The HIT Policy Committee, a body of industry stakeholders who advise federal officials, on Sept. 4 adopted final recommendations for a risk-based regulatory framework for health information technology.
The recommendations now go to the Food and Drug Administration, Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, which are expected to release a proposal in January 2014 for public comment.
The final recommendations by the HIT Policy Committee, intended to guide the work ahead in coming months by the three agencies, include:
* HIT should not be subject to FDA premarket requirements except for medical device accessories to be clearly defined by FDA; certain forms of high-risk clinical decision support such as computer-aided diagnostics to be clearly defined by FDA; or higher-risk software use cases including those where the intended use elevates aggregate risk.
* Vendors should be required to list products which are considered to represent at least some risk if a non-burdensome approach can be identified.
* A collaborative process including stakeholders is needed to develop better post-market surveillance of HIT. This should include user self-reporting and reporting from vendors, as well as post-implementation testing to ensure key safety-related decision support is in place.
* Approaches are needed to allow aggregation of safety issues at the national level, which would include federal support.
The HIT Policy Committee also calls for adoption of existing standards and creation of needed new standards to address specific areas such as health information exchange, and a public policy for customer rating of HIT--facilitated by an independent group using validated measurements--to enhance transparency. This work can be done through private and/or public sector efforts.
The committee also believes that certification regimens should be used judiciously. “When specifying specific implementations, they can narrow creativity and innovation to a specific or narrowed list of solutions,” according to the recommendations, which note there are some instances, such as interoperability standards, where narrowing choice is desirable.
The recommendations call for using transparency to differentiate the market instead of certification, as transparency is more efficient and richer in content. “Certification just reveals that the system passed the certification test and all vendors will—at that point, there is no differentiation.” Further, national goals that focus on the problem agenda and not the product agenda should be encouraged. “They do change and, if well set, correct the market and create markets. Where the market goes, vendors will follow.”
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