Centers for Disease Control(CDC) National Committee on Vital and Health Statistics (NCVHS) Work Group on the Health Insurance Portability and Accountability Act (HIPAA) of 1996
Thank you for the invitation to participate in this panel. I am representing 3M Health Information Systems, a private information systems vendor supplying clinical-based information systems to nearly 4,000 hospitals, health networks, and managed care organizations.
During the last several years, we have seen an accelerating trend among care delivery organizations to combine and integrate their operations. One consequence of such integration is the need to share information that is being gathered in a variety of ways from multiple settings. Clinicians need this shared data to make informed decisions about patient care. Organizations need it for outcomes research, data-driven clinical guideline development, and the growth of medical knowledge through data analysis.
One industry response to the need for data sharing has been the shift from monolithic systems to component architecture, with the goals of interoperability and information sharing across systems. This is a useful step in the right direction, but open architecture alone will not accomplish data sharing and data integration. The ability to share data is highly dependent on the existence of industry standards. Without standards, each connection to a different system becomes a complex, costly investment for providers and information system vendors, with the potential for the loss or corruption of data.
Ironically, as electronic systems proliferate and the need for standards increases, the effort to develop standards becomes more fragmented and competitive. The federal government may be the one body that can draw the line between areas that need to be standardized and those that are best developed in an open and competitive market.
Two components of the electronic patient record are key to the realization of data sharing: the coded vocabulary and the information model.
These two components are closely related. The information model depends on the coded vocabulary for concepts to “fill in” the description of a specific medical event.
Today, the industry is far from having standards for either of these components. For medical vocabularies, there are overlapping, competitive sources, but no single complete source containing all the data needed to support health information systems. In terms of information models, HL7 is a commonly used model for data messaging. However, there are efforts within CORBAMed and DICOM that overlap and compete with HL7.
In 3M’s Healthcare Enterprise Management System, the 3M Healthcare Data Dictionary is the source of the coded vocabulary and one of the vehicles used to link the vocabulary terms to the information model. Using the internal standards provided by the dictionary, this system successfully integrates data from multiple sources within an enterprise. But if all the information systems in the enterprise used a uniform set of standards, the development and support efforts now focused on interfaces and mapping could be directed toward advancing functionality and providing greater enhancements to the quality and efficiency of patient care.
We interpret the instruction from Congress as a request for guidelines and specific recommendations about how the federal government can take the lead in eliminating the chaos that now reigns in the area of data structure of electronic medical data.
There are currently no uniform standards because individual vendors creating parts of (or variations on) an electronic medical record all have different motivations and business needs. The Inventory of Clinical Data Standards illustrates how many organizations are working on ways to represent specialized subsets of patient data. But there is no coordination or collaboration among those organizations. In fact, in spite of their good intentions, they often end up competing with each other. This is partly because the field of overall medical record standards is too broad for most vendors to care about or deal with. In addition, consensus takes an enormous amount of time and effort, and a business organization must use its time and effort to address the specific markets and needs associated with its own products. Competition is a stronger motivation than cooperation in most cases. Even where standards organizations have grown out of the cooperative efforts of multiple vendors, any standards they develop can only be recommendations. No one, not even the organization’s members, is bound to adhere to them.
We think of the “private sector” as independent information system vendors and healthcare organizations whose combined role is to care for patients. With respect to the standards we’re focusing on today—coded vocabularies and information models—the private sector also includes several standards organizations and vocabulary content organizations. In the solution we’re recommending, each of these private sector groups has a specific role, as does the federal government. Our model allows the private sector to do what it does best—using its expertise, experience, and skills to develop standards for electronic exchange of information. But the private sector does not have the requisite unified motivation to agree on a single set of standards. So we propose that the government assume the role of providing a common motivation in those areas where there are currently conflicting agendas.
Existing standards organizations should continue to develop and maintain standards for an information model. Through open participation of all interested parties, these organizations are in a position to develop standards based on the real-world needs, knowledge, and experience of providers, healthcare organizations, and patients. In the same way, vocabulary content organizations also serve as skilled, practical developers of coded vocabularies.
The places where both types of organizations fall short are in reaching industry-wide consensus, preventing duplication, and being able to mandate and enforce standards. This is where government assistance can help.
Government participation could be useful when the private sector cannot reach agreement on which standards to apply across all organizations—where private agendas and competition get in the way of consensus and collaboration. The government could eliminate those roadblocks and provide valuable support in these ways:
The private sector should be responsible for developing software that uses, and adds value to, the selected standards. Private information systems vendors are equipped with the expertise as well as the motivation to respond quickly to the needs of healthcare providers. Vendors are in a position fill market needs and constantly improve technology to the greatest benefit of the industry.
If computer systems are to improve the quality of health care, they must be able to exchange data promptly and accurately, and to aggregate data in an efficient, cost-effective manner. Data sharing requires a common data model, and a defined vocabulary within the model.
Information systems businesses will move forward by creating software applications that add value to information that is already being collected, as opposed to investing development time in devising new ways to collect or share data. Here again, data sharing is the goal and the vocabulary and data model are the tools needed to reach the goal.
Delay in implementing standards means significant costs to vendors as well as healthcare providers. Whatever systems are developed and implemented now, based on vendor-specific standards, will have to be modified to exchange information using the uniform standards that are eventually adopted. The time, effort, and money invested by vendors and providers in the meantime are only temporary. And resources being put into those temporary solutions are not available for creating and implementing value-added applications or improving the quality and efficiency of patient care. Not only will development efforts have to be repeated, but data now being gathered will probably have to be restructured, translated, or reformatted in some way if it is to be used as part of the body of medical data to be analyzed and acted upon.
The four focus areas are good goal statements and guidelines but will need additional focus and action items specifically addressing
Focus area #4 should not be limited to medical records information but should include all types of data affected by the standards.
As a health information systems vendor, 3M recommends that the government assist in the establishment of standards for electronic patient records by mandating a standard composite vocabulary and a standard information model. These standards should be selected from existing, proven technologies, with the help of industry-wide collaborative standards organizations. The standards should be mandated for use in government as well as private information systems. And the government should fund and oversee a process and organization to provide ongoing maintenance and progress of the selected vocabulary source.