Several U.S. government agencies are asking for input on a new regulatory framework for healthcare information technology.
The U.S. Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC) said they are requesting comments from stakeholders and experts on the elements that should be considered as they develop a proposed strategy for an appropriate, risk-based regulatory framework for health IT.
The framework, which would include mobile medical applications, would aim to promote innovation, protect patient safety, and avoid regulatory duplication, according to the agencies in the May 30 notice in the Federal Register.
To assist in developing the report, the FDA collaborated with ONC and FCC to form a new workgroup, called the Food and Drug Administration Safety and Innovation Act (FDASIA) workgroup. The workgroup will help the HIT Policy Committee provide appropriate input and recommendations to the FDA, ONC, and FCC.
The workgroup is requesting public comments on three areas:
- Taxonomy: What types of health IT should be addressed by the report developed by the FDA, ONC, and FCC?
- Risk and innovation: What are the risks to patients posed by health IT, and what is the likelihood of these risks? What factors or approaches could be included in a risk-based regulatory approach for health IT to promote innovation and protect patient safety?
- Regulation: Are there current areas of regulatory overlap among the FDA, ONC, and/or FCC, and, if so, what are they?
Comments are requested before June 30. The FDASIA workgroup is also hosting an in-person meeting in Washington, DC, that will also be webcast. Electronic comments can be submitted here.
