A coalition of 58 patient organizations, providers and vendors sent a letter Oct. 7 to members of Congress urging them to pass legislation this year to “provide clarity and certainty for appropriate, risk-based oversight of health information technology.”

The urgent appeal to lawmakers is in direct response to a proposed strategy and recommendations for a risk-based regulatory framework for health IT publicly released in April and developed by the Food and Drug Administration, the Office of the National Coordinator for HIT and the Federal Communications Commission. Based on functionality and risk, the draft regulatory framework for HIT focuses on what a product does regardless of the platform on which it operates. 

“The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 called upon the Administration to provide recommendations to Congress on an appropriate risk-based framework,” states the letter. “With the release of the recommendations 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.”

In their letter, the broad group of stakeholders argued it is imperative that the House and Senate take legislative action before the end of the 113th Congress to “clarify the lines of regulatory jurisdiction by updating the law under which health IT is currently regulated.” They make the case that while health IT has the potential to greatly improve the efficiency and quality of care delivery, current regulatory uncertainty continues to stifle healthcare innovation.

"Fifty-eight groups have a very clear message for Congress--regulatory reform is needed, and needed now,” said Joel White, executive director of the Health IT Now Coalition, in a written statement. “There is ample bipartisan support from both chambers of Congress and from federal agencies that changes to the oversight framework are needed. It is time for modern laws to reflect the technological advancements made in our healthcare system over the past four decades. 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.”

In May, the FDA along with ONC and FCC held a three-day public meeting to get industry comment on the federal government's draft strategy for regulating health IT. At the meeting, stakeholders told the federal agencies that drafted recommendations for a risk-based HIT regulatory framework didn’t go far enough and that true regulation certainty can only come from congressional legislation.

But, not everyone is in agreement that passing legislation is the appropriate direction at this point in time. Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, argues that the the FDA should be allowed to do its job without making changes to the existing law that in the end could only cause harm.  

“Rushing to do something is a recipe for bad policy,” Thompson told Health Data Management. “If Congress acts precipitously, it can cause more harm than good, and bring more confusion than clarity. We support clarity. We agree fundamentally that for this HIT engine to drive improvements in healthcare, government regulation needs to be as clear as possible. That's why, while we are working with policymakers to identify the best approach, we are also urging FDA to publish guidance documents that really clarify at a granular level what gets regulated versus what doesn't.”

“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 added. “We would like to see those guidance documents as soon as possible. We believe meaningful clarity in that area will help unleash the potential that is found in health IT.”


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