The final rule detailing the 2015 edition certification criteria for EHRs, released Oct. 6, is structured differently from prior editions and focuses more on interoperability throughout the "care continuum," not just on the Meaningful Use program, according to officials with the Office of the National Coordinator for Health IT.
On a webinar Oct. 7, Michael L. Lipinski, ONC's division director for federal policy and regulatory affairs, pointed out that the edition supports the objectives of Stage 3 of the Meaningful Use program, but said that of the 19 new criteria, seven support care in other settings and uses, such as long term care and behavioral health.
Overall, the 2015 edition has 60 criteria, 16 of which are unchanged from 2014 and 25 revised from the 2014 edition.
Certification is now "module based" and requires health IT modules, not just EHR modules, according to Elise Sweeney Anthony, deputy director of ONC's Office of Policy. "There is no 'complete EHR'," she said. The goals of the 2015 edition require more rigorous testing of health IT exchange capabilities, explicit requirements for transparency of health IT and enhanced privacy and security requirements.
Some of the highlights include:
- The 2015 edition no longer includes policy to support the electronic health record incentive programs. The program is now "agnostic" so that any care setting can use this technology
- The edition not only supports Meaningful Use, but also other laws and programs, such as the Centers for Medicare & Medicaid Services' chronic care management services in the physician fee schedule
- Developers must provide information on additional types of implementation costs and limitations of their products
- Every health IT module will need to meet applicable privacy and security certification criteria
- ONC Authorized Certification Bodies now need to ensure that products can perform not just when tested but also once deployed
- Sexual and gender identity data was added to the demographics criterion.
Some proposed criteria, such as vital signs and work and industrial/occupational data, were not adopted.
The 2015 edition of certification criteria is required for Stage 3 in 2018, but providers can use it earlier. The 2014 edition can be used through 2017.
This version of the 2015 edition should not be confused with last year's "voluntary" 2015 certification criteria, which was widely decried and never implemented.
Certification has been receiving increased attention in recent months after two EHR systems had their certification is terminated for failing to continue to meet the EHR certification program requirements.
Sens. Bill Cassidy (R-La.) and Sheldon Whitehouse (D-R.I.) this week introduced a bill to help ensure that certified health IT systems work as promised. Under the legislation, the Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015, ONC would be required to set up a rating system and publish results on its website of product performance in three areas: security, usability and interoperability. Vendors would have to provide information on user practices that may inhibit interoperability. They also would be required to report on the performance of their health IT products every two years with fines assessed--and some products decertified--for those who do not report.