Close to 60 health IT stakeholders--including the American Medical Informatics Association and Health IT Now--want to see congressional involvement in clarifying appropriate risk-based oversight of health IT.
In a letter sent to Congress on Oct. 7, 58 organizations said that now is the time for legislation "that achieves the complementary goals of protecting patients, ensuring safe and effective care and fostering innovation in the rapidly growing health IT field."
The groups outline four reasons for legislative action, including:
- The potential of health IT to boost efficiency and quality of care
- Regulatory uncertainty, which "stifles" innovation
- The need for a risk-based framework for health IT
- Broad support on both sides of the political isle
"Considering the vast potential for improved outcomes, enhanced patient safety and reduced costs, 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," the groups said.
In June, Republican Reps. Fred Upton (Mich.), Joseph Pritts (Pa.), Marsha Blackburn (Tenn.) and Greg Walden (Ore.) sent a letter to National Coordinator for Health IT Karen DeSalvo, questioning ONC's regulatory authority as outlined in the proposed strategy and draft recommendations for health IT risk-based framework.
Brad Thompson, a health attorney with Epstein Becker Green, said while fundamentally he agrees that legislation may be needed, policymakers have not found common ground as far as the direction of such efforts.
"Rushing to do something is a recipe for bad policy," Thompson told FierceHealthIT in an email. "It can cause more harm than good and bring more confusion than clarity."
To that end, Thompson said, he and his colleagues want to see "granular-level" guidance from the U.S. Food and Drug Administration on regulation.
"We are hopeful that yet this fall FDA will publish guidance documents on the difference between wellness and disease, the scope of medical device accessories and the portion of clinical decision support software the agency regulates," he told FierceHealthIT. "We believe meaningful clarity in that area will help unleash the potential that is found in health IT."
To learn more:
- read the letter (.pdf)