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'Openness' In Health Care System Would Improve Results

Armen Hareyan's picture

American health care can be greatly improved by embracing "openness" throughout the health care arena. That is the principle finding of a new report, Harnessing Openness to Transform American Health Care, released by the Digital Connections Council (DCC) of the Committee for Economic Development (CED). The DCC has been developing the concept of openness in a series of reports.

"There are tremendous benefits to our society if we apply openness to health care," said Dr. Paul Horn, Chair of the DCC and former Senior Vice President, Research, IBM Corporation. "A major drawback of our current system is that information is not shared in a prompt way and we do not take advantage of contributions that researchers, medical professionals, and patients can make. This leads, for example, to a tremendous time lag between scientific medical advances and when they are generally used by medical professionals," Dr. Horn continued.

Several studies noted in the CED report have found that it takes 13-17 years for 14 percent of research findings to get into general medical practice. Harnessing Openness to Transform American Healthcare recommends greater openness through making information available under far less restrictive conditions and increasing the ability of others to contribute to it, so that, for example, research findings are more actively disseminated, become part of medical best practices, and improve patient outcomes.

For this report, the DCC decided to look at how "openness" was being or might usefully be employed throughout the healthcare arena. This area, which now constitutes approximately 16-17 percent of GDP, has long frustrated policymakers, practitioners, and patients. Bringing greater openness in different parts of the health care production chain can lead to substantial benefits by facilitating collaboration, speeding research, stimulating innovation, lowering costs, reducing errors, and closing the gap between discovery and treatment delivery.

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The report focuses in part on biomedical research and the disclosure of research findings, the processes for evaluating drugs and devices, the emergence of electronic health records, the development and implementation of treatment regimes by caregivers and patients, and the interdependence of the global public health system. Areas covered include (topic in bold):

Biomedical Research is being transformed by the success of the Human Genome Project (HGP). The HGP demonstrated the possibilities of mass collaboration and the beneficial results of allowing data to be accessed immediately and manipulated by researchers around the world. Other research projects have adopted this open model and are flourishing by encouraging collaboration, and sharing data, applications, and even network resources. The DCC recommends that the federal research agencies push further by enunciating clear policies favoring openness, funding further work on standards for protocols, formats, terminology and nomenclature that allow the sharing and manipulation of data, and supporting experiments with differing levels of openness to determine the optimal level of openness for research under various scenarios.

In Clinical Trials, questions about the openness of clinical trials have been raised vigorously over the last decade. Although the Food and Drug Administration (FDA) had long required the registration of clinical trials involving life-threatening interventions, there have been disputes as to the completeness of these registrations -- and about the lack of registration of other clinical trials. Advocates of greater openness here and around the world have been concerned not only about registrations, but also about access to trial results and, perhaps more important, to the data that underlie the results -- and whether the data will be available in a computable form. The report calls for greater availability of data from trials in electronic form to speed research and detect possible safety problems.

The use of Electronic Health Records (EHRs) raises new openness issues. Utilizing such records, caregivers at any location would have access to a patient's medical history. Results of tests and treatments could be added easily as they become available, thereby improving treatment, preventing duplicative testing, and reducing medical errors. Eventually, EHRs could be constructed including family medical histories, genomic and pharmacogenomic data, environmental exposures, lifestyle and other information, easing the way toward the "personalization" of treatment. The aggregation of such records and others could then facilitate the achievement of a genuine "evidence-based" medical system. Such records provide far richer data than clinical trials, and could serve as the basis for predictive models similar to those used in other scientific domains. Harnessing Openness to Transform American Health Care stresses these benefits but recognizes the need to protect patient privacy and data security if the potential gains from EHR's are to be realized.

The DCC believes that greater openness in software-controlled Medical Devices creates new opportunities and challenges. The history of practitioner innovation in scientific instruments and the malleability of software suggest the potential for a dramatic increase in practitioner-driven customization. The report recommends that the FDA begin an examination of how to benefit from the user-driven innovation while maintaining appropriate oversight for safety and efficacy.

"The United States has long been a leader in medical innovation and treatment. Health care continues to grow as a percentage of our economy. Future economic growth will benefit by greater openness in the field. The recommendations in Harnessing Openness to Transform American Health Care provide a way to greater access to information by more people, and more possibilities for them to contribute based on their own expertise and energy. It shows us a path to improve health care without great additional expense," said Charles Kolb, CED President.