2015 Edition EHR Certification Criteria to be Voluntary, Proposes HHS

HHS has proposed that the 2015 Edition Electronic Health Record (EHR) certification criteria be voluntary for participants, in an effort to implement a more frequent rulemaking approach that provides EHR technology developers more time to create and plan products. The Agency’s notice of proposed rulemaking with comment period, which is scheduled to be published February 26, 2014, sets forth how it plans to implement its frequent rulemaking approach, the benefits of frequent rules, 2015 Edition EHR certification criteria provisions, and the cost of implementing the 2015 Edition.

Purpose

HHS believes that a more frequent rulemaking approach would help manage the length of time it takes to publish updates to certification regulations and the consequent amount of time it takes EHR technology developers to create and release EHR products. The current two to three-year regulatory cycle was found to be sub-optimal, as it limits health IT developers from creating effective programs and EHR technology developers’ ability to plan development and product releases. Consequently, HHS proposes a 12 to 18 month increment for publishing proposed and final rules. While some incremental rules would need to be voluntary, such as the 2015 Edition, the Office of the National Coordinator for Health Information Technology would be better able to: (1) adapt to regulations more effectively and efficiently; (2) create “bug fixes” for regulations more quickly, (3) plan for “enhanced interoperability, information exchange, quality improvement, patient engagement, and patient safety;” and (4) release smaller regulatory requirements that are easier for technology developers to integrate into software development cycles. The benefits for technology developers include: (1) new capabilities, standards and implementation guides that encourage interoperability; (2) certification criteria that inspires innovation, new market opportunities and more choices for the electronic health information exchange; and (3) earlier implementation for regulatory updates, leading to greater efficiency.

Major Provisions

The proposed 2015 Edition adopts about 60 percent of the 2014 Edition EHR certification criteria. However, the remaining certification criteria proposals include: (1) clarifying regulatory text revisions, including frequently asked questions; (2) adopting or referring to voluntary consensus standards, except OMB Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, transport standards, standards that identify data elements referenced in clinical quality measures, and protection of electronic health information standards; (3) restructuring that makes certification criteria more clear and improves market opportunities for stakeholders; and (4) a few new certification criteria proposals to provide for new functionality.

Costs

According to HHS, the proposed rule is not economically significant, as overall costs total less than $100 million in a year. Because the 2015 Edition certification criteria is not mandatory, the agency does not believe that a large amount of EHR technology developers will seek to be tested and certified to the 2015 Edition. HHS anticipates that the cost of development and preparation for the 2015 Edition would be split over the course of 2014 and 2015. The total average development and preparation costs for EHR technology developers are estimated to be $56.46 million. The high cost estimate is $93.26 million over 2014 and 2015, and the low cost estimate is $19.65 million.