News Feature | April 22, 2014

HIT Workshop Scheduled For May

Christine Kern

By Christine Kern, contributing writer

Government HIT Workshop

FDA, ONC, and FCC propose HIT risk-based regulatory framework workshop

The Food and Drug Administration (FDA), in conjunction with Office of the National Coordinator for Health Information Technology (ONC) and Federal Communication Commission (FCC), is announcing a three-day public workshop entitled “Proposed Risk-Based Regulatory and Framework and Strategy for Health Information Technology.”

FDA is seeking “broad input from stakeholders and experts. The topic to be discussed is the FDASIA health IT report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication.” The framework drew criticism for leaving open many questions, but an FDA official said it is "turning point" in establishing a new regulatory paradigm.

According to Inside Health Policy, the tri-agency draft proposal for a risk-based health information technology framework was intended to be the start of a "conversation" on issues like clinical decision support software risk categorization. The expectation was that stakeholders would help federal agencies further clarify issues like clinical decision support software risk categorization, Bakul Patel, senior advisor for FDA's device center, recently said.

The FDA announced that the agencies will hold a public workshop May 13-15 specifically seeking feedback on how to promote the use of quality standards in health IT, which quality management principles should be applied, and how they should be applied to different stakeholders at different stages of the product life cycle.

ONC, FDA and FCC also plan to identify priority areas for standards and best practices and the types of conformity assessment tools that should be leveraged as part of a risk-based HIT framework. Additionally, the workshop will focus on determining the governance structure and functions of the proposed Health IT Safety Center – a public-private entity that will focus on patient safety and the creation of an integrated health IT learning system – and how industry could facilitate the development of a non-governmental process for listing health IT products.

To register for the conference, click here.