More Groups Weigh In on Proposed Health IT Regulatory Framework

July 11, 2014 in News

The federal government’s risk-based health IT regulatory framework continues to prompt both positive and negative feedback from health care stakeholders, FierceHealthIT reports (Bowman, FierceHealthIT, 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 draft framework.

Monday was the final day for comments to be submitted (iHealthBeat, 7/8).

AMA Comments

The American Medical Association in a letter to FDA warned that the draft health IT framework fails to provide a viable approach to addressing patient safety risks without stifling innovation, EHR Intelligence reports.

In addition, AMA Executive Vice President and CEO James Madara in the letter expressed concern that FDA’s stated goal of creating an environment of learning and continual improvement was too vague. Madara urged FDA to put “a well-defined and fully funded set of mechanisms” in place to:

  • Avert or mitigate adverse events;
  • Monitor for adverse events; and
  • Receive data about adverse events.

AMA also offered additional recommendations on:

  • Clinical decision support;
  • Design and implementation flaws;
  • The mobile health application space; and
  • Understanding health beyond electronic health records.

CHIME and AMDIS Joint Comments

In joint comments, the College of Healthcare Information Management Executives and the Association of Medical Directors of Information Systems called on ONC to “retool” its health IT certification program to improve patient safety and interoperability by focusing on:

  • Beta-testing;
  • Live-setting standards adherence; and
  • Performance after certification.

CHIME and AMDIS urged FDA to design a “certification program that more closely resembles the software development lifecycle” and publicly share testing results to better inform providers about which EHR systems are working well and adhering to federal standards (Murphy, EHR Intelligence, 7/10).

CHIME CEO Russell Branzell in a statement said, “The single biggest action federal regulators could take to improve patient safety is to identify clear standards and require strict adherence to those standards” (FierceHealthIT, 7/8).

HIMSS Comments

The Healthcare Information and Management Systems Society in a letter to FDA Commissioner Margaret Hamburg said that it “supports the general approach described in the draft report,” but urged FDA to add an additional health IT category to its framework (Sullivan, mHealthNews, 7/8).

FDA’s draft framework for regulating health IT includes three categories for:

  • Administrative functions;
  • Management functions; and
  • Medical device functions (iHealthBeat, 4/3). 

HIMSS recommended that a fourth category be added to include health IT functions related to:

  • Diagnostics;
  • Pharmacy; and
  • Procedural health.

HIMSS said areas of focus within the category should include:

  • Labs;
  • Medication management;
  • Radiology; and
  • Surgery.

HIMSS also recommended that FDA include domains for behavioral health, optometry and dentistry, and covering complementary therapies, as appropriate, in all domains (mHealthNews, 7/8).

NNU Comments

Meanwhile, National Nurses United — the largest organization of nurses in the U.S. — on Monday submitted comments that called on FDA to strengthen regulation of “unproven medical technology.”

In a letter to FDA, NNU Executive Director RoseAnn DeMoro recommended that FDA:

  • Ensure legal protection for nurses and other medical staff who override health IT system recommendations;
  • Improve transparency, such as by using open-source computer codes that are available on a public website;
  • Increase government testing and research on health IT systems;
  • Regulate health IT systems as medical devices; and
  • Require pre-testing of all devices and reporting of all adverse events and “near misses” (NNU statement, 7/8).
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