Groups Submit Comments on Fed Gov’t’s Health IT Framework

July 8, 2014 in News

Stakeholders remain divided on the federal government’s risk-based health IT regulatory draft framework, Politico‘s “Morning eHealth” reports (Gold/Allen, “Morning eHealth,” Politico, 7/8).


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.”

In April, HHS released a draft report that included a proposed strategy and recommendations for creating the related framework.  FDA then published a notice in the Federal Register seeking comments on the framework (iHealthBeat, 4/8).

Monday was the final day for comments to be submitted.

American Hospital Association Comments

The American Hospital Association in a letter to FDA said that it opposes the framework and instead supports “existing safety reporting requirements and initiatives.”

AHA Senior Vice President for Public Policy Analysis Development Linda Fishman in the letter specifically called for a framework that highlights three main components:

  • Better use of existing data sources to analyze health IT-related safety incidents;
  • Expanding access to data sources related to health IT in safety incidents through continued collaboration with private and public-sector stakeholders; and
  • Increased transparency and communication about safety and health IT aimed to improve stakeholders’ knowledge (Murphy, EHR Intelligence, 7/8).

Bipartisan Policy Center Comments

In a release, the Bipartisan Policy Center commended the draft report “for its inclusive and public approach towards the development of its proposed strategy and health IT regulatory framework and its inclusion of key principles and recommendations reflected in our report of last year.”

BPC also urged Congress to take appropriate action to support the draft report (BPC release, 7/7).

HIMSS Electronic Health Record Association Comments

The HIMSS Electronic Health Record Association — which includes about 40 EHR vendors — in a letter  to FDA Commissioner Margaret Hamburg on July 7 voiced its support for the FDA’s draft report, Healthcare IT News reports.  

EHRA’s letter stated that the organization “supports the approach proposed in the draft report that categorizes health IT based on the level and nature of risk, then applying appropriate oversight mechanisms.”

EHRA added that the organization has “promoted such an approach for some time” (Monegain, Healthcare IT News, 7/8).

However, in its comments, EHRA recommended that the final guidance include:

  • A comprehensive framework for all health IT categories regardless of the agency or agencies tasked with oversight;
  • Additional risks and controls for platform-specific technologies needed to ensure the framework is accessible across platforms; and
  • Clear and more detailed risk category definitions (EHR Association letter, 7/7).

mHealth Regulatory Council Comments

Meanwhile, Merrill Thompson of the mHealth Regulatory Council criticized the report’s lack of detail regarding clinical decision software, saying “the report doesn’t go deep enough, specific enough, to get to the important issues” (“Morning eHealth,” Politico, 7/8).

Telecommunications Industry Association Comments

Meanwhile, the Telecommunications Industry Association said it supports the framework in comments submitted to the FDA

Specifically, TIA commended the draft report for taking “notable steps towards providing clarity, and towards more clearly defining for stakeholders the role of different agencies.”

However, TIA cautioned against “an approach that would categorize all health [information and communications technology] into three large categories,” adding, “Instead, TIA encourages a more flexible approach to products and devices, while also reflecting the overall service being delivered to the patient on the network or system level” (TIA comments, 7/7).

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