Since May of 2009, a Federal Advisory Committee called the HIT Standards Committee (HITSC) has been identifying standards that will help stakeholders select and meaningfully use electronic health record (EHR) systems.
What is a standard?
A standard (per the definition of the Healthcare Information Technology Standards Panel) specifies a well-defined approach that supports a business process and: (1) has been agreed upon by a group of experts; (2) has been publicly vetted; (3) provides rules, guidelines, or characteristics; (4) helps to ensure that materials, products, processes, and services are fit for their intended purpose; (5) is available in an accessible format; and (6) is subject to an ongoing review and revision process.
Mature standards are those with running implementations in diverse environments.
HITSC is charged with recommending standards, certification criteria, and implementation guidance, that will help accelerate interoperability in the context of the policy goals recommended by the HIT Policy Committee for the meaningful use of EHR systems. All stakeholders are represented – consumers, government, industry, payers, providers, and employers. HITSC has 4 working groups – Privacy and Security which focuses on technical security and data integrity; Clinical Quality which focuses on metrics that measure quality; Clinical Operations which focuses on the content and vocabulary standards that enable data exchange between organizations for quality measurement, clinical care, population health, and patient engagement; and Implementation which identifies and mitigates barriers to interoperability.
The Privacy and Security matrices specify the standards, certification criteria and implementation guidance recommended by the Committee to protect privacy and ensure data integrity. The work includes standards for products and standards for the infrastructure on which the products operate. The first matrix includes functionality, standards, a timeframe for adoption, and certification criteria. The second matrix includes functionality, standards, and implementation guidance. These spreadsheets include standards for authentication, authorization, auditing, access control, secure transmission, and exchange of documents. You’ll find an English description of the certification and implementation guidance here.
The Clinical Quality matrices specify the metrics, data types, and implementation guidance recommended by the Committee to measure quality – an important part of meaningful use. Of the 29 metrics listed, 17 are measures of quality which are being retooled by quality measure authors to be based on data elements captured in an EHR. Of the remaining 12, two are privacy/security related (Full compliance with HIPAA Privacy and Security Rules, Conduct or update a security risk assessment and implement security updates as necessary) and 10 are related to the adoption of EHR function (i.e. % of orders for medications, lab tests, procedures, radiology, and referrals entered directly by physicians through CPOE).
There are a number of stakeholders for quality data exchange:
- Measure definition entities such as the National Quality Forum, which endorses measures developed by various measure stewards.
- Providers who record clinical data in electronic health records.
- Data Collection Assistant entities such as Healthcare Information Exchanges which gather data from EHRs and transport it for a multitude of purposes.
- Quality Report Processing entities such as registry providers, performance analysis companies, or specialty societies which gather benchmarking data.
- Receiver entities which collect quality reports as part of a reimbursement process.
Among these stakeholders, you can imagine several kinds of data exchange:
- Transport of the new or revised definitions of measures from measure authors to all the other stakeholders in an unambiguous structured format rather than by verbal documents
- Transport from EHRs to existing Physician Quality Reporting Initiative (PQRI) registries and any new PQRI registries
- Transport from EHRs to CMS, where the EHR performs all filtering, aggregation, measure calculation, and measure submission functions
- Transport through an intermediary where the EHR performs filtering of data elements needed for the measure, but a third party “quality report processing entity” aggregates data, calculates, and submits the measure to CMS
- Transport through multiple intermediaries where the EHR generates data, but a “data collection assistant” intermediary filters data for the measure from all data of the patient, then submits relevant patient-level data to a “quality report processing entity” intermediary that aggregates, calculates, and submits the measure to CMS.
The HIT Standards Committee has recommended standards for 2-5, but these standards have varying degrees of maturity. The work of the next several months will be to fill gaps and accelerate adoption of the standards needed to support these exchanges.
The Clinical Operations matrices include standards and implementation guidance (health outcomes priority, meaningful use measure, subject area, 2011 implementation guidance, 2013 implementation guidance, and future trajectory) for clinical care and clinical quality. You’ll find plain English explanations of these standards here. You’ll find a description of all the “dependencies” (when a standard is selected there are often supporting standards required) here.
We welcome your thoughts about this work to accelerate interoperability. We’ve done our best to create a glide path from 2011 to 2015 which balances the need for secure interoperability, existing installed systems, and the change management required to embrace a more connected healthcare future.
– Dr. John Halamka, HIT Standards Committee Co-Chair
Tags: FACA, HIT Standards Committee
We need an endorsed and visible cross cutting national health data strategy to increase the value of data sharing in the near and long term. The lack of an articulated health data strategy that can be incrementally adopted within and across information domains and venues may lead to a missed opportunity to achieve the right value from health IT because of redundant and / or disparate approaches to defining what is shared.
The ARRA HITECH Meaningful Use legislation provides a rare opportunity to advance health IT in a systematic way to improve care delivery by addressing areas of inefficiency, waste, and poor quality, all which drive up healthcare cost and lead to less effective patient outcomes. To make the most of this opportunity, we must create national health data standards for health information exchange that transcends federal, state, and local and even global boundaries. The adoption of these standards must balance public health and individual benefits and recognize the reality of the timelines and costs for implementing vocabulary standards in patient care settings.
As testified by Girish Kuman Navani, CEO, eClinicalWorks, the foremost issue is not a lack of standards when it comes to the use of structured vocabulary necessary to achieve semantic interoperability, as there are many – LOINC, CPT, ICD, SNOMED, etc. The real issue is the lack of agreement on standardized vocabulary that is used across information domains, inclusive of patient care, quality, research, and financial needs.
In addition to many standards, there are many efforts to build subsets of vocabulary. To name a few, HIPAA (National Providers Identifiers, claims attachments), HITEP (quality data set), CDISC (clinical research), etc., each one having a focus on achieving a specific data sharing need. However, data (such as conditions, labs, medications) in each domain is intended to support the end to end process of managing health and needs to be the same when used in each domain. Otherwise, the same concept has to be captured in more than one way, which means more data entry and less data integrity. To effectively and economically share information, an overarching data strategy is necessary. This data strategy will precisely define vocabulary for health data, such as medications, test results, demographics, conditions, orders, etc. as well as potentially develop a “sweet spot” of the most valuable data elements to be shared and encoded. This more systematic approach to adoption of semantic interoperability will make data sharing easier and less costly, while maximizing the value it provides. As testified by Alan Bosworth, the government can also make sure that the vocabularies can be used legally and without warranties by all parties.
While the most commonly used and provider-friendly list of data vocabulary standards will accelerate use and adoption, having an endorsed and visible national health data strategy will substantively increase the value of health data. By establishing a minimum data set and content, health data captured at the point of care will be the same health data necessary to support indirect care functions.
Agree or Disagree:
7 
1 (+6)