Congress committed billions to health IT as part of the American Recovery and Reinvestment Act of 2009 (ARRA), and the U.S. Department of Health and Human Services (HHS) has officially entered rulemaking season on the health IT provisions. Just two weeks ago, the agency posted guidance listing the technologies and methodologies  that qualify as making protected health information "unusable, unreadable, or indecipherable to unauthorized individuals," which is a critical component of the new breach notification provisions. However, the talk lately has focused on defining the term "meaningful use." What's the significance of "meaningful use"? Well, it triggers $17 billion in Medicare and Medicaid incentives for the adoption of electronic health record (EHR) systems by eligible professionals (clinicians) and hospitals to improve the quality of health care and patient outcomes. While "meaningful use" is currently defined by ARRA in a loose manner (full text of the bill is available here , with criteria listed under Subtitle-A Medicare Incentives), it's the core criteria (along with the other loosely defined term "certified EHR") for determining whether or not clinicians and hospitals can collect these incentive payments. These payouts don't begin until 2011, but with so many dollars at stake, it's clear that these words need to be, well, more meaningfully, defined. The National Committee on Vital and Health Statistics (NCVHS)  - the public advisory body to HHS - got a jumpstart on tackling definitions for these terms during a two-day hearing in Washington D.C. last week. Dr. David Blumenthal, the new National Coordinator for Health Information Technology, gave introductory remarks and emphasized the importance of defining these terms, stating that it is foundational to ensuring that federal investments in health IT lead to tangible improvements in health care. Overall, 39 witnesses offered varied input and suggestions on what constitutes "meaningful use" and a "certified EHR" with each panelist sharing ideas on patient access and information sharing. (See: http://www.ncvhs.hhs.gov/090428ag.htm  for a complete list of participants, as well as testimony from most of the panelists).
The Markle Foundation's Connecting for Health Initiative  also informed the discussion on the issue by releasing a report containing a consensus framework  for defining both "meaningful use" and "certified or qualified EHR." The new framework lays out seven principles that provide thoughtful and useful guidance for defining these terms, and put a major emphasis on protecting patient privacy. In addition to the above principles, Markle proposes a simple definition of "meaningful use." According to the framework, "patient-centered, meaningful use of health IT demonstrates that the provider makes use of, and the patient has access to, clinically relevant electronic information about the patient to improve patient outcomes and health status, improve the delivery of care, and control the growth of costs." Markle also stresses the need for the definition to achievable for providers and benefit to patients and consumers. To do this, Markle believes the initial focus should be on using and sharing information for medication management and care coordination because they address critical deficiencies in our health care system and provide opportunities for early, achievable wins through the increased use of health IT.
In defining "certified or qualified EHR" technology, Markle emphasizes the need to take a broader view, one that includes room for innovation. Comprehensive EHR systems, Markle believes, should be able to co-exist alongside the basic health IT systems, PHRs, and other internet-enables technologies and networks. Furthermore, for EHR technology to be considered "certified," it should enable the provider to demonstrate "meaningful use." The technology should also support the technical privacy and security requirements under HIPAA and ARRA through the use of audit trails, data security, and authentication of providers and patients.
The Markle framework for "meaningful use" and "certified or qualified EHR" was supported by CDT and a broad range of stakeholders and lays a clear path forward for defining these terms. The framework, coupled with the testimony from the NCVHS hearings, provide HHS with important guidance as the agency begins to flesh out these terms. Of particular importance to CDT is how HHS, in focusing on promoting information sharing, will incorporate privacy and security protections into these definitions. The pace of these decisions is likely to ramp up in the near future, so stay tuned for further developments.