ONC Fact Sheet

ONC Fact Sheet:

2014 Edition Standards & Certification Criteria (S&CC)

Final Rule

Summary

The 2014 Edition S&CC final rule completes the Office of the National Coordinator for
Health IT’s (ONC) second full rulemaking cycle to adopt standards, implementation
specifications, and certification criteria for EHR technology. This final rule complements the
newly released Centers for Medicare & Medicaid Services (CMS) final rule which
establishes Stage 2 of the Medicare and Medicaid Electronic Health Record (EHR) Incentive
Programs, updates Stage 1, and includes other program modifications.
The 2014 Edition S&CC final rule reflects ONC’s commitment to reduce regulatory burden;
promote patient safety and patient engagement; enhance EHR technology’s interoperability,
electronic health information exchange capacity, public health reporting, and security;
enable clinical quality measure data capture, calculation, and electronic submission to CMS
or States; and introduce greater transparency and efficiency to the certification process.

Specific Highlights

The 2014 Edition S&CC final rule:

• Redefines the meaning of Certified EHR Technology as well as introduces more efficient
  means for certification to permit greater innovation and reduce regulatory burden;
• Adopts vocabulary, content exchange, transport, functional, and security standards in
  certification criteria;
• Adopts certification criteria for transitions of care that will ensure EHR technology
  supports standards-based electronic health information exchange;
• Requires that test reports used for EHR technology certification be made publicly
  available and that EHR technology developers follow certain price transparency
  practices related to the types of costs (i.e., one-time, ongoing, or both) associated with
  EHR technology implementation for meaningful use; and
• Makes available for the first time, “gap certification” for certain certification criteria, which will enable more efficient EHR technology certification.

Certified EHR Technology (CEHRT) Definition
The revised CEHRT definition enables providers to have the option to have only the EHR
technology they need to meet the meaningful use stage they seek to meet. Changes to the
CEHRT definition allow for providers to choose and customize the EHR technology that
works for them and their patients:

• For EHR reporting periods prior to the fiscal year (FY)/calendar year (CY) 2014, the
  final rule includes additional flexibilities for eligible providers. Eligible providers will be
  able to meet the CEHRT definition in any one of the following three ways:
  1. Adopt EHR technology certified to the 2011 Edition EHR certification criteria that
     meets all applicable certification criteria (the original CEHRT definition
     established in the S&CC July 2010 final rule);
  2. Upgrade parts of their 2011 Edition EHR technology to the equivalent 2014 Edition
     EHR technology (same as way # 1, but with a mix of EHR technology certified to
     either the 2011 or equivalent 2014 Edition); or
  3. Adopt EHR technology that meets the CEHRT definition for FY/CY 2014.
• For EHR reporting periods during and after FY/CY 2014, eligible providers will need to
  have EHR technology certified to the 2014 Edition EHR certification criteria that meets a
  required base amount of functionality and then any other functionality they need to
  achieve meaningful use.
• EHR technology certified to the 2014 Edition EHR certification criteria will be able to
  support an eligible provider’s attempt to achieve either meaningful use Stage 1 or 2.Improved Security, Interoperability, Data Portability, and Other Requirements
  Adopted in the 2014 Edition S&CC Final Rule

Privacy and Security

• Adopted a certification criterion that focuses on the encryption of health information if it is stored on end-user devices.
• Adopted a new certification criterion that would require EHR technology to be able to
  support corrections and amendments to a patient record.
• Adopted a new certification criterion that enables secure messaging between a provider
  and a patient.
• Adopted a new certification criterion that permits a patient to securely view, download,
  and electronically transmit his or her health information, including the ability to track the
  use of these patient capabilities.

Interoperability

• In many instances, certification criteria reference single vocabulary and context
  exchange standards for recording and representing clinical health information for use
  during electronic health information exchange.
• Adopted transport standards for the exchange of transitions of care/referral summaries
  as well as the transmission of patient summaries as part of the view, download, and
  transmit to a third party certification criterion.
• The “transitions of care” certification criterion focused on receipt was revised to include
  the display of previously adopted summary care record standards: CCD/C32 and CCR,
  providing a form of backwards compatibility.
• The test procedure for the transitions of care/referral certification criteria is expected to ascertain EHR technology’s ability to engage in standards-based exchange with any
  other EHR technology that has also implemented the adopted transport standards.
• Adopted a new certification criterion focused on improving the exchange of laboratory
  test results between hospitals and ambulatory providers as well as a certification
  criterion focused on the receipt of laboratory test results which references a common
  interface standard for ambulatory EHR technology.
• Adopted certification criteria that improve EHR technology’s ability to report information
  to public health agencies, including reporting cancer case information to cancer
  registries.

Data Portability

• Adopted a new certification criterion that will enable providers to create a set of “patient summaries.” In the event a provider switches EHR technology, this capability will help
  prevent the need to manually re-enter basic patient information into the new EHR.

Safety and Usability

• Adopted two new certification criteria related to patient safety – one that focuses on the application of user-centered design to medication-related certification criteria and
  another that focuses on the quality management system (QMS) used during the EHR technology design.

Clinical Quality Measures

• Adopts three certification criteria for clinical quality measures (CQMs) that focus on
  electronic data capture, calculation, and enabling electronic submission of CQM data to
  CMS.

Reducing Regulatory Burden and Increasing Flexibility

• The final rule allows for EHR technology that had been certified to the 2011 Edition to
  be used through 2013.
• Newer versions of adopted minimum standards code sets can be efficiently used for
  certification and routinely incorporated into EHR technology without requiring additional
  certification.
• Adopted a requirement that will make EHR Module certification more efficient than
  previously established under the temporary certification program.

EHR Technology Price Transparency

• To promote transparency and limit purchasing confusion, the final rule requires ONCACBs
  (authorized certification bodies) to ensure that an EHR technology developer
  notifies eligible providers about additional types of costs (i.e., one-time, ongoing, or
  both) that affect a certified Complete EHR or certified EHR Module’s total cost of
  ownership for the purposes of achieving meaningful use.

Test Result Transparency

• The final rule requires that ONC-ACBs (authorized certification bodies) submit a
  hyperlink of the test results used to issue a certification to a Complete EHR or EHR
  Module. This transparency requirement enables providers to access the test results
  used to certify EHR technology and provides a potential starting point from which to
  assess any implementation issues associated with certified Complete EHRs and
  certified EHR Modules.
• Test results will be made publicly available on ONC’s Certified HIT Products List (CHPL)
  along with all of the other information ONC-ACBs report to ONC.