Health IT Risk-Based Framework
Health information technology, or health IT, is defined by the federal government’s Office of the National Coordinator for Health IT (ONC) as, “hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information.”
Health IT is the framework that enables the management of health information across multiple electronic systems and devices, such as wireless medical devices, hospital information systems, communications infrastructure, and electronic health record (EHR) systems. Three federal agencies, the FDA, ONC and the Federal Communications Commission (FCC) each have unique responsibilities in the health IT arena.
As health IT evolves, we believe that all stakeholders should understand regulatory requirements surrounding its use. Under the direction of the Food and Drug Administration Safety Innovation Act (FDASIA) of 2012, the FDA is working with FCC and ONC to propose a strategy and make recommendations on an appropriate, risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids unnecessary and duplicative regulation.
The three agencies are committed to a vision that supports a strong health system based on safe and innovative health IT that improves and advances public health.
On 4/3/2014, the FDA, FCC and ONC released the FDASIA Health IT Report outlining a proposed strategy and recommendations for a risk-based framework.
FDASIA Health IT Report
- Memorandum of Understanding (MOU) among the Federal Communications Commission, the Office of the National Coordinator for Health Information Technnology, and the Food and Drug Administration
- Press Release: New strategy proposed for health information technology products to promote innovation, protect patients, and clarify oversight
FDASIA Work Group Final Recommendations to the Health IT Policy Committee
- More Information on FDASIA (PDF)
- Press Release: HHS announces members of the FDASIA Workgroup of the Health IT Policy Committee
- Federal Register: Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report; Notice to Public of Availability of the Report and Web Site Location; Request for Comments