During a Sept. 4 meeting of the Office of the National Coordinator for Health IT's HIT Policy Committee, members of a subgroup discussed the health IT likely to be subject to Food and Drug Administration regulation in the near future.
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
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