Legislative Context

The Library is intended to support the national imperative to encourage the practice of evidence-based medicine, including the efforts of the U.S. government to support the adoption of Public Health and Promoting Interoperability Programs (formerly, known as Electronic Health Records Meaningful Use) for certified electronic health records (EHR) under the Health Information Technology for Economic and Clinical Health Act (HITECH) to achieve specified improvements in care delivery.

The HITECH Act requires, among other interventions, that healthcare providers implement clinical decision support (CDS) systems as part of certified EHRs. CDS systems are tools designed to aid directly in clinical decision making, in which characteristics of individual patients are used to generate patient specific interventions, assessments, recommendations, or other forms of guidance that are then presented to a decision making recipient or recipients that can include clinicians, patients, and others involved in care delivery. The Centers for Medicare & Medicaid Services state that CDS represents one of the most promising tools to mitigate the ever-increasing complexity of the day-to-day care practice of medicine.

The effective use of a clinical decision support system means patients get the right tests, the right medications, and the right treatment, particularly for chronic conditions.

While the HITECH Act provides the general context for the establishment of the Library, a more recent Federal statute known as the Protecting Access to Medicare Act of 2014 (42 USC 1395m, “PAMA”), signed into law on April 1, 2014, created a sense of urgency for this effort and identified medical imaging evidence as the initial domain focus for the Library. Starting on January 1, 2017, PAMA requires healthcare providers to use approved CDS systems to consult specified appropriate use criteria when ordering certain advanced imaging procedures. PAMA defines the term appropriate use criteria as “criteria, only developed or endorsed by national professional medical specialty societies or other provider-led entities, to assist ordering professionals and furnishing professionals in making the most appropriate treatment decision for a specific clinical condition for an individual. To the extent feasible, such criteria shall be evidence-based.”

"The effective use of a clinical decision support system means patients get the right tests, the right medications, and the right treatment"

PAMA instructs the U.S. Secretary of Health and Human Services (HHS) to specify the first list of approved Appropriate Use Criteria by November 15, 2015. In specifying applicable appropriate use criteria the Secretary of HHS is required to take into account whether the criteria have stakeholder consensus, are scientifically valid and evidence based and are based on studies that are published and reviewable by stakeholders.

In response to this deadline the Harvard Medical School Library of Evidence, under the leadership of healthcare providers drawn from teaching hospitals, community hospitals and private medical practices, will initially focus on assembling and curating evidence related to the appropriate use of medical imaging, and will establish a national resource of appropriate use criteria meeting the definition in PAMA for medical imaging. The Library will seek approval for this resource by the Secretary of HHS under 42 USC 1395m (q)(2)(A), with an initial list of Appropriate Use Criteria that will be supplemented annually.