Senators Request Clarity on mHealth App Regulation from FDA | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

Senators Request Clarity on mHealth App Regulation from FDA

March 19, 2014
by Gabriel Perna
| Reprints

A group of U.S. Senators have sent a letter to Food and Drug Administration (FDA) Commissioner, Margaret A. Hamburg, M.D. seeking further clarity and transparency on how the agency plans on regulating medical mobile health (mHealth) apps.

Senators Michael Bennet (D-Colo.), Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn), Mark Warner (D-Va), and Richard Burr (R-NC) sent the letter to Dr. Hamburg, asking for further clarification  for medical software application developers. Referring to the FDA's final guidance over mHealth apps, the Senators note that the agency used a risk-based approach in defining what it considers to be a mobile medical application, focused on high-risk medical software in particular. The Senators say a large number of apps could be actively regulated under this definition and more transparency is required for developers.

"While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated," the Senators wrote in the letter.

The Senators include a series of questions within the letter that it requests the FDA answer within three weeks of its receipt. Some of those questions include:

  • Compared to current FDA guidance, what impact would Congress establishing categories of medical software in legislation have on the FDA’s oversight of medical mobile applications?
  • What role, if any, can statutory definitions play to clarify any uncertainty with respect to assigning risk level to medical software?

  • How is the FDA determining what types of medical software updates, even minor updates, change the function of or add a function to the medical software and would require FDA review?

  • How has the FDA been coordinating with the Office of the National Coordinator and Federal Communications Commission to address the recent FDA Safety and Innovation Act working group’s concerns over interoperability?

The letter, in its entirety, can be read by clicking the link below.

 

Read the source article at Michael Bennet

Topics

News

Cardiac Monitoring Companies Will Pay $13.45 Million to Resolve False Claims Act Allegations

Companies involved in remote heart monitoring through the use of the Pocket ECG device have agreed to pay the Justice Department $13.4 million to resolve allegations that they violated the False Claims Act by billing Medicare for higher and more expensive levels of cardiac monitoring services than requested by the ordering physicians.

HHS Will Award $195 Million to Health Centers to Leverage Health IT

HHS announced the availability of $195 million in a new funding opportunity for community health centers to expand access to mental health and substance abuse services focusing on the treatment, prevention and awareness of opioid abuse in all U.S. states.

Senators Push for Timeline, Planning on VA-Cerner EHR Project

Three U.S. senators have written a letter to Veterans Affairs (VA) Secretary David Shulkin, M.D. and Defense Secretary James Mattis asking for a timeline for VA’s Cerner EHR project and for plans to ensure that the technology systems of the VA and DoD will be integrated.

Anil K Jain, M.D. Appointed to Health IT Advisory Committee

Anil K. Jain, M.D., IBM vice president and chief health informatics officer, has been appointed by Senate Majority Leader Mitch McConnell to the 25-member Health Information Technology Advisory Committee as mandated by the 21st Century Cures Act.

Orange Care Group, Memorial Team Up to Share Epic’s Population Health Platform

Miami-based Orange Care Group’s accountable care organizations (ACOs) and independent physician association have announced a collaboration with South Florida-based Memorial Healthcare System to adopt Epic's Healthy Planet platform.

Expanding a Population Health Tool That Provides City-Level Data

A new data visualization tool that helps cities understand the health status of their populations will soon expand from four pilot cities to hundreds of cities nationwide.