AEGIS Support at the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) Draft Report

The Office of the National Coordinator for Health IT (ONC), along with the Food and Drug Administration (FDA) and Federal Communications Commission(FCC), released a draft report that includes a proposed strategy and recommendations for a risk-based framework as required by the FDA Safety and Innovation Act of 2012 (FDASIA) Health IT Report. The report specifically called upon the these entities to develop and post on their respective web sites “a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”

AEGIS supports many of the proposed recommendations. We have identified several takeaways from the FDASIA report including:

  • ONC adopts standards for health IT through regulations and leverages public-private collaboration to identify and specify standards and implementation specifications that could be used through the Standards & Interoperability Framework activity.
  • Identification, development, and adoption of Standards Development Organizations (SDOs) standards and best practices in key aspects of a health IT framework that promotes innovation and protects patient safety.
  • Educate and emphasis the importance of interoperability with the provider and stakeholder communities; and finally
  • Provide a standard list of questions for Electronic Health Record (EHR) vendors that address interoperability; ability of their products to easily and reliably share data; and implement and test interoperability standards.

AEGIS participated in the Public Workshop – Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology held May 13 – 15 at the National Institute of Standards and Technology (NIST). Mario Hyland, Senior Vice President and Barry Dickman, Senior Consultant both provided public comments to the recorded sessions on Risk-Based Frameworks, Standards & Interoperabilityand Conformance Assessments.

AEGIS fully supports the recommendation that, “emphasis should be placed on the importance of interoperability.” Furthermore, “due to the current lack of clear or complete oversight of health IT interoperability, a national strategy should be developed to create efficient, standardized data exchange that promotes the safe use of the data that has been exchanged; identify funding to support development of standards; and establish interoperability standards that reflect today’s need for rapid development and adoption.”

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