The HHS Office of the National Coordinator for Health Information Technology (ONC) has issued an advance release of a Proposed rule introducing a 2015 Edition of Health Information Technology (IT) Certification Criteria (2015 Edition), proposing a new 2015 Edition Base Electronic Health Record (EHR) definition, and modifying the ONC’s Health IT Certification Program to make it accessible to more types of health IT and health IT supporting various care and practice settings.
The 2015 Edition Proposed rule would also establish the capabilities, standards, and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to achieve meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs).
The Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (the Recovery Act) (P. L. 111–5), was enacted on February 17, 2009. The
HITECH Act amended the Public Health Service Act (PHSA) (42 U.S.C. 201 et. seq.) and created “Title XXX – Health Information Technology and Quality” to improve health care quality, safety, and efficiency through the promotion of Health IT and electronic health information exchange. Section 3001(c)(5) of the PHSA (42 U.S.C. sec. 300jj-11) provides the National Coordinator with the authority to establish a certification program or programs for the voluntary certification of health IT.
On July 28, 2010, HHS issued a Final rule adopting the initial set of standards, implementation specifications, and certification criteria and realigning them with the final objectives and measures established for the Medicare and Medicaid EHR Incentive Programs Stage 1 (75 FR 44590), referred to as the “2011 Edition Final rule.”
On September 4, 2012, a Final rule was issued to adopt the 2014 Edition set of standards, implementation specifications, and certification criteria and realign them with the final objectives and measures established for the EHR Incentive Programs Stage 2 as well as Stage 1 revisions (77 FR 54163), referred to as the “2014 Edition Final rule.”
Then, on September 11, 2014, another Final rule was published which revised the 2014 Edition EHR certification criteria to provide flexibility, clarity, and enhance health information exchange (79 FR 54430), referred to as the “2014 Edition Release 2 Final rule.”
2015 Edition certification criteria
HHS’ 2015 Edition Proposed rule builds on this prior rulemaking to facilitate greater interoperability and enable health information exchange through new and enhanced certification criteria, standards, and implementation specifications. HHS believes that these changes will spur innovation, open new market opportunities, and provide more choices to providers when it comes to electronic health information exchange. To achieve these goals, the 2015 Edition Proposed rule would:
- improve interoperability for specific purposes by adopting new and updated vocabulary and content standards for the structured recording and exchange of health information, including a Common Clinical Data Set composed primarily of data expressed using adopted standards; and rigorously testing an identified content exchange standard (Consolidated Clinical Document Architecture (C-CDA));
- facilitate the accessibility and exchange of data by including enhanced data portability, transitions of care, and application programming interface (API) capabilities in the 2015 Edition Base EHR definition;
- establish a framework that makes the ONC Health IT Certification Program open and accessible to more types of health IT, health IT that supports a variety of care and practice settings, various HHS programs, and public and private interests;
- support the Medicare and Medicaid EHR Incentive Programs through the adoption of a set of certification criteria that align with proposals for Stage 3;
- address health disparities by providing certification standards for the collection of social, psychological, and behavioral data; for the exchange of sensitive health information; and for the accessibility of health IT;
- ensure all health IT presented for certification possess the relevant privacy and security capabilities;
- improve patient safety by applying enhanced user-center design principles to health IT, enhancing patient matching, requiring relevant patient information to be exchanged, improving the surveillance of certified health IT, and making more information about certified products publicly available and accessible;
- increase the reliability and transparency of certified health IT through surveillance and disclosure requirements; and
- provide health IT developers with more flexibility and opportunities for certification that support both interoperability and innovation.
The 2015 Edition Proposed rule will publish in the Federal Register on March 30, 2015. Comments on the Proposed rule may be submitted through May 29, 2015.