ONC targets interoperability, privacy in proposed rule

07 Oct 2015 1:24 PM | Brian Kelley (Administrator)

By Joseph Conn  | March 20, 2015

Electronic health-record interoperability is at the heart of the Office of the National Coordinator for Health Information Technology's half of a two-pronged federal rule-making effort announced Friday. 

The new rule covers the next phase of the government's $28 billion EHR incentive payment program. The ONC portion deals with the technical aspects that EHR developers must meet for their systems to quality for use in the program. A tandem rule for Stage 3 meaningful use also was released Friday by the CMS covering providers' use of the technology.

The ONC portion takes dead aim on achieving interoperability, a goal set by Congress in 2009 that has been on the back burner as regulators initially focused on promoting EHR adoption. 

The proposed new rule “identifies how health IT certification can support the establishment of an interoperable nationwide health information infrastructure” and also lists nine priorities. 

Topping the list is a proposal to adopt “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.” 

It also specifies use of the Consolidated Clinical Document Architecture, or C-CDA, an exchange standard developed by Health Level 7, a not-for-profit healthcare standards development organization.

The rule also listed as a top priority facilitating the exchange of healthcare data through “application programming interface capabilities,” which would make the use of APIs a testing and certification requirement. APIs are essentially software intermediaries that allow different devices and systems to understand each other and to share data.

The shift in emphasis to interoperability was foreshadowed in January when the ONC issued a 10-year “Interoperability Roadmap” that, among other things, set as a target the selection, adoption and widespread use and exchange of a common set of electronic clinical information at the nationwide level by the end of 2017. 

Using federal persuasion to move the healthcare industry toward the widespread use of APIs was a key recommendation in a 2014 report by a panel of scientist/advisors known as the JASON, which looked at interoperability problems confronting the healthcare industry under contract with the Agency for Healthcare Research and Quality. 

A modified version of the JASON recommendations are being explored by a consortium of several large healthcare providers and major health IT developers known as the Argonaut initiative. 

Another priority in the new rule is the required adoption of technology known as data segment for privacy, or DS4P, which uses so-called metadata tagging to earmark certain data for special handling in compliance with federal and state privacy laws. 

One particularly stringent healthcare privacy law, known as 42 CFR Part 2, requires that providers obtain the consent of patients in federally funded drug and alcohol treatment programs each time their medical records are disclosed to another healthcare organization, even for treatment, payment or other healthcare operations. DS4P technology enables the attachment of those consents—or constraints—to patient's electronic records. 

The ONC noted DS4P technology has moved from the drawing board into use by providers, pointing out that a Florida organization with DS4P technology “has saved some hospitals millions of dollars associated with the cost of care.” That's because “the patients they treat with substance abuse or behavioral health issues were able to send an electronic referral and get a discharge performed earlier in the process,” the rule makers wrote. 

Last year, a federal advisory panel recommended taking only “baby steps” toward requiring the use of DS4P technology in the EHR incentive payment program. 

ONC rule makers said they are proposing only an “initial step.” They're requiring qualifying developers to create EHRs that can apply privacy tags only to entire documents containing sensitive information, and that these documents can be sent and received with the tags. 

The ONC will not require vendors to develop systems that can tag discreet data elements within a record, such as a specific, sensitive prescription or lab test result, even though that's technically possible to do.

The 431-page ONC rule is slated for official publication in the Federal Register March 30, which will trigger a 60-day public comment period. A final rule is expected to be issued this year. 

Software in compliance with provisions of the 2015 Edition criteria won't be required for use by providers in the EHR incentive payment program until 2018, but, theoretically, the systems could be adopted as early as next year if vendors perform the upgrades and have their systems tested and certified to the new standards before then.

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