A large group of healthcare IT stakeholders is urging Congress to push forward with legislation tied to FDASIA's health IT recommendations – but at least one mHealth expert says that may do more harm than good.
In a letter dated Oct. 7 and signed by 58 groups, Congress is urged to act now on recommendations developed by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which were drafted by a federal committee and unveiled in April. The draft covers a wide range of regulatory issues related to health IT, including how emerging technologies like mHealth should be governed.
"Fifty-eight groups have a very clear message for Congress – regulatory reform is needed, and needed now," Joel White, executive director of the Health IT Now Coalition, said in a blog accompanying the letter. "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.”
But Bradley Merrill Thompson, a Washington D.C. attorney and legal counsel for the mHealth Regulatory Coalition, says there are no clear recommendations for Congress to act on just yet. He noted that the FDASIA committee floated a draft a recommendations in April and asked for further comments. As a result, he said, the committee "received a ton of comments … and many disagreed with the draft recommendations."
"Rushing to do something is a recipe for bad policy," Thompson said in an e-mail to mHealth News. "If Congress acts precipitously, it can cause more harm than good, and bring more confusion than clarity."
The letter urges lawmakers to pass legislation before the end of the 113th Congress for four reasons – that healthcare IT has the potential to improve quality and efficiency of healthcare delivery; that the uncertainty around current regulations is hindering innovation; that there is a "broad consensus on the need for a risk-based framework for health IT"; and that this consensus is bipartisan.
"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 letter states. "FDASIA clearly lays out a multi-step process consisting of recommendations by the Administration to Congress (the FDASIA Report), followed by Congressional action, informed by those recommendations, to effectuate changes to ensure an appropriate regulatory framework for health IT."
But Thompson argues those recommendations from the FDASIA Committee aren't ready to be acted on by Congress yet. He points out that the FDASIA draft categorized all health information technology into three groups – which many mHealth advocates argue is too simplistic for such a complex field.
"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," he wrote. Thompson also urged the FDA to publish guidance documents to clarify a number of thorny issues, including the difference between wellness and disease, scope of medical device accessories, and what aspects of clinical decision support the FDA intends to regulate.
"We would like to see those guidance documents as soon as possible," Thompson said.
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