Today, the U.S. House Energy and Commerce Subcommittee on Health held a hearing to examine federal regulation of mobile medical “apps” and health software. The hearing focused on the Food and Drug Administration’s (FDA) final guidance on medical apps published in September 2013 and the Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act of 2013—bipartisan legislation introduced by U.S. Representatives Marsha Blackburn (R-TN), G.K. Butterfield (D-NC), Diana DeGette (D-CO), Dr. Phil Gingrey (R-GA), Gene Green (D-TX), and Greg Walden (R-OR) in October 2013.
BPC’s Health Innovation Initiative has devoted considerable attention for more than a year on the need for and the development of key principles and elements of a new oversight framework for health information technology (IT) that first and foremost protects patient safety, while also providing the flexibility needed to promote much-needed innovation to continue to improve the quality, safety, cost-effectiveness, and patient experience of care in the U.S.
This work, based on research and conducted in collaboration with more than 100 clinicians, consumers, health plans, hospitals and other providers, mobile companies, patient safety organizations, research institutions, and technology companies, culminated in the development of the report, An Oversight Framework for Patient Safety in Health Information Technology released by BPC in February 2013.
The SOFTWARE Act, similar to BPC’s recommendations, categorizes health IT based on levels of risk, including medical software, which constitutes the highest level of risk; clinical software, which is used to inform care delivery, such as electronic health records; and health software, such as software used for administrative or population health purposes. It also calls for the development of a new risk-based regulatory framework for clinical software and health software that promotes patient safety, reduces regulatory burdens, and fosters innovation—which also aligns with BPC’s recommendations. Click here for BPC’s formal statement on The SOFTWARE Act of 2013.
BPC urges federal policymakers to fully consider the collaborative recommendations on principles and key elements of an oversight framework for health IT included in its recent report. Work is now underway to flesh out in further detail, key policies and actions needed to operationalize such a framework. An overview of the principles and key elements of the oversight framework included in BPC’s report is provided 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
Clinical software should be subject to a new oversight framework that includes four key elements:
- Agreement on and assurance of 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.