Medical Devices
Health IT Regulatory 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.
The FDA, FCC and ONC plan to compile the strategy and recommendations into a report that is slated for release in 2014.
FDASIA Workgroup
In order to help us develop this framework, the FDA, FCC and ONC have formed the FDASIA Workgroup (FDASIA refers to a law passed by Congress in 2012). The workgroup exists under the ONC’s HIT Policy Committee (HITPC) and will provide input and recommendations to the Health IT Policy Committee on a risk-based regulatory framework for health IT. To ensure the report benefits from the input of a range of stakeholders, workgroup members represent groups that could be impacted by this framework including agency officials, patients, consumers, health care providers, third-party payers, venture capital investors, and information technology vendors and purchasers.
Similar to other ONC HITPC workgroups, documents discussed at meetings of the FDASIA Workgroup meetings will be made public and there will be opportunity for public comment.
How to Participate
Participate in the development of the regulatory framework:
Participate in Online Meetings:
- View the Health IT Policy Committee Meeting Calendar.
- Get more information on upcoming meetings or view the materials from past meetings.
Additional Resources
- More Information on FDASIA (PDF)
- Press Release: HHS announces members of the FDASIA Workgroup of the Health IT Policy Committee.
