Federal agencies propose health IT regulatory framework, seek stakeholder input and participation in new initiatives

By Mary B Langowski and Kristen E Ratcliff

A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, the Federal Communications Commission and the Office of the National Coordinator for Health IT (ONC) have released a draft report outlining a proposed strategy and recommendations for a ‘risk-based’ regulatory framework for health information technology.

Mandated by section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), the draft report was released amid stakeholder calls for additional clarity on how the federal government will regulate the health IT industry — an industry that has seen significant growth in recent years due to the incentives for adoption and use of electronic health records (EHRs) offered under the HITECH Act, as well as the use of technology to support emerging payment and delivery models.

This draft report is likely one in a series of guidance documents and regulations that will shape the federal government’s footprint in this space over the years to come. It outlines a number of opportunities for private sector stakeholders to engage with the agencies as they continue to shape their policies and thinking in this space and may also inform subsequent legislative efforts…

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