FDA, ONC and FCC Encourage Stakeholder Engagement on Proposed Health IT Strategy and Framework

By: Bakul Patel

Last month I blogged about a report outlining our proposed strategy and recommendations on an appropriate risk-based regulatory framework for health information technology (health IT). Issued by the Food and Drug Administration (FDA), the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), the report was followed by a three-day public workshop with consumer, patient, health care and industry stakeholders.

Bakul PatelOur goals: to promote innovation, protect patients and avoid regulatory duplication. We just posted video of the workshop discussions online so that interested parties can view (or revisit) the events; a written transcript will follow. And public comments on the strategy and recommendations are open until July 7, 2014.

At the workshop, a series of structured panel discussions guided various talks among those present, including health IT experts, representatives from industry (mobile health, medical device and electronic health records), health care providers, research organizations and consumers. Topics ranged from industry best practices to the promotion of an environment of learning and continual improvement, including the proposed risk-based framework and the categories of health IT. In fact, promoting an environment of learning—a core priority area that our report establishes under the health management function—emerged as one of the most discussed priority areas. On the last day, participants discussed how to create and sustain the learning environment, guided by the proposed safety center, led by ONC.

In general, workshop participants agreed with the core of our report, including the need for a risk-based approach that focuses on functionality rather than platform. There also was support for the concept of a multi-stakeholder, public-private Health IT Safety Center—as proposed in the report—although participants wanted additional clarity on its participants, role and governance.

Many viewed the report as “moving the ball forward,” but all recognized that the health IT community still has much work to do. (Some called the event a “starting point.”)

This collaboration with health IT stakeholders is important. The workshop was just one step in the strengthening of our nationwide health IT infrastructure, and we look forward to continued public dialogue and participation. Engagement between health IT stakeholders and the federal government is key to realizing the promise of health IT. We encourage comments on our proposed recommendations for this multifaceted area of health care.

To submit your comments on our proposed strategy, please visit regulations.gov.

Bakul Patel is senior policy advisor in FDA’s Center for Devices and Radiological Health.

More information:

Learn more about the Health IT Risk-Based Framework.

Read more about the meeting.

Watch the workshop webcast.

Read the FDASIA Health Report.

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