In this new century, health care will again be transformed. During the last hundred years, medicine incorporated new science, new approaches to management, and new strategies for professional education. Great 20th century institutions were created: universities, research institutes, pharmaceutical companies, health insurance plans, hospital and clinic networks, government oversight agencies, and public health infrastructures. Extraordinary change and improvement occurred in the lives of many.

And during that remarkable period, even as we realized its benefits, society also discovered the limits of institutional medicine. The more science and applied technology we possessed, the higher our expectations became and the more we were frustrated when these expectations were not met. Practice variations, less–than–optimal outcomes of care, and life–threatening errors persisted despite the explosion of medical knowledge. We learned that the availability of new information does not necessarily improve — and may in fact diminish — the quality of care if practitioners do not have the tools to interpret and apply it effectively. The sophistication and complexity of our health care system introduced new costs, inefficiencies and workforce challenges. A payment system — birthed in the 1930s to pay for hospital services — proved to be inept at rewarding the comprehensive, coordinated, outcomes–oriented and patient–centered care suited to an aging population facing multiple chronic illnesses.

During the last hundred years, the patients changed too. In 1910, 13% of American adults had completed high school; today it's 84%. In today's information-based economy, the median new job requires 13.5 years of education. Prescription drug use has grown dramatically. Today more than 40% of Americans take prescription medicines on a daily basis, and one person in six takes three or more. In daily life, people are responsible for managing their own health. More patients seek out health information on the Web, in libraries, and on TV and try to assimilate it into their own care. The health care system built in the 1950s and 1960s is not the system we need or want for the 21st century.

We need to construct a health information environment that is based on safe, high-quality and efficient modern medical care. We are reminded of one of the remarkable stories from "Achieving Electronic Connectivity in Healthcare: A Preliminary Roadmap from the Nation's Public and Private-Sector Healthcare Leaders" published in July 2004 by Connecting for Health (www.connectingforhealth.org). Dr. J.T. Finnell was able to avert a dangerous medical error common to Emergency Departments across the country, thanks to a connected information environment at the Wishard Memorial Hospital. A patient complaining of crushing chest pain was admitted to the ER but was not able to recount his medical history. Typically a patient with symptoms suggesting a heart attack would have been given a blood thinner. Fortunately, attending physicians were able to access the patient's health records electronically from another institution, learning instantaneously that he had recently been treated for a head injury. Giving the patient a blood thinner would have put him at risk for bleeding in his brain and caused serious injury. With the right information, doctors were able to prescribe the appropriate treatment. The chest pain was relieved and turned out not to be a heart attack. Time, money, and possibly a patient's life were saved.

The urgency and importance of making this transformation to a better use of information and related technologies in the health system is very widely appreciated. Unacceptable rates of avoidable medical errors, as much as $300 billion in unnecessary expense, and continuing disparities in health care quality constitute a call to action to the health care system and to policymakers. We must act and we must act together now. Dozens of communities and innovative networks across America have begun implementing information exchange solutions ­ yet they are following no common pathway, no uniform standards, and have established no basis for eventual information exchange among them or with the important national information networks already in existence. A common framework is needed to guide and maximize the value of the enthusiastic efforts already in the field.

This document represents a collaborative — indeed a consensus — process among hundreds of the leading contributors to the American health care system. Some of us have worked together for several years under the umbrella of the Connecting for Health initiative. Others have participated actively in professional and industry associations, each of which represents hundreds and thousands of members, and we all chose to come together to seek common ground on this most essential strategy for modernizing and improving our health system. This document is based upon a collaborative effort of organizations that diverge on many issues of policy, business, and philosophy ­ except their shared belief in the importance of a new national framework for exchanging health information. We represent America's clinical leadership, academic institutions, health insurance plans, consumer and patient leaders, technology vendors, employers, and some of the foremost thinkers on information technology. This submission was crafted during seven weeks of intensive weekly work sessions and conference calls. The Markle Foundation's Connecting for Health leadership and staff organized and carried out the work of drafting the document and integrating the thoughtful input of the collaborative organizations listed below. An expansive, unprecedented network of collaborators generated the input, with specific and concentrated participation by:

