Wednesday, May 30, 2012

'Open' Health IT Standards

Mention standards and my eyes usually start to glaze over. However, standards can be exciting and do matter, especially to businesses, because they may have to ensure that their products interoperate with the dominant industry standards if they are to succeed. Where standards don't exist, a particular business may try to ensure the proprietary specifications they have been using to develop their own products become the industry standard that others must follow. This will give them an edge or head-start on their competitors. However, the optimum approach for both consumers and industry as a whole is for a truly collaborative and set of 'open standards' to emerge that all companies must adhere to.

The aim of 'open standards' is to have companies bring various implementations of products to market that comply with the industry standard. Consumers then benefit from this as companies compete to produce a range of standard compliant products for them differentiated by quality, price, and innovative new features.  With regards to information technology (IT) in particular, this also allows consumers to change products their using without losing data or facing significant conversion costs, thereby preventing lock-in to a particular vendor's product. Further, open standards tend to help protect against the emergence of monopolies that unfairly control the market.

Usage of the term 'open standard' varies considerably. There is agreement upon what constitutes a standard, but some disagreement on what is required for a standard to be considered open.

'Open' Terminology

·  Open Source Software - A software program in which the source code is available to anyone for use. It can be modified by anyone from its original design free of up-front license fees. The source code is available for review, modification, and sharing by the at-large community.
·  Open Standards - A set of specifications developed to define interoperability between diverse systems. The standards are owned and maintained by a vendor-neutral organization rather than by a specific commercial developer.
·  Open Systems - Hardware and/or software systems that use or adhere to 'open standards' and are interoperable to some degree.

Selected Characteristics of 'Open Standards'

The following are some key characteristics associated with 'open standards':

·       The standard must be owned and managed by an official standards development organization (SDO) or by an open group or consortium. It must not be owned or controlled by a single party, and no single party must have special rights to it.
·       The standard must be defined and managed according to an open process. Every interested party must be able to join the standardization process, which must be based on an open decision-making process, i.e. consensus.
·       The standard must be free to implement for all interested parties, without any royalty fee. Any patented technologies included in the standard must be licensed with royalty-free nondiscriminatory terms.
·       The standard specification document must be made publicly available, either free of charge or at a nominal fee.
·       Proper development and maintenance of an open standard should allow for some leeway with regards to granting vendors the right to add innovative extensions to the standard, as long as it doesn't ultimately lead to the subversion of a standard.
·       You can tell when an open standard has achieved success when it allows companies to produce competing instances of standard compliant products that can be substituted, not just in theory, but in reality.
·       It has been observed by some that many successful 'open standards' can usually point to several 'open source' implementations of the standard.

Standards can be classified according to their openness. For example, consider the following categories:

·       Closed: The standard is owned by a company and is kept secret.
·       Closed, but Disclosed: The standard is owned by a company but is made available to other companies and users.
·       Open de facto: There is a loosely managed 'open' participation process through which the standard is defined by collaborating organizations.
·       Open de jure: The standards are owned and managed by official international or national standards development organization (SDO).

Selected 'Open Standards' Organizations

The following is a list of some of the key organizations focused on 'open standards' for the information technology (HIT) and healthcare industries:

·        American National Standards Institute (ANSI) - The Institute oversees the creation, promulgation and use of thousands of standards, norms, and guidelines that directly impact businesses in nearly every sector – including information technology.
·        ASTM Continuity of Care Record (CCR) Standard - A core data set of the most relevant administrative, demographic, and clinical information facts about a patient.
·        Certification Commission for Health Information Technology (CCHIT)  - Accelerating the adoption of health IT established a practical definition of what capabilities are needed in EHR systems along with a system certification process.
·        Clinical Data Interchange Standards Consortium (CDISC) - Developing global, platform-independent data standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
·        Digital Imaging and Communications in Medicine (DICOM) - A global Information Technology (IT) standard designed to ensure the interoperability of medical images that is used in virtually all hospitals worldwide.
·        European Comittee for Standardization (CEN) - Provides a platform for the development of European Standards and other technical specifications. 
·        Health Information Technology Standards Panel (HITSP) - A cooperative partnership between the public and private sectors to harmonize and integrate standards that will meet clinical and business needs for sharing information between systems.
·        Health IT Standards Federal Advisory Committee  - Charged with making recommendations to the Office of the National Coordinator for Health IT (ONCHIT) on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information.
·        Health Level Seven (HL7) International - A leading global organization working on standards for interoperability of health information technology, with members in over 55 countries
·        International Health Terminology Standards Development Organization (IHTSDO)  - Owns and administers the rights to SNOMED CT and other health terminologies and related standards used by health systems around the world.
·        International Standards Organization (ISO) - A network of national standards institutes from countries around the world.
·        Logical Observation Identifiers Names and Codes (LOINC)  - A set of universal codes and names to identify laboratory and other clinical observations maintained by the Regenstrief Institute, an international health care and informatics research organization.
·        National Council for Prescription Drug Programs  - NCPDP creates and promotes the transfer of data related to medications, supplies, and services within the healthcare system through the development of standards and industry guidance.
·        NHIN Direct Project - This project is developing specifications for a secure, scalable, standards-based way to establish universal health addressing and transport needed to send encrypted health information directly to known, trusted recipients over the Internet.
·        Object Management Group (OMG)  - An international, 'open' computer industry consortium developing enterprise integration standards for a wide range of technologies. OMG’s modeling standards, including the Unified Modeling Language (UML) and Model Driven Architecture (MDA).
·        Open Embedded Software Foundation (OESF) - Promoting standardization of a common 'open'  Android-based framework and platform for embedded technology & solutions.
·        Open Group - Architecture & Standards  - A vendor-neutral and technology-neutral consortium, whose vision of Boundaryless Information Flow™ will enable access to integrated information based on open standards and global interoperability.
·        Organization for the Advancement of Structured Information Standards (OASIS) - A non-profit consortium that drives the development, convergence and adoption of open standards for the global information society.
·        Unified Medical Language System (UMLS) - Key terminology, classification and coding standards related to biomedical information systems and services.
·        World Wide Web Consortium (W3C) - An international community that develops standards to ensure the long-term growth of the Web. 

What other 'open standards' and standards development organizations (SDO) for the health IT industry should we know about? Send us your suggestions.

1 comment:

Grahame Grieve said...

Hi Peter

Open means several things; beyond a process, how is it made available? There's a wide variety of approaches to this covered in your list.

See for what a truly open standard means