Act on FDASIA, IT groups tell Congress

October 9, 2014 in Medical Technology

Arguing that the current up-in-the-air regulatory climate is hindering innovation in health information technology, an array of vendors and industry groups have called on Congress to clarify its plans for patient safety rules.?

[See also: FDA goes for 'light touch' on health IT]

The Food and Drug Administration Safety and Innovation Act of 2012, or FDASIA, called for the development of a list recommendations to Congress – suggestions for crafting a judicious risk-based framework for health IT oversight.

Those proposals were published in April. Now it’s time for the denizens of Capitol Hill to “pass legislation that achieves the complementary goals of protecting patients, ensuring safe and effective care, and fostering continued innovation,” according to the Oct. 7  letter, which was signed by vendors such as athenahealth, Oracle, IBM and McKesson, and membership organizations including AMIA and the U.S. Chamber of Commerce.

[See also: Feds push for health IT safety center]

Perhaps over-optimistically, the groups want the Senate and House to act before the end of the 113th Congress – which is so far on pace to be the least productive in modern history.

But the 60 widely-varied organizations that signed the letter hope their reasons will compel Capitol Hill to act. Among them:

  • Health IT is just the thing to improve care and lower costs. “Patients and their caregivers use health information software to manage their health and wellness,” the groups write. “Wide availability, ease of use, and familiarity with these technologies allow patients and their caregivers to integrate disease management and wellness activities into their daily routines. This technology increases adherence to care plans and reduces preventable hospitalization and associated costs.”
  • The current state of uncertainty is stifling innovation. Across the healthcare industry, “there is near universal agreement that regulatory certainty is essential for continued innovation,” according to the letter. “We are concerned that there is significant confusion in the market about what technologies may be regulated, by which agencies, and to what standards. …. The potential cost and delay created by current regulatory uncertainty may further deter software and system developers from creating products that have the ability to greatly benefit patients.”
  • There’s wide agreement about the need for risk-based IT regulation. Both houses of Congress, both political parties, regulatory agencies, providers, patient advocates and others all agree on the basics of health IT safety regulation. The consensus is that there are three categories of health IT. FDA regulation should continue to be focused on that category of technologies that present a high risk to patient safety, the letter argues, and technologies presenting no risk to patient safety “should remain unregulated.” That third category – which comprises certain types of IT that might pose safety risks – “should be subject to risk-based oversight that uses consensus standards and private certification bodies.”
  • Health IT is a rare bipartisan issue. “The urgent need for technological modernization of the nation’s care delivery system is one of the relatively few health policy imperatives that generates bipartisan and bicameral support,” according to the letter. “It is time for modern laws that reflect the technological advancements made in our health care system over the past four decades, and codify a framework that achieves rather than impedes the potential of health IT to protect patients and enhance clinical safety.”

FDASIA “clearly lays out a multi-step process” to develop appropriate rules for health IT, the letter concludes, and Congress should meet its responsibilities mapped out therein.

“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.”

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