The U.S. Food and Drug Administration (“FDA”), the Office of the National Coordinator for Health Information Technology (“ONC”) and the Federal Communications Commission (“FCC”) are accepting comments on their recently issued final FDASIA Health IT Report, entitled Proposed Strategy and Recommendations for a Risk-Based Framework

The agencies are seeking public comment on the questions below.  The majority of the questions pertain to the category of Health IT products that the agency has designated as “Health Management Functionality.”

  • Are the focus areas identified in the report the appropriate ones, and will the proposed next steps lead to an environment where patient safety is protected, innovation is promoted and regulatory duplication is avoided?
  • What steps should be taken to encourage and foster private sector participation in the identified priority areas and in the Health IT Safety Center?
  • What essential quality management principles should apply to Health IT? How should they apply to different stakeholders and at different stages of the Health IT product lifecycle?
  • How do we ensure stakeholder accountability for adoption of quality management principles? Is there a role for a non-governmental, independent program to assess stakeholder adherence to quality management principles? Is there a role for government?
  • Are the identified priority areas for standards and best practices the proper areas of focus? If not, what areas should be prioritized?
  • How can the private sector help facilitate the development and adoption of applicable Health IT standards and best practices? Is there a role for a non-governmental, independent program to assess product and stakeholder adherence to standards and best practices? Is there a role for government?
  • What conformity assessment tools, if any, should be incorporated into a risk-based Health IT framework? How should they apply to different stakeholders and at different stages of the Health IT product lifecycle? How can adoption of and adherence to conformity assessment programs be promoted?
  • Should interoperability be tested? How should tests to validate interoperability be conducted? Should interoperability standard(s) be adopted and used for conformity assessments (i.e., develop a functional standard that specifies interoperability characteristics that could be used for conformity assessment)?
  • How should the intended user (e.g., health care provider, consumer, etc.) affect the type of conformity assessment performed?
  • How should conformance assessment results be communicated to stakeholders?
  • Is there a role for a non-governmental, independent Health IT conformity assessment program? Is there a role for government? Should the ONC Health IT Certification Program be leveraged to protect patient safety through the use of conformity assessment tools?
  • What should be the governance structure and functions of the Health IT Safety Center in order for it to serve as a central point for a learning environment, complement existing systems, facilitate reporting and promote transparent sharing of adverse events, near misses, lessons learned and best practices?
  • How can comparative user experiences with Health IT be captured and made available to the Health IT community and other members of the public to promote learning?
  • How can the private sector help facilitate the development of a non-governmental process for listing selected Health IT products? What types of products and information should be included? Should the results of conformity assessments, such as conformance with certain clinical or privacy and security standards, be included?
  • In terms of risk management, what type of safety-related surveillance is appropriate for Health IT products categorized as health management functionality? What continued or expanded role(s), if any, should the ONC Health IT Certification Program play in the safety-related surveillance of Health IT products?
  • What role should government play in creating an environment of learning and continual improvement for health IT?
  • What types of CDS functionality should be subject to the Health Management Health IT framework? Which types should be the focus of FDA oversight?
  • How should the priority areas identified in the Health Management Health IT Framework be applied to CDS categorized as Health Management Health IT functionality?
  • Are there additional safeguards for CDS, such as greater transparency with respect to CDS rules and information sources that are needed to appropriately balance patient safety and the promotion of innovation?
  • Does the certification of CDS functionalities, such as those functionalities currently certified under the ONC Health IT Certification Program, sufficiently balance patient safety and the promotion of innovation?
  • How can the private sector help ensure the facilitation of the development, application and adoption of high quality CDS with Health Management Health IT functionality in lieu of a regulatory approach? What role, if any, should government play?

Hall Render is coordinating comments by interested parties. If you would like to submit comments, contact information is provided below. You may also submit comments to the agencies directly.  Comments are due to the FDA by July 7, 2014 at 5:00 P.M.  Comments may be submitted by mail, hand delivered or submitted electronically here.  Commenters should reference file code “FDA–2014–N–0339” in their submissions to ensure their comments are considered. Click here  to view the Federal Register Notice.

For more information, please see our companion articles on the agencies’ report click here and on the FDA’s challenges related to medical software click here.  Our attorneys will also be hosting a short webinar or teleconference to discuss the details of the FDASIA report and its potential implications.  Further details will be available in the near future.