Health IT Stakeholders Push for More Regulatory Certainty

May 16, 2014 in News

During a three-day public meeting on proposed federal health IT regulations, stakeholders stressed the need for concrete guidelines affirmed through legislative action, Health Data Management reports (Slabodkin, Health Data Management, 5/14).


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.”

Last month, HHS released a draft report that included a proposed strategy and recommendations for creating a risk-based health IT regulatory framework (iHealthBeat, 4/8).

Among other things, the draft report shifts the focus of health IT regulation to products’ functionality, dividing products into three categories:

  • Administrative health IT;
  • Health management health IT; and
  • Medical device health IT.

Meeting Details

The public meeting — which was hosted by FDA, ONC and FCC — was held to allow industry stakeholders to comment on the proposal.

Specifically, the meeting addressed how the industry can:

  • Create an environment of continual learning and improvement;
  • Identify and adopt health IT best practices;
  • Leverage conformity assessment tools; and
  • Promote the use of quality management principles.

Attendees’ Comments

Overall, stakeholders were supportive of the proposal.

Joel White, executive director of the Health IT Now Coalition, told federal officials, “We think your approach is on track. We would suggest that it needs a lot more specificity around it. I think that’s one of the goals of why we are here today” (Slabodkin, Health Data Management, 5/13)

However, federal regulators and stakeholders were at odds over whether congressional legislation is needed to provide regulatory certainty.

Dan Haley — vice president of government and regulatory affairs for athenahealth — said, “Simply put, a statement of present regulatory intent does not and cannot provide regulatory certainty.” He added, “For all the excellent and encouraging language in the draft, in the end absent congressional action to codify its recommendations, what the agencies are asking of industry is that we trust not only that the human beings currently making regulatory policy will stick to their own recommendations over time, but that their successors will share their perspective as well. That isn’t certainty. It’s the opposite. It’s a leap of faith.”

Haley said, “My understanding from previous presentations since the draft was released is that the agencies do not believe they need, nor do they necessarily want, congressional action to implement the recommended framework.”

Meanwhile, Baku Patel, a senior policy adviser for FDA’s Center for Devices and Radiological Health, said that passing legislation would not allow for regulatory flexibility that is critical to keeping up with constantly changing health IT (Health Data Management, 5/14).

Stakeholders Differ on Functionality Definition

During the meeting, stakeholders also voiced differing opinions on how regulators should define functionality.

Brad Thompson, general counsel for the mHealth Regulatory Coalition and CDS Coalition, in an interview with FierceHealthIT, said some stakeholders attending the meeting said function should focus on “mechanical aspects” of what software can do, while others argued that intended uses and users are more important.

In addition, some stakeholders disagreed on how to sort such tools, with some attendees favoring breaking down the health management functionality category into smaller, more specific “buckets” (Bowman, FierceHealthIT, 5/14).

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