Nearly 60 health information technology (IT) stakeholders want Congress to take action to clear up uncertainty surrounding the regulation and oversight of health IT, according to a letter the group sent to Congress earlier this month.
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The companies wrote that uncertainty surrounding health IT is stifling innovation and preventing all manner of technology products, from apps to remote monitoring, from helping to improve patient care.
“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 reads.
The groups, which include software companies, electronic health record vendors and advocacy organizations, emphasize four reasons why congressional action is needed:
- Health IT has the potential to greatly improve the efficiency and quality of care delivered. “Wide availability, ease of use, and familiarity with these technologies allow patients and their caregivers to integrate disease management and wellness activities in their daily routines,” the letter reads.
- Current regulatory uncertainty stifles healthcare innovation. “We are concerned that there is significant confusion in the market about what technologies may be regulated, by which agencies, and to what standards.”
- There is broad consensus on the need for a risk-based framework for health IT. The letter says that there is broad agreement on a number of areas, including the need for U.S. Food and Drug Administration regulation of technologies that present a high risk to patient safety, and the need to have some risk-based oversight based on standards for technologies that may pose some risk.
- The need of technology to help the nation’s healthcare system is “one of the relatively few health policy imperatives that generates bipartisan and bicameral support,” the organizations say.
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