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Dr. David Blumenthal: Eight Recommended Updates to the Federal Health IT Strategic Plan

Dr. David Blumenthal: Eight Recommended Updates to the Federal Health IT Strategic Plan - top government contractors - best government contracting event
National Coordinator for Health IT David Blumenthal
National Coordinator for Health IT David Blumenthal
National Coordinator for Health IT David Blumenthal

Writing on the Office of the National Coordinator (ONC) for health IT, National Coordinator David Blumenthal announced the publication of ONC’s Health IT Strategic Framework (on Adoption/Certification and Privacy/Security) , “a foundation for updates to the Federal Health IT Strategic Plan.”

He writes that almost two years ago, in June of 2008, ONC published the Federal Health IT Strategic Plan, “a roadmap for the implementation of nationwide health IT.”  Dr. Blumenthal says that the ONC is addressing the need to update this plan to take into account the progress made towards health IT adoption by the HITECH vision and pursuant technological advances and serious challenges that have arisen over the past two years.  “The experiences of providers and health IT professionals working ‘on the ground’ play an enormous role in crafting these adjustments to the Federal Health IT Strategic Plan and setting the course of our future efforts.”  Here are eight recommendations outlined in the ONC workgroup’s publications:

  1. A key recommendation is that all components of electronic health records be comprehensively tested and certified by HHS for interoperability, privacy and security. “The Workgroup strongly endorses a default rule that all EHR modules must meet all privacy and security certification criteria,” but wants clarification on the following exceptions, that EHRs are exempt from testing if it would be “technically infeasible” for an EHR module to be tested and certified
  2. The ONC’s recommendation reads, “Exception 1 deals with EHR modules are presented as an “integrated“ bundle, which would allow them to be certified similar to a Complete EHR. If a group of modules are tested for privacy and security as a bundle as if the bundle were a Complete EHR, we recommend that certification should only apply to the entire bundle and not to any of the individual module components.”
  3. Another recommendation is that “certified EHR modules be required to be sold with a label indicating that HHS has not tested the module for interoperability with other modules,” but due to the complex nature of developing new standards for testing (as none currently exist), the ONC thinks that it shouldn’t be the organization to test and certify EHR modules. “Instead, in order to avoid market confusion, we are making a labeling recommendation. Because the term “certification“ is used freely in the marketplace, the labeling requirement is extremely important.”
  4. ONC does think, however, that applicants for certification should “be allowed to seek more limited authorization to test and certify complete EHRs for an ambulatory setting, and applicants should be allowed to seek authorization to test and certify complete EHRs for hospital settings,” meaning that there should be two separate standards: one for first-responders and one for hospitals.
  5. For “self-developed or open source software that is tested at the site of a healthcare organization (including remote testing),” ONC recommends that the certification should specify that testing was conducted remotely or on-site at the hospital.  ONC writes that these organizations should not be permitted to market their products as “certified,” to avoid market confusion.
  6. ONC supports a minimum of “floor” standard for Health IT reliability, but this concept should mean “that subsequent revisions are automatically considered to be compliant with the regulation for existing users. Users of certified EHR technology need flexibility to upgrade to newer versions of standards in order to promptly respond to operational challenges (errors) that the subsequent versions might address.”
  7. The workgroup recommends that National Coordinator, currently Dr. David Blumenthal, have the executive authority to revoke certified status “based upon his/her determination of the severity of the violations” on a case-by-case basis, and “does not recommend establishing a specific number of Type-2 violations that cause automatic revocation.”
  8. Finally, ONC recommends that a product’s labeling “be required to indicate which stage specific technology has been tested and certified,” instead of just the date it was tested on.  They also recommend that a website be established and maintained so that service providers can access specific details of test results and find a product that best fits their needs.
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