• The American Health Information Management Association (AHIMA): the national association of health information management professionals. AHIMA's 50,000 members are dedicated to the effective management of personal health information needed to deliver quality healthcare to the public.
• The American Medical Informatics Association (AMIA): AMIA is dedicated to the development and application of medical informatics in support of patient care, teaching, research, and health care administration.
• The American National Standards Institute, Healthcare Informatics Standards Board (ANSI HISB): ANSI HISB provides an open, public forum for the voluntary coordination of healthcare informatics standards among all United States standard-developing organizations.
• The Center for Information Technology Leadership (CITL): CITL is a non-profit research group based at Partners HealthCare in Boston and supported by HIMSS that assesses the value of clinical information technologies to help provider organizations maximize the value of their IT investments, to help technology firms understand how to improve the value proposition of their healthcare products, and to inform national healthcare IT policy discussions.
• The Connecting for Health Steering Group (CFH): Connecting for HealthŠA Public Private Collaborative was conceived and is operated by the Markle Foundation and receives additional support from The Robert Wood Johnson Foundation. The Steering Group includes more than 60 diverse stakeholders from the public and private sector, committed to accelerating actions on a national basis to tackle the technical, financial and policy challenges of bringing healthcare into the information age.
• The eHealth Initiative (eHI): eHI is an independent, non-profit consortium of practicing clinicians, employers and healthcare purchasers, health plans, healthcare information technology vendors, hospitals and other healthcare providers, manufacturers, patient and consumer organizations, and public health agencies, whose mission is to improve the quality, safety and efficiency of healthcare through information and information technology.
• The Healthcare Information and Management Systems Society (HIMSS): HIMSS is the healthcare industry's membership organization exclusively focused on providing leadership for the optimal use of healthcare information technology and management systems for the betterment of human health.
• Health Level Seven, Inc. (HL7): HL7's comprehensive suite of ANSI accredited standards for the exchange of demographic and clinical information provides the syntax and semantics for interoperability in a large number of provider organizations in the United States and around the world.
• HIMSS EHR Vendor Association (EHRVA): Representing more than 25 Electronic Health Record (EHR) vendors with a mission to address national efforts relative to health information interoperability, standards, EHR certification, performance and quality measures, and other evolving government, industry and physician association initiatives and requests (www.ehrva.org).
• Integrating the Healthcare Enterprise (IHE): (American College of Cardiology, Healthcare Information and Management Systems Society, and Radiological Society of North America): IHE drives standards adoption to address specific clinical needs, by creating a framework and testing vendor implementations for passing vital health information seamlessly — from application to application, system to system and setting to setting — across and between healthcare enterprises (www.ihe.net).
• Internet2: Internet2 is a consortium being led by over 200 universities working in partnership with industry and government to develop and deploy advanced network applications and technologies, introduce innovations, and expand technological capabilities, accelerating the creation of tomorrow's Internet for a broad spectrum of organizations, including those in the health sciences.
• The Liberty Alliance Project: Liberty Alliance is a consortium of more than 150 organizations from across the globe, committed to developing open standards for federated network identity that support all current and emerging network devices.
• The National Alliance for Health Information Technology (NAHIT): The Alliance is a diverse partnership of influential leaders from all healthcare sectors working to achieve measurable improvements in patient safety, quality and efficiency through information technology.

In addition, through targeted sessions, Connecting for Health sought out additional input into the core principles embedded in this document from broad national networks of consumer and patient advocates, groups representing the research community, and health care purchasers and payers. Across the enormous range of this broad group, we discovered an essential consensus:

We believe that general adoption of a small set of critical tools can permit rapid attainment of an interoperable information environment that supports modern health care practice.

In our view, the NHIN consists of a carefully planned Health Information Environment that meets society's requirements through widespread adoption of a formal set of technical components, standardized methodologies, and explicit policies for use and governance.

