HealthIT Standards 101

This started out as a single article, but after I got through the first section, it's clear that this has become a series.  What I wanted to accomplish is to provide Executive, IT Managers and Implementers of Healthcare IT with an overview of applicable Healthcare Standards, along with a brief explanation of their key features and how they work.  This first post provides an overview for the series. 

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Health IT Standards 101

There are a variety of standards used in the Healthcare Industry to enable interoperable exchange of information.  IEEE (a standards and professional organization) originally defined interoperability (in perhaps the most oft-quoted definition in Health IT standards) as:

The ability of two or more systems or components to exchange information and to use the information that has been exchanged.

A more customer focused definition comes from the IEEE website:

Ability of a system or a product to work with other systems or products without special effort on the part of the customer. Interoperability is made possible by the implementation of standards.

I really like this definition, because it talks about the impact of the standard on the part of the consumer, rather than the innards.  The standards these definitions speak of are standards for information and communication technology.  These are often referred to as IT Standards, ICT Standards (more common outside the US), or even more specifically, Healthcare IT Standards.

There are a variety of different kinds of standards.  Standards can be classified based upon the functionality standardized, the syntax that they use, or their purpose of use. Putting each of these into context:

·        Functionally:
IT standards can support transport of communications between systems, define the content used in exchanged, or describe particular computations or operations performed by a system. I covered some of this classification model in a previous post.

·        Syntactically:
The standards can use traditional text-based forms of electronic data interchange (EDI), use XML, ODL, IDL or UML, or binary data formats (e.g. ASN.1) for exchange.

·        Purpose:
Health IT standards can support treatment, payment or operations, or a combination of those.

Who creates Standards?

Standards are developed by a variety of Standards Development Organizations (SDOs).  Interestingly enough, there are few “standard” definitions for the term SDO.  The American National Standards Institute (ANSI) is a body that accredits (essentially certifies) standards bodies, based on a number of rules.  They describe an SDO as including professional societies, industry and trade associations and membership organizations that develop standards within their area of expertise.  That’s a bit weak, since it doesn’t really define other than by who engages in the activity.  The US government does have a pretty good definition which I’ve summarized in the section on Government Participation below.

People involved in the development of standards include:

·        Health IT Developers (geeks like me)

·        Healthcare Providers

·        Policy Makers and Influencers

·        Consumers and Consumer Advocates

Sadly, the most under-represented population is consumers of Healthcare and their advocates.

The major developers of Healthcare IT related standards in relevant to the US include:

·        Health Level Seven International (HL7) [various]

·        Digital Imaging and Communication in Medicine (DICOM) [Imaging]

·        Accredited Standards Committee (ASC) X12 [Insurance Transactions]

·        National Council for Prescription Drug Programs (NCPDP) [ePrescribing]

·        Regienstrief (LOINC) [Laboratory Vocabulary]

·        International Health Terminology SDO (IHTSDO) [Clinical Terminology]

·        International Standards Organization (ISO) [various]

·        ASTM International (ASTM) [various]

·        Institute of Electrical and Electronics Engineers (IEEE) [Medical Devices]

Other IT standards organizations have a major impact on Healthcare, including:

·        World Wide Web Consortium (W3C) [XML, HTML]

·        Internet Engineering Task Force (IETF) [Internet]

·        Organization for the Advancement of Structured Information Standards (OASIS) [Business use of XML]

What other kinds of organizations are Involved?

Profiling bodies don’t necessarily create standards, but instead show how to use existing standards to support solutions to specific use cases in implementation guides (or profiles).  While these organizations don’t claim to create standards, they often are very hard to distinguish from an SDO. 

·        Integrating the Healthcare Enterprise (IHE) [EHR, HIE, and various Medical Specialties]

·        Continua Health Alliance [Home Health Devices]

·        CAQH/CORE [Payer Transactions]

·        ONC Standards and Interoperability Framework (S&I) [EHR]

Industry Associations play an important role in the promotion of Healthcare IT standards.

·        Electronic Health Records Association (EHRA) [EHR]

·        NEMA [Imaging]

·        Workgroup for Electronic Data Interchange (WEDI) [Payer Transactions]

Professional Societies also play an important role:

·        Health Information Management  Systems Society (HIMSS)

·        American Health Information Management Association (AHIMA)

US Government Involvement

The US government advocates for, uses, participates in, develops and mandates the use of standards.

According to the US government, a standards development organization is a body, international or domestic, that provides an open and balanced forum for the planning, development, establishment, or coordination of voluntary standards through a consensus based process (paraphrased from OMB Circular A-119, last revised in 1998 and now under review).  In the US the use of voluntary rather than government mandated and/or created standards are preferred by law (see notes under UTILIZATION OF CONSENSUS TECHNICAL STANDARDS BY FEDERAL AGENCIES in 15 USC 252).

Most of the Federal Agencies involved in Health IT standardization operate within Health and Human Services (HHS), and include (not a complete list):

·        Centers for Medicare and Medicaid Services (CMS),

·        Centers for Disease Control (CDC),

·        Food and Drug Administration (FDA),

·        Office of the National Coordinator for Healthcare IT (ONC), and

·        National Library of Medicine (NLM)

·        Others (see the HHS Org Chart)

Other agencies involved include:

·        Veterans Administration (VA)

·        Department of Defense (DOD)

·        National Institute of Standards and Technology (NIST)

The DOD and VA are major procurers of Healthcare and Healthcare IT.  NIST is involved from the perspective of standards development, certification and testing.

CMS, ONC, and FDA are major regulators of Healthcare IT, and require the use of certain standards in a variety of regulations.  Major regulations promoting the use of Health IT standards include:

·        Transactions and Standards Rules [CMS/HIPAA]
Mandates the use of X12, NCPDP, ICD, NDC and CPT for Claims Transactions

·        ePrescribing Rule [CMS/Medicare Part D]
Mandates the use of NCPDP Standards for ePrescribing

·        Meaningful Use Incentives [CMS/HITECH]
Requires the use of certified EHR systems which implement standards.

·        Meaningful Use Standards and Certification [ONC/HITECH]
Defines requirements of EHR systems for certification.

ONC is both a regulator and a developer of standards through its “Standards and Interoperability Framework” program.  It develops implementation guides through a consensus process that it has defined; promotes them to the HIT Standards Federal Advisory Committee (which it appoints), requires them to be used by State HIE organizations it has funded through HITECH grants, and proposes them for use in Federal regulation.

Subsequent posts will address

·        EDI and related Standards (including HL7, X12 and NCPDP)

·        XML Based Standards (including HL7 CDA and V3)

·        Vocabulary Standards (ICD, SNOMED, RxNORM, NDC, LOINC, CPT)

·        Profiles of Standards (IHE)