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"Oversight, privacy's impact on mHealth"

By Sudip Bhandari | 29 Aug, 2014

Recent developments in mobile health bring forth an important debate regarding the role of the Food and Drug Administration (FDA) in regulating and monitoring mobile health applications.

Some argue that the FDA’s role could encourage further investments because investors would be able to predict how the regulator will respond to a new product.. Others claim that the FDA need not keep track of every change that happens in this fast growing environment. In fact, entities other than the FDA could play a role in monitoring and evaluation of these apps. Intertwined in this debate is the important question of privacy - new technologies might not have traditional authentication methods. Take Google Glass, for example: it does not require users to enter a username or password.

While we want to foster innovation, we cannot neglect the safety and privacy of patients. In light of this argument, I am curious to hear from members about their perspectives on what should be the priority - innovation or regulation? Can they go hand in hand? Where should the FDA come in?

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Heather Pearson Replied at 12:27 PM, 29 Aug 2014

As it stands now, the FDA lacks the regulatory authority and ability to
take on a new generation of mHealth initiatives in addition to the roles
and responsibilities the agency currently has. This agency is chronically
underfunded, does not have the independent research-based facilities, and
is subject to political folly as an agency under the President's appointed
Secretary of Health and Human Services. Shouldn't the agency address its
serious shortcomings as a regulatory authority before taking on this new
and ever-evolving task?

The disastrous consequences of inadequate regulation based on insufficient
resources is evidenced in the 2006 Vioxx litigation where the painkiller,
that was fully approved by the FDA led to the deaths of over 60,000 people
in the US due to heart attacks. If 'innovation' is prioritized, these gaps
in regulation only compound and further put the health (and health privacy)
of the public at risk.

To me, it seems like the funds and resources to be made available to
monitoring and regulating applications for dissemination of information
(health-based or otherwise) would better be spend fundamentally improving
the regulation-gaps as they stand now.

Heather Pearson

Mighty Casey Replied at 12:10 PM, 2 Sep 2014

At last years mHealth Summit in DC, I found myself heckling FDA Commish Margaret Hamburg via Twitter during her keynote, wherein she giggled her way through telling the mHealth industry that she was un-mobile and un-tech. This was to prevent my actually heckling her, or throwing something at her (I was in the front row), in my frustration at her real-time demo of why the FDA is so hopelessly inept.

That institution has never recovered from thalidomide, but then Vioxx. And their inability to create any kind of guidelines on digital/so-me. Meanwhile, they let every Tom, Dick, and Lab-rat exhort consumers to "ask their doctors about" all sorts of meds of questionable value. Blockbuster = "works OK in 40% or so of people with the condition."

We are all up against the K Street Mafia, and the arm-twisting and horse trading that goes on under the guise of "industry guidance" of regulatory agencies. Including the FDA. Our tax dollars at work ...

This Community is Archived.

This community is no longer active as of December 2018. Thanks to those who posted here and made this information available to others visiting the site.