This new Health Information Environment — based on open, consensus–driven and non–proprietary standards, uniform policies that protect privacy, assure security, and support existing trust relationships, and a common technical approach to linking personal health information — can be the springboard to a generation of innovation and improvement in health care and in personal health. Clinical models, self-care and decision–support tools, application and communications software, and even redesigned care practices will emerge within this new environment. Research and innovative approaches to prevention and treatment can be strengthened and the results integrated more rapidly into health care and health-related decision making. The delivery of high quality care can become more likely, less expensive, and timelier — bringing the right skills and knowledge to the right person at the right time. We can put patients and families at the very center of the health care system, supported and surrounded by an information environment that they can use — or allow others to use — to make decisions, monitor health, provide feedback, and support strategic analytic functions that produce measurable improvements in health.

Critical elements of the Health Information Environment are:

• Facilitates and structures connectivity.
• Builds connectivity on the Internet and other existing networks without "new wires."
• Provides the capabilities to support near real-time information access when essential for routine and emergency clinical care and also supports ongoing monitoring of disease outbreaks and threats of bioterrorism, research, and quality improvement.
• Leverages existing (and upcoming) open, non-proprietary standards for data content and transmission.
• A national Common Framework supports and guides all participation. The Common Framework consists of the essential technical and policy standards necessary to ensure interoperability, serve the patients whose data it shares, and connect systems of varying technical sophistication.
• A Standards and Policy Entity (SPE) identifies and recommends standards and policies for the Common Framework, to be used to meet the ongoing requirements for interoperability.
• Governance is transparent and accountable and includes consumer, patient, and other stakeholder representation at all levels.
• Connectivity respects and serves patients and is built on the premise of patient control and authorization.
• Data is decentralized — stays where captured.
• Connectivity is achieved through a federated structure for policies, procedures, and standards.
• Patient identification is based on standardized methodologies but without a mandated national unique health identifier.
• Record Locator Services (RLS), situated in regional or other sub-networks, are new infrastructure components.
• The "build" of the new information environment happens incrementally, through accretion of sub–networks.
• A mechanism for validating compliance with the standards of the Common Framework is required for the early phases (there is uncertainty about how long this may be necessary), but the network eventually becomes entirely self-validating.
• Privacy and security are among the primary design considerations.
• The Health Information Environment facilitates growth, innovation and competition in private industry.
• Health IT financing is multi–stakeholder with public and independent funding for the national Standards and Policy Entity; seed grants and funding for Record Locator Services and regional start-ups; incentives built into routine payment and operations at the regional and local level are tied to the use of the Common Framework.
• The Health Information Environment provides financial value to the entire health enterprise. The value that is generated ultimately funds the financial incentives for performance and stimulates the availability of private capital.

Challenges ahead

The collaborators who have come together to develop this response are proud of their progress in identifying consensus strategies for a national health information environment. We have found that we hold far more in common than we ever imagined. And the process of seeking agreement on the fundamentals has also revealed complex problems that deserve continued examination and discussion. We have identified some of these complex problems in an appendix to our response, in addition to a glossary providing our definition of certain key terms.

We applaud ONCHIT's commitment to dramatic improvements in the use of health information technology. We believe strongly in rapid-cycle times to develop and test both technical and policy mechanisms to drive interoperability. The most critical initial steps to defining the Common Framework will be to identify and implement the essential standards, define policies and technical tools, and evaluate them in the field by listening closely to the experience of its diverse users. The health information environment will be an organic and evolving community of users, technologies, and resources.

In preparing this response to the ONCHIT RFI, we have had the privilege of talking with hundreds of organizations across the entire sweep of U.S. health care. Many of our most active participants have represented associations which themselves include hundreds and thousands of members. It has not been possible, of course, to capture the views or seek the formal endorsement of every individual organization or person. All of our participants, signatories to this submission, agree with the principles outlined here. And some have particular expertise or interest in topics that go beyond the consensus on core principles that is presented in this document. They may provide ONCHIT directly with additional information reflecting their own views.

As ONCHIT continues to evaluate and coordinate national efforts, we will be ready to help in any appropriate way. We represent the widest diversity of our great health care system — patients, professionals, payers, researchers, technologists, regulators — and we want to see our national system fulfill its potential to help every American achieve the best possible health with the available resources. Our approach is above all pragmatic; it is based not on any particular ideology or economic interest, but on our shared sense of what practical actions will bring results. We can work together to achieve the President's vision of an interconnected health information system by 2014.