Groups, Stakeholders Comment on FDA’s Health IT Framework

April 8, 2014 in News

On Monday, FDA published a notice in the Federal Register seeking comments on its recently released risk-based health IT regulatory framework, Health Data Management reports (Slabodkin, Health Data Management, 4/6).


The Food and Drug Administration Safety and Innovation Act directed FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission to develop “a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT including mobile medical applications that promotes innovation, protects patient safety and avoids regulatory duplication.”

The report was originally due to Congress by January 2014.

Last week, HHS released a draft report that includes a proposed strategy and recommendations for creating a risk-based health IT regulatory framework (iHealthBeat, 4/3).

Lawmakers, Stakeholders Criticize Proposed Framework

Some lawmakers — including Sens. Deb Fischer (R-Neb.), Angus King (I-Maine) and Rep. Marsha Blackburn (R-Tenn.) — criticized the amount of regulatory oversight in the proposed framework, CQ HealthBeat reports (Reichard, CQ HealthBeat, 4/7).

In a statement, Fischer and King — co-sponsors of the PROTECT Act (S 2007), which aims to reduce regulation of clinical and health software — said the report “assumes continued and undefined authority over regulation of low-risk health information technologies” (Slabodkin [1], Health Data Management, 4/4).

In addition, Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, also expressed disappointment with the framework. He said, “Frankly, just about everything in the [clinical decision support] section was already known … there just wasn’t much new there.” He added, “I would like to have seen more in the report about where the agency plans to go with regard to” clinical decision support, among other things (Slabodkin [2], Health Data Management, 4/4).

However, Thompson did offer FDA praise, saying, “At a high level, I think the agency did an excellent job of following the recommendations of the working group” (Mottl, FierceMobileHealthcare, 4/7).

Stakeholders Applaud Health IT Framework

Meanwhile, ACT, an international grassroots coalition representing about 5,000 mobile application developers and IT firms, applauded the framework. ACT Executive Director Morgan Reed in a statement said that the group welcomes “the report’s conclusion that functionality should be the key regulatory determinant.” He added, “We support the report’s findings that regulation need not be the first approach to provide safe and effective mobile health care solutions” (Wicklund/Manos, Healthcare IT News, 4/4).

Joel White, executive director for the Health IT Now Coalition, also said the organization is “pleased” with the framework, calling its recommendations “steps in the right direction” (Health IT Now Coalition release, 4/4).

Tom Leary, Healthcare Information and Management Systems Society’s vice president for government relations, also applauded FDA’s report and noted that HIMSS was “pleased to see that the report includes several” recommendations the group had suggested last year (HIMSS release, 4/4).

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