The Food and Drug Administration Safety and Innovation Act of 2012 requires HHS to develop a proposed risk-based framework for regulating health IT by January 2014. The subgroup formulated a taxonomy that determines whether a technology should be subject to a risk-based regulatory framework, based largely on the ability the technology has to affect clinical decision-making.
Technology that will likely be subject to the risk-based framework includes:
- Electronic health records
- Decision support algorithms
- Health information exchange software
- Templating software tools for digital image surgical planning
Technology likely to not be subject to the framework includes:
- Claims processing software
- General purpose communications software used by health professionals, like email
- Cost-effectiveness analytic software
- Disease registries
More Articles on ONC Workgroups:
ONC Workgroup Releases Meaningful Use Stage 3 Recommendations
HHS Seeks Comments on Regulatory Framework for Health IT, mHealth Apps
HHS, FCC Form New Health IT Workgroup for Patient Safety
