A Proposed National Health Information Network Architecture and Complementary Federal Preemption of State Health Information Privacy Laws

As evinced by the current national debate, the U.S. faces a health care crisis of monumental proportions, with complex issues of access, quality, and affordability. In terms of its cost, politics, quality, and efficiency, health care is a national issue that seriously threatens the U.S. economy. Electronic health care (e-health) applications are proposed as a partial solution, and increased use of health information technology (HIT) is a common element of most serious U.S. health care reform proposals. At their zenith, such applications would include a national health information network (NHIN) that holds great potential for improving the quality and efficiency of health care while lowering its cost. When it comes to health care reform, however, questions of policy and law often overlap. Such is the case with a NHIN. Two major, interdependent impediments to a fully operational NHIN are the lack of rapid progress, given the current evolutionary approach to NHIN architecture, and the tension between operational efficiency and patients’ privacy rights in their health information. The resolution of this tension depends upon the rationalization of myriad disparate state privacy laws layered upon federal law. HIT holds great potential for improving the flow of information necessary for high-quality health care. As Congress and the administration struggle to find cost savings in health care expenditures, while increasing access for the uninsured and improving quality, a NHIN should play an integral role.A NHIN has been described as the relatively seamless electronic flow of patient information for national interoperability among hospitals, outpatient clinics, and external laboratories, allowing clinicians to have access to patients’ longitudinal test results on a twenty-four-hour-seven-days-a-week basis from virtually any location. The benefits include reductions of redundant tests, delays, costs associated with results reporting, and errors. Interoperability with pharmacies would enable the formation of complete medication lists and would reduce duplicate therapies, drug interactions, and other adverse drug events. A NHIN would bring attendant pharmacy benefits of automated refill alerts, easy clinician access to prescription refills, identification of patients affected in the event of drug recalls, and detection of drug side effects among broad patient populations. Provider–provider interoperability would save time in handling referrals and chart requests, and interoperable electronic medical records (EMRs) could become building blocks in a nationwide network for assembling and distributing up-to-the-minute health studies showing which treatments work best. Despite these benefits, progress toward a NHIN has been slow for two reasons. First, past and present national administrations have embraced a bottom-up, evolutionary approach to the development of NHIN architecture Fan approach that has yet to prove efficacious or to resolve the privacy law tensions that interoperability causes. Second, for a NHIN to be effective it must be accompanied by other reforms. Among these reforms is the need to revise the various federal and state laws that pertain to the privacy of patients’ protected health care information (PHI), which represent a huge legal barrier to a NHIN. There is general consensus that the movement toward widespread implementation of e-health must be attended by appropriate protections for privacy and security of personal health information. Most states have enacted health information privacy laws. Evidence suggests, however, that complexities and disparities associated with state laws are impeding the advance of e-health, as illustrated by states that both have more stringent privacy laws and experience lower rates of adoption of EMRs. Widespread EMR adoption is a prerequisite for NHIN enablement. As we argue later, NHIN architecture and privacy law protection are nonrecursive because of their interdependency. Privacy protection affects the choice of architecture, which in turn affects how privacy laws should complement the architecture. As we demonstrate, a revolutionary federal blueprint for NHIN construction is integral to realizing a NHIN in a timely manner. We propose a NHIN construction framework coupled with a complementary federal privacy protection regime. In Part I, we briefly review key elements of the national health care crisis, discuss the potential benefits of a NHIN, and lay a foundation for subsequent discussion of NHIN architecture by examining the flawed current strategy to build a NHIN upon regional health information organizations (RHIOs). In Part II, we discuss current federal privacy laws and proposed model statutes meant to promote uniformity across states. We also analyze certain key elements of state privacy laws, showing why such disparate laws are incompatible with a smoothly functioning NHIN and concluding with recommendations for new, preemptive federal privacy legislation. In Part III, we propose a revolutionary, rather than evolutionary, cloud-computing-based NHIN architecture that would satisfy the need for protecting patient privacy affordably. Finally, in Part IV we examine legal arguments that question whether the federal government can constitutionally take an assertive role in fostering the development of a NHIN, as well as stronger counterarguments based on relevant Supreme Court precedents. In analysis that forms the core of Part IV, we conclude that the federal legislation necessary for the development of a NHIN would be a permissible exercise of Commerce Clause power and would therefore withstand a constitutional challenge.