by William Edward Hammond , PhD, Charles Jaffe , MD, PhD, and Rebecca Daniels Kush , PhD
Technical standards are essential to improving healthcare. For health IT to reduce medical errors and risk to patient safety, improve access to medical records, and support innovations in “individual-based” care, its tools must adhere to certain data interchange standards. Standards also enable aggregation of information from disparate sources and sophisticated reviews of such information to glean knowledge that can inform clinical decisions.
Since the mid-1980s, a number of organizations have formed to develop such standards. Often these standards developing organizations (SDOs) form because of a perception that a new requirement is not met by an existing organization. The unfortunate result is a multitude of SDOs, which risks generating industry confusion over standards adoption rather than enhancing interoperability among disparate communities.
The multiplication of organizations happens naturally enough. At the time of an SDO’s creation, the reasons and need for it seem realistic, at least to the individuals creating the organization. Over the subsequent years, its scope widens to meet the needs of its domain. Globally, similar SDOs are created to meet national and regional requirements.
There has been limited collaboration to date. However, collaboration in the generation of harmonized standards from the very onset of development can be mutually beneficial, complementary, and valuable to the entire industry. The success of this approach is exemplified by the relationship of Health Level Seven (HL7) and the Clinical Data Interchange Standards Consortium (CDISC).
Recognizing common interests, the two organizations agreed to share resources and build upon common interests. Joint work groups serve as forums in which members of both organizations harmonize standards and work together on common products.
The Value of Collaboration
Collaboration can save the standards developing community resources and improve the quality of the standards they develop.
Most of the healthcare and informatics community feel that standards developing efforts have been unnecessarily delayed and often are achieved with disappointing results. There are many gaps in the set of needed standards. One challenge is limited resources.
Most standards development organizations only meet face-to-face a few times each year. Clearly, volunteer time is a precious commodity, and staff contributions to the production and support of standards generation varies. The need to expand scope to address the gaps and to produce standards more efficiently requires an increase in paid staff, which cannot be achieved without an increase in revenue. In existing models, these funds have been almost exclusively generated from membership dues and educational fees.
Simple management of an SDO also requires increasing resources. Unfortunately, resources are limited, as funding, staff, and volunteers are stressed. This is invariably exaggerated with SDOs competing for those funds.
However, there is significant value to working together. This is true not only from the point of view of resource management and increased efficiencies, but also by ensuring harmonized and noncompetitive standards. For example, CDISC and HL7 have effectively increased the number of face-to-face meetings and teleconferences through collaboration.
Collaboration also leads to greater consistency in the standards produced. A global common information model and a common data model invariably increase consistency across standards. Reuse of models and tools provides a direct benefit for the organization and the end user. Consistent and compatible standards are a consequence of common models.
Collaboration also leads to the development and sharing of common tool sets. This is particularly true in those circumstances in which standard development is based upon common models and a common methodology.
Most SDOs in the US have a different standards development approach based upon the origins and focus of the organization. For example, the National Council for Prescription Drug Programs includes principally individuals from the prescription drug reimbursement domain. CDISC is largely comprised of biopharmaceutical and academic clinical researchers and technology and service providers for clinical research. HL7 is represented by government agencies, health IT vendors, and care providers. The standards organization X12 is almost exclusively limited to payers focused on claims reimbursement.
As a consequence, a natural duplication or overlap of requirements and desired uses for standards evolved. At times, standards developed by each entity became more duplicative and ultimately more disparate and competitive. When SDOs collaborate in the production of standards, the end user always profits from the shared expertise across these often artificial boundaries.
Benefits to End Users
Ultimately, SDO collaboration results in the creation of a single standard for a single specific purpose, thereby reducing or eliminating competing and often unnecessarily duplicative standards. For the developer or end user, this collaboration removes the artificial decision of which standard to choose and implement. In the final analysis, the industry benefits and the motivation to more rapidly adopt and implement appropriate standards becomes much greater. Both vendors and users are able to plan a path for both adoption and deployment of these common standards.
SDOs working together in meaningful and complementary ways will benefit a number of different communities and stakeholders. For example, in a large technology company, standards enable faster development and more rapid time to market. This almost always achieves lower cost structures. Deploying standardized interfaces rather than customized ones in a vendor solution results in a software solution that also will be more scalable.
In a global biopharmaceutical company, the development and adoption of health information standards will enable better decision making, reduce redundancy and rework, enable more effective clinical research at lower cost, and bring better therapies to patients more rapidly. For regulatory authorities, standards improve reviews, enabling the use of standard tools for viewing data.
Within academic research institutions, sharing of research information is being encouraged through governmental funding agencies. These grants encourage improvement in the way biomedical research is conducted and promote the engagement of communities in clinical research. The most effective means of exchanging research data is through the use of common standards. Standards harmonization that enables the secure flow of clinical information from electronic health records can benefit clinical research studies, safety reporting, and other use cases.
For example, technical standards can ensure that a subset of appropriately de-identified data can be aggregated at an academic center or study sponsor site to assess the effectiveness or safety of a therapy. Standards for regulated clinical research (such as the CDISC Operational Data Model) are accompanied by an audit trail, allowing clinical study monitors or regulatory authorities or auditors to trace the data they receive in support of a marketing application back to its origin to ensure accuracy and integrity of the information they are reviewing before approving a new product.
Barriers to Collaboration
The barriers to collaboration are many. Most SDOs depend on volunteers, who often may have a limited view of the broad impact of standards development, either nationally or internationally. In addition, all SDOs take direction from their stakeholders, whether it be government, directorates, or customers. These stakeholders perceive value in very different ways, which places very competitive forces on overarching development strategy.
In addition, every SDO is motivated to produce key standards that are implemented widely. That drive for survival is perhaps the most important barrier to collaboration. In simple terms, an SDO can be driven by a fear of becoming irrelevant. Most groups are willing to address the issues of cooperation and collaboration, but turning that willingness into action is a consistent challenge. At the most simplistic level, the proposition of a merger may only mean that the more dominant SDO would be willing to oversee the dissolution of its competitor and the adoption of its own long-term strategy, leadership, rules, and governance.
Another barrier is the inherent belief that one organization’s end users are fundamentally different from those of another organization—for example, more limited in scope or more diverse. Most frequently this leads an SDO to reject initiatives that appear to be less relevant. Inclusion of nonhuman (animal) subjects is one such barrier that often leads to contentious opposition to collaboration.
Finally, a significant, often critical barrier is the difference in governance models, including policies for balloting and for publishing standards. In scope, one organization may support draft standards for trial use, while another does not provide for this option. Questions about leadership, work process, and joint work structures may be difficult to resolve. The treatment of intellectual property, particularly when shared, may become contentious. Even access to the shared standard, particularly if it is freely given to the public domain by one organization, may play havoc with the business model of the other.
Source:
Hammond, William Edward; Jaffe, Charles; Kush Rebecca Daniels. «»Healthcare Standards Development: The Value of Nurturing Collaboration «» Journal of AHIMA 80, no.7 (July 2009): 44-50.
