BPC Submits Response to HHS Request for Comments on a Risk-Based Regulatory Framework for Health IT
WASHINGTON, Sept. 4, 2013 /PRNewswire-USNewswire/ -- As policymakers develop a strategy and risk-based regulatory framework for health information technology (IT) in response to requirements of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the Bipartisan Policy Center (BPC) encourages consideration of the principles and recommendations released in its February 2013 report, An Oversight Framework for Assuring Patient Safety in Health Information Technology.
BPC summarized key elements of the report in a formal response to the Department of Health and Human Services (HHS), which issued a request for public comments on the development of a risk-based regulatory framework and strategy for health IT in the Federal Register this spring. Today, the Health IT Policy Committee—an HHS federal advisory committee established under the Health Information Technology and Economic and Clinical Health Act of 2009-- will hear final recommendations from the FDASIA Workgroup, which was established by HHS in April to also provide formal input into the administration's development of a regulatory framework for health IT.
Public comments received in response to the HHS request, along with final recommendations drawn from the FDASIA Workgroup, are expected to inform the development of a report by the HHS Secretary by January 2014. FDASIA—passed by Congress and signed into law in July 2012—calls upon the Secretary to work with the Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to post a report within 18 months, that contains "a proposed strategy and recommendations for an appropriate, risk-based regulatory framework pertaining to health IT, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."
Through a collaborative five-month effort, BPC conducted research and engaged more than 100 clinicians, consumers, health plans, hospitals and other providers, mobile technology companies, patient safety organizations, research institutions, and technology companies, to develop a set of principles and recommendations for an oversight framework that protects patient safety, is risk-based and flexible, promotes innovation, leverages existing quality and patient safety-related systems and processes, and avoids regulatory duplication.
Key principles and framework elements outlined in the BPC report are summarized below:
Principles for an Oversight Framework for Health IT:
- Any oversight framework for safety should recognize and support the important role that health IT plays in improving the quality, safety, and cost-effectiveness of care, as well as the patient's experience of care.
- Assuring patient safety, along with enabling positive patient outcomes, is a shared responsibility that must involve the entire health care system, including those who develop, implement, and use health IT.
- Any framework for patient safety in health IT should be risk-based, flexible, and not stifle innovation.
- Existing safety and quality-related processes, systems, and standards should be leveraged for patient safety in health IT.
- Reporting of patient safety events related to health IT is essential; a non-punitive environment should be established to encourage reporting, learning, and improvement.
Key Elements of an Oversight Framework for Health IT:
- Agreement on and adherence to recognized standards and guidelines for assuring patient safety in the development, implementation, and use of health IT.
- Support for the implementation of standards and guidelines as well as development and dissemination of best practices through education, training, and technical assistance.
- Participation in patient safety activities, including reporting, analysis, and response, by those who develop, implement, and use clinical software, while leveraging patient safety organizations.
- Creation of a learning environment through the aggregation and analysis of data to identify and monitor trends, mitigate future risk, and facilitate learning and improvement.
"Health IT plays a significant, foundational role in rapidly emerging innovations designed to improve the cost, quality, and patient experience of care," said Janet Marchibroda, director of BPC's Health Innovation Initiative. "A new framework is needed to support the ongoing oversight of health IT: one which engages those who develop, implement, and use health IT in a learning environment that encourages reporting, promotes collaborative assessment, facilitates rapid response, and most importantly, advances continuous innovation and improvement."
To learn more about BPC's work related to patient safety and an oversight framework for health IT, go to http://bipartisanpolicy.org/projects/health-innovation-initiative/oversight-framework
Key Links to BPC's Work Related to a Health IT Oversight Framework:
- BPC Report: An Oversight Framework for Assuring Patient Safety in Health Information Technology
- BPC Formal Response to FDASIA: Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health IT
- BPC Blog: FDASIA Workgroup Key Themes: Innovation, Accountability and a Learning Environment, Align with BPC Oversight Framework
- About the BPC Health Innovation Initiative
About the Bipartisan Policy Center
Founded in 2007 by former Senate Majority Leaders Howard Baker, Tom Daschle, Bob Dole and George Mitchell, the Bipartisan Policy Center (BPC) is a non-profit organization that drives principled solutions through rigorous analysis, reasoned negotiation and respectful dialogue. With projects in multiple issue areas, BPC combines politically balanced policymaking with strong, proactive advocacy and outreach. www.bipartisanpolicy.org
SOURCE Bipartisan Policy Center