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Will FDA Clarify Approach to Clinical Decision Support in 2015?

January 21, 2015
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Some vendors argue that ambiguity about what will be regulated is stifling innovation

CIOs and the software companies they work with didn’t used to care much about what the Food & Drug Administration was up to. But the FDA’s Center for Device and Radiological Health has a lot on its plate in 2015 regarding digital health devices, which may impact innovation in the field. It just released draft guidance about how it will treat general wellness apps and another draft guidance document related to how it will treat accessories to medical devices. The FDA also has released its schedule for developing guidance for the 2015 fiscal year, and prioritized on the list is medical device clinical decision support software.

Many in the health IT device and software arena are relieved that the FDA has prioritized clinical decision support, but they are frustrated that it has taken so long.

They argue that ambiguity about what will be regulated is stifling innovation. For the January issue of Government Technology magazine, I interviewed a handful of executives about the FDA’s approach, as well as entrepreneurs’ concerns about meeting FDA and HIPAA requirements.

“We have been asking the FDA since 2011, over three years, to publish a guidance document defining the portion of clinical decision support software that they intend to regulate,” said Bradley Merrill Thompson, general counsel of the mHealth Regulatory Coalition.

In the FDASIA Health IT Report, the FDA said it would figure out later what to do about clinical decision support, according to Joel White, executive director of the Health IT Now Coalition, which represents patient groups, provider organizations, employers and payers. “Later is now for companies like IBM trying to put products based on Watson on the market that link people with clinical trials using clinical decision support,” White told me.

White also claimed to know software developers who have opted to go into other things rather than mobile apps they think would be subject to FDA approval now or in the future. “And I know companies that are building regulatory risk premiums into their product development, which would make them more expensive,” he added. “Either way, it is not a good situation, which is why we want more clarity so we can have an environment that promotes innovation.”

As I noted in the Government Technology article, the FDA is taking a fairly hands-off approach and requiring approval for few types of applications while it learns more about the burgeoning market. But that ambiguity is tough on entrepreneurs seeking venture capital funding.

Last year legislation was introduced in both houses of Congress that would create three definitions of health-related software: “medical software,” “clinical software” and “health software.”  Only medical software would be subject to regulation by the FDA.

In response, the FDA, working with ONC and the FCC, issued a lengthy draft report (the FDASIA Health IT Report) that recommends a similar three-bucket regulatory risk-based framework, but doesn’t set the categories in stone and leaves some questions unanswered, critics say.

 “Members of Congress want to lock the definitions and process in, and FDA is saying we don’t know enough to draw those lines with enough certainty that a year from now we won’t need to revisit them,” said Thompson. “FDA is saying you need to leave us flexibility about what causes harm and allow us to be flexible in how we apply the rules. Innovators are saying we don’t know whether our product will be regulated or not and investors need to know. There has to be some compromise between those positions.”

Read the whole Government Technology story here.

As mobile devices and patient engagement become increasingly important to health IT leaders, Healthcare Informatics will follow the latest regulatory developments and reactions.

 

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It just released draft guidance about how it will treat general wellness apps and another draft guidance document related to how it will treat accessories to medical devices.