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Congress Asked to Enact IT Law on Health Product Risk

Congress Asked to Enact IT Law on Health Product Risk
A diverse group of companies and organizations, including IBM and the U.S. Chamber of Commerce, want Congress to clear up risk-based oversight of health IT.  

By Jim Dickinson

Some 60 organizations have written to members of Congress urging them to act this year “to provide clarity and certainty for appropriate risk-based oversight of health information technology.”

The groups, which include companies such as IBM and WellDoc as well as organizations such as the U.S. Chamber of Commerce, note that as required by the FDA Safety and Innovation Act of 2012, the agency has given Congress its recommendations on an appropriate risk-based framework.

“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,” the letter says.

The groups say that prompt action is needed for the following reasons:

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

“Considering the vast potential for improved outcomes, enhanced patient safety, and reduced costs,” the groups conclude, “we hope the administration and Congress will work together to pass legislation this year to clarify the lines of regulatory jurisdiction by updating the law under which health IT is currently regulated…. This overdue action will allow the administration to focus its limited resources, staff, and expertise on ensuring the safety of new medical technologies that pose the highest potential risk to patients, and will promote a new era of medical innovation that will improve care and lower costs.”

Jim Dickinson is MD+DI's contributing editor.

[image courtesy of Vichaya Kiatying-Angsulee/FREEDIGITALPHOTOS.NET]
 

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