The FDA, ONC, and FCC release proposal to clarify oversight of health IT, reduce patient risk, and empower innovation.
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The Department of Health and Human Services (HHS) released a draft report outlining a proposed strategy and recommendations for a health IT framework designed to clarify oversight of health IT products based on risk, not platform, while reducing duplicate regulation and encouraging innovation.
The Food & Drug Administration (FDA), which oversees medical devices, developed the FDA Safety and Innovation Act (FDASIA) Health IT Report in conjunction with HHS's Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC). The FDA will solicit comments on the document, posted Thursday, and will hold a public meeting in May.
"The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach," HHS secretary Kathleen Sebelius said in a statement. "This proposed strategy is designed to promote innovation and provide technology to consumers and healthcare providers while maintaining patient safety."
Under the proposed framework, health IT products will be segmented by function and risk level, not platform (such as mobile, medical device, or cloud).
The first segment is products designed for administrative use -- including billing and scheduling -- which pose little to no risk to patients.
The second category is IT products with health management functions such as medication management, provider order entry, and knowledge management. Because they pose little risk to patients, even if they meet the statutory definition of a "medical device," the FDA does not intend to review them, said Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, during a conference call. Instead, developers and healthcare organizations should rely on ONC-coordinated educational activities, industry best-practices, and industry standards, the proposal recommended.
However, the FDA will continue to oversee products that have medical device health IT functions. They include radiation treatment software and computer-aided detection software, technologies that could pose a risk to patients if they malfunction or stop working, he said.
"We do not believe that new, extensive regulations need to be the first approach," said Dr. Shuren. "This draft framework is... a risk-based approach focused on function and the amount of risk posed."
To further improve patient care and the country's health, the report writers outlined four "priority areas":
Promote adoption of quality management principles
Identify, develop, and adopt best-practices and standards
Use assessment tools
Create environments that embrace ongoing education and learning
The FCC also wants to simplify how wireless developers and users operate. The FCC's medical testing license, for example, gives some healthcare providers more latitude, said Matt Quinn, director of the FCC's healthcare initiatives.
During the conference call, executives from the FDA, FCC, and ONC stressed the importance of reducing government involvement when patient risk is low. Agency executives also noted the value of partnering with private organizations and creating a framework flexible enough to address new and not yet invented technologies.
No matter the technology in use, healthcare providers and developers can learn from each other by sharing best-practices. To support these efforts, the report recommends creating a Health IT Safety Center. The center, which President Barack Obama included in his 2015 budget, will be open to public and private organizations, fostering an environment of education, collaboration, and innovation, said Jodi Daniel, director of the Office of Planning and Policy at the ONC, which will operate the center. The facility could use analytics to further improve best-practices and education, she added.
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Alison Diana has written about technology and business for more than 20 years. She was editor, contributors, at Internet Evolution; editor-in-chief of 21st Century IT; and managing editor, sections, at CRN. She has also written for eWeek, Baseline Magazine, Redmond Channel ... View Full Bio
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