Magazine article Clinical Psychiatry News

Medical Applications Are Not Easily Defined or Regulated

Magazine article Clinical Psychiatry News

Medical Applications Are Not Easily Defined or Regulated

Article excerpt

The Food and Drug Administration 1 could soon sharpen the regulatory line separating mobile applications meant for medical decision-making from more patient-oriented apps.

Currently, a fuzzy line exists between apps that physicians directly use in practice and those meant to encourage changes in patient behaviors, experts said recently at a Capitol Hill briefing sponsored by the Alliance for Health Reform.

The FDA issued proposed guidelines in July 2011 outlining its plans to regulate medical applications, and even smartphones, as medical devices. The FDA will not unveil its final guidelines until later this year, but stakeholders are weighing in now on where the line should fall.

"Information that doesn't look like health care information in one context is in fact relevant to your health in other contexts," said Deven McGraw, director of the Health Privacy Project at the Center for Democracy and Technology "I don't know that I want to say, 'FDA, go away,' [regarding] some of these apps that in fact are designed to be used to make medically relevant decisions. …

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