and
quantitatively. Observations are an important component of usability testing but are insufficient for assessment of the root cause of usability issues. Alternatively, quantitative data such as number of clicks, time to complete tasks, and error rates can help the vendor identify tasks that may present usability issues but must be further explored to identify underlying issues. A mix of structured qualitative and quantitative approaches, incorporating at minimum an assessment of the three basic factors directly contributing to product usability—ease of learning, effectiveness, and satisfaction—will serve to broaden the impact of usability assessments beyond the informal methods commonly employed today.

Postdeployment Monitoring and Patient Safety

Decrease dependence on postdeployment review supporting usability assessments. Usability issues are usually not simple, one-function problems, but tend to be pervasive throughout the EHR. So while small-scale issues are often reported and corrected after deployment, the identified issue may not be the primary determinant of a product’s usability. It is chiefly within the main displays of information that are omnipresent, such as menu listings, use of pop-up boxes, and the interaction between screens, that the EHR’s usability is determined. Even with the best of intentions, it is unlikely that vendors will be able to resolve major usability issues after release. By not identifying critical usability issues through a wide range of user testing during design and development, vendors are opening the door to potential patient safety incidents and costly postrelease fixes.

Increase research and development of best practices supporting designing for patient safety. Monitoring and designing for patient safety, like usability testing, appear to be most prevalent late in the design of the product or during its release cycle. Vendors’ heavy reliance on end users or advisory panels to point out patient safety issues in many ways mirrors the informal methods used to advance usability of their products. While patient safety similarly lacks specific standards for vendors to follow, vendors are currently collaborating on patient safety issues. These collaborations appear to be in their early stages, but they provide an opportunity toenhance vendor awareness and vendor response to potential patient safety issues within their products and improve their ability to incorporate patient safety much earlier in the design process. Further work must be done to directly connect design to patient safety and ensure that standards are created and disseminated throughout the industry.

Role of Certification in Evaluating Usability

Certification programs should be carefully designed and valid. Any certification or outside evaluation will be initially approached with questions as to its validity, and the concept of usability certification is no exception. Usability is a complex multifaceted system characteristic, and usability certification must reflect that complexity. Further complicating this issue is the fact that vendors have already participated in a certification process that most did not find particularly valuable in enhancing their product. Driving the EHR market toward creation of usable products requires development of a process that accurately identifies usable products, establishes and disseminates standards, and encourages innovation.

References

(1). Belden J, Grayson R, Barnes J. Defining and Testing EMR Usability: Principles and Proposed Methods of EMR Usability Evaluation and Rating. Healthcare Information Management and Systems Society Electronic Health Record Usability Task Force. Available at:
http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf
Accessed June 2009.

(2). Armijo D, McDonnell C, Werner K. Electronic Health Record Usability: Interface Design Considerations. AHRQ Publication No. 09(10)-0091-2-EF. Rockville, MD: Agency for Healthcare Research and Quality. October 2009.

(3). Armijo D, McDonnell C, Werner K. Electronic Health Record Usability: Evaluation and Use Case Framework. AHRQ Publication No. 09(10)-0091-1-EF. Rockville, MD: Agency for Healthcare Research and Quality. October 2009.

(4). TechSmith. Morae: usability testing and market research software. Available at: http://www.techsmith.com/morae.asp .

(5). Ammenwerth E, Talmon J, Ash JS, et al. Impact of CPOE on mortality rates—contradictory findings, important messages. Methods Inf Med 2006;45:586-93.

(6). Koppel R, Metlay JP, Cohen A, et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA 2005;293:1197-203.

(7). Gilb T, Finzi S. Principles of software engineering management. Reading, MA: Addison-Wesley Pub. Co.; 1988

The report includes two appendices: Summary of Interviewed Vendors and Description of Electronic Health Records.

Vendors interviewed were
athenahealth, Inc. — athenaClinicals 9.15.1
Cerner Corporation – Cerner Millenium Powerchart/PowerWorks EMR 2007.19
Criterions, LLC — Criterions 1.0.0
e-MDs — e-MDs Solution Series 6.3
EHS — CareRevolution 5.3
GE Healthcare — Centricity Electronic Medical Record 9.2
NextGen — NextGen EMR 5.5
Veterans Administration –VISTA

See PDF file for complete report.

e-Healthcare Marketing

Health Information Exchange, Electronic Health Records and Personal Health Records

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