Groups press Congress for action on FDASIA

A group of 58 patient advocates, providers and employers is calling on Congress to provide clarity on appropriate risk-based oversight of health IT.

The FDA Safety and Innovation Act (FDASIA) of 2012 requires that the FDA, in consultation with the Office of the National Coordinator for Health IT and the Federal Communications Commission, develop and post on their websites a report on a proposed strategy and recommendations on a risk-based framework for health IT.

With the publication of the FDASIA Health IT Report in April, “it is now time for lawmakers to pass legislation that achieves the complementary goals of protecting patients, ensuring safe and effective care and fostering continued innovation in the rapidly-growing health IT field,” according to the group’s letter.

Congress should act before the end of the 113^th Congress for the following reasons, according to the letter:

• Health IT has the potential to greatly improve the efficiency and quality of care delivery.
• Current regulatory uncertainty stifles healthcare innovation.
• There is a broad consensus on the need for a risk-based framework for health IT.
• This is a bipartisan issue that is ready for bipartisan action.

“Developers, healthcare providers, patients and others still face ambiguity on the framework for health IT oversight. Without a clearly defined, risk-based oversight framework, we cannot effectively facilitate innovation in the use of technologies to improve health, protect patients and enhance clinical safety,” said Joel White, executive director of the Health IT Now Coalition, in a statement.

Read the letter here.