Authors of the federal government’s proposed strategy of a regulatory framework for health information technology take pains to ensure stakeholders that the framework actually won’t be heavy on regulation. For instance, there is no call for new or additional areas of Food and Drug Administration oversight. What the report makes clear is that the industry is expected to aggressively regulate itself.

“We recommend a limited, narrowly-tailored approach that primarily relies on ONC-coordinated activities and private sector capabilities,” report authors from the Food and Drug Administration, Office of the National Coordinator for Health IT and Federal Communications Commission say. “For example, we do not recommend the need for any new or additional areas of FDA oversight. Rather, we believe a better approach is to foster the development of a culture of safety and quality, leverage standards and best practices, employ industry-led testing and certification, and selectively use tools such as voluntary listing, reporting and training to enable the development of a transparent learning healthcare environment that fosters continual health IT improvement. We do not believe that regulation should be, or needs to be, the first approach used to reach this outcome.”

The strategy will follow five core principles:

* Employ a risk-based approach to appropriately mitigate patient safety risks while avoiding unnecessary regulatory oversight;

* Leverage private sector knowledge, experience and expertise;

* Facilitate, rather than impede, innovation;

* Promote transparency of product performance and safety; and

* Create/support an environment of learning and continual improvement.

Further, to support the core principles, the four priority areas for a risk-based regulatory framework are:

* Promote the use of quality management principles;

* Identify, develop and adopt standards and best practices;

* Leverage conformity assessment tools; and

* Create an environment of learning and continual improvement.

“These priority areas share three critical characteristics: Their application can be tailored using a risk-based approach; they have relevance to all stages of the health IT product lifecycle and to all health IT stakeholders; and they support both innovation and patient safety.”

To support the priority areas, the government calls for creation of a Health IT Safety Center, a public-private entity created by ONC in collaboration with FDA, FCC, AHRQ and other federal agencies, as well as stakeholders. The center would serve as a trusted entity to convene stakeholders to focus on specific activities that promote safety and a sustainable learning system. “The Health IT Safety Center could enable a deeper understanding of how these four priorities can and should be integrated into the programs and activities of stakeholders in health IT safety. To be successful, the Health IT Safety Center will require a strong governance mechanism and involvement by participants in programs and activities. “

These programs and activities will include:

* Establishment of a broad and engaged stakeholder membership and leadership base;

* Focus on high-value issues affecting promotion of innovation and protection of patient safety;

* Build upon an evidence-based foundation for HIT safety by analyzing the best available information and identifying interventions and opportunities for improvement based on data and evidence;

* Create or inform HIT safety priority goals and measures that align with broader patient safety goals and initiatives;

* Provide education on HIT that covers best practices regarding risks, migration strategies, and usability and workflow to improve the commitment and capabilities of stakeholders to improve safety, and evaluate outcomes of the education.

The government is seeking input on whether the focus areas are the appropriate ones and whether the proposed steps will lead to improved safety and innovation with less regulatory duplication. The agencies plan to announce a public meeting to solicit comments on the draft report and gather feedback on the outlined strategy and approach. A docket will also be made available for the public to submit any additional comments.